BIOLOPTIM-IXE: Therapeutic Drug Monitoring of Ixekizumab in Psoriasis Patients
Study Details
Study Description
Brief Summary
Biologics, such as ixekizumab, are currently the most effective treatment option for patients with moderate-to-severe psoriasis. But they are costly for health care systems and prescribed according to a 'one dose fits all' dosing regimen, leading to potential over- and undertreatment. Within this study the investigators aim to investigate the predictive value of early serum trough levels of ixekizumab and determine the therapeutic window of ixekizumab in psoriasis patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Patients will be included after siging informed consent. After inclusion, patients will continue on standard dosing schedule of ixekizumab (i.e. one loading dose of 2 subcutaneous injections (160 mg) at week 0, followed by one subcutaneous injection (80 mg) every 2 weeks for 12 weeks, and then one subcutaneous injections (80 mg) every 4 weeks). During each study visit, blood will be taken in order to quantify Ctroughs and/or anti-drug antibodies towards ixekizumab. In addition, the Psoriasis Severity and Area Index (PASI) and the Investigator's Global Assessment (IGA) score will be evaluated by a physician. Patients complete the Dermatology Life Quality Index (DLQI) and European quality of life EQ-5D instrument at each visit.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Standard of care - ixekizumab Patient will continue to receive ixekizumab according to standard of care dosing regimen, i.e. loading dose first (160 mg) at week 0; 80 mg every 2 weeks until week 12, then 80 mg every 4 weeks |
Procedure: Venapuncture
Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of ixekizumab
Other: Patient questionnaires
The study participant will complete the Dermatology Quality of Life Index (DLQI) and EQ5D5L questionnaires at each study visit.
|
Outcome Measures
Primary Outcome Measures
- Predictive value of early serum trough concentrations of ixekizumab [Week 0 until week 24 of treatment]
Prediction of the clinical response (PASI) at week 12 and/or week 24 based on serum trough concentrations measurements taken from week 0, 1, 2, 3 and/or 4.
- Predictive value of early anti-drug antibodies of ixekizumab [Week 0 until week 24 of treatment]
Prediction of the clinical response (PASI) at week 12 and/or week 24 based on anti-drug antibodies measurements taken from week 0, 1, 2, 3 and/or 4.
- The development of a therapeutic window of ixekizumab in psoriasis [Week 0 until week 52 of treatment]
Defining a therapeutic window for ixekizumab based on serum trough levels corresponding with adequate clinical response.
Secondary Outcome Measures
- DLQI [Week 0 until week 52 of treatment]
The DLQI (Dermatology Life Quality Index) (range 0-30) is a dermatology specific quality of life (QoL) instrument designed to assess the impact of the disease on participant's QoL. It is a ten item questionnaire that, in addition to evaluated overall QoL, can be used to assess six different aspects that may affect QoL: 1) symptoms and feelings, 2) daily activities, 3) leasure, 4) work or school performances, 5) personal relationships, and 6) treatment. The scoring of each question is as follows: Very much - scored 3; A lot - scored 2; A little - scored 1; Not at all - scored 0; Not relevant - scored 0; Question 7, 'prevented work or studying' - scored 3. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
- EQ5D5L [Week 0 until week 52 of treatment]
The 5-level EQ-5D version (EQ-5D-5L) was introduced by the EuroQol Group in 2009 to improve the instrument's sensitivity and to reduce ceiling effects. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems (level 1), slight problems (level 2), moderate problems (level 3), severe problems (level 4) and extreme problems (level 5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state, which is the outcome result. There is no minimum or maximum score since the the 5 digit-number is a non-numeric variable.
- EQ VAS [Week 0 until week 52 of treatment]
The EQ VAS (Visual Analogue Scale) (range 0-10) records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. Minimum score is 0%, max. score is 100%. Lower values mean 'worse health the patient can imagine', higher values mean 'better health the patient can imagine'.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis
-
Participants must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
Exclusion Criteria:
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Participants who have currently a predominant nonplaque form of psoriasis
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Participants who are pregnant, nursing or planning a pregnancy
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Participants who are unable or unwilling to undergo multiple venapunctures
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Participants who are treated according to a different dosing schedule than standard dosing of ixekizumab
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AZ Maria Middelares | Ghent | Oost-Vlaanderen | Belgium | 9000 |
| 2 | AZ Sint-Lucas | Ghent | Oost-Vlaanderen | Belgium | 9000 |
| 3 | University Hospital of Ghent | Ghent | Oost-Vlaanderen | Belgium | 9000 |
| 4 | Private Practice Dermatology | Maldegem | Oost-Vlaanderen | Belgium | 9990 |
| 5 | UZ Hospital | Leuven | Vlaams-Brabant | Belgium | 3000 |
| 6 | AZ Sint-Jan | Bruges | West-Vlaanderen | Belgium | 8000 |
| 7 | AZ Delta Rembert | Torhout | West-Vlaanderen | Belgium | 8820 |
Sponsors and Collaborators
- University Hospital, Ghent
- KU Leuven
- University Ghent
Investigators
- Principal Investigator: Jo Lambert, Prof., University Ghent
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BIOLOPTIM-IXE