Direct comparison of risankizumab and fumaric acid esters in systemic–therapy‐naive patients with moderate to severe plaque psoriasis: A randomized controlled trial
British Journal of Dermatology May 20, 2021
Thaçi D, Eyerich K, Pinter A, et al. - This is the first head-to-head psoriasis trial comparing the effectiveness and safety of subcutaneous (SC) risankizumab (Skyrizi) with oral fumaric acid esters (FAEs; Fumaderm) in adult patients in Germany who had moderate to severe plaque psoriasis and were naive to systemic therapy. This phase 3, randomized, active-controlled, multicenter, open-label study with blinded assessment of efficacy was performed at 21 sites in Germany between August 22, 2017, and July 6, 2018. Study participants were randomized (1:1) to subcutaneous risankizumab 150 mg (weeks 0, 4, 16) or oral FAEs at increasing doses from 30 mg/d (week 0) up to 720 mg/d (weeks 8–24). The FAEs group had increased incidences of gastrointestinal disorders, flushing, lymphopenia, and headache. Risankizumab was found to be superior to FAEs in terms of giving sooner and better improvement in psoriasis outcomes that lasted with continuous treatment, as well as more positive safety results that were consistent with the known safety profile. There were no new safety signals for risankizumab or FAEs observed.
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