Efficacy and safety of risankizumab vs. secukinumab in patients with moderate-to-severe plaque psoriasis (IMMerge): results from a phase III, randomized, open-label, efficacy-assessor-blinded clinical trial

Background Patients with plaque psoriasis treated with biologic therapies need more efficacious, safe and convenient treatments to improve quality of life. Risankizumab and secukinumab inhibit interleukin-23 and interleukin-17A, respectively, and are effective in adult patients with moderate-to-severe plaque psoriasis but have different dosing regimens. Objectives To compare directly the efficacy and safety of risankizumab vs. secukinumab over 52 weeks. Methods IMMerge was an international, phase III, multicentre, open-label, efficacy-assessor-blinded, active-comparator study, in which adult patients with chronic, moderate-to-severe plaque psoriasis were randomized in a 1 : 1 ratio to treatment with risankizumab 150 mg or secukinumab 300 mg. Primary efficacy endpoints were the proportions of patients achieving >= 90% improvement from baseline in Psoriasis Area and Severity Index (PASI 90) at week 16 (noninferiority comparison with margin of 12%) and week 52 (superiority comparison). Results In total 327 patients from nine countries were treated with risankizumab (n =164) or secukinumab (n =163). Risankizumab was noninferior to secukinumab in the proportion of patients achieving PASI 90 at week 16 [73 center dot 8% vs. 65 center dot 6%; difference of 8 center dot 2%, 96 center dot 25% confidence interval (CI)-2 center dot 2 to 18 center dot 6; within the 12% noninferiority margin] and superior to secukinumab at week 52 (86 center dot 6% vs. 57 center dot 1%; difference of 29 center dot 8%, 95% CI 20 center dot 8-38 center dot 8;P< 0 center dot 001), thus meeting both primary endpoints. All secondary endpoints (PASI 100, static Physician's Global Assessment 0 or 1, and PASI 75) at week 52 demonstrated superiority for risankizumab vs. secukinumab (P< 0 center dot 001). No new safety concerns were identified. Conclusions At week 52, risankizumab demonstrated superior efficacy and similar safety with less frequent dosing compared with secukinumab.