Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 2 study

Abstract

Objective: PsA is a chronic inflammatory disease in which the skin and joints are affected. In this follow-up analysis, the 52-week efficacy and safety of risankizumab 150 mg in patients with active PsA who had previous inadequate response/intolerance to one or two biologic therapies (Bio-IR) or one or more conventional synthetic DMARDs (csDMARD-IR) were evaluated.

Methods: In the ongoing, phase 3, KEEPsAKE 2 trial, patients with active PsA were randomized 1:1 to receive subcutaneous risankizumab 150 mg or placebo at weeks 0, 4 and 16 (period 1). At week 24 (period 2), patients who received placebo were switched to risankizumab, and all patients received risankizumab 150 mg every 12 weeks from weeks 28 to 208.

Results: At week 24, 51.3% of risankizumab-treated patients (n = 224) achieved ≥20% improvement in ACR criteria (ACR 20) vs 26.5% of placebo-treated patients (n = 220; P < 0.001). At week 52, 58.5% of patients randomized to receive continuous risankizumab achieved ACR20, and 55.7% of patients who switched from placebo to risankizumab at week 24 achieved ACR20. Similar trends were observed for other efficacy measures. Rates of serious treatment-emergent adverse events (TEAEs) and TEAEs leading to discontinuation remained stable through week 52, and no deaths were reported.

Conclusion: Risankizumab was well tolerated and improved symptoms of PsA in Bio-IR/csDMARD-IR patients, with a consistent long-term safety profile from weeks 24 to 52.

Trial registration: United States National Library of Medicine clinical trials database www.clinicaltrials.gov; KEEPsAKE 2; NCT03671148.

Keywords: DMARD; IL-23; PsA; biologic agent; risankizumab.

Figure 1.

ACR responses over time. ACR20 (NRI-C/NRI) (A), ACR20 (AO) (B), ACR50 (NRI-C/NRI) (C), ACR50 (AO) (D), ACR70 (NRI-C/NRI) (E) and ACR70 (AO) (F) response rates for risankizumab 150 mg and placebo over the 24-week, double-blind treatment period and for open-label risankizumab 150 mg from weeks 24 through 52. ^aBased on full analysis set, NRI-C was used. ^bBased on full analysis set, NRI (as observed with imputation) was used. ACR20/50/70: ≥20/50/70% improvement in American College of Rheumatology criteria; AO: as observed; NRI: non-responder imputation; NRI-C: NRI incorporating multiple imputation to handle missing data due to COVID-19; PBO: placebo; RZB: risankizumab

Figure 2.

PASI 90 response over time^a. PASI 90 (NRI-C/NRI) (A) and PASI 90 (AO) (B) response rates over the 24-week, double-blind treatment period for risankizumab 150 mg and placebo and response rates for open-label risankizumab 150-mg treatment from weeks 24 through 52. ^aAmong patients with ≥3% body surface area affected by psoriasis at baseline. ^bBased on full analysis set, NRI-C was used. ^cBased on full analysis set, NRI (as observed with imputation) was used. AO: as observed; NRI: non-responder imputation; NRI-C: NRI incorporating multiple imputation to handle missing data due to COVID-19; PASI 90: ≥90% reduction in Psoriasis Area and Severity Index; PBO: placebo; RZB: risankizumab