Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial

Abstract

ObjectivesRisankizumab is an interleukin-23 inhibitor under study for the treatment of patients with psoriatic arthritis (PsA). The phase 3 KEEPsAKE 2 trial investigated the efficacy and safety of risankizumab versus placebo in patients with active PsA who had previous inadequate response or intolerance to ≤2 biological therapies (Bio-IR) and/or ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR). Results through week 24 are reported here.MethodsAdults with PsA who were Bio-IR and/or csDMARD-IR were randomised to receive subcutaneously administered risankizumab 150 mg or placebo at weeks 0, 4 and 16 during a 24-week, double-blind treatment period. The primary endpoint was the proportion of patients who achieved ≥20% improvement in American College of Rheumatology score (ACR20) at week 24. Secondary endpoints assessed key domains of PsA and patient-reported outcomes.ResultsA total of 444 patients (median age 53 years, range 23–84 years) were randomised to risankizumab (n=224) or placebo (n=220); 206 patients (46.5%) were Bio-IR. At week 24, a significantly greater proportion of patients receiving risankizumab achieved the primary endpoint of ACR20 (51.3% vs 26.5%, p<0.001) and all secondary endpoints (p<0.05) compared with placebo. Serious adverse events were reported for 4.0% and 5.5% of risankizumab-treated and placebo-treated patients, respectively; serious infections were reported for 0.9% and 2.3%, respectively.ConclusionTreatment with risankizumab resulted in significant improvements versus placebo in key disease outcomes and was well tolerated in patients with PsA who were Bio-IR and/or csDMARD-IR.Trial registration numberNCT03671148.

Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 1 trial

“…The companion KEEPsAKE 2 trial (NCT03671148) is evaluating similar endpoints in a patient population that includes patients with a history of inadequate response or intolerance to biological agents. 5 The results of the initial 24-week double-blind period of the ongoing KEEPsAKE 1 study are reported herein.…”

Improved patient-reported outcomes in patients with psoriatic arthritis treated with risankizumab: analysis of the Phase 3 trial KEEPsAKE 2

“…A total of 444 patients with PsA were randomised to receive RZB (n=224) or PBO (n=220), and baseline characteristics were balanced between groups (table 1). One patient was randomised but did not receive the study drug and thus was excluded from the full analysis set population 14. As previously reported, 215 (96.0%) and 199 (90.5%) patients who received RZB or PBO, respectively, completed the week 24 study visit 14…”

“…KEEPsAKE 2 (NCT03671148) is a Phase 3, randomised, PBO-controlled, double-blind, multicentre study comparing the effects of RZB with PBO after 24 weeks of treatment in patients with active PsA who have an inadequate response or intolerance to one or two biologic disease-modifying antirheumatic drugs (DMARDs) (Bio-IR) and/or to ≥1 conventional synthetic DMARD (csDMARD-IR) 14. Patients were randomised 1:1 to receive RZB 150 mg or PBO by subcutaneous injection at weeks 0, 4 and 16.…”

“…Risankizumab (RZB) is an interleukin (IL-23) inhibitor currently under development for the treatment of adults diagnosed with active PsA. Phase 2 and Phase 3 studies in patients with PsA have shown that RZB treatment significantly improves patient pain, physical functioning (determined by Health Assessment Questionnaire-Disability index) and disease severity, as seen by reduced Psoriasis Area and Severity Index and American College of Rheumatology scores 12–14. This analysis aimed to characterise the impact of 24-week treatment with RZB versus placebo (PBO) on PROs in patients with active PsA who are enrolled in KEEPsAKE 2 to understand treatment benefits of RZB from the patient perspective.…”

New Insights on Juvenile Psoriatic Arthritis

“…Interestingly, IL-23 inhibitors include other agents initially used for psoriasis, such as guselkumab and risankizumab, that, following recent trials, showed efficacy and are now approved for adult PsA ( 71 – 75 ). Although few data are available for pediatric patients, this opens other future possibilities for juvenile psoriasis and JPsA.…”