Direct Comparison of Risankizumab and Fumaric Acid Esters in Systemic-Therapy-Naive Patients With Moderate to Severe Plaque Psoriasis: A Randomized Controlled Trial.

Fumaric acid esters (FAEs; Fumaderm® ) are the most frequently prescribed first-line systemic treatment for moderate-to-severe plaque psoriasis in Germany. Risankizumab (Skyrizi® ) is a humanized IgG1 monoclonal antibody that specifically binds to the p19 subunit of interleukin-23.This study compared risankizumab treatment with FAEs in psoriasis patients.This phase 3, randomized, active-controlled, open-label study with blinded assessment of efficacy was conducted in Germany. Patients were randomized (1:1) to subcutaneous risankizumab 150mg (weeks 0, 4, 16) or oral FAEs at increasing doses from 30mg/d (week 0) up to 720mg/d (weeks 8-24). Enrolled patients were adults naive to and candidates for systemic therapy, with chronic, moderate-to-severe plaque psoriasis. Phototherapy was not allowed within 14 days before or during the study.Key efficacy endpoints were met at week 24 for risankizumab (N=60) versus FAEs (N=60) (P

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Authors: D Thaçi, K Eyerich, A Pinter, M Sebastian, K Unnebrink, S Rubant, D A Williams, P Weisenseel