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
Abstract
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.
To compare directly the efficacy and safety of risankizumab vs. secukinumab over 52 weeks. 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). 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 [73.8% vs. 65.6%; difference of 8.2%, 96.25% confidence interval (CI)-2.2 to 18.6; within the 12% noninferiority margin] and superior to secukinumab at week 52 (86.6% vs. 57.1%; difference of 29.8%, 95% CI 20.8-38.8; P < 0.001), 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 < 0.001).
No new safety concerns were identified. At week 52, risankizumab demonstrated superior efficacy and similar safety with less frequent dosing compared with secukinumab.