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.

BACKGROUND In a phase 3 clinical study, patients from Germany with moderate to severe psoriasis who were naive 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 versus FAEs at Weeks 16 and 24 for total and psoriasis-associated redness, itching, and burning scores (P<0.001). DLQI scores were significantly lower (reflecting better health-related quality of life) with risankizumab versus FAEs, with least squares (LS) mean differences of -7.4 and -7.6 at Weeks 16 and 24, respectively (both P<0.001). Patients randomized to risankizumab also had larger improvements in SF-36 Physical and Mental Component Summary scores, HADS anxiety and depression scores, PtGA, and EQ-5D-5L index and visual analog scale scores (all P≤0.002) at Weeks 16 and 24 compared with FAEs. PBI was significantly higher, indicating greater benefit, with risankizumab versus FAEs, with an LS mean difference of 1.1 and 1.3 at Weeks 16 and 24, respectively (both P<0.001). CONCLUSIONS Risankizumab provides significant benefits over FAEs in improving PROs across several dimensions in patients with moderate to severe psoriasis.