Proactive Therapeutic Drug Monitoring Versus Routine Care With Novel Biologics in Psoriasis: A Pragmatic, Multicentric, Randomised, Controlled Study

What this Trial Is About

Researchers are evaluating the use of therapeutic drug monitoring (TDM) to optimize dosing of biologics in patients with moderate to severe psoriasis vulgaris. The study compares the standard fixed dosing of new biologics that block interleukin 17 and 23 with a dosing approach guided by measured drug concentrations in the blood. The goal is to improve clinical response, safety, patient satisfaction, and reduce healthcare costs by adjusting doses to achieve target drug levels. Participants will be randomly assigned to two groups in 14 Belgian hospitals: one receiving standard care with fixed doses of secukinumab, ixekizumab, or guselkumab, and the other undergoing proactive TDM-based dose adjustments. Dose modifications will be made stepwise by shortening or lengthening the interval between injections based on drug levels, with changes initially by 33% then 50%, and further weekly adjustments until the target concentration is reached. During the 18-month study, participants will have clinical visits every 12 weeks to monitor disease activity, quality of life, treatment satisfaction, and safety. Researchers will measure psoriasis severity using the Psoriasis Area and Severity Index (PASI) and collect questionnaires on quality of life and health status. Drug pharmacokinetics, immunogenicity, and healthcare use will also be tracked. The study monitors adverse events and aims to confirm sustained disease control over 76 weeks.

Proactive TDM Versus Standard Use of Biologics in Psoriasis