This Study is to Describe and Evaluate Patients in Finland Treated With Tofacitinib for the Treatment of Ulcerative Colitis Using Real World Data.
Study Details
Study Description
Brief Summary
The aim of this study is to describe and evaluate clinical outcomes, treatment lines, and to identify the key characteristics of the patients treated with tofacitinib.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients treated with Tofacitinib Patients treated with tofacitinib for ulcerative colitis in Finland. |
Outcome Measures
Primary Outcome Measures
- Participant demographics at tofacitinib treatment initiation [Baseline]
Age, gender, weight, height, smoking status, body mass index (BMI), treating hospital
- Disease characteristics at tofacitinib treatment initiation [Baseline]
Age at diagnosis, duration of disease and extent of colonic involvement according to the Montreal classification: E1 (ulcerative proctitis), E2 (left sided, distal colitis), E3 (pancolitis)
- Disease severity at tofacitinib treatment initiation [Baseline]
Assessed by Mayo score and fecal calprotectin (f-calprotectin)
- Laboratory results for biochemical inflammatory markers at tofacitinib treatment initiation [Baseline]
Plasma C-reactive protein (P-CRP), blood thrombocytes (B-thromb), plasma albumin (P-alb), blood leukocytes (B-leuk), blood lymphocytes (B-ly), blood neutrophiles (B-neutr), blood hemoglobin (B-hb) and f-calprotectin
- Endoscopic findings including histology at tofacitinib treatment initiation [Baseline]
Secondary Outcome Measures
- Proportion of patients who are taking tofacitinib [Weeks 8, 16, 24, 52]
- Rate of clinical remission based on full Mayo score [Weeks 8, 16, 24, 52]
A clinical remission is defined as a full Mayo score of ≤2 points with no individual sub score exceeding 1 point, with rectal bleeding sub-score of 0
- Rate of clinical remission based on partial Mayo score [Weeks 8, 16, 24, 52]
A clinical remission is defined as a partial Mayo score <2 points with rectal bleeding sub-score of 0
- Rate of clinical response based on full Mayo score [Weeks 8, 16, 24, 52]
A clinical response is defined as a full Mayo score decrease of ≥3 points and a decrease of ≥30% from baseline, with a decrease of ≥1 point on the rectal bleeding sub score or an absolute rectal bleeding score of ≤1
- Rate of clinical response based on partial Mayo score [Weeks 8, 16, 24, 52]
A clinical response is defined as a partial Mayo score decrease of ≥2 points and reduction of at least 25% in partial Mayo score from baseline with an accompanying decrease in rectal bleeding sub score of ≥1 point or absolute rectal bleeding sub score of ≤1
- Proportion of participants in steroid-free clinical remission [Weeks 8, 16, 24, 52]
Steroid-free clinical remission is defined by full or partial Mayo who did not require any corticosteroid treatment during the period ≥4 weeks prior to the visit
- Proportion of participants reaching clinical response based on full Mayo score [Weeks 8, 16, 24, 52]
A clinical response is defined as a full Mayo score decrease of ≥3 points and a decrease of ≥30% from baseline, with a decrease of ≥1 point on the rectal bleeding sub score or an absolute rectal bleeding score of ≤1.
- Proportion of participants reaching clinical response based on partial Mayo score [Weeks 8, 16, 24, 52]
A clinical response is defined as a partial Mayo score decrease of ≥2 points and reduction of at least 25% in partial Mayo score from baseline with an accompanying decrease in rectal bleeding sub score of ≥1 point or absolute rectal bleeding sub score of ≤1
- Time to response as assessed by a decrease based on full Mayo score. [Weeks 8, 16, 24, 52]
- Time to response as assessed by a decrease based on partial Mayo score. [Weeks 8, 16, 24, 52]
- Proportion of participants that had f-calprotectin above 250 mg/kg [Baseline]
- Change from baseline in fecal calprotectin [Baseline, Weeks 8, 16, 24, 52]
- Proportion of participants reaching f-calprotectin below 250 mg/kg of those with active disease based on f-calprotectin at baseline [Weeks 8, 16, 24, 52]
Active disease defined as fecal calprotectin (f-calprotectin) >250mg/kg.
- Proportion of participants in sustained remission (full Mayo score) [Week 8 to week 16, 24 and 52]
- Proportion of participants in sustained remission (full Mayo score) [Week 16 to week 24 and 52]
- Proportion of participants in sustained remission (partial Mayo score) [Week 8 to week 16, 24 and 52]
- Proportion of participants in sustained remission (partial Mayo score) [Week 16 to week 24 and 52]
- Proportion of participants in sustained steroid free remission (full Mayo score) (for all patients and for those treated with corticosteroids at baseline). [Week 16 to 24 and 52]
- Proportion of participants in sustained steroid free remission (partial Mayo score) (for all patients and for those treated with corticosteroids at baseline). [Week 16 to 24 and 52]
- Change in full Mayo score [Baseline, Weeks 8, 16, 24, 52]
- Change in partial Mayo score [Baseline, Weeks 8, 16, 24, 52]
- Proportion of participants in sustained endoscopic remission, mucosal healing or endoscopic response [Baseline, Week 8 to week 16, 24 and 52]
Endoscopic remission is defined as a sub score = 0. Mucosal healing is defined as a sub score 0-1. Endoscopic response is defined as a sub score reduction from baseline of ≥1.
- Proportion of participants in physician assessed histological remission determined as inactive disease, or normal histology, and change from baseline in histology assessment [Baseline, Weeks 8, 16, 24, 52]
Active disease is defined as an endoscopic Mayo sub-score of ≥2 or fecal-calprotectin (f-calprotectin) >250mg/kg. Histology is assessed as subscore 0= normal histology, 1= inactive disease and 2 = active disease.
- Proportion of participants in sustained steroid free remission (partial Mayo score) (for all patients and for those treated with corticosteroids at baseline) and endoscopic remission, mucosal healing or endoscopic response [Baseline, Week 8 to week 16, 24 and 52]
Endoscopic remission is defined as a sub score = 0. Mucosal healing is defined as a sub score 0-1. Endoscopic response is defined as a sub score reduction from baseline of ≥1.
- Proportion of participants in sustained steroid free remission (full Mayo score) (for all patients and for those treated with corticosteroids at baseline) and endoscopic remission, mucosal healing or endoscopic response [Baseline, Week 8 to week 16, 24 and 52]
Endoscopic remission is defined as a sub score = 0. Mucosal healing is defined as a sub score 0-1. Endoscopic response is defined as a sub score reduction from baseline of ≥1.
- Comparison of response and remission (full Mayo score) based on the extent of colonic involvement according to the Montreal classification [Baseline, Weeks 8, 16, 24, 52]
- Comparison of response and remission (partial Mayo score) based on the extent of colonic involvement according to the Montreal classification [Baseline, Weeks 8, 16, 24, 52]
- Proportion of participants with corticosteroid tapering and their tapering rates and doses [Baseline, Weeks 8, 16, 24, 52]
- Proportion of participants with improvement in stool frequency and change from baseline in stool frequency sub score [Baseline, Weeks 8, 16, 24, 52]
Improvement in stool frequency defined as sub score improvement of 1 or more points
- Proportion of patients with improvement in rectal bleeding and change from baseline in rectal bleeding sub score [Baseline, Weeks 8, 16, 24, 52]
Improvement inrectal bleeding defined as sub score improvement of 1 or more points
- Proportion of participants reaching normal plasma C-reactive protein (P-CRP) levels and change from baseline [Baseline, Weeks 8, 16, 24, 52]
Normal P-CRP levels defined as below 4mg/L
- Proportion of participants reaching normal blood hemoglobin (B-hb) levels and change from baseline [Baseline, Weeks 8, 16, 24, 52]
Normal B-hb levels defined as men=134-167 g/L, women=117-155 g/L
- Proportion of participants reaching normal blood leukocyte (B-leuk) levels and change from baseline [Baseline, Weeks 8, 16, 24, 52]
Normal B-leuk levels defined as 3.4-8.2 x 109/L
- Proportion of participants reaching normal blood thrombocytes (B-Thromb) levels and change from baseline [Baseline, Weeks 8, 16, 24, 52]
Normal B-Thromb levels defined as 150-360 x 109/L
- Proportion of participants reaching normal blood lymphocyte (B-ly) levels and change from baseline [Baseline, Weeks 8, 16, 24, 52]
Normal B-ly levels defined as 1.3-3.6 x 109/L
- Proportion of participants reaching normal blood neutrophile (B-neutr) levels and change from baseline [Baseline, Weeks 8, 16, 24, 52]
Normal B-neutr levels defined as 1.5-6.7 x 109/L
- Proportion of participants reaching normal plasma albumin (P-alb) levels and change from baseline [Baseline, Weeks 8, 16, 24, 52]
Normal P-alb levels defined as 18-39 years=36-48 g/L, 40-69 years=36-45 g/L, 70 years and over=34-45 g/L
- Proportion of participants with extended tofacitinib induction dose [Baseline, Weeks 8, 16, 24, 52]
Participants with induction dose after 8 weeks
- Real-world dosing of tofacitinib [Baseline, Weeks 8, 16, 24, 52]
- Survival without drug discontinuation, colectomy or UC-related hospitalization [Baseline, Weeks 8, 16, 24, 52]
- To Assess Treatment Lines Prior to Tofacitinib Treatment. [Baseline]
Number and type of previous UC treatments.
- Proportion of responders defined by a fecal calprotectin (f-calprotectin) reduction of ≥50%, ≥75% or ≥90% compared to baseline [Baseline, Weeks 8, 16, 24, 52]
Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Xeljanz (tofacitinib) usage for ulcerative colitis
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Diagnosis of ulcerative colitis (ICD-10: K51.0, K51.1, K51.2, K51.3, K51.5, K51.8, K51.9) between January 2010 and December 2021 (incident or prevalent).
Exclusion Criteria:
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Age < 18 years at the start of tofacitinib use
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Use of tofacitinib before reimbursement (1.3.2019)
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< 8 weeks of treatment with tofacitinib at the start of data mining
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History of panproctocolectomy, IPAA or ileostomy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer | Helsinki | Finland |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- A3921390
- FinTofUC