Patient‐reported outcomes with risankizumab versus fumaric acid esters in systemic therapy‐naïve patients with moderate to severe plaque psoriasis: a phase 3 clinical trial

• Published in: Journal of the European Academy of Dermatology and Venereology 2021-08, Vol.35 (8), p.1686-1691
• Main Authors: Thaçi, D., Soliman, A.M., Eyerich, K., Pinter, A., Sebastian, M., Unnebrink, K., Rubant, S., Williams, D.A., Weisenseel, P.
• Format: Article
• Language: English
• ISSN: 0926-9959; 1468-3083
• DOI: 10.1111/jdv.17109

Background In a phase 3 clinical study, patients from Germany with moderate to severe psoriasis who were naïve to systemic treatment and received risankizumab had greater and more rapid disease improvements compared with those who received fumaric acid esters (FAEs). Objective To evaluate patient‐reported outcomes (PROs) in patients treated with risankizumab compared with FAEs. Methods Adult patients were randomized 1:1 to receive either risankizumab 150 mg subcutaneous injections at weeks 0, 4 and 16 or FAEs (Fumaderm®) provided according to the prescribing label. PRO secondary endpoints assessed were Psoriasis Symptom Scale (PSS), Dermatology Life Quality Index (DLQI), 36‐Item Short Form Health Survey, version 2 (SF‐36v2), Patient Benefit Index (PBI), Hospital Anxiety and Depression Scale (HADS), Patient Global Assessment (PtGA) and European Quality of Life 5 Dimensions 5 Level (EQ‐5D‐5L). PROs were assessed at weeks 0, 16 and 24. Results Sixty patients each were randomized to receive risankizumab or FAEs. A significant PSS improvement was observed with risankizumab vs. FAEs at weeks 16 and 24 for total and psoriasis‐associated redness, itching and burning scores (P