Biologics such as tildrakizumab are currently the most effective treatment option for patients with moderate to severe psoriasis. But they are costly for healthcare systems and still described according to a 'one dose fits all' dosing regimen, leading to potential over-and undertreatment. In this study, the investigators aim to investigate the predictive value of early serum trough levels of tildrakizumab and determine the therapeutic window of tildrakizumab in psoriasis patients.
Patients will be included after signing informed consent. After inclusion, patients will continue on standard dosing schedule of tildrakizumab (i.e. subcutaneous injections at weeks 0 and 4, then every 12 weeks (100mg)). During each study visit blood will be taken in order to quantify Ctroughs and/or anti-drug antibodies towards tildrakizumab. In addition, Psoriasis Area and Severity Index (PASI) and 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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of tildrakizumab.
The study participants will complete the Dermatology Quality of Life (DLQI) and EQ-5D-5L questionnaire at each study visit.
University Hospital Ghent
Ghent, East-Flanders, Belgium
RECRUITINGUniversity Hospital Ghent
Ghent, Belgium
RECRUITINGCorrelation between early serum trough concentrations of tildrakizumab and clinical response
To assess the predictive value of early serum trough levels of tildrakizumab (µg/ml), the clinical response (PASI) at week 12 and/or week 24 will be correlated with serum trough concentrations of tildrakizumab measurements taken from week 0,1,2,3 and/or 4.
Time frame: Week 0 until week 24 of treatment
Predictive value of early anti-drug antibodies of tildrakizumab
To assess the predictive value of early anti-drug antibodies of tildrakizumab (µg/ml), the clinical response (PASI) at week 12 and/or week 24 will be correlated with serum trough concentrations of tildrakizumab measurements taken from week 0,1,2,3 and/or 4.
Time frame: Week 0 until week 24 of treatment
Development of the therapeutic window of tildrakizumab in psoriasis
Defining a therapeutic window for tildrakizumab based on serum trough concentrations corresponding with adequate clinical response (ROC analysis and concentration-effect curve).
Time frame: Week 0 until week 52 of treatment
DLQI
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.
Time frame: Week 0 until week 52 of treatment
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EQ-5D-5L
The EQ-5D-5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.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 of the five dimensions can be combined into a 5- digit number that describes the patients' health state.
Time frame: Week 0 until week 52 of treatment
EQ VAS
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.
Time frame: Week 0 until week 52 of treatment