Exposure‐Response Relationships for Efficacy and Safety of Risankizumab in Phase 2 and 3 Trials in Psoriasis Patients

Risankizumab has demonstrated efficacy in phase III trials in patients with moderate-to-severe plaque psoriasis. The exposure-response relationships for risankizumab efficacy (Psoriasis Area and Severity Index (PASI)75, PASI90, PASI100, and static Physician's Global Assessment (sPGA)0/1) at week 16 (N = 1,732) and week 52 (N = 598) as well as safety (incidence of any adverse event, serious adverse event, infection and infestation, or serious infection) over up to 52 weeks were characterized using the data from risankizumab phase II and III clinical trials in patients with moderate-to-severe plaque psoriasis. Impact of clinically relevant covariates was evaluated. Risankizumab phase III regimen (150 mg subcutaneously at weeks 0, 4, and every 12 weeks thereafter) achieved the plateau of the exposure-efficacy relationships with model-estimated PASI90 and sPGA0/1 response probabilities of 77%, and 87%, respectively, at week 16 and 85%, and 88%, respectively, at week 52. There was no apparent relationship between risankizumab plasma exposure and the evaluated safety variables.