Maldegem

Researchers are evaluating the long-term safety of Deucravacitinib compared to Ustekinumab in adults with moderate-to-severe plaque psoriasis. This Phase 3b4 study focuses on cardiovascular events and other health outcomes over an extended period, aiming to understand how these treatments impact patients with psoriasis who have cardiovascular risk factors. The study is led by Bristol-Myers Squibb and involves random assignment of participants to either treatment. Participants receive either Deucravacitinib or Ustekinumab at specified doses on scheduled days. The study is open-label, meaning both participants and researchers know which treatment is being given. This trial runs for up to 5 years, during which patients are monitored for cardiovascular safety and other health events related to their psoriasis treatment. Throughout the study, participants undergo regular assessments to track major cardiovascular events like heart attacks, strokes, and hospitalizations, as well as monitoring for infections, cancer, and treatment side effects. Researchers collect data on liver function and lipid levels up to 60 days after the last dose. The long-term follow-up helps evaluate safety and health outcomes over several years, with study activities continuing until early 2031.

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.

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 Investigators 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.