Efficacy and safety of risankizumab vs. secukinumab in patients with moderate-to-severe plaque psoriasis (IMMerge):Results from a phase 3, randomised, 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 (IL)-23 and IL-17A, respectively, and are effective in adult patients with moderate-to-severe plaque psoriasis but have different dosing regimens.OBJECTIVES: Directly compare efficacy and safety of risankizumab vs. secukinumab over 52 weeks.METHODS: IMMerge was an international, phase 3, multicentre, open-label, efficacy assessor-blinded, active-comparator study, in which adult patients with chronic, moderate-to-severe plaque psoriasis were randomised in a 1:1 ratio to treatment with risankizumab 150mg or secukinumab 300mg. Primary efficacy end points were proportions of patients achieving ≥90% improvement from baseline in Psoriasis Area Severity Index (PASI 90) at week 16 (noninferiority comparison with margin of 12%) and week 52 (superiority comparison).RESULTS: A total of 327 patients from nine countries were treated with risankizumab (n=164) or secukinumab (n=163). Risankizumab was noninferior to secukinumab in 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, 18∙6] within 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); PCONCLUSIONS: At week 52, risankizumab demonstrated superior efficacy and similar safety with less frequent dosing compared with secukinumab.