Evaluation of Early Brodalumab Blood Levels and Anti-drug Antibodies to Define Therapeutic Window in Psoriasis Patients

What this Trial Is About

Researchers are studying the use of brodalumab, a biologic treatment, in patients with moderate-to-severe psoriasis. The study aims to understand how early blood levels of brodalumab and the presence of anti-drug antibodies can predict treatment response. It also seeks to define the optimal therapeutic range of brodalumab dosing to avoid over- or undertreatment, which is important because current dosing follows a fixed schedule that may not suit all patients. Participants will continue receiving brodalumab according to the standard dosing schedule: a loading dose of 210 mg, followed by weekly doses of 210 mg for two weeks, then 210 mg every two weeks. During each study visit, blood samples will be taken to measure brodalumab trough levels and anti-drug antibodies. Physicians will assess psoriasis severity using the Psoriasis Severity and Area Index (PASI) and Investigator's Global Assessment (IGA) scores. Patients will also complete quality-of-life questionnaires, including the Dermatology Life Quality Index (DLQI) and the European quality of life EQ-5D instrument. Throughout the study, participants will have regular visits to provide blood samples and complete assessments to track treatment levels, antibody presence, disease severity, and quality of life. The main outcomes include the predictive value of early drug levels and antibodies up to 24 weeks, and the development of a concentration-response curve over 52 weeks. Secondary measures include quality of life scores collected up to 52 weeks. This monitoring helps researchers understand the best dosing to improve treatment management for psoriasis patients.

Therapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO)