A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057
Sponsor
Human Genome Sciences Inc., a GSK Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00712933
Collaborator
GlaxoSmithKline (Industry)
738
110
2
102.3
6.7
0.1
Study Details
Study Description
Brief Summary
This is a long-term continuation study to provide continuing treatment to subjects with SLE.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
This trial is a long-term continuation study to provide continuing treatment to subjects with System Lupus Erythematosus (SLE).
Study Design
Study Type:
Interventional
Actual Enrollment
:
738 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™)a Fully Human Monoclonal Anti-BLyS Antibody in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057
Actual Study Start Date
:
May 30, 2008
Actual Primary Completion Date
:
Dec 9, 2016
Actual Study Completion Date
:
Dec 9, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 1 mg/kg dose of belimumab given IV every 28 days. |
Drug: belimumab
Recombinant, fully human, monoclonal antibody
Comparison of the 1 mg/kg and 10 mg/kg dose of belimumab given IV every 28 days.
Other Names:
|
| Experimental: 2. 10 mg/kg dose of belimumab given IV every 28 days. |
Drug: belimumab
Recombinant, fully human, monoclonal antibody
Comparison of the 1 mg/kg and 10 mg/kg dose of belimumab given IV every 28 days.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Adverse Events (AE) [Up to 9 years]
An adverse event is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. This includes worsening (example: increase in frequency or severity) of preexisting conditions. Participants with incidences of any event at any time post-baseline are presented by yearly interval. Only treatment-emergent AEs are summarized.
- AE Rates by System Organ Class (SOC) During the Study [Up to 9 years]
AE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent AEs are summarized. The event rate of an AE was calculated as the number of events per 100 participant years. Participant years were calculated as sum across all participants ([last visit of interval day - first visit of interval day + 1] divided by365). Participant years excluded between study gaps if participant had not started extension study on date of last visit of parent study.
- Number of Participants With Serious Adverse Events (SAE) [Up to 9 years]
An adverse event resulting in death, is life threatening (ie, an immediate threat to life), inpatient hospitalization, prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or any other situation which is medically important is categorized as SAE. Only treatment-emergent AEs are summarized.
- SAE Rates by SOC During the Study [Up to 9 years]
SAE rates by SOC adjusting for participants-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent SAEs are summarized. The event rate of an SAE was calculated as the number of events per 100 participant years. Participants years were calculated as = sum across all participants ([last visit of interval day - first visit of interval day + 1] divided by 365). Participants years excluded between study gaps if participant had not started extension study on date of last visit of parent study.
- Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points [Baseline and up to 9 years]
Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point
- Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points [Baseline and up to 9 years]
Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Plt, Lymp, Leu, Eos, Baso, Mono, Neu, NeuBF, and NueS are summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
- Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points [Baseline and up to 9 years]
Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Hg is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
- Change From Baseline in Hematocrit at the Indicated Time Points [Baseline and up to 9 years]
Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks). Change from Baseline in Hematocrit is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
- Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points [Baseline and up to 9 years]
Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Erythrocytes is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
- Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points [Baseline and up to 9 years]
Electrolytes parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 electrolytes parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Ca,CO2, Chloride, Mg, Phos, K and Na were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
- Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points [Baseline and up to 9 years]
Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in BUN/Cr is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
- Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points [Baseline and up to 9 years]
Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Alb and Protein were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
- Change From Baseline in BUN and Glucose at the Indicated Time Points [Baseline and up to 9 years]
Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in BUN and Glucose were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
- Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points [Baseline and up to 9 years]
Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Cr and Urate were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
- Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels [Baseline and up to 9 years]
Liver function parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 liver function parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in ALT, ALP, AST, GGT and LDH were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.NA indicates standard deviation was not calculable for a single data point.
- Change From Baseline in Bilirubin (Bili) Levels [Baseline and up to 9 years]
Liver function parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 liver function parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Bili were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
- Change From Baseline in Immunoglobulin G (IgG) Levels [Baseline and up to 9 years]
Immunoglobulin (Ig) parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 Ig parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Ig G were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.
- Number of Participants With Immunogenic Response by Year [Up to 9 years]
Immunogenic response was analyzed using serum samples for anti-belimumab antibody measurements in MITT population. Categories of response are Negative, Transient Positive (+) means single + response that does not occur at the final assessment, and Persistent + means + response that occurs at least 2 consecutive assessments or a single result at the final assessment. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
- Number of Participants With IgG Values Below the Lower Limit of Normal by Year [Up to 9 years]
Blood samples were collected to evaluate IgG levels at Baseline and at Weeks 12, 24 and 48 during Year 1. From Year 2-9, IgG was evaluated at Week 24 and 48 ; Exit visit and at follow-up visit (up to 8 weeks post last infusion). Number of participants with IgG immunoglobulin values below the LLN at each one year interval are presented. Baseline includes Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. If a participant had more than one response within a year, then the last response within the year interval (usually the Week 48 assessment) was summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
- Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit [Up to 9 years]
Participants who had improving SLE disease activity for at least 8 weeks, at the investigator's discretion, the steroid dose was reduced by reduction to 7.5 mg/day. If the participant continued to have stable or improving disease activity after 4 weeks on a reduced dose, then the investigator considered reducing the dose again. Baseline includes extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. Number of participants with shifts from Baseline total daily dose category by visit is summarized.
- Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit [Up to 9 years]
The SLICC/ACR Damage Index was assessed every 48 weeks and at the exit visit as a measure of disease activity. It was developed to assess the accumulated damage since the onset of the disease. The number of participants with worsening in their SLICC/ACR Damage Index score compared with Baseline have been presented. Worsening was defined as a change in score (post-Baseline visit score - Baseline score) > 0. Baseline includes extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. For years in which a participant was withdrawn from the study, the exit visit assessment was used in place of the Week 48 assessment for the year. This value was not carried forward through later years. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Have completed the HGS 1006-C1056 or HGS 1006-C1057 protocol through the Week 72 or Week 48 visits, respectively.
Exclusion Criteria:
- Have developed any other medical disease or condition that has made the patient unsuitable for this study in the opinion of their physician.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Ciudad Autonoma de Buenos Aires | Buenos Aires | Argentina | 1015 |
| 2 | GSK Investigational Site | Ciudad Autonoma de Buenos Aires | Buenos Aires | Argentina | C1419AHN |
| 3 | GSK Investigational Site | La Plata | Buenos Aires | Argentina | B1904CFH, |
| 4 | GSK Investigational Site | Rosario | Santa Fe | Argentina | 2000 |
| 5 | GSK Investigational Site | San Miguel de Tucuman | Tucumán | Argentina | T4000AXL |
| 6 | GSK Investigational Site | Buenos Aires | Argentina | C1280AEB | |
| 7 | GSK Investigational Site | Ciudad Autonoma Buenos Aires | Argentina | C1426AAL | |
| 8 | GSK Investigational Site | Ciudad Autónoma de Buenos Aires | Argentina | C1417EYG | |
| 9 | GSK Investigational Site | Vienna | Austria | A-1100 | |
| 10 | GSK Investigational Site | Liège | Belgium | 4000 | |
| 11 | GSK Investigational Site | Salvador | Bahía | Brazil | 40.150-410 |
| 12 | GSK Investigational Site | Goiania | Goiás | Brazil | 74110-120 |
| 13 | GSK Investigational Site | Juiz de Fora | Minas Gerais | Brazil | 36010-570 |
| 14 | GSK Investigational Site | Recife | Pernambuco | Brazil | 50670-420 |
| 15 | GSK Investigational Site | Porto Alegre | Rio Grande Do Sul | Brazil | 90610000 |
| 16 | GSK Investigational Site | Sao Paulo | São Paulo | Brazil | 04039-901 |
| 17 | GSK Investigational Site | Campinas | Brazil | 13083-888 | |
| 18 | GSK Investigational Site | Rio de Janeiro | Brazil | 22411-001 | |
| 19 | GSK Investigational Site | São Paulo | Brazil | 04032-060 | |
| 20 | GSK Investigational Site | São Paulo | Brazil | 04266-010 | |
| 21 | GSK Investigational Site | Toronto | Ontario | Canada | M5T 2S8 |
| 22 | GSK Investigational Site | Montreal | Quebec | Canada | H3G 1A4 |
| 23 | GSK Investigational Site | Viña del Mar | Valparaíso | Chile | 2570017 |
| 24 | GSK Investigational Site | Santiago | Chile | 8431657 | |
| 25 | GSK Investigational Site | Barranquilla | Colombia | ||
| 26 | GSK Investigational Site | Bogota | Colombia | ||
| 27 | GSK Investigational Site | Bucaramanga | Colombia | ||
| 28 | GSK Investigational Site | Medellin | Colombia | ||
| 29 | GSK Investigational Site | Brno - Bohunice | Czechia | 625 00 | |
| 30 | GSK Investigational Site | Hradec Králové | Czechia | 500 05 | |
| 31 | GSK Investigational Site | Olomouc | Czechia | 775 20 | |
| 32 | GSK Investigational Site | Praha 2 | Czechia | 128 50 | |
| 33 | GSK Investigational Site | Suresnes | France | 92150 | |
| 34 | GSK Investigational Site | Freiburg | Baden-Wuerttemberg | Germany | 79106 |
| 35 | GSK Investigational Site | Erlangen | Bayern | Germany | 91054 |
| 36 | GSK Investigational Site | Frankfurt | Hessen | Germany | 60590 |
| 37 | GSK Investigational Site | Hannover | Niedersachsen | Germany | 30625 |
| 38 | GSK Investigational Site | Mainz | Rheinland-Pfalz | Germany | 55131 |
| 39 | GSK Investigational Site | Leipzig | Sachsen | Germany | 04103 |
| 40 | GSK Investigational Site | Jena | Thueringen | Germany | 07743 |
| 41 | GSK Investigational Site | Berlin | Germany | 10117 | |
| 42 | GSK Investigational Site | Berlin | Germany | 14059 | |
| 43 | GSK Investigational Site | Kiel | Germany | 24105 | |
| 44 | GSK Investigational Site | Chai Wan | Hong Kong | ||
| 45 | GSK Investigational Site | New Territories | Hong Kong | ||
| 46 | GSK Investigational Site | Bangalore | India | 560034 | |
| 47 | GSK Investigational Site | Hyderabad, Andhra Pradesh | India | 500482 | |
| 48 | GSK Investigational Site | Lucknow | India | 226003 | |
| 49 | GSK Investigational Site | Secunderabad | India | 500003 | |
| 50 | GSK Investigational Site | Trivandrum | India | 695029 | |
| 51 | GSK Investigational Site | Beer Sheva | Israel | 84101 | |
| 52 | GSK Investigational Site | Haifa | Israel | 31048 | |
| 53 | GSK Investigational Site | Haifa | Israel | 31096 | |
| 54 | GSK Investigational Site | Haifa | Israel | 34362 | |
| 55 | GSK Investigational Site | Petach Tikva | Israel | 49100 | |
| 56 | GSK Investigational Site | Ramat-Gan | Israel | 52621 | |
| 57 | GSK Investigational Site | Rehovot | Israel | 76100 | |
| 58 | GSK Investigational Site | Roma | Italy | 00152 | |
| 59 | GSK Investigational Site | Busan | Korea, Republic of | 602-715 | |
| 60 | GSK Investigational Site | Daejeon | Korea, Republic of | 302-799 | |
| 61 | GSK Investigational Site | Incheon | Korea, Republic of | 400-711 | |
| 62 | GSK Investigational Site | Pusan | Korea, Republic of | 602-739 | |
| 63 | GSK Investigational Site | Seoul | Korea, Republic of | 137-701 | |
| 64 | GSK Investigational Site | Seoul | Korea, Republic of | ||
| 65 | GSK Investigational Site | Suwon, Kyonggi-do | Korea, Republic of | 443-721 | |
| 66 | GSK Investigational Site | Guadalajara | Jalisco | Mexico | 44160 |
| 67 | GSK Investigational Site | Guadalajara | Jalisco | Mexico | 44280 |
| 68 | GSK Investigational Site | Mexico | Mexico | 7760 | |
| 69 | GSK Investigational Site | San Luis Potosí | Mexico | 78240 | |
| 70 | GSK Investigational Site | Maastricht | Netherlands | 6229 HX | |
| 71 | GSK Investigational Site | Rotterdam | Netherlands | 3015 CE | |
| 72 | GSK Investigational Site | Rotterdam | Netherlands | 3083 AN | |
| 73 | GSK Investigational Site | Surco | Lima | Peru | |
| 74 | GSK Investigational Site | Callao | Peru | Callao 2 | |
| 75 | GSK Investigational Site | Lima 27 | Peru | Lima 27 | |
| 76 | GSK Investigational Site | Cebu City | Philippines | 6000 | |
| 77 | GSK Investigational Site | Davao City | Philippines | 8000 | |
| 78 | GSK Investigational Site | Las Pinas | Philippines | 1740 | |
| 79 | GSK Investigational Site | Manila | Philippines | 1000 | |
| 80 | GSK Investigational Site | Quezon City | Philippines | 1102 | |
| 81 | GSK Investigational Site | Sampaloc Manila | Philippines | 1008 | |
| 82 | GSK Investigational Site | Konskie | Poland | 26-200 | |
| 83 | GSK Investigational Site | Ponce | Puerto Rico | 00716 | |
| 84 | GSK Investigational Site | San Juan | Puerto Rico | 00936-5067 | |
| 85 | GSK Investigational Site | Bucharest | Romania | 020125 | |
| 86 | GSK Investigational Site | Bucuresti | Romania | 020475 | |
| 87 | GSK Investigational Site | Bucuresti | Romania | 021392 | |
| 88 | GSK Investigational Site | Cluj Napoca | Romania | 400006 | |
| 89 | GSK Investigational Site | Moscow | Russian Federation | 115522 | |
| 90 | GSK Investigational Site | Saint Petersburg | Russian Federation | 194291 | |
| 91 | GSK Investigational Site | Saint-Petersburg | Russian Federation | 190068 | |
| 92 | GSK Investigational Site | St. Petersburg | Russian Federation | 191015 | |
| 93 | GSK Investigational Site | Yaroslavl | Russian Federation | 150003 | |
| 94 | GSK Investigational Site | Yaroslavl | Russian Federation | 150023 | |
| 95 | GSK Investigational Site | Piestany | Slovakia | 921 12 | |
| 96 | GSK Investigational Site | Barcelona | Spain | 08036 | |
| 97 | GSK Investigational Site | Madrid | Spain | 28046 | |
| 98 | GSK Investigational Site | Stockholm | Sweden | SE-171 76 | |
| 99 | GSK Investigational Site | Dalin Township, Chiayi County | Taiwan | 662 | |
| 100 | GSK Investigational Site | Gueishan Township,Taoyuan County | Taiwan | 333 | |
| 101 | GSK Investigational Site | Hualien | Taiwan | 970 | |
| 102 | GSK Investigational Site | Kaohsiung | Taiwan | 807 | |
| 103 | GSK Investigational Site | Kaohsiung | Taiwan | 813 | |
| 104 | GSK Investigational Site | Kaohsiung | Taiwan | 833 | |
| 105 | GSK Investigational Site | Taichung | Taiwan | 402 | |
| 106 | GSK Investigational Site | Taichung | Taiwan | 404 | |
| 107 | GSK Investigational Site | Taichung | Taiwan | 40705 | |
| 108 | GSK Investigational Site | Taipei | Taiwan | 100 | |
| 109 | GSK Investigational Site | London | United Kingdom | SE1 7EH | |
| 110 | GSK Investigational Site | Newcastle Upon Tyne | United Kingdom | NE7 7DN |
Sponsors and Collaborators
- Human Genome Sciences Inc., a GSK Company
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Publications
- Bruce IN, Urowitz M, van Vollenhoven R, Aranow C, Fettiplace J, Oldham M, Wilson B, Molta C, Roth D, Gordon D. Long-term organ damage accrual and safety in patients with SLE treated with belimumab plus standard of care. Lupus. 2016 Jun;25(7):699-709. doi: 10.1177/0961203315625119. Epub 2016 Mar 1.
- van Vollenhoven RF, Navarra SV, Levy RA, Thomas M, Heath A, Lustine T, Adamkovic A, Fettiplace J, Wang ML, Ji B, Roth D. Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension. Rheumatology (Oxford). 2020 Feb 1;59(2):281-291. doi: 10.1093/rheumatology/kez279.
Responsible Party:
Human Genome Sciences Inc., a GSK Company
ClinicalTrials.gov Identifier:
NCT00712933
Other Study ID Numbers:
- 112234
- 2007-007648-85
First Posted:
Jul 10, 2008
Last Update Posted:
Dec 5, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Human Genome Sciences Inc., a GSK Company
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | This was a multi-center, continuation trial of belimumab and was conducted at 115 centers in 28 countries. Participants with Systemic Lupus Erythematosus (SLE), who had completed the Phase 3 HGS1006-C1056 or HGS1006-C1057 trial or participants who had previously received subcutaneous belimumab in Protocol HGS1006-C1070 were included in this trial. |
|---|---|
| Pre-assignment Detail | 738 participants were enrolled in the study and 735 received at least one dose of belimumab.Out of 735 participants, 368 completed the study and 370 withdrew from the study. |
| Arm/Group Title | Belimumab 10mg/kg IV |
|---|---|
| Arm/Group Description | Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial. |
| Period Title: Overall Study | |
| STARTED | 735 |
| COMPLETED | 368 |
| NOT COMPLETED | 367 |
Baseline Characteristics
| Arm/Group Title | Belimumab 10mg/kg IV |
|---|---|
| Arm/Group Description | Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial. |
| Overall Participants | 735 |
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
37.2
(11.17)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
695
94.6%
|
| Male |
40
5.4%
|
| Race/Ethnicity, Customized (Count of Participants) | |
| Black or African American/African Heritage |
18
2.4%
|
| American Indian or Alaska Native |
225
30.6%
|
| East Asian Heritage |
118
16.1%
|
| South Asian Heritage |
38
5.2%
|
| Southeast Asian Heritage |
58
7.9%
|
| Middle East/North African Heritage |
22
3%
|
| White/Caucasian/European Heritage |
256
34.8%
|
Outcome Measures
| Title | Number of Participants With Adverse Events (AE) |
|---|---|
| Description | An adverse event is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. This includes worsening (example: increase in frequency or severity) of preexisting conditions. Participants with incidences of any event at any time post-baseline are presented by yearly interval. Only treatment-emergent AEs are summarized. |
| Time Frame | Up to 9 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT Population |
| Arm/Group Title | Belimumab 10mg/kg IV |
|---|---|
| Arm/Group Description | Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial. |
| Measure Participants | 735 |
| Any-time post Baseline,n=735 |
706
96.1%
|
| Year 0-1,n=735 |
617
83.9%
|
| Year 1-2 ,n =701 |
502
68.3%
|
| Year 2-3, n= 620 |
441
60%
|
| Year 3-4,n= 514 |
344
46.8%
|
| Year 4-5,n= 442 |
261
35.5%
|
| Year 5-6, n =345 |
181
24.6%
|
| Year 6-7, n= 219 |
92
12.5%
|
| Year 7-8, n = 65 |
26
3.5%
|
| Year 8 plus,n = 6 |
3
0.4%
|
| Title | AE Rates by System Organ Class (SOC) During the Study |
|---|---|
| Description | AE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent AEs are summarized. The event rate of an AE was calculated as the number of events per 100 participant years. Participant years were calculated as sum across all participants ([last visit of interval day - first visit of interval day + 1] divided by365). Participant years excluded between study gaps if participant had not started extension study on date of last visit of parent study. |
| Time Frame | Up to 9 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT Population |
| Arm/Group Title | Belimumab 10mg/kg IV |
|---|---|
| Arm/Group Description | Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial. |
| Measure Participants | 735 |
| Measure Subject years | 3352 |
| Infections and infestations |
101.8
|
| Gastrointestinal disorders |
32.8
|
| Musculoskeletal and connective tissuedisorder |
32.8
|
| Nervous system disorders |
22.6
|
| Skin and subcutaneous and tissue disorders |
22.5
|
| Respiratory,thoracic and mediastinal disorder |
14.9
|
| Vascular disorders |
13.3
|
| General disorders and administration sitecondition |
11.8
|
| Injury, poisoning andprocedural complications |
11.5
|
| Blood and lymphatic system disorders |
7.5
|
| Eye disorders |
6.6
|
| Reproductive system and breast disorders |
6.4
|
| Investigations |
5.8
|
| Psychiatric disorders |
5.6
|
| Renal and urinary and disorder |
5.3
|
| Metabolism and nutrition disorder |
3.6
|
| Cardiac disorders |
3.0
|
| Ear and labyrinth disorder |
2.4
|
| Neoplasms benign,malignant andunspecified |
2.2
|
| Hepatobiliary disorders |
1.8
|
| Immune system disorder |
1.2
|
| Endocrine disorders |
1.0
|
| Social circumstances |
0.7
|
| Congenital, familial and genetic disorders |
0.1
|
| Pregnancy, puerperium and perinatal conditions |
0.1
|
| Product Issues |
0.1
|
| Title | Number of Participants With Serious Adverse Events (SAE) |
|---|---|
| Description | An adverse event resulting in death, is life threatening (ie, an immediate threat to life), inpatient hospitalization, prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or any other situation which is medically important is categorized as SAE. Only treatment-emergent AEs are summarized. |
| Time Frame | Up to 9 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT Population |
| Arm/Group Title | Belimumab 10mg/kg IV |
|---|---|
| Arm/Group Description | Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial. |
| Measure Participants | 735 |
| Any post-Baseline,n=735 |
231
31.4%
|
| Year 0-1,n=735 |
78
10.6%
|
| Year 1-2,n = 701 |
58
7.9%
|
| Year 2-3,n = 620 |
66
9%
|
| Year 3-4,n= 514 |
44
6%
|
| Year 4-5 ,n= 442 |
27
3.7%
|
| Year 5-6,n=345 |
16
2.2%
|
| Year 6-7,n= 219 |
11
1.5%
|
| Year 7-8,n= 65 |
1
0.1%
|
| Year 8 plus,n= 6 |
0
0%
|
| Title | SAE Rates by SOC During the Study |
|---|---|
| Description | SAE rates by SOC adjusting for participants-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent SAEs are summarized. The event rate of an SAE was calculated as the number of events per 100 participant years. Participants years were calculated as = sum across all participants ([last visit of interval day - first visit of interval day + 1] divided by 365). Participants years excluded between study gaps if participant had not started extension study on date of last visit of parent study. |
| Time Frame | Up to 9 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT Population |
| Arm/Group Title | Belimumab 10mg/kg IV |
|---|---|
| Arm/Group Description | Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial. |
| Measure Participants | 735 |
| Measure Subject years | 3352 |
| Infections and infestations |
5.1
|
| Blood and lymphatic system disorders |
1.0
|
| Musculoskeletal and connective tissue disorder |
1.0
|
| Gastrointestinal disorders |
1.0
|
| Renal and urinary disorders |
0.8
|
| Vascular disorders |
0.8
|
| Injury, poisoning andprocedural complications |
0.8
|
| General disorders and administration sitecondition |
0.6
|
| Nervous system disorders |
0.6
|
| Respiratory, thoracic and mediastinal disorder |
0.5
|
| Cardiac disorders |
0.5
|
| Skin and subcutaneous tissue disorders |
0.5
|
| Neoplasms benign, malignant and unspecified |
0.4
|
| Reproductive system and breast disorder |
0.4
|
| Psychiatric disorders |
0.4
|
| Hepatobiliary disorders |
0.3
|
| Metabolism and nutrition disorders |
0.1
|
| Pregnancy, puerperium and perinatal condition |
0.1
|
| Endocrine disorders |
0.1
|
| Immune system disorders |
0.1
|
| Ear and labyrinth disorders |
0.1
|
| Eye disorders |
0.1
|
| Title | Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points |
|---|---|
| Description | Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point |
| Time Frame | Baseline and up to 9 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT Population |
| Arm/Group Title | Belimumab 10mg/kg IV |
|---|---|
| Arm/Group Description | Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial. |
| Measure Participants | 735 |
| Year1,Week4,APTT,n=208 |
0.7
(5.27)
|
| Year1,Week12,APTT,n=208 |
2.1
(12.31)
|
| Year1,Week24,APTT,n=686 |
0.1
(9.10)
|
| Year1,Week36,APTT,n=193 |
2.5
(5.75)
|
| Year1,Week48,APTT,n=666 |
0.8
(9.48)
|
| Year2,Week24,APTT,n=625 |
2.7
(9.74)
|
| Year2,Week48,APTT,n=572 |
2.7
(9.66)
|
| Year3,Week24,APTT,n=521 |
3.4
(10.01)
|
| Year3,Week48,APTT,n=470 |
3.9
(11.41)
|
| Year4,Week24,APTT,n=422 |
3.5
(10.70)
|
| Year4,Week48,APTT,n=412 |
4.2
(6.63)
|
| Year5,Week24,APTT,n=383 |
4.1
(10.71)
|
| Year5,Week48,APTT,n=349 |
3.5
(6.35)
|
| Year6,Week24,APTT,n=292 |
3.8
(6.58)
|
| Year6,Week48,APTT,n=277 |
4.3
(7.91)
|
| Year7,Week24,APTT,n=177 |
6.4
(14.52)
|
| Year7,Week48,APTT,n=131 |
4.1
(6.23)
|
| Year8,Week24,APTT,n=52 |
5.6
(7.54)
|
| Year8,Week48,APTT,n=13 |
4.2
(3.98)
|
| Year9,Week24,APTT,n=6 |
5.0
(6.39)
|
| Year9,Week48,APTT,n=1 |
9.0
(NA)
|
| Exit, APTT,n=586 |
3.2
(10.71)
|
| 8 Week,Follow up,n=524 |
3.4
(8.14)
|
| Year1,Week4,PT,n=205 |
-0.22
(5.139)
|
| Year1,Week12,PT,n=206 |
1.71
(19.533)
|
| Year1,Week24,PT,n=686 |
-0.43
(8.267)
|
| Year1,Week36,PT,n=193 |
0.13
(3.357)
|
| Year1,Week48,PT,n=666 |
-0.45
(8.174)
|
| Year2,Week24,PT,n=626 |
0.15
(11.528)
|
| Year2,Week48,PT,n=572 |
-0.26
(8.925)
|
| Year3,Week24,PT,n=521 |
0.12
(9.609)
|
| Year3,Week48,PT,n=469 |
0.63
(14.334)
|
| Year4,Week24,PT,n=422 |
0.06
(10.458)
|
| Year4,Week48,PT,n=412 |
0.40
(4.228)
|
| Year5,Week24,PT,n=384 |
-0.14
(10.810)
|
| Year5,Week48,PT,n=349 |
0.61
(11.276)
|
| Year6,Week24,PT,n=292 |
0.64
(8.023)
|
| Year6,Week48,PT,n=278 |
0.85
(12.414)
|
| Year7,Week24,PT,n=177 |
1.76
(14.272)
|
| Year7,Week48,PT,n=131 |
0.36
(2.290)
|
| Year8,Week24,PT,n=52 |
1.21
(6.716)
|
| Year8,Week48,PT,n=13 |
0.52
(0.600)
|
| Year9,Week24,PT,n=6 |
0.50
(0.657)
|
| Year9,Week48,PT,n=1 |
1.00
(NA)
|
| Exit,PT, n=587 |
0.25
(9.973)
|
| 8 Week, Follow up,n=524 |
0.50
(4.965)
|
| Title | Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points |
|---|---|
| Description | Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Plt, Lymp, Leu, Eos, Baso, Mono, Neu, NeuBF, and NueS are summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. |
| Time Frame | Baseline and up to 9 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT Population |
| Arm/Group Title | Belimumab 10mg/kg IV |
|---|---|
| Arm/Group Description | Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial. |
| Measure Participants | 735 |
| Baso,Year1,Week4,n=693 |
0.002
(0.0172)
|
| Baso,Year1,Week12,n=694 |
0.002
(0.0187)
|
| Baso,Year1,Week24,n=696 |
0.002
(0.0176)
|
| Baso,Year1,Week36,n=682 |
0.002
(0.0179)
|
| Baso,Year1,Week48,n=684 |
0.003
(0.0183)
|
| Baso,Year2,Week24,n=629 |
0.004
(0.0190)
|
| Baso,Year2,Week48,n=589 |
0.004
(0.0200)
|
| Baso,Year3,Week24,n=533 |
0.005
(0.0165)
|
| Baso,Year3,Week48,n=476 |
0.008
(0.0194)
|
| Baso,Year4,Week24,n=446 |
0.007
(0.0192)
|
| Baso,Year4,Week48,n=423 |
0.008
(0.0202)
|
| Baso,Year5,Week24,n=389 |
0.007
(0.0191)
|
| Baso,Year5,Week48,n=360 |
0.005
(0.0191)
|
| Baso,Year6,Week24,n=306 |
0.006
(0.0184)
|
| Baso,Year6,Week48,n=282 |
0.007
(0.0198)
|
| Baso,Year7,Week24,n=181 |
0.007
(0.0211)
|
| Baso,Year7,Week48,n=130 |
0.012
(0.0259)
|
| Baso,Year8,Week24,n=52 |
0.014
(0.0187)
|
| Baso,Year8,Week48,n=13 |
0.001
(0.0166)
|
| Baso,Year9,Week24,n=6 |
0.003
(0.0082)
|
| Baso,Year9,Week48,n=1 |
0.010
(NA)
|
| Baso,Exit,n=614 |
0.005
(0.0204)
|
| Baso,8 Week,Follow up,n=532 |
0.009
(0.0253)
|
| Eos,Year1,Week4,n=693 |
0.007
(0.1597)
|
| Eos,Year1,Week12,n=694 |
0.003
(0.1595)
|
| Eos,Year1,Week24,n=696 |
0.000
(0.1614)
|
| Eos,Year1,Week36,n=682 |
0.020
(0.1866)
|
| Eos,Year1,Week48,n=684 |
0.001
(0.1763)
|
| Eos,Year2,Week24,n=629 |
0.004
(0.1605)
|
| Eos,Year2,Week48,n=589 |
-0.004
(0.1858)
|
| Eos,Year3,Week24,n=533 |
-0.011
(0.2074)
|
| Eos,Year3,Week48,n=476 |
-0.026
(0.2053)
|
| Eos,Year4,Week24,n=446 |
-0.041
(0.1792)
|
| Eos,Year4,Week48,n=423 |
-0.047
(0.1676)
|
| Eos,Year5,Week24,n=389 |
-0.035
(0.1949)
|
| Eos,Year5,Week48,n=360 |
-0.045
(0.1807)
|
| Eos,Year6,Week24,n=306 |
-0.046
(0.1801)
|
| Eos,Year6,Week48,n=282 |
-0.037
(0.1976)
|
| Eos,Year7,Week24,n=181 |
-0.046
(0.1710)
|
| Eos,Year7,Week48,n=130 |
-0.020
(0.2276)
|
| Eos,Year8,Week24,n=52 |
-0.017
(0.1753)
|
| Eos,Year8,Week48,n=13 |
-0.041
(0.1130)
|
| Eos,Year9,Week24,n=6 |
-0.088
(0.1078)
|
| Eos,Year9,Week48,n=1 |
-0.040
(NA)
|
| Eos, Exit, n=614 |
-0.026
(0.1754)
|
| Eso, 8 Week Follow up, n=532 |
-0.030
(0.1920)
|
| Leu,Year1,Week4,n=696 |
0.16
(1.928)
|
| Leu,Year1,Week12,n=697 |
0.19
(2.106)
|
| Leu,Year1,Week24,n=697 |
0.04
(2.142)
|
| Leu,Year1,Week36,n=682 |
0.05
(2.190)
|
| Leu,Year1,Week48,n=684 |
0.02
(2.274)
|
| Leu,Year2,Week24,n=630 |
-0.19
(2.287)
|
| Leu,Year2,Week48,n=589 |
-0.11
(2.449)
|
| Leu,Year3,Week24,n=533 |
-0.03
(2.544)
|
| Leu,Year3,Week24,n=476 |
0.06
(2.393)
|
| Leu,Year4,Week24,n=446 |
-0.01
(2.520)
|
| Leu,Year4,Week48,n=423 |
-0.06
(2.661)
|
| Leu,Year5,Week24,n=389 |
0.05
(2.430)
|
| Leu,Year5,Week48,n=360 |
-0.06
(2.463)
|
| Leu,Year6,Week24,n=306 |
0.04
(2.449)
|
| Leu,Year6,Week48,n=282 |
0.17
(2.579)
|
| Leu,Year7,Week24,n=181 |
0.12
(2.395)
|
| Leu,Year7,Week48,n=130 |
0.48
(2.354)
|
| Leu,Year8,Week24,n=52 |
0.38
(2.761)
|
| Leu,Year8,Week48,n=13 |
-0.65
(3.136)
|
| Leu,Year9,Week24,n=6 |
-0.35
(3.422)
|
| Leu,Year9,Week48,n=1 |
-3.90
(NA)
|
| Leu, Exit, n=614 |
0.18
(2.650)
|
| Leu, 8 Week Follow up,n=532 |
0.21
(2.496)
|
| Lymp,Year1,Week4,n=693 |
0.093
(0.5986)
|
| Lymp,Year1,Week12,n=694 |
0.107
(0.6607)
|
| Lymp,Year1,Week24,n=696 |
0.066
(0.6544)
|
| Lymp,Year1,Week36,n=682 |
0.119
(0.6583)
|
| Lymp,Year1,Week48,n=684 |
0.048
(0.6361)
|
| Lymp,Year2,Week24,n=629 |
0.051
(0.6898)
|
| Lymp,Year2,Week48,n=589 |
0.067
(0.6971)
|
| Lymp,Year3,Week24,n=533 |
0.057
(0.6717)
|
| Lymp,Year3,Week48,n=476 |
0.038
(0.6676)
|
| Lymp,Year4,Week24,n=446 |
0.054
(0.6858)
|
| Lymp,Year4,Week48,n=423 |
0.067
(0.7186)
|
| Lymp,Year5,Week24,n=389 |
0.023
(0.6810)
|
| Lymp,Year5,Week48,n=360 |
0.078
(0.7485)
|
| Lymp,Year6,Week24,n=306 |
0.147
(0.7251)
|
| Lymp,Year6,Week48,n=282 |
0.168
(0.7523)
|
| Lymp,Year7,Week24,n=181 |
0.175
(0.7670)
|
| Lymp,Year7,Week48,n=130 |
0.169
(0.6639)
|
| Lymp,Year8,Week24,n=52 |
0.300
(0.7553)
|
| Lymp,Year8,Week48,n=13 |
0.052
(0.5252)
|
| Lymp,Year9,Week24,n=6 |
-0.032
(0.6156)
|
| Lymp,Year9,Week48,n=1 |
-0.460
(NA)
|
| Lymp,Exit,n=614 |
0.128
(0.7808)
|
| Lymp,8 Week Follow up,n=532 |
0.140
(0.7453)
|
| Mono,Year1,Week4,n=693 |
0.025
(0.2108)
|
| Mono,Year1,Week12,n=694 |
0.036
(0.2043)
|
| Mono,Year1,Week24,n=696 |
0.028
(0.2127)
|
| Mono,Year1,Week36,n=682 |
0.053
(0.2053)
|
| Mono,Year1,Week48,n=684 |
0.050
(0.2069)
|
| Mono,Year2,Week24,n=629 |
0.034
(0.1992)
|
| Mono,Year2,Week48,n=589 |
0.050
(0.2172)
|
| Mono,Year3,Week24,n=533 |
0.053
(0.2314)
|
| Mono,Year3,Week48,n=476 |
0.084
(0.1994)
|
| Mono,Year4,Week24,n=446 |
0.071
(0.2085)
|
| Mono,Year4,Week48,n=423 |
0.076
(0.2040)
|
| Mono,Year5,Week24,n=389 |
0.089
(0.2015)
|
| Mono,Year5,Week48,n=360 |
0.088
(0.2044)
|
| Mono,Year6,Week24,n=306 |
0.087
(0.2043)
|
| Mono,Year6,Week48,n=282 |
0.086
(0.2063)
|
| Mono,Year7,Week24,n=181 |
0.113
(0.2155)
|
| Mono,Year7,Week48,n=130 |
0.134
(0.2090)
|
| Mono,Year8,Week24,n=52 |
0.173
(0.2014)
|
| Mono,Year8,Week48,n=13 |
0.021
(0.1503)
|
| Mono,Year9,Week24,n=6 |
0.022
(0.1931)
|
| Mono,Year9,Week48,n=1 |
-0.120
(NA)
|
| Mono, Exit,n=614 |
0.083
(0.2157)
|
| Mono, 8 Week Follow up, n=532 |
0.084
(0.2189)
|
| Neu,Yaer1,Week4,n=688 |
0.024
(2.0482)
|
| Neru,Year1,Week12,n=690 |
0.047
(2.1575)
|
| Neu,Year1,Week24,n=691 |
-0.059
(2.1845)
|
| Neu,Year1,Week36,n=677 |
-0.141
(2.1907)
|
| Neu,Year1,Week48,n=679 |
-0.078
(2.3164)
|
| Neu,Year2,Week24,n=624 |
-0.286
(2.2746)
|
| Neu,Year2,Week48,n=584 |
-0.230
(2.3963)
|
| Neu,Year3,Week24,n=528 |
-0.135
(2.4914)
|
| Neu,Year3,Week48,n=471 |
-0.049
(2.3683)
|
| Neu,Year4,Week24,n=446 |
-0.104
(2.3846)
|
| Neu,Year4,Week48,n=423 |
-0.160
(2.5563)
|
| Neu,Year5,Week24,n=384 |
-0.031
(2.3060)
|
| Neu,Year5,Week48,n=356 |
-0.198
(2.3952)
|
| Neu,Year6,Week24,n=306 |
-0.151
(2.3083)
|
| Neu,Year6,Week48,n=282 |
-0.060
(2.4314)
|
| Neu,Year7,Week24,n=181 |
-0.129
(2.3908)
|
| Neu,Year7,Week48,n=130 |
-0.687
(3.0412)
|
| Neu,Year8,Week24,n=52 |
-0.092
(2.3908)
|
| Neu,Year8,Week48,n=13 |
-0.687
(3.0412)
|
| Neu,Year9,Week24,n=6 |
-0.257
(2.9192)
|
| Neu,Year9,Week48,n=1 |
-3.300
(NA)
|
| Neu, Exit, n=609 |
-0.006
(2.5612)
|
| Neu,8 Week Follow up,n=528 |
0.001
(2.3935)
|
| NeuBF,Year1,Week4,n=4 |
0.013
(0.1473)
|
| NeuBF,Year1,Week12,n=4 |
0.073
(0.1106)
|
| NeuBF,Year1,Week24,n=5 |
-0.000
(0.2699)
|
| NeuBF,Year1,Week36,n=4 |
0.045
(0.0465)
|
| NeuBF,Year1,Week48,n=2 |
0.105
(0.1909)
|
| NeuBF,Year2,Week24,n=1 |
0.120
(NA)
|
| NeuBF,Year3,Week24,n=1 |
0.070
(NA)
|
| NeuBF,Exit,n=2 |
0.465
(0.6435)
|
| NeuS,Year1,Week4,n=693 |
0.021
(2.0450)
|
| NeuS,Year1,Week12,n=694 |
0.051
(2.1519)
|
| NeuS,Year1,Week24,n=696 |
-0.055
(2.1757)
|
| NeuS,Year1,Week36,n=682 |
-0.139
(2.1819)
|
| NeuS,Year1,Week48,n=684 |
-0.079
(2.3128)
|
| NeuS,Year2,Week24,n=629 |
-0.289
(2.2609)
|
| NeuS,Year2,Week48,n=589 |
-0.226
(2.3846)
|
| NeuS,Year3,Week24,n=533 |
-0.130
(2.4736)
|
| NeuS,Year3,Week48,n=476 |
-0.041
(2.3547)
|
| NeuS,Year4,Week24,n=446 |
-0.097
(2.3804)
|
| NeuS,Year4,Week48,n=423 |
-0.158
(2.5542)
|
| NeuS,Year5,Week24,n=389 |
-0.024
(2.2893)
|
| NeuS,Year5,Week48,n=360 |
-0.184
(2.3831)
|
| NeuS,Year6,Week24,n=306 |
-0.147
(2.3029)
|
| NeuS,Year6,Week48,n=282 |
-0.058
(2.4310)
|
| NeuS,Year7,Week24,n=181 |
-0.151
(2.2248)
|
| NeuS,Year7,Week48,n=130 |
0.191
(2.2514)
|
| NeuS,Year8,Week24,n=52 |
-0.092
(2.3908)
|
| NeuS,Year8,Week48,n=13 |
-0.687
(3.0412)
|
| NeuS,Year9,Week24,n=6 |
-0.257
(2.9192)
|
| NeuS,Year9,Week48,n=1 |
-3.300
(NA)
|
| NeuS,Exit,n=614 |
-0.008
(2.5501)
|
| NeuS,8 Week Followup,n=532 |
0.007
(2.3824)
|
| Plt,Year1,Week4,n=683 |
8.1
(38.82)
|
| Plt,Year1,Week12,n=690 |
4.6
(43.63)
|
| Plt,Year1,Week24,n=687 |
-0.5
(47.73)
|
| Plt,Year1,Week36,n=680 |
-2.9
(50.25)
|
| Plt,Year1,Week48,n=677 |
-9.3
(50.81)
|
| Plt,Year2,Week24,n=631 |
-15.4
(53.80)
|
| Plt,Year2,Week48,n=583 |
-20.3
(56.39)
|
| Plt,Year3,Week24,n=526 |
-19.9
(57.88)
|
| Plt,Year3,Week48,n=476 |
-13.4
(65.16)
|
| Plt,Year4,Week24,n=441 |
-14.0
(59.05)
|
| Plt,Year4,Week48,n=420 |
-18.2
(63.80)
|
| Plt,Year5,Week24,n=388 |
-19.3
(61.49)
|
| Plt,Year5,Week48,n=360 |
-17.9
(63.36)
|
| Plt,Year6,Week24,n=305 |
-13.3
(61.54)
|
| Plt,Year6,Week48,n=282 |
-13.4
(60.89)
|
| Plt,Year7,Week24,n=181 |
-15.3
(63.95)
|
| Plt,Year7,Week48,n=130 |
-16.3
(70.75)
|
| Plt,Year8,Week24,n=52 |
-2.3
(80.69)
|
| Plt,Year8,Week48,n=13 |
-29.9
(88.66)
|
| Plt,Year9,Week24,n=6 |
-5.0
(82.67)
|
| Plt,Year9,Week48,n=1 |
57.0
(NA)
|
| Plt,Exit,n=613 |
-11.0
(64.36)
|
| Plt,8Week Followup,n=530 |
-11.2
(60.57)
|
| Title | Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points |
|---|---|
| Description | Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Hg is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. |
| Time Frame | Baseline and up to 9 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT Population |
| Arm/Group Title | Belimumab 10mg/kg IV |
|---|---|
| Arm/Group Description | Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial. |
| Measure Participants | 735 |
| Hg,Year1, Week 4,n=697 |
-0.3
(7.05)
|
| Hg,Year1,Week12,n=698 |
0.1
(8.75)
|
| Hg,Year1,Week24,n=699 |
0.1
(9.48)
|
| Hg,Year1,Week36,n=688 |
0.3
(9.90)
|
| Hg,Year1,Week48,n=686 |
1.0
(11.03)
|
| Hg,Year2,Week24,n=635 |
1.0
(11.31)
|
| Hg,Year2,Week48,n=591 |
1.3
(12.12)
|
| Hg,Year3,Week24,n=534 |
2.2
(12.79)
|
| Hg,Year3,Week48,n=478 |
2.9
(12.67)
|
| Hg,Year4,Week24,n=446 |
2.6
(12.93)
|
| Hg,Year,Week48,n=424 |
2.4
(13.59)
|
| Hg,Year5,Week24,n=390 |
2.9
(12.76)
|
| Hg,Year5,Week48,n=362 |
3.2
(13.26)
|
| Hg,Year6,Week24,n=306 |
2.7
(13.19)
|
| Hg,Year6,Week48,n=282 |
2.3
(13.83)
|
| Hg,Year7,Week24,n=181 |
2.9
(14.54)
|
| Hg,Year7,Week48,n=130 |
4.0
(14.66)
|
| Hg,Year8,Week24,n=52 |
1.5
(14.84)
|
| Hg,Year8,Week48,n=13 |
-0.2
(13.95)
|
| Hg,Year9,Week24,n=6 |
-0.7
(20.67)
|
| Hg,Year9,Week48,n=1 |
-29.0
(NA)
|
| Hg,Exit,n=619 |
3.2
(13.90)
|
| Hg,8 Week Follow up,n=534 |
2.8
(13.71)
|
| Title | Change From Baseline in Hematocrit at the Indicated Time Points |
|---|---|
| Description | Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks). Change from Baseline in Hematocrit is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. |
| Time Frame | Baseline and up to 9 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT Population |
| Arm/Group Title | Belimumab 10mg/kg IV |
|---|---|
| Arm/Group Description | Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial. |
| Measure Participants | 735 |
| Hematocrit,Year1,Week4,n=697 |
0.01
(2.250)
|
| Hematocrit,Year1,Week12,n=698 |
0.38
(2.729)
|
| Hematocrit,Year1,Week24,n=699 |
0.75
(2.928)
|
| Hematocrit,Year1,Week36,n=688 |
0.53
(2.954)
|
| Hematocrit,Year1,Week48,n=686 |
0.35
(3.286)
|
| Hematocrit,Year2,Week24,n=635 |
0.94
(3.427)
|
| Hematocrit,Year2,Week48,n=591 |
0.78
(3.584)
|
| Hematocrit,Year3,Week24,n=534 |
1.29
(3.828)
|
| Hematocrit,Year3,Week48,n=478 |
1.39
(3.800)
|
| Hematocrit,Year4,Week24,n=446 |
1.67
(3.834)
|
| Hematocrit,Year4,Week48,n=424 |
1.15
(3.998)
|
| Hematocrit,Year5,Week24,n=390 |
1.69
(3.776)
|
| Hematocrit,Year5,Week48,n=362 |
1.98
(3.842)
|
| Hematocrit,Year6,Week24,n=306 |
1.93
(3.939)
|
| Hematocrit,Year6,Week48,n=282 |
2.07
(4.023)
|
| Hematocrit,Year7,Week24,n=181 |
1.81
(4.251)
|
| Hematocrit,Year7,Week48,n=130 |
2.11
(4.238)
|
| Hematocrit,Year8,Week24,n=52 |
1.42
(4.390)
|
| Hematocrit,Year8,Week48,n=13 |
1.48
(4.234)
|
| Hematocrit,Year9,Week24,n=6 |
2.03
(6.001)
|
| Hematocrit,Year9,Week48,n=1 |
-6.00
(NA)
|
| Hematocrit,Exit,n=619 |
1.91
(4.202)
|
| Hematocrit,8 Week Follow up,n=534 |
1.85
(4.077)
|
| Title | Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points |
|---|---|
| Description | Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Erythrocytes is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. |
| Time Frame | Baseline and up to 9 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT Population |
| Arm/Group Title | Belimumab 10mg/kg IV |
|---|---|
| Arm/Group Description | Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial. |
| Measure Participants | 735 |
| Eryth,Year1,Week4,n=697 |
-0.00
(0.231)
|
| Eryth,Year1,Week12,n=698 |
0.04
(0.280)
|
| Eryth,Year1,Week24,n=699 |
0.06
(0.293)
|
| Eryth,Year1,Week36,n=688 |
0.06
(0.299)
|
| Eryth,Year1,Week48,n=686 |
0.06
(0.328)
|
| Eryth,Year2,Week24,n=635 |
0.07
(0.335)
|
| Eryth,Year2,Week48,n=591 |
0.04
(0.362)
|
| Eryth,Year3,Week24,n=534 |
0.04
(0.364)
|
| Eryth,Year3,Week48,n=478 |
0.05
(0.381)
|
| Eryth,Year4,Week24,n=446 |
0.06
(0.372)
|
| Eryth,Year,Week48,n=424 |
0.05
(0.379)
|
| Eryth,Year5,Week24,n=390 |
0.09
(0.375)
|
| Eryth,Year5,Week48,n=362 |
0.11
(0.383)
|
| Eryth,Year6,Week24,n=306 |
0.12
(0.396)
|
| Eryth,Year6,Week48,n=282 |
0.17
(0.408)
|
| Eryth,Year7,Week24,n=181 |
0.17
(0.415)
|
| Eryth,Year7,Week48,n=130 |
0.22
(0.387)
|
| Eryth,Year8,Week24,n=52 |
0.21
(0.375)
|
| Eryth,Year8,Week48,n=13 |
0.15
(0.207)
|
| Eryth,Year9,Week24,n=6 |
0.30
(0.374)
|
| Eryth,Year9,Week48,n=1 |
0.20
(NA)
|
| Eryth,Exit,n=619 |
0.14
(0.431)
|
| Eryth,8 Week Follow up,n=534 |
0.13
(0.411)
|
| Title | Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points |
|---|---|
| Description | Electrolytes parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 electrolytes parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Ca,CO2, Chloride, Mg, Phos, K and Na were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. |
| Time Frame | Baseline and up to 9 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT Population |
| Arm/Group Title | Belimumab 10mg/kg IV |
|---|---|
| Arm/Group Description | Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial. |
| Measure Participants | 735 |
| Ca,Year1,Week4,n=697 |
0.0030
(0.0763)
|
| Ca,Year1,Week12,n=696 |
0.0020
(0.0749)
|
| Ca,Year1,Week24,n=696 |
-0.0035
(0.0750)
|
| Ca,Year1,Week36,n=677 |
0.0024
(0.0836)
|
| Ca,Year1,Week48,n=687 |
-0.0065
(0.0778)
|
| Ca,Year2,Week24,n=636 |
-0.0075
(0.0764)
|
| Ca,Year2,Week48,n=587 |
-0.0091
(0.0837)
|
| Ca,Year3,Week24,n=526 |
-0.0047
(0.0810)
|
| Ca,Year3,Week48,n=481 |
-0.0123
(0.0800)
|
| Ca,Year4,Week24,n=438 |
-0.0056
(0.0771)
|
| Ca,Year,Week48,n=418 |
-0.0193
(0.0805)
|
| Ca,Year5,Week24,n=387 |
-0.0129
(0.0885)
|
| Ca,Year5,Week48,n=358 |
-0.0140
(0.0919)
|
| Ca,Year6,Week24,n=303 |
-0.0053
(0.0903)
|
| Ca,Year6,Week48,n=283 |
-0.0146
(0.0870)
|
| Ca,Year7,Week24,n=182 |
-0.0076
(0.0839)
|
| Ca,Year7,Week48,n=130 |
-0.0079
(0.1172)
|
| Ca,Year8,Week24,n=51 |
0.0003
(0.0806)
|
| Ca,Year8,Week48,n=13 |
-0.0395
(0.0611)
|
| Ca,Year9,Week24,n=6 |
-0.0402
(0.0336)
|
| Ca,Year9,Week48,n=1 |
-0.0642
(NA)
|
| Ca,Exit,n=619 |
0.0006
(0.0864)
|
| Ca,8 Week Follow up,n=534 |
-0.0014
(0.0909)
|
| CO2,Year1,Week4,n=701 |
-0.0
(2.77)
|
| CO2,Year1,Week12,n=700 |
-0.1
(2.76)
|
| CO2,Year1,Week24,n=701 |
-0.1
(2.73)
|
| CO2,Year1,Week36,n=682 |
0.1
(2.73)
|
| CO2,Year1,Week48,n=692 |
-0.1
(2.78)
|
| CO2,Year2,Week24,n=641 |
-0.3
(2.94)
|
| CO2,Year2,Week48,n=692 |
-0.3
(2.87)
|
| CO2,Year3,Week24,n=531 |
-0.2
(2.90)
|
| CO2,Year3,Week48,n=486 |
-0.4
(2.75)
|
| CO2,Year4,Week24,n=438 |
-0.0
(2.76)
|
| CO2,Year4,Week48,n=418 |
-0.5
(3.04)
|
| CO2,Year5,Week24,n=393 |
-0.2
(2.90)
|
| CO2,Year5,Week48,n=361 |
-0.8
(2.82)
|
| CO2,Year6,Week24,n=303 |
-0.0
(2.86)
|
| CO2,Year6,Week48,n=284 |
-0.5
(2.76)
|
| CO2,Year7,Week24,n=182 |
0.2
(2.78)
|
| CO2,Year7,Week48,n=130 |
0.2
(2.67)
|
| CO2,Year8,Week24,n=52 |
1.0
(2.78)
|
| CO2,Year8,Week48,n=13 |
0.4
(3.38)
|
| CO2,Year9,Week24,n=6 |
-0.3
(0.82)
|
| CO2,Year9,Week48,n=1 |
-3.0
(NA)
|
| CO2,Exit,n=625 |
-0.3
(3.00)
|
| CO2,8 week Follow up,n=538 |
-0.2
(3.00)
|
| Chloride,Year1,Week4,n=707 |
0.3
(2.33)
|
| Chloride,Year1,Week12,n=704 |
0.6
(2.56)
|
| Chloride,Year1,Week24,n=703 |
0.6
(2.42)
|
| Chloride,Year1,Week36,n=684 |
0.6
(2.47)
|
| Chloride,Year1,Week48,n=693 |
0.4
(2.44)
|
| Chloride,Year2,Week24,n=643 |
0.5
(2.62)
|
| Chloride,Year2,Week48,n=598 |
0.5
(2.81)
|
| Chloride,Year3,Week24,n=535 |
0.7
(3.04)
|
| Chloride,Year3,Week48,n=488 |
0.6
(2.73)
|
| Chloride,Year4,Week24,n=439 |
0.5
(2.74)
|
| Chloride,Year4,Week48,n=421 |
0.7
(2.84)
|
| Chloride,Year5,Week24,n=392 |
0.6
(2.95)
|
| Chloride,Year5,Week48,n=362 |
0.6
(2.77)
|
| Chloride,Year6,Week24,n=304 |
1.0
(2.74)
|
| Chloride,Year6,Week48,n=286 |
0.8
(2.67)
|
| Chloride,Year7,Week24,n=183 |
0.7
(2.57)
|
| Chloride,Year7,Week48,n=130 |
1.1
(2.73)
|
| Chloride,Year8,Week24,n=52 |
1.3
(2.86)
|
| Chloride,Year8,Week48,n=13 |
1.2
(3.54)
|
| Chloride,Year9,Week24,n=6 |
3.2
(1.47)
|
| Chloride,Year9,Week48,n=1 |
1.0
(NA)
|
| Chloride,Exit,n=624 |
0.4
(3.06)
|
| Chloride,8 Week Follow up,n=538 |
0.4
(2.82)
|
| Mg,Year1,Week4,n=707 |
-0.003
(0.0583)
|
| Mg,Year1,Week 12,n=705 |
-0.006
(0.0647)
|
| Mg,Year1,Week 24,n=703 |
-0.003
(0.0604)
|
| Mg,Year1,Week 36,n=684 |
-0.004
(0.0616)
|
| Mg,Year1,Week 48,n=693 |
0.002
(0.0597)
|
| Mg,Year2,Week 24,n=643 |
0.002
(0.0694)
|
| Mg,Year2,Week 48,n=598 |
0.001
(0.0711)
|
| Mg,Year3,Week 24,n=535 |
0.010
(0.0668)
|
| Mg,Year3,Week 48,n=488 |
0.010
(0.0669)
|
| Mg,Year4,Week 24,n=439 |
0.016
(0.0700)
|
| Mg,Year4,Week 48,n=421 |
0.017
(0.0709)
|
| Mg,Year 5,Week 24,n=393 |
0.016
(0.0673)
|
| Mg,Year 5,Week 48,n=362 |
0.021
(0.0688)
|
| Mg,Year 6,Week 24,n=304 |
0.013
(0.0718)
|
| Mg,Year 6,Week 48,n=286 |
0.011
(0.0639)
|
| Mg,Year 7,Week 24,n=183 |
0.010
(0.0692)
|
| Mg,Year 7,Week 48,n=130 |
0.013
(0.0635)
|
| Mg,Year 8,Week 24,n=52 |
0.025
(0.0702)
|
| Mg,Year 8,Week 48,n=13 |
0.042
(0.0685)
|
| Mg,Year 9,Week 24,n=6 |
0.030
(0.0613)
|
| Mg,Year 9,Week 48,n=1 |
0.040
(NA)
|
| Mg, Exit,n=625 |
0.022
(0.0738)
|
| Mg,8 Week Follow up,n=539 |
0.021
(0.0729)
|
| Phos, Year1, Week4,n=707 |
0.0102
(0.1908)
|
| Phos, Year1, Week12,n=705 |
0.0004
(0.1999)
|
| Phos, Year1, Week24,n=703 |
-0.0126
(0.1964)
|
| Phos, Year1, Week 36,n=684 |
0.0101
(0.1976)
|
| Phos, Year1, Week48,n=693 |
-0.0110
(0.2086)
|
| Phos, Year2, Week24,n=643 |
-0.0026
(0.2138)
|
| Phos, Year2, Week48,n=598 |
-0.0044
(0.2062)
|
| Phos, Year3, Week24,n=535 |
-0.0109
(0.2028)
|
| Phos, Year3, Week48,n=488 |
-0.0185
(0.2138)
|
| Phos, Year4, Week24,n=439 |
-0.0072
(0.2067)
|
| Phos, Year4, Week48,n=421 |
-0.0143
(0.2118)
|
| Phos, Year5, Week24,n=393 |
-0.0199
(0.2751)
|
| Phos, Year5, Week48,n=362 |
-0.0320
(0.2145)
|
| Phos, Year6, Week24,n=304 |
-0.0238
(0.2214)
|
| Phos, Year6, Week48,n=286 |
-0.0123
(0.2113)
|
| Phos, Year 7, Week 24,n=183 |
-0.0196
(0.1970)
|
| Phos, Year 7, Week 48,n=130 |
-0.0101
(0.1912)
|
| Phos, Year 8, Week 24,n=52 |
-0.0041
(0.2038)
|
| Phos, Year 8, Week48,n=13 |
-0.0340
(0.1337)
|
| Phos, Year9, Week 24,n=6 |
-0.0803
(0.0823)
|
| Phos, Year 9, Week 48,n=1 |
0.0447
(NA)
|
| Phos, Exit, n=625 |
-0.0111
(0.2243)
|
| Phos, 8 Week Follow up,n=539 |
-0.0034
(0.2233)
|
| K, Year 1, Week 4, n=701 |
0.07
(0.411)
|
| K, Year 1, Week 12, n=700 |
0.03
(0.380)
|
| K, Year 1, Week 24, n=701 |
0.01
(0.377)
|
| K, Year 1, Week 36, n=682 |
0.04
(0.387)
|
| K, Year 1, Week 48, n=692 |
0.01
(0.377)
|
| K, Year 2, Week 24, n=641 |
0.01
(0.393)
|
| K, Year 2, Week 48, n=592 |
0.02
(0.372)
|
| K, Year 3, Week 24, n=531 |
0.05
(0.401)
|
| K, Year 3, Week 48, n=486 |
0.06
(0.421)
|
| K, Year 4, Week 24, n=438 |
0.06
(0.408)
|
| K, Year 4, Week 48, n=418 |
0.03
(0.397)
|
| K, Year 5, Week 24, n=393 |
0.08
(0.427)
|
| K, Year 5, Week 48, n=362 |
0.02
(0.404)
|
| K, Year 6, Week 24, n=303 |
0.06
(0.429)
|
| K, Year 6, Week 48, n=284 |
0.05
(0.437)
|
| K, Year 7, Week 24, n=182 |
0.05
(0.445)
|
| K, Year 7, Week 48, n=130 |
0.05
(0.413)
|
| K, Year 8, Week 24, n=52 |
-0.02
(0.418)
|
| K, Year 8, Week 48, n=13 |
-0.12
(0.300)
|
| K, Year 9, Week 24, n=6 |
0.05
(0.259)
|
| K, Year 9, Week 48, n=1 |
0.00
(NA)
|
| K, Exit, n=624 |
0.06
(0.435)
|
| K, 8 Week Follow up, n=537 |
0.07
(0.452)
|
| Na, Year 1, Week 4, n=707 |
0.1
(2.07)
|
| Na, Year 1, Week 12, n=705 |
0.3
(2.25)
|
| Na, Year 1, Week 24, n=703 |
0.4
(2.16)
|
| Na, Year 1, Week 36, n=684 |
0.4
(2.10)
|
| Na, Year 1, Week 48, n=693 |
0.1
(2.09)
|
| Na, Year 2, Week 24, n=643 |
-0.0
(2.30)
|
| Na, Year 2, Week 48, n=598 |
0.1
(2.63)
|
| Na, Year 3, Week 24, n=535 |
0.2
(2.54)
|
| Na, Year 3, Week 48, n=488 |
0.3
(2.36)
|
| Na, Year 4, Week 24, n=439 |
0.1
(2.31)
|
| Na, Year 4, Week 48, n=421 |
0.3
(2.36)
|
| Na, Year 5, Week 24, n=393 |
0.3
(2.61)
|
| Na, Year 5, Week 48, n=362 |
0.3
(2.18)
|
| Na, Year 6, Week 24, n=304 |
0.3
(2.22)
|
| Na, Year 6, Week 48, n=286 |
0.4
(2.44)
|
| Na, Year 7, Week 24, n=183 |
0.1
(2.22)
|
| Na, Year 7, Week 48, n=130 |
0.1
(2.38)
|
| Na, Year 8, Week 24, n=52 |
0.2
(2.67)
|
| Na, Year 8, Week 48, n=13 |
0.1
(2.14)
|
| Na, Year 9, Week 24, n=6 |
1.0
(1.79)
|
| Na, Year 9, Week 48, n=1 |
-3.0
(NA)
|
| Na, Exist, n=624 |
0.1
(2.55)
|
| Na, 8 Week Follow up, n=538 |
0.3
(2.36)
|
| Title | Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points |
|---|---|
| Description | Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in BUN/Cr is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Time Frame | Baseline and up to 9 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT Population |
| Arm/Group Title | Belimumab 10mg/kg IV |
|---|---|
| Arm/Group Description | Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial. |
| Measure Participants | 735 |
| BUN/Cr,Year1,Week4,n=707 |
-0.2
(4.66)
|
| BUN/Cr,Year1,Week12,n=705 |
-0.3
(4.88)
|
| BUN/CrYear1,Week24,n=703 |
-0.7
(5.02)
|
| BUN/Cr,Year1,Week36,n=683 |
-0.5
(5.61)
|
| BUN/Cr,Year1,Week48,n=693 |
-0.2
(5.26)
|
| BUN/Cr,Year2,Week24,n=643 |
-0.1
(5.68)
|
| BUN/Cr,Year2,Week48,n=598 |
0.5
(5.55)
|
| BUN/Cr,Year3,Week24,n=535 |
1.4
(5.48)
|
| BUN/Cr,Year3,Week48,n=488 |
1.2
(5.92)
|
| BUN/Cr,Year4,Week24,n=439 |
1.4
(5.65)
|
| BUN/Cr,Year 4,Week48,n=421 |
1.0
(5.85)
|
| BUN/Cr,Year5,Week24,n=393 |
0.7
(5.51)
|
| BUN/Cr,Year5,Week48,n=362 |
1.0
(5.62)
|
| BUN/Cr,Year6,Week24,n=304 |
1.0
(5.35)
|
| BUN/Cr,Year6,Week48,n=286 |
1.3
(5.74)
|
| BUN/Cr,Year7,Week24,n=183 |
0.8
(5.68)
|
| BUN/Cr,Year7,Week48,n=130 |
1.2
(5.47)
|
| BUN/Cr,Year8,Week24,n=52 |
3.3
(4.64)
|
| BUN/Cr,Year8,Week48,n=13 |
3.5
(6.04)
|
| BUN/Cr,Year9,Week24,n=6 |
3.5
(3.08)
|
| BUN/Cr,Year9,Week48,n=1 |
1
(2.0)
|
| BUN/Cr,Exit,n=625 |
0.9
(6.05)
|
| BUN/Cr,8 Week Follow up,n=539 |
0.9
(5.91)
|
| Title | Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points |
|---|---|
| Description | Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Alb and Protein were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. |
| Time Frame | Baseline and up to 9 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT Population |
| Arm/Group Title | Belimumab 10mg/kg IV |
|---|---|
| Arm/Group Description | Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial. |
| Measure Participants | 735 |
| Alb,Year1,Week4,n=707 |
-0.1
(2.36)
|
| Alb,Year1,Week12,n=705 |
0.2
(2.67)
|
| Alb,Year1,Week24,n=703 |
0.6
(3.03)
|
| Alb,Year1,Week36,n=684 |
0.7
(3.23)
|
| Alb,Year1,Week48,n=693 |
1.2
(3.52)
|
| Alb,Year2,Week24,n=643 |
1.2
(3.49)
|
| Alb,Year2,Week48,n=598 |
1.2
(3.67)
|
| Alb,Year3,Week24,n=535 |
1.2
(3.78)
|
| Alb,Year3,Week48,n=488 |
1.4
(4.02)
|
| Alb,Year4,Week24,n=439 |
1.7
(4.02)
|
| Alb,Year 4,Week48,n=421 |
1.9
(4.04)
|
| Alb,Year5,Week24,n=393 |
1.9
(3.85)
|
| Alb,Year5,Week48,n=362 |
2.3
(3.89)
|
| Alb,Year6,Week24,n=304 |
2.2
(3.78)
|
| Alb,Year6,Week48,n=286 |
2.1
(4.07)
|
| Alb,Year7,Week24,n=183 |
2.0
(3.60)
|
| Alb,Year7,Week48,n=130 |
2.3
(3.92)
|
| Alb,Year8,Week24,n=52 |
1.9
(4.16)
|
| Alb,Year8,Week48,n=13 |
1.1
(4.11)
|
| Alb,Year9,Week24,n=6 |
0.7
(3.01)
|
| Alb,Year9,Week48,n=1 |
1.0
(NA)
|
| Alb,Exit,n=625 |
1.8
(4.74)
|
| Alb,8 Week Follow up,n=539 |
1.7
(4.66)
|
| Pro,Year1,Week4,n=707 |
-1.4
(3.81)
|
| Pro,Year1,Week12,n=705 |
-2.0
(4.30)
|
| Pro,Year1,Week24,n=703 |
-1.9
(4.68)
|
| Pro,Year1,Week36,n=684 |
-2.3
(4.75)
|
| Pro,Year1,Week48,n=693 |
-1.8
(4.94)
|
| Pro,Year2,Week24,n=643 |
-2.3
(5.05)
|
| Pro,Year2,Week48,n=598 |
-2.7
(5.53)
|
| Pro,Year3,Week24,n=535 |
-3.1
(5.62)
|
| Pro,Year3,Week48,n=488 |
-3.5
(5.91)
|
| Pro,Year4,Week24,n=439 |
-3.2
(5.87)
|
| Pro,Year 4,Week48,n=421 |
-3.2
(6.07)
|
| Pro,Year5,Week24,n=393 |
-3.5
(5.75)
|
| Pro,Year5,Week48,n=362 |
-3.6
(5.78)
|
| Pro,Year6,Week24,n=304 |
-3.9
(5.57)
|
| Pro,Year6,Week48,n=286 |
-4.0
(5.79)
|
| Pro,Year7,Week24,n=183 |
-4.3
(5.36)
|
| Pro,Year7,Week48,n=130 |
-3.9
(5.32)
|
| Pro,Year8,Week24,n=52 |
-5.1
(6.38)
|
| Pro,Year8,Week48,n=13 |
-4.8
(5.02)
|
| Pro,Year9,Week24,n=6 |
-7.7
(7.03)
|
| Pro,Year9,Week48,n=1 |
0.0
(NA)
|
| Pro,Exit,n=625 |
-3.4
(6.45)
|
| Pro,8 Week Follow up,n=539 |
-3.7
(6.42)
|
| Title | Change From Baseline in BUN and Glucose at the Indicated Time Points |
|---|---|
| Description | Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in BUN and Glucose were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. |
| Time Frame | Baseline and up to 9 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT Population |
| Arm/Group Title | Belimumab 10mg/kg IV |
|---|---|
| Arm/Group Description | Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial. |
| Measure Participants | 735 |
| BUN,Year1,Week4,n=707 |
0.0299
(1.6783)
|
| BUN,Year1,Week12,n=705 |
0.0402
(1.9768)
|
| BUN,Year1,Week24,n=703 |
-0.1443
(1.3723)
|
| BUN,Year1,Week36,n=683 |
-0.0592
(1.6916)
|
| BUN,Year1,Week48,n=693 |
-0.0406
(1.5541)
|
| BUN,Year2,Week24,n=643 |
-0.0760
(1.6652)
|
| BUN,Year2,Week48,n=598 |
0.0631
(1.6429)
|
| BUN,Year3,Week24,n=535 |
0.0524
(1.6850)
|
| BUN,Year3,Week48,n=488 |
-0.1013
(1.6910)
|
| BUN,Year4,Week24,n=439 |
0.0967
(1.9398)
|
| BUN,Year 4,Week48,n=421 |
0.0672
(2.1393)
|
| BUN,Year5,Week24,n=393 |
-0.0291
(2.0169)
|
| BUN,Year5,Week48,n=362 |
0.0899
(2.0903)
|
| BUN,Year6,Week24,n=304 |
0.0959
(1.9852)
|
| BUN,Year6,Week48,n=286 |
0.2325
(2.2724)
|
| BUN,Year7,Week24,n=183 |
-0.0026
(1.6623)
|
| BUN,Year7,Week48,n=130 |
0.1455
(1.7145)
|
| BUN,Year8,Week24,n=52 |
0.5458
(1.7299)
|
| BUN,Year8,Week48,n=13 |
0.3883
(1.4603)
|
| BUN,Year9,Week24,n=6 |
0.1648
(1.0466)
|
| BUN,Year9,Week48,n=1 |
0.5700
(NA)
|
| BUN,Exit,n=625 |
0.2448
(2.4618)
|
| BUN,8 Week Follow up,n=539 |
0.0822
(2.5567)
|
| Glucose,Year1,Week4,n=707 |
-0.0031
(1.0221)
|
| Glucose,Year1,Week12,n=705 |
0.0333
(1.0627)
|
| Glucose,Year1,Week24,n=702 |
-0.0396
(1.2656)
|
| Glucose,Year1,Week36,n=684 |
0.0099
(1.0269)
|
| Glucose,Year1,Week48,n=693 |
0.0010
(1.1726)
|
| Glucose,Year2,Week24,n=643 |
0.0143
(1.3227)
|
| Glucose,Year2,Week48,n=598 |
-0.0082
(1.1352)
|
| Glucose,Year3,Week24,n=535 |
-0.0159
(1.3222)
|
| Glucose,Year3,Week48,n=488 |
0.0309
(1.1841)
|
| Glucose,Year4,Week24,n=439 |
-0.0160
(1.2213)
|
| Glucose,Year 4,Week48,n=421 |
-0.0259
(1.1936)
|
| Glucose,Year5,Week24,n=393 |
0.0554
(1.1255)
|
| Glucose,Year5,Week48,n=362 |
0.0655
(1.2946)
|
| Glucose,Year6,Week24,n=303 |
0.1290
(1.1163)
|
| Glucose,Year6,Week48,n=286 |
0.2001
(1.2411)
|
| Glucose,Year7,Week24,n=183 |
0.2303
(1.0514)
|
| Glucose,Year7,Week48,n=130 |
0.2335
(0.8346)
|
| Glucose,Year8,Week24,n=52 |
0.3301
(0.9052)
|
| Glucose,Year8,Week48,n=13 |
0.1431
(0.8115)
|
| Glucose,Year9,Week24,n=6 |
0.2128
(0.4914)
|
| Glucose,Year9,Week48,n=1 |
0.4739
(NA)
|
| Glucose,Exit,n=624 |
0.1842
(1.8723)
|
| Glucose,8 Week Follow up,n=539 |
0.0338
(1.4139)
|
| Title | Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points |
|---|---|
| Description | Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Cr and Urate were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. |
| Time Frame | Baseline and up to 9 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT Population |
| Arm/Group Title | Belimumab 10mg/kg IV |
|---|---|
| Arm/Group Description | Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial. |
| Measure Participants | 735 |
| Urate,Year1,Week4,n=707 |
1.0332
(45.8504)
|
| Urate,Year1,Week12,n=704 |
0.4089
(54.3182)
|
| Urate,Year1,Week24,n=703 |
-0.0510
(49.2328)
|
| Urate,Year1,Week36,n=684 |
0.6713
(50.7341)
|
| Urate,Year1,Week48,n=693 |
-1.5147
(50.5928)
|
| Urate,Year2,Week24,n=643 |
2.7246
(55.7467)
|
| Urate,Year2,Week48,n=598 |
4.1255
(60.0251)
|
| Urate,Year3,Week24,n=535 |
6.7497
(60.4118)
|
| Urate,Year3,Week48,n=488 |
6.9744
(63.6876)
|
| Urate,Year4,Week24,n=439 |
5.9658
(66.6167)
|
| Urate,Year 4,Week48,n=421 |
4.0772
(67.9587)
|
| Urate,Year5,Week24,n=393 |
-0.5634
(66.9130)
|
| Urate,Year5,Week48,n=362 |
-0.8979
(67.3843)
|
| Urate,Year6,Week24,n=304 |
2.9530
(62.3168)
|
| Urate,Year6,Week48,n=286 |
1.1244
(67.3175)
|
| Urate,Year7,Week24,n=183 |
2.1521
(53.0854)
|
| Urate,Year7,Week48,n=130 |
4.0062
(58.3577)
|
| Urate,Year8,Week24,n=52 |
-1.1003
(51.8840)
|
| Urate,Year8,Week48,n=13 |
29.2043
(80.1811)
|
| Urate,Year9,Week24,n=6 |
0.2187
(45.1947)
|
| Urate,Year9,Week48,n=1 |
-69.6640
(NA)
|
| Urate,Exit,n=625 |
1.6479
(74.4078)
|
| Urate,8 Week Follow up,n=539 |
-2.7404
(75.5887)
|
| Cr,Year1,Week4,n=707 |
0.913
(14.2222)
|
| Cr,Year1,Week12,n=705 |
0.751
(14.0933)
|
| Cr,Year1,Week24,n=703 |
0.823
(9.5372)
|
| Cr,Year1,Week36,n=684 |
1.313
(13.1107)
|
| Cr,Year1,Week48,n=693 |
0.439
(11.1364)
|
| Cr,Year2,Week24,n=643 |
-0.217
(13.9502)
|
| Cr,Year2,Week48,n=598 |
-0.922
(13.6541)
|
| Cr,Year3,Week24,n=535 |
-3.870
(17.8146)
|
| Cr,Year3,Week48,n=488 |
-4.844
(17.7059)
|
| Crea,Year4,Week24,n=439 |
-3.196
(22.2874)
|
| Crea,Year 4,Week48,n=421 |
-2.145
(30.9370)
|
| Cr,Year5,Week24,n=393 |
-1.999
(32.6689)
|
| Cr,Year5,Week48,n=362 |
-1.918
(28.8788)
|
| Cr,Year6,Week24,n=304 |
-2.125
(24.2374)
|
| Cr,Year6,Week48,n=286 |
-1.534
(28.8012)
|
| Cr,Year7,Week24,n=183 |
-2.511
(15.6881)
|
| Cr,Year7,Week48,n=130 |
-2.586
(14.0864)
|
| Cr,Year8,Week24,n=52 |
-4.659
(16.3056)
|
| Cr,Year8,Week48,n=13 |
-6.175
(6.6311)
|
| Cr,Year9,Week24,n=6 |
-8.933
(5.6925)
|
| Cr,Year9,Week48,n=1 |
0.040
(NA)
|
| Cr,Exit,n=624 |
0.606
(35.9813)
|
| Cr,8 Week Follow up,n=539 |
-1.108
(39.0635)
|
| Title | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels |
|---|---|
| Description | Liver function parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 liver function parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in ALT, ALP, AST, GGT and LDH were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.NA indicates standard deviation was not calculable for a single data point. |
| Time Frame | Baseline and up to 9 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT Population |
| Arm/Group Title | Belimumab 10mg/kg IV |
|---|---|
| Arm/Group Description | Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial. |
| Measure Participants | 735 |
| ALT, Year 1 Week 4, n=707 |
-0.4
(10.18)
|
| ALT, Year 1 Week 12, n=705 |
-0.9
(12.31)
|
| ALT, Year 1 Week 24, n=703 |
-0.9
(19.46)
|
| ALT, Year 1 Week 36, n=684 |
-1.0
(15.61)
|
| ALT, Year 1 Week 48, n=693 |
-0.7
(15.04)
|
| ALT, Year 2 Week 24, n=643 |
0.2
(23.56)
|
| ALT, Year 2 Week 48, n=598 |
2.7
(57.67)
|
| ALT, Year 3 Week 24, n=535 |
-1.3
(14.40)
|
| ALT, Year 3 Week 48, n=488 |
0.1
(21.21)
|
| ALT, Year 4 Week 24, n=439 |
-0.1
(18.72)
|
| ALT, Year 4 Week 48, n=421 |
-0.6
(17.59)
|
| ALT, Year 5 Week 24, n=393 |
-1.3
(18.74)
|
| ALT, Year 5 Week 48, n=362 |
-0.4
(22.72)
|
| ALT, Year 6 Week 24, n=304 |
-0.2
(20.54)
|
| ALT, Year 6 Week 48, n=286 |
0.9
(20.94)
|
| ALT, Year 7 Week 24, n=183 |
1.3
(19.46)
|
| ALT, Year 7 Week 48, n=130 |
-0.1
(16.79)
|
| ALT, Year 8 Week 24, n=52 |
2.7
(31.15)
|
| ALT, Year 8 Week 48, n=13 |
5.8
(33.54)
|
| ALT, Year 9 Week 24, n=6 |
9.3
(27.77)
|
| ALT, Year 9 Week 48, n=1 |
-6.0
(NA)
|
| ALT, Exit, n=624 |
-0.6
(17.03)
|
| ALT, 8 Week follow-up, n=539 |
-0.8
(17.06)
|
| ALP, Year 1 Week 4, n=707 |
0.0
(11.85)
|
| ALP, Year 1 Week 12, n=705 |
0.5
(13.31)
|
| ALP, Year 1 Week 24, n=703 |
2.1
(17.76)
|
| ALP, Year 1 Week 36, n=684 |
1.7
(22.81)
|
| ALP, Year 1 Week 48, n=693 |
4.6
(21.18)
|
| ALP, Year 2 Week 24, n=643 |
5.1
(21.58)
|
| ALP, Year 2 Week 48, n=598 |
6.1
(23.23)
|
| ALP, Year 3 Week 24, n=535 |
5.9
(18.95)
|
| ALP, Year 3 Week 48, n=488 |
7.3
(22.22)
|
| ALP, Year 4 Week 24, n=439 |
7.2
(21.56)
|
| ALP, Year 4 Week 48, n=421 |
8.1
(27.35)
|
| ALP, Year 5 Week 24, n=393 |
7.2
(21.01)
|
| ALP, Year 5 Week 48, n=362 |
8.5
(20.61)
|
| ALP, Year 6 Week 24, n=304 |
9.4
(23.28)
|
| ALP, Year 6 Week 48, n=286 |
11.5
(27.39)
|
| ALP, Year 7 Week 24, n=183 |
10.9
(28.08)
|
| ALP, Year 7 Week 48, n=130 |
7.5
(22.50)
|
| ALP, Year 8 Week 24, n=52 |
12.9
(26.64)
|
| ALP, Year 8 Week 48, n=13 |
6.1
(30.04)
|
| ALP, Year 9 Week 24, n=6 |
4.2
(35.43)
|
| ALP, Year 9 Week 48, n=1 |
12.0
(NA)
|
| ALP, Exit, n=625 |
7.5
(25.35)
|
| ALP, 8 Week follow-up, n=539 |
6.1
(23.00)
|
| AST, Year 1 Week 4, n=701 |
-0.6
(10.56)
|
| AST, Year 1 Week 12, n=700 |
-1.3
(14.12)
|
| AST, Year 1 Week 24, n=701 |
-1.0
(20.79)
|
| AST, Year 1 Week 36, n=682 |
-1.0
(17.88)
|
| AST, Year 1 Week 48, n=692 |
-0.9
(14.38)
|
| AST, Year 2 Week 24, n=641 |
-0.4
(22.22)
|
| AST, Year 2 Week 48, n=592 |
2.9
(57.25)
|
| AST, Year 3 Week 24, n=531 |
-1.4
(13.26)
|
| AST, Year 3 Week 48, n=486 |
-0.5
(17.23)
|
| AST, Year 4 Week 24, n=438 |
-0.9
(14.60)
|
| AST, Year 4 Week 48, n=418 |
-0.7
(15.32)
|
| AST, Year 5 Week 24, n=393 |
-1.3
(16.07)
|
| AST, Year 5 Week 48, n=362 |
-0.8
(18.57)
|
| AST, Year 6 Week 24, n=303 |
-0.5
(16.95)
|
| AST, Year 6 Week 48, n=284 |
-0.2
(19.00)
|
| AST, Year 7 Week 24, n=182 |
0.6
(13.43)
|
| AST, Year 7 Week 48, n=130 |
-0.3
(10.78)
|
| AST, Year 8 Week 24, n=52 |
3.0
(33.93)
|
| AST, Year 8 Week 48, n=13 |
5.8
(24.01)
|
| AST, Year 9 Week 24, n=6 |
7.7
(19.63)
|
| AST, Year 9 Week 48, n=1 |
0.0
(NA)
|
| AST, Exit, n=625 |
-0.6
(18.88)
|
| AST, 8 Week follow-up, n=539 |
-1.1
(16.58)
|
| GGT, Year 1 Week 4, n=707 |
-0.4
(23.39)
|
| GGT, Year 1 Week 12, n=705 |
-1.4
(23.12)
|
| GGT, Year 1 Week 24, n=703 |
-0.2
(39.50)
|
| GGT, Year 1 Week 36, n=684 |
1.0
(64.60)
|
| GGT, Year 1 Week 48, n=693 |
0.9
(35.99)
|
| GGT, Year 2 Week 24, n=643 |
-0.7
(34.81)
|
| GGT, Year 2 Week 48, n=598 |
0.1
(34.63)
|
| GGT, Year 3 Week 24, n=535 |
-1.6
(33.88)
|
| GGT, Year 3 Week 48, n=488 |
1.7
(45.42)
|
| GGT, Year 4 Week 24, n=439 |
0.1
(39.13)
|
| GGT, Year 4 Week 48, n=421 |
1.1
(54.41)
|
| GGT, Year 5 Week 24, n=393 |
-2.0
(37.17)
|
| GGT, Year 5 Week 48, n=362 |
-0.7
(43.39)
|
| GGT, Year 6 Week 24, n=304 |
-1.0
(42.04)
|
| GGT, Year 6 Week 48, n=286 |
1.3
(41.84)
|
| GGT, Year 7 Week 24, n=183 |
1.8
(37.06)
|
| GGT, Year 7 Week 48, n=130 |
-1.0
(27.86)
|
| GGT, Year 8 Week 24, n=52 |
2.7
(39.90)
|
| GGT, Year 8 Week 48, n=13 |
-0.3
(27.97)
|
| GGT, Year 9 Week 24, n=6 |
13.3
(26.96)
|
| GGT, Year 9 Week 48, n=1 |
-7.0
(NA)
|
| GGT, Exit, n=625 |
0.7
(41.40)
|
| GGT, 8 Week follow-up, n=539 |
0.2
(39.22)
|
| LDH, Year 1 Week 4, n=701 |
-4.1
(77.93)
|
| LDH, Year 1 Week 12, n=700 |
-6.0
(80.55)
|
| LDH, Year 1 Week 24, n=701 |
-6.6
(80.09)
|
| LDH, Year 1 Week 36, n=682 |
-8.8
(80.05)
|
| LDH, Year 1 Week 48, n=692 |
-7.3
(81.32)
|
| LDH, Year 2 Week 24, n=641 |
-9.4
(85.83)
|
| LDH, Year 2 Week 48, n=592 |
-9.6
(95.52)
|
| LDH, Year 3 Week 24, n=532 |
-11.8
(93.90)
|
| LDH, Year 3 Week 48, n=486 |
-15.1
(94.65)
|
| LDH, Year 4 Week 24, n=438 |
-16.5
(99.93)
|
| LDH, Year 4 Week 48, n=418 |
-16.9
(102.11)
|
| LDH, Year 5 Week 24, n=393 |
-17.5
(106.45)
|
| LDH, Year 5 Week 48, n=362 |
-19.8
(108.33)
|
| LDH, Year 6 Week 24, n=303 |
-21.7
(115.77)
|
| LDH, Year 6 Week 48, n=284 |
-21.3
(122.62)
|
| LDH, Year 7 Week 24, n=182 |
-15.2
(44.05)
|
| LDH, Year 7 Week 48, n=130 |
-16.3
(42.51)
|
| LDH, Year 8 Week 24, n=52 |
-14.3
(40.14)
|
| LDH, Year 8 Week 48, n=13 |
-31.5
(53.04)
|
| LDH, Year 9 Week 24, n=6 |
-27.2
(32.64)
|
| LDH, Year 9 Week 48, n=1 |
-65.0
(NA)
|
| LDH, Exit, n=624 |
-13.1
(90.39)
|
| LDH, 8 Week follow-up, n=538 |
-12.7
(95.65)
|
| Title | Change From Baseline in Bilirubin (Bili) Levels |
|---|---|
| Description | Liver function parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 liver function parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Bili were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. |
| Time Frame | Baseline and up to 9 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT Population |
| Arm/Group Title | Belimumab 10mg/kg IV |
|---|---|
| Arm/Group Description | Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial. |
| Measure Participants | 735 |
| Year 1 Week 4, n=707 |
0.142
(2.8398)
|
| Year 1 Week 12, n=705 |
0.008
(2.6383)
|
| Year 1 Week 24, n=703 |
0.217
(3.1280)
|
| Year 1 Week 36, n=684 |
0.173
(2.7566)
|
| Year 1 Week 48, n=693 |
0.367
(2.8441)
|
| Year 2 Week 24, n=643 |
0.488
(2.9346)
|
| Year 2 Week 48, n=598 |
0.540
(3.2181)
|
| Year 3 Week 24, n=535 |
0.606
(3.1612)
|
| Year 3 Week 48, n=488 |
0.637
(3.2474)
|
| Year 4 Week 24, n=439 |
0.548
(2.9773)
|
| Year 4 Week 48, n=421 |
0.629
(3.4680)
|
| Year 5 Week 24, n=393 |
0.410
(2.6931)
|
| Year 5 Week 48, n=362 |
0.788
(3.1324)
|
| Year 6 Week 24, n=304 |
0.801
(2.9946)
|
| Year 6 Week 48, n=285 |
0.638
(3.0669)
|
| Year 7 Week 24, n=183 |
0.938
(2.8158)
|
| Year 7 Week 48, n=130 |
1.129
(3.0314)
|
| Year 8 Week 24, n=52 |
1.280
(3.0707)
|
| Year 8 Week 48, n=13 |
0.768
(3.0434)
|
| Year 9 Week 24, n=6 |
0.028
(2.0182)
|
| Year 9 Week 48, n=1 |
-2.870
(NA)
|
| Exit, n=624 |
0.573
(3.3274)
|
| 8 Week follow-up, n=539 |
0.572
(3.1052)
|
| Title | Change From Baseline in Immunoglobulin G (IgG) Levels |
|---|---|
| Description | Immunoglobulin (Ig) parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 Ig parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Ig G were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point. |
| Time Frame | Baseline and up to 9 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT Population |
| Arm/Group Title | Belimumab 10mg/kg IV |
|---|---|
| Arm/Group Description | Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial. |
| Measure Participants | 735 |
| Year 1 Week 12, n=213 |
-1.571
(2.2970)
|
| Year 1 Week 24, n=709 |
-1.963
(2.7334)
|
| Year 1 Week 48, n=695 |
-2.507
(3.1054)
|
| Year 2 Week 24, n=482 |
-3.058
(3.6147)
|
| Year 2 Week 48, n=605 |
-3.232
(3.7414)
|
| Year 3 Week 24, n=143 |
-3.453
(3.7073)
|
| Year 3 Week 48, n=405 |
-3.791
(4.0450)
|
| Year 4 Week 24, n=146 |
-3.839
(4.1411)
|
| Year 4 Week 48, n=362 |
-3.794
(3.8780)
|
| Year 5 Week 24, n=111 |
-4.356
(3.6399)
|
| Year 5 Week 48, n=322 |
-4.323
(4.0169)
|
| Year 6 Week 24, n=71 |
-5.111
(3.8846)
|
| Year 6 Week 48, n=268 |
-4.697
(3.9599)
|
| Year 7 Week 24, n=50 |
-4.803
(3.5908)
|
| Year 7 Week 48, n=115 |
-4.982
(4.0769)
|
| Year 8 Week 24, n=18 |
-6.016
(3.8450)
|
| Year 8 Week 48, n=12 |
-5.520
(5.1564)
|
| Year 9 Week 48, n=1 |
0.710
(NA)
|
| Exit, n=627 |
-4.138
(4.0025)
|
| 8 Week Follow up, n=543 |
-4.325
(4.0246)
|
| Title | Number of Participants With Immunogenic Response by Year |
|---|---|
| Description | Immunogenic response was analyzed using serum samples for anti-belimumab antibody measurements in MITT population. Categories of response are Negative, Transient Positive (+) means single + response that does not occur at the final assessment, and Persistent + means + response that occurs at least 2 consecutive assessments or a single result at the final assessment. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Time Frame | Up to 9 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT Population |
| Arm/Group Title | Belimumab 10mg/kg IV |
|---|---|
| Arm/Group Description | Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial. |
| Measure Participants | 735 |
| Year 0-1 Negative, n=717 |
707
96.2%
|
| Year 1-2 Negative, n=684 |
656
89.3%
|
| Year 2-3 Negative, n=590 |
577
78.5%
|
| Year 3-4, Negative, n=502 |
498
67.8%
|
| Year 4-5 Negative, n=432 |
432
58.8%
|
| Year 5-6 Negative, n=336 |
336
45.7%
|
| Year 6-7 Negative, n=212 |
212
28.8%
|
| Year 7-8 Negative, n=64 |
64
8.7%
|
| Year 8 plus Negative, n=6 |
6
0.8%
|
| Year 0-1 Transient +, n=717 |
10
1.4%
|
| Year 1-2 Transient + n=684 |
18
2.4%
|
| Year 2-3 Transient +, n=590 |
9
1.2%
|
| Year 3-4 Transient +, n=502 |
4
0.5%
|
| Year 4-5 Transient +, n=432 |
0
0%
|
| Year 5-6 Transient +, n=336 |
0
0%
|
| Year 6-7 Transient +, n=212 |
0
0%
|
| Year 7-8 Transient +, n=64 |
0
0%
|
| Year 8 plus Transient +, n=6 |
0
0%
|
| Year 0-1 Persistent+,n=717 |
0
0%
|
| Year 1-2 Persistent+,n=684 |
10
1.4%
|
| Year 2-3 Persistent+,n=590 |
3
0.4%
|
| Year 3-4 Persistent+,n=502 |
0
0%
|
| Year 4-5 Persistent+,n=432 |
0
0%
|
| Year 5-6 Persistent+,n=336 |
0
0%
|
| Year 6-7 Persistent+,n=212 |
0
0%
|
| Year 7-8 Persistent+,n=64 |
0
0%
|
| Year 8 plus Persistent+,n=6 |
0
0%
|
| Year 0-1 Unknown, n=717 |
0
0%
|
| Year 1-2 Unknown, n=684 |
0
0%
|
| Year 2-3 Unknown, n=590 |
1
0.1%
|
| Year 3-4 Unknown, n=502 |
0
0%
|
| Year 4-5 Unknown, n=432 |
0
0%
|
| Year 5-6 Unknown, n=336 |
0
0%
|
| Year 6-7 Unknown, n=212 |
0
0%
|
| Year 7-8 Unknown, n=64 |
0
0%
|
| Year 8 plus Unknown, n=6 |
0
0%
|
| Title | Number of Participants With IgG Values Below the Lower Limit of Normal by Year |
|---|---|
| Description | Blood samples were collected to evaluate IgG levels at Baseline and at Weeks 12, 24 and 48 during Year 1. From Year 2-9, IgG was evaluated at Week 24 and 48 ; Exit visit and at follow-up visit (up to 8 weeks post last infusion). Number of participants with IgG immunoglobulin values below the LLN at each one year interval are presented. Baseline includes Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. If a participant had more than one response within a year, then the last response within the year interval (usually the Week 48 assessment) was summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Time Frame | Up to 9 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT Population |
| Arm/Group Title | Belimumab 10mg/kg IV |
|---|---|
| Arm/Group Description | Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial. |
| Measure Participants | 735 |
| Baseline, n=735 |
6
0.8%
|
| Any Time Post Baseline, n=735 |
64
8.7%
|
| Year 0-1, n=735 |
22
3%
|
| Year 1-2, n=701 |
24
3.3%
|
| Year 2-3, n=620 |
22
3%
|
| Year 3-4, n=514 |
19
2.6%
|
| Year 4-5, n=442 |
15
2%
|
| Year 5-6, n=345 |
10
1.4%
|
| Year 6-7, n=219 |
8
1.1%
|
| Year 7-8, n=65 |
2
0.3%
|
| More than 8 Years, n=6 |
0
0%
|
| Title | Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit |
|---|---|
| Description | Participants who had improving SLE disease activity for at least 8 weeks, at the investigator's discretion, the steroid dose was reduced by reduction to 7.5 mg/day. If the participant continued to have stable or improving disease activity after 4 weeks on a reduced dose, then the investigator considered reducing the dose again. Baseline includes extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. Number of participants with shifts from Baseline total daily dose category by visit is summarized. |
| Time Frame | Up to 9 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT Population |
| Arm/Group Title | Participants With no Prednisone and Other Steroids at Baseline | Participants With Baseline Daily Dose of >0 to <=7.5 mg | Participants With Baseline Daily Dose of >7.5 to <=40 mg | Participants With Baseline Daily Dose of >40 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants were not receiving prednisone and other steroids at Baseline. | Participants were receiving a daily dose of >0 to <=7.5 mg of prednisone and other steroids at Baseline. | Participants were receiving a daily dose of >7.5 to <=40 mg of prednisone and other steroids at Baseline. | Participants were receiving a daily dose of >40 mg of prednisone and other steroids at Baseline. |
| Measure Participants | 43 | 227 | 462 | 1 |
| Total daily dose=0, Year 1, Week 24 |
40
5.4%
|
5
NaN
|
1
NaN
|
0
NaN
|
| Total daily dose >0 to <=7.5, Year 1, Week 24 |
1
0.1%
|
194
NaN
|
71
NaN
|
0
NaN
|
| Total daily dose >7.5 to <=40, Year 1, Week 24 |
2
0.3%
|
18
NaN
|
376
NaN
|
1
NaN
|
| Total daily dose >40, Year 1, Week 24 |
0
0%
|
0
NaN
|
1
NaN
|
0
NaN
|
| Total daily dose=0, Year 1, Week 48 |
40
5.4%
|
13
NaN
|
13
NaN
|
0
NaN
|
| Total daily dose >0 to <=7.5, Year 1, Week 48 |
2
0.3%
|
180
NaN
|
123
NaN
|
0
NaN
|
| Total daily dose >7.5 to <=40, Year 1, Week 48 |
0
0%
|
19
NaN
|
301
NaN
|
1
NaN
|
| Total daily dose >40, Year 1, Week 48 |
1
0.1%
|
0
NaN
|
4
NaN
|
0
NaN
|
| Total daily dose=0, Year 2, Week 24 |
39
5.3%
|
19
NaN
|
20
NaN
|
0
NaN
|
| Total daily dose >0 to <=7.5, Year 2, Week 24 |
3
0.4%
|
157
NaN
|
145
NaN
|
0
NaN
|
| Total daily dose >7.5 to <=40, Year 2, Week 24 |
0
0%
|
25
NaN
|
237
NaN
|
1
NaN
|
| Total daily dose >40, Year 2, Week 24 |
0
0%
|
0
NaN
|
5
NaN
|
0
NaN
|
| Total daily dose=0, Year 2, Week 48 |
36
4.9%
|
24
NaN
|
21
NaN
|
0
NaN
|
| Total daily dose >0 to <=7.5, Year 2, Week 48 |
1
0.1%
|
143
NaN
|
163
NaN
|
0
NaN
|
| Total daily dose >7.5 to <=40, Year 2, Week 48 |
1
0.1%
|
26
NaN
|
195
NaN
|
1
NaN
|
| Total daily dose >40, Year 2, Week 48 |
0
0%
|
0
NaN
|
1
NaN
|
0
NaN
|
| Total daily dose=0, Year 3, Week 24 |
33
4.5%
|
19
NaN
|
25
NaN
|
0
NaN
|
| Total daily dose >0 to <=7.5, Year 3, Week 24 |
3
0.4%
|
130
NaN
|
159
NaN
|
0
NaN
|
| Total daily dose >7.5 to <=40, Year 3, Week 24 |
1
0.1%
|
27
NaN
|
157
NaN
|
1
NaN
|
| Total daily dose >40, Year 3, Week 24 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Total daily dose=0, Year 3, Week 48 |
31
4.2%
|
20
NaN
|
30
NaN
|
0
NaN
|
| Total daily dose >0 to <=7.5, Year 3, Week 48 |
3
0.4%
|
122
NaN
|
127
NaN
|
0
NaN
|
| Total daily dose >7.5 to <=40, Year 3, Week 48 |
0
0%
|
23
NaN
|
145
NaN
|
1
NaN
|
| Total daily dose >40, Year 3, Week 48 |
0
0%
|
0
NaN
|
2
NaN
|
0
NaN
|
| Total daily dose=0, Year 4, Week 24 |
28
3.8%
|
17
NaN
|
34
NaN
|
0
NaN
|
| Total daily dose >0 to <=7.5, Year 4, Week 24 |
3
0.4%
|
110
NaN
|
134
NaN
|
0
NaN
|
| Total daily dose >7.5 to <=40, Year 4, Week 24 |
2
0.3%
|
23
NaN
|
120
NaN
|
1
NaN
|
| Total daily dose >40, Year 4, Week 24 |
0
0%
|
0
NaN
|
2
NaN
|
0
NaN
|
| Total daily dose=0, Year 4, Week 48 |
22
3%
|
18
NaN
|
40
NaN
|
0
NaN
|
| Total daily dose >0 to <=7.5, Year 4, Week 48 |
3
0.4%
|
100
NaN
|
129
NaN
|
1
NaN
|
| Total daily dose >7.5 to <=40, Year 4, Week 48 |
1
0.1%
|
16
NaN
|
108
NaN
|
0
NaN
|
| Total daily dose >40, Year 4, Week 48 |
0
0%
|
1
NaN
|
0
NaN
|
0
NaN
|
| Total daily dose=0, Year 5, Week 24 |
19
2.6%
|
28
NaN
|
33
NaN
|
0
NaN
|
| Total daily dose >0 to <=7.5, Year 5, Week 24 |
3
0.4%
|
84
NaN
|
124
NaN
|
1
NaN
|
| Total daily dose >7.5 to <=40, Year 5, Week 24 |
1
0.1%
|
16
NaN
|
99
NaN
|
0
NaN
|
| Total daily dose >40, Year 5, Week 24 |
0
0%
|
0
NaN
|
2
NaN
|
0
NaN
|
| Total daily dose=0, Year 5, Week 48 |
17
2.3%
|
26
NaN
|
34
NaN
|
0
NaN
|
| Total daily dose >0 to <=7.5, Year 5, Week 48 |
1
0.1%
|
75
NaN
|
119
NaN
|
1
NaN
|
| Total daily dose >7.5 to <=40, Year 5, Week 48 |
1
0.1%
|
13
NaN
|
85
NaN
|
0
NaN
|
| Total daily dose >40, Year 5, Week 48 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Total daily dose=0, Year 6, Week 24 |
10
1.4%
|
25
NaN
|
33
NaN
|
0
NaN
|
| Total daily dose >0 to <=7.5, Year 6, Week 24 |
2
0.3%
|
62
NaN
|
99
NaN
|
1
NaN
|
| Total daily dose >7.5 to <=40, Year 6, Week 24 |
0
0%
|
10
NaN
|
76
NaN
|
0
NaN
|
| Total daily dose >40, Year 6, Week 24 |
0
0%
|
0
NaN
|
2
NaN
|
0
NaN
|
| Total daily dose=0, Year 6, Week 48 |
10
1.4%
|
24
NaN
|
35
NaN
|
0
NaN
|
| Total daily dose >0 to <=7.5, Year 6, Week 48 |
1
0.1%
|
54
NaN
|
90
NaN
|
1
NaN
|
| Total daily dose >7.5 to <=40, Year 6, Week 48 |
0
0%
|
11
NaN
|
68
NaN
|
0
NaN
|
| Total daily dose >40, Year 6, Week 48 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Total daily dose=0, Year 7, Week 24 |
4
0.5%
|
10
NaN
|
29
NaN
|
0
NaN
|
| Total daily dose >0 to <=7.5, Year 7, Week 24 |
0
0%
|
41
NaN
|
64
NaN
|
1
NaN
|
| Total daily dose >7.5 to <=40, Year 7, Week 24 |
1
0.1%
|
3
NaN
|
40
NaN
|
0
NaN
|
| Total daily dose >40, Year 7, Week 24 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Total daily dose=0, Year 7, Week 48 |
4
0.5%
|
3
NaN
|
24
NaN
|
0
NaN
|
| Total daily dose >0 to <=7.5, Year 7, Week 48 |
0
0%
|
32
NaN
|
34
NaN
|
1
NaN
|
| Total daily dose >7.5 to <=40, Year 7, Week 48 |
0
0%
|
6
NaN
|
29
NaN
|
0
NaN
|
| Total daily dose >40, Year 7, Week 48 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Total daily dose=0, Year 8, Week 24 |
2
0.3%
|
1
NaN
|
8
NaN
|
0
NaN
|
| Total daily dose >0 to <=7.5, Year 8, Week 24 |
0
0%
|
13
NaN
|
15
NaN
|
1
NaN
|
| Total daily dose >7.5 to <=40, Year 8, Week 24 |
0
0%
|
2
NaN
|
11
NaN
|
0
NaN
|
| Total daily dose >40, Year 8, Week 24 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Total daily dose=0, Year 8, Week 48 |
1
0.1%
|
0
NaN
|
5
NaN
|
0
NaN
|
| Total daily dose >0 to <=7.5, Year 8, Week 48 |
0
0%
|
3
NaN
|
6
NaN
|
0
NaN
|
| Total daily dose >7.5 to <=40, Year 8, Week 48 |
0
0%
|
2
NaN
|
1
NaN
|
0
NaN
|
| Total daily dose >40, Year 8, Week 48 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Total daily dose=0, Year 9, Week 24 |
0
0%
|
0
NaN
|
1
NaN
|
0
NaN
|
| Total daily dose >0 to <=7.5, Year 9, Week 24 |
0
0%
|
1
NaN
|
3
NaN
|
0
NaN
|
| Total daily dose >7.5 to <=40, Year 9, Week 24 |
0
0%
|
1
NaN
|
0
NaN
|
0
NaN
|
| Total daily dose >40, Year 9, Week 24 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Total daily dose=0, Year 9, Week 48 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Total daily dose >0 to <=7.5, Year 9, Week 48 |
0
0%
|
1
NaN
|
4
NaN
|
0
NaN
|
| Total daily dose >7.5 to <=40, Year 9, Week 48 |
0
0%
|
1
NaN
|
0
NaN
|
0
NaN
|
| Total daily dose >40, Year 9, Week 48 |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Title | Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit |
|---|---|
| Description | The SLICC/ACR Damage Index was assessed every 48 weeks and at the exit visit as a measure of disease activity. It was developed to assess the accumulated damage since the onset of the disease. The number of participants with worsening in their SLICC/ACR Damage Index score compared with Baseline have been presented. Worsening was defined as a change in score (post-Baseline visit score - Baseline score) > 0. Baseline includes extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. For years in which a participant was withdrawn from the study, the exit visit assessment was used in place of the Week 48 assessment for the year. This value was not carried forward through later years. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Time Frame | Up to 9 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT Population |
| Arm/Group Title | Belimumab 10mg/kg IV |
|---|---|
| Arm/Group Description | Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial. |
| Measure Participants | 735 |
| Year 1,Week 48, n=716 |
39
5.3%
|
| Year 2,Week 48, n=667 |
50
6.8%
|
| Year 3,Week 48, n=580 |
56
7.6%
|
| Year 4,Week 48, n=488 |
57
7.8%
|
| Year 5,Week 48, n=423 |
51
6.9%
|
| Year 6,Week 48, n=330 |
41
5.6%
|
| Year 7,Week 48, n=213 |
28
3.8%
|
| Year 8,Week 48, n=65 |
8
1.1%
|
| Year 9,Week 48, n=6 |
0
0%
|
Adverse Events
| Time Frame | On-treatment SAEs and non-serious adverse events (AEs) were collected from the start of investigational product and until 8 Weeks after the last infusion of trial medication (Approximately 8 years plus) | |
|---|---|---|
| Adverse Event Reporting Description | The MITT consisted of all randomized participants who received at least one dose of trial medication. | |
| Arm/Group Title | Belimumab 10mg/kg IV | |
| Arm/Group Description | Participants received belimumab every 28 days by intravenous (IV) infusion at 1 milligram per kilogram (mg/kg) or 10 mg/kg body weight. Participants who received either 1 mg/kg or 10 mg/kg belimumab in their parent studies continued to receive the same dose of belimumab. Participants randomized to receive placebo in the parent studies received 10 mg/kg beliumamb. Subsequently, the dose of belimumab for participants receiving 1 mg/kg was increased to 10 mg/kg .All participants also received SoC SLE therapy while participating in this trial. | |
All Cause Mortality |
||
| Belimumab 10mg/kg IV | ||
| Affected / at Risk (%) | # Events | |
| Total | 11/735 (1.5%) | |
Serious Adverse Events |
||
| Belimumab 10mg/kg IV | ||
| Affected / at Risk (%) | # Events | |
| Total | 231/735 (31.4%) | |
| Blood and lymphatic system disorders | ||
| Leukopenia | 8/735 (1.1%) | 9 |
| Anaemia | 7/735 (1%) | 7 |
| Thrombocytopenia | 6/735 (0.8%) | 7 |
| Haemolytic anaemia | 2/735 (0.3%) | 2 |
| Lymphadenopathy | 2/735 (0.3%) | 2 |
| Neutropenia | 2/735 (0.3%) | 2 |
| Agranulocytosis | 1/735 (0.1%) | 1 |
| Disseminated intravascular coagulation | 1/735 (0.1%) | 1 |
| Febrile neutropenia | 1/735 (0.1%) | 1 |
| Haemorrhagic disorder | 1/735 (0.1%) | 1 |
| Thrombotic thrombocytopenic purpura | 1/735 (0.1%) | 1 |
| Cardiac disorders | ||
| Myocardial ischaemia | 2/735 (0.3%) | 2 |
| Angina pectoris | 1/735 (0.1%) | 1 |
| Angina unstable | 1/735 (0.1%) | 1 |
| Aortic valve sclerosis | 1/735 (0.1%) | 1 |
| Atrioventricular block second degree | 1/735 (0.1%) | 1 |
| Cardiac arrest | 1/735 (0.1%) | 1 |
| Cardiac tamponade | 1/735 (0.1%) | 1 |
| Cardiogenic shock | 1/735 (0.1%) | 1 |
| Coronary artery occlusion | 1/735 (0.1%) | 1 |
| Lupus myocarditis | 1/735 (0.1%) | 1 |
| Myocardial infarction | 1/735 (0.1%) | 1 |
| Pericardial effusion | 1/735 (0.1%) | 1 |
| Pericarditis | 1/735 (0.1%) | 1 |
| Pericarditis lupus | 1/735 (0.1%) | 1 |
| Sinus tachycardia | 1/735 (0.1%) | 1 |
| Ear and labyrinth disorders | ||
| Vertigo positional | 1/735 (0.1%) | 1 |
| Endocrine disorders | ||
| Hyperthyroidism | 1/735 (0.1%) | 1 |
| Hypothyroidism | 1/735 (0.1%) | 1 |
| Eye disorders | ||
| Maculopathy | 1/735 (0.1%) | 1 |
| Gastrointestinal disorders | ||
| Gastritis | 5/735 (0.7%) | 5 |
| Abdominal pain | 3/735 (0.4%) | 3 |
| Pancreatitis acute | 3/735 (0.4%) | 3 |
| Haemorrhoids | 2/735 (0.3%) | 2 |
| Oesophagitis | 2/735 (0.3%) | 2 |
| Vomiting | 2/735 (0.3%) | 2 |
| Abdominal adhesions | 1/735 (0.1%) | 1 |
| Abdominal hernia | 1/735 (0.1%) | 1 |
| Abdominal pain upper | 1/735 (0.1%) | 1 |
| Duodenitis | 1/735 (0.1%) | 1 |
| Food poisoning | 1/735 (0.1%) | 1 |
| Gastrooesophageal reflux disease | 1/735 (0.1%) | 1 |
| Haematemesis | 1/735 (0.1%) | 1 |
| Haemorrhoidal haemorrhage | 1/735 (0.1%) | 1 |
| Ileus | 1/735 (0.1%) | 1 |
| Lupus enteritis | 1/735 (0.1%) | 2 |
| Mouth ulceration | 1/735 (0.1%) | 1 |
| Nausea | 1/735 (0.1%) | 1 |
| Proctitis | 1/735 (0.1%) | 1 |
| Rectal ulcer | 1/735 (0.1%) | 1 |
| General disorders | ||
| Pyrexia | 9/735 (1.2%) | 10 |
| Non-cardiac chest pain | 4/735 (0.5%) | 4 |
| Complication associated with device | 1/735 (0.1%) | 1 |
| Cyst | 1/735 (0.1%) | 1 |
| Face oedema | 1/735 (0.1%) | 1 |
| Fatigue | 1/735 (0.1%) | 1 |
| Oedema peripheral | 1/735 (0.1%) | 1 |
| Pain | 1/735 (0.1%) | 1 |
| Peripheral swelling | 1/735 (0.1%) | 1 |
| Hepatobiliary disorders | ||
| Cholelithiasis | 5/735 (0.7%) | 5 |
| Biliary dilatation | 1/735 (0.1%) | 1 |
| Cholangitis acute | 1/735 (0.1%) | 1 |
| Cholecystitis acute | 1/735 (0.1%) | 1 |
| Gallbladder non-functioning | 1/735 (0.1%) | 1 |
| Lupus hepatitis | 1/735 (0.1%) | 1 |
| Portal vein thrombosis | 1/735 (0.1%) | 1 |
| Immune system disorders | ||
| Drug hypersensitivity | 2/735 (0.3%) | 2 |
| Infections and infestations | ||
| Pneumonia bacterial | 14/735 (1.9%) | 16 |
| Cellulitis | 12/735 (1.6%) | 14 |
| Urinary tract infection | 9/735 (1.2%) | 9 |
| Urinary tract infection bacterial | 9/735 (1.2%) | 11 |
| Pneumonia | 8/735 (1.1%) | 8 |
| Appendicitis | 6/735 (0.8%) | 6 |
| Gastroenteritis | 5/735 (0.7%) | 5 |
| Herpes zoster | 5/735 (0.7%) | 5 |
| Bacterial pyelonephritis | 3/735 (0.4%) | 3 |
| Bacterial sepsis | 3/735 (0.4%) | 3 |
| Septic shock | 3/735 (0.4%) | 4 |
| Viral upper respiratory tract infection | 3/735 (0.4%) | 3 |
| Abscess soft tissue | 2/735 (0.3%) | 2 |
| Acute sinusitis | 2/735 (0.3%) | 2 |
| Bronchitis | 2/735 (0.3%) | 2 |
| Bronchitis bacterial | 2/735 (0.3%) | 2 |
| Cytomegalovirus infection | 2/735 (0.3%) | 2 |
| Diarrhoea infectious | 2/735 (0.3%) | 2 |
| Escherichia infection | 2/735 (0.3%) | 2 |
| Gastroenteritis viral | 2/735 (0.3%) | 2 |
| Influenza | 2/735 (0.3%) | 2 |
| Pyelonephritis acute | 2/735 (0.3%) | 2 |
| Respiratory tract infection viral | 2/735 (0.3%) | 2 |
| Soft tissue infection | 2/735 (0.3%) | 2 |
| Subcutaneous abscess | 2/735 (0.3%) | 2 |
| Wound infection bacterial | 2/735 (0.3%) | 2 |
| Abdominal infection | 1/735 (0.1%) | 1 |
| Abscess of salivary gland | 1/735 (0.1%) | 1 |
| Acinetobacter bacteraemia | 1/735 (0.1%) | 1 |
| Acinetobacter infection | 1/735 (0.1%) | 1 |
| Amoebic dysentery | 1/735 (0.1%) | 1 |
| Anal abscess | 1/735 (0.1%) | 2 |
| Bronchitis viral | 1/735 (0.1%) | 1 |
| Bursitis infective | 1/735 (0.1%) | 1 |
| Bursitis infective staphylococcal | 1/735 (0.1%) | 1 |
| Cellulitis staphylococcal | 1/735 (0.1%) | 1 |
| Cutaneous tuberculosis | 1/735 (0.1%) | 1 |
| Enterococcal bacteraemia | 1/735 (0.1%) | 1 |
| Enterocolitis infectious | 1/735 (0.1%) | 1 |
| Erysipelas | 1/735 (0.1%) | 1 |
| Escherichia bacteraemia | 1/735 (0.1%) | 1 |
| Escherichia sepsis | 1/735 (0.1%) | 1 |
| Fungaemia | 1/735 (0.1%) | 1 |
| Gastroenteritis bacterial | 1/735 (0.1%) | 1 |
| Gastrointestinal fungal infection | 1/735 (0.1%) | 1 |
| Gastrointestinal infection | 1/735 (0.1%) | 1 |
| Gastrointestinal viral infection | 1/735 (0.1%) | 1 |
| Hepatitis A | 1/735 (0.1%) | 1 |
| Herpes zoster cutaneous disseminated | 1/735 (0.1%) | 1 |
| Infectious colitis | 1/735 (0.1%) | 1 |
| Infectious pleural effusion | 1/735 (0.1%) | 2 |
| Joint abscess | 1/735 (0.1%) | 1 |
| Joint tuberculosis | 1/735 (0.1%) | 1 |
| Kidney infection | 1/735 (0.1%) | 3 |
| Latent tuberculosis | 1/735 (0.1%) | 1 |
| Meningitis aseptic | 1/735 (0.1%) | 2 |
| Osteomyelitis chronic | 1/735 (0.1%) | 1 |
| Parasitic gastroenteritis | 1/735 (0.1%) | 1 |
| Pelvic inflammatory disease | 1/735 (0.1%) | 1 |
| Peritonitis | 1/735 (0.1%) | 1 |
| Peritonitis bacterial | 1/735 (0.1%) | 1 |
| Postoperative wound infection | 1/735 (0.1%) | 1 |
| Pulmonary mycosis | 1/735 (0.1%) | 1 |
| Pulmonary tuberculosis | 1/735 (0.1%) | 1 |
| Pyelonephritis | 1/735 (0.1%) | 1 |
| Salmonella bacteraemia | 1/735 (0.1%) | 1 |
| Sepsis | 1/735 (0.1%) | 1 |
| Sialoadenitis | 1/735 (0.1%) | 2 |
| Skin candida | 1/735 (0.1%) | 1 |
| Staphylococcal abscess | 1/735 (0.1%) | 1 |
| Streptococcal bacteraemia | 1/735 (0.1%) | 1 |
| Tracheitis | 1/735 (0.1%) | 1 |
| Tubo-ovarian abscess | 1/735 (0.1%) | 1 |
| Upper respiratory tract infection | 1/735 (0.1%) | 1 |
| Upper respiratory tract infection bacterial | 1/735 (0.1%) | 1 |
| Urinary tract infection fungal | 1/735 (0.1%) | 1 |
| Urosepsis | 1/735 (0.1%) | 1 |
| Injury, poisoning and procedural complications | ||
| Foot fracture | 2/735 (0.3%) | 2 |
| Humerus fracture | 2/735 (0.3%) | 2 |
| Pelvic fracture | 2/735 (0.3%) | 2 |
| Radius fracture | 2/735 (0.3%) | 2 |
| Ankle fracture | 1/735 (0.1%) | 1 |
| Contusion | 1/735 (0.1%) | 1 |
| Craniocerebral injury | 1/735 (0.1%) | 1 |
| Femoral neck fracture | 1/735 (0.1%) | 1 |
| Fibula fracture | 1/735 (0.1%) | 1 |
| Hip fracture | 1/735 (0.1%) | 1 |
| Joint dislocation | 1/735 (0.1%) | 1 |
| Laceration | 1/735 (0.1%) | 1 |
| Ligament sprain | 1/735 (0.1%) | 1 |
| Lower limb fracture | 1/735 (0.1%) | 1 |
| Post procedural fistula | 1/735 (0.1%) | 1 |
| Post procedural haemorrhage | 1/735 (0.1%) | 1 |
| Spinal compression fracture | 1/735 (0.1%) | 1 |
| Subdural haematoma | 1/735 (0.1%) | 1 |
| Tendon rupture | 1/735 (0.1%) | 1 |
| Tibia fracture | 1/735 (0.1%) | 1 |
| Ulna fracture | 1/735 (0.1%) | 1 |
| Upper limb fracture | 1/735 (0.1%) | 1 |
| Metabolism and nutrition disorders | ||
| Dehydration | 1/735 (0.1%) | 1 |
| Hypoalbuminaemia | 1/735 (0.1%) | 1 |
| Hypokalaemia | 1/735 (0.1%) | 1 |
| Obesity | 1/735 (0.1%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Back pain | 5/735 (0.7%) | 5 |
| Osteonecrosis | 5/735 (0.7%) | 10 |
| Arthralgia | 4/735 (0.5%) | 4 |
| SLE arthritis | 3/735 (0.4%) | 3 |
| Fibromyalgia | 2/735 (0.3%) | 2 |
| Myalgia | 2/735 (0.3%) | 2 |
| Arthritis | 1/735 (0.1%) | 1 |
| Intervertebral disc protrusion | 1/735 (0.1%) | 1 |
| Kyphosis | 1/735 (0.1%) | 1 |
| Neck pain | 1/735 (0.1%) | 1 |
| Osteoarthritis | 1/735 (0.1%) | 1 |
| Osteochondrosis | 1/735 (0.1%) | 1 |
| Pain in extremity | 1/735 (0.1%) | 1 |
| Pathological fracture | 1/735 (0.1%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Cervix carcinoma stage 0 | 2/735 (0.3%) | 2 |
| Uterine leiomyoma | 2/735 (0.3%) | 2 |
| Benign breast neoplasm | 1/735 (0.1%) | 2 |
| Benign neoplasm of skin | 1/735 (0.1%) | 1 |
| Bowen's disease | 1/735 (0.1%) | 1 |
| Intraductal papilloma of breast | 1/735 (0.1%) | 1 |
| Invasive ductal breast carcinoma | 1/735 (0.1%) | 1 |
| Papillary thyroid cancer | 1/735 (0.1%) | 1 |
| Rectal adenocarcinoma | 1/735 (0.1%) | 1 |
| Rectal cancer | 1/735 (0.1%) | 1 |
| Vulval cancer stage 0 | 1/735 (0.1%) | 1 |
| Nervous system disorders | ||
| Headache | 3/735 (0.4%) | 3 |
| Syncope | 2/735 (0.3%) | 2 |
| Cerebral infarction | 1/735 (0.1%) | 1 |
| Cerebral thrombosis | 1/735 (0.1%) | 1 |
| Extrapyramidal disorder | 1/735 (0.1%) | 1 |
| Hypoaesthesia | 1/735 (0.1%) | 2 |
| Intracranial pressure increased | 1/735 (0.1%) | 1 |
| Ischaemic stroke | 1/735 (0.1%) | 1 |
| Lacunar stroke | 1/735 (0.1%) | 1 |
| Migraine | 1/735 (0.1%) | 1 |
| Myasthenia gravis | 1/735 (0.1%) | 2 |
| Neuropsychiatric lupus | 1/735 (0.1%) | 1 |
| Paraesthesia | 1/735 (0.1%) | 1 |
| Paraplegia | 1/735 (0.1%) | 1 |
| Tension headache | 1/735 (0.1%) | 1 |
| Pregnancy, puerperium and perinatal conditions | ||
| Abortion spontaneous | 2/735 (0.3%) | 2 |
| Gestational diabetes | 1/735 (0.1%) | 1 |
| Psychiatric disorders | ||
| Anxiety | 2/735 (0.3%) | 2 |
| Depression | 2/735 (0.3%) | 4 |
| Suicide attempt | 2/735 (0.3%) | 2 |
| Confusional state | 1/735 (0.1%) | 1 |
| Mania | 1/735 (0.1%) | 1 |
| Panic attack | 1/735 (0.1%) | 1 |
| Suicidal ideation | 1/735 (0.1%) | 1 |
| Renal and urinary disorders | ||
| Lupus nephritis | 12/735 (1.6%) | 14 |
| Acute kidney injury | 2/735 (0.3%) | 3 |
| Nephrotic syndrome | 2/735 (0.3%) | 2 |
| Proteinuria | 2/735 (0.3%) | 3 |
| Bladder diverticulum | 1/735 (0.1%) | 1 |
| Cystitis haemorrhagic | 1/735 (0.1%) | 1 |
| Renal colic | 1/735 (0.1%) | 1 |
| Renal impairment | 1/735 (0.1%) | 1 |
| Renal tubular acidosis | 1/735 (0.1%) | 1 |
| Renal tubular necrosis | 1/735 (0.1%) | 1 |
| Reproductive system and breast disorders | ||
| Cervical dysplasia | 2/735 (0.3%) | 2 |
| Ovarian cyst | 2/735 (0.3%) | 2 |
| Dysfunctional uterine bleeding | 1/735 (0.1%) | 1 |
| Endometriosis | 1/735 (0.1%) | 2 |
| Haemorrhagic ovarian cyst | 1/735 (0.1%) | 1 |
| Ovarian cyst ruptured | 1/735 (0.1%) | 1 |
| Ovarian cyst torsion | 1/735 (0.1%) | 1 |
| Parovarian cyst | 1/735 (0.1%) | 1 |
| Uterine haemorrhage | 1/735 (0.1%) | 1 |
| Uterine polyp | 1/735 (0.1%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Pulmonary embolism | 2/735 (0.3%) | 2 |
| Acute respiratory distress syndrome | 1/735 (0.1%) | 1 |
| Acute respiratory failure | 1/735 (0.1%) | 1 |
| Asthma | 1/735 (0.1%) | 1 |
| Atelectasis | 1/735 (0.1%) | 1 |
| Epistaxis | 1/735 (0.1%) | 1 |
| Haemoptysis | 1/735 (0.1%) | 1 |
| Haemothorax | 1/735 (0.1%) | 1 |
| Interstitial lung disease | 1/735 (0.1%) | 1 |
| Lower respiratory tract inflammation | 1/735 (0.1%) | 1 |
| Lupus pneumonitis | 1/735 (0.1%) | 1 |
| Pleural effusion | 1/735 (0.1%) | 1 |
| Pulmonary congestion | 1/735 (0.1%) | 1 |
| Pulmonary haemorrhage | 1/735 (0.1%) | 1 |
| Respiratory distress | 1/735 (0.1%) | 1 |
| Rhinitis hypertrophic | 1/735 (0.1%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Systemic lupus erythematosus rash | 3/735 (0.4%) | 4 |
| Urticaria | 3/735 (0.4%) | 3 |
| Alopecia | 2/735 (0.3%) | 2 |
| Skin ulcer | 2/735 (0.3%) | 2 |
| Drug eruption | 1/735 (0.1%) | 1 |
| Erythema | 1/735 (0.1%) | 1 |
| Hyperhidrosis | 1/735 (0.1%) | 1 |
| Pemphigoid | 1/735 (0.1%) | 1 |
| Pyoderma gangrenosum | 1/735 (0.1%) | 1 |
| Vascular disorders | ||
| Raynaud's phenomenon | 5/735 (0.7%) | 9 |
| Lupus vasculitis | 4/735 (0.5%) | 4 |
| Hypertension | 3/735 (0.4%) | 3 |
| Deep vein thrombosis | 2/735 (0.3%) | 2 |
| Vasculitis | 2/735 (0.3%) | 2 |
| Aortic dissection | 1/735 (0.1%) | 1 |
| Aortic stenosis | 1/735 (0.1%) | 1 |
| Hypertensive crisis | 1/735 (0.1%) | 1 |
| Peripheral arterial occlusive disease | 1/735 (0.1%) | 1 |
| Peripheral artery stenosis | 1/735 (0.1%) | 1 |
| Peripheral ischaemia | 1/735 (0.1%) | 1 |
| Varicose vein | 1/735 (0.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Belimumab 10mg/kg IV | ||
| Affected / at Risk (%) | # Events | |
| Total | 614/735 (83.5%) | |
| Blood and lymphatic system disorders | ||
| Anaemia | 45/735 (6.1%) | 56 |
| Gastrointestinal disorders | ||
| Diarrhoea | 143/735 (19.5%) | 235 |
| Nausea | 64/735 (8.7%) | 97 |
| Abdominal pain | 60/735 (8.2%) | 78 |
| Abdominal pain upper | 60/735 (8.2%) | 80 |
| Gastritis | 52/735 (7.1%) | 59 |
| Vomiting | 50/735 (6.8%) | 70 |
| Dyspepsia | 39/735 (5.3%) | 50 |
| General disorders | ||
| Pyrexia | 73/735 (9.9%) | 92 |
| Fatigue | 56/735 (7.6%) | 61 |
| Oedema peripheral | 47/735 (6.4%) | 56 |
| Non-cardiac chest pain | 38/735 (5.2%) | 41 |
| Infections and infestations | ||
| Nasopharyngitis | 155/735 (21.1%) | 396 |
| Influenza | 132/735 (18%) | 274 |
| Urinary tract infection bacterial | 87/735 (11.8%) | 163 |
| Viral upper respiratory tract infection | 84/735 (11.4%) | 196 |
| Upper respiratory tract infection | 82/735 (11.2%) | 151 |
| Urinary tract infection | 68/735 (9.3%) | 99 |
| Herpes zoster | 55/735 (7.5%) | 56 |
| Upper respiratory tract infection bacterial | 54/735 (7.3%) | 108 |
| Gastroenteritis | 49/735 (6.7%) | 59 |
| Bronchitis bacterial | 48/735 (6.5%) | 81 |
| Bronchitis | 46/735 (6.3%) | 64 |
| Oral herpes | 45/735 (6.1%) | 89 |
| Pharyngitis bacterial | 39/735 (5.3%) | 85 |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 134/735 (18.2%) | 217 |
| Back pain | 102/735 (13.9%) | 141 |
| Myalgia | 64/735 (8.7%) | 77 |
| Pain in extremity | 49/735 (6.7%) | 73 |
| Nervous system disorders | ||
| Headache | 205/735 (27.9%) | 407 |
| Dizziness | 61/735 (8.3%) | 82 |
| Psychiatric disorders | ||
| Insomnia | 55/735 (7.5%) | 64 |
| Depression | 49/735 (6.7%) | 57 |
| Respiratory, thoracic and mediastinal disorders | ||
| Cough | 120/735 (16.3%) | 176 |
| Rhinitis allergic | 37/735 (5%) | 47 |
| Skin and subcutaneous tissue disorders | ||
| Rash | 56/735 (7.6%) | 77 |
| Alopecia | 48/735 (6.5%) | 62 |
| Pruritus | 44/735 (6%) | 55 |
| Vascular disorders | ||
| Hypertension | 67/735 (9.1%) | 111 |
| Hypotension | 39/735 (5.3%) | 192 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
| Name/Title | GSK Response Center |
|---|---|
| Organization | GlaxoSmithKline |
| Phone | 866-435-7343 |
Responsible Party:
Human Genome Sciences Inc., a GSK Company
ClinicalTrials.gov Identifier:
NCT00712933
Other Study ID Numbers:
- 112234
- 2007-007648-85
First Posted:
Jul 10, 2008
Last Update Posted:
Dec 5, 2019
Last Verified:
Nov 1, 2019