Background/Purpose: Risankizumab (RZB), an anti-interleukin 23p19 monoclonal antibody, is approved for the treatment of adults with active PsA. We report the efficacy and safety of RZB in patients with active PsA through week 244 of the KEEPsAKE 1 trial.

Methods: The ongoing, global, phase 3 KEEPsAKE 1 trial evaluates RZB for patients with moderately to severely active PsA (NCT03675308). Eligible patients were aged ≥ 18 years, naïve to biologic therapy, and demonstrated an inadequate response, intolerance, or contraindication to ≥ 1 conventional synthetic DMARD (csDMARD-IR). After a 24-week double-blind treatment period where patients were randomized to subcutaneous (SC) RZB 150 mg or PBO patients receive open-label SC RZB 150 mg every 12 weeks in an extension period. Efficacy outcomes at week 244 and treatment-emergent adverse events (TEAEs) through data cutoff for all randomized patients who received ≥ 1 dose of study drug are reported.

Results: Of 964 randomized patients, 939 (97.4%) entered the extension period and 714 were actively enrolled at the data cutoff date. At week 244, 36.2% of patients receiving continuous RZB 150 mg (RZB) and 38.0% of patients who switched from PBO to RZB 150 mg (PBO/RZB) achieved ACR50 (Figure 1). Rates of achieving minimal disease activity were 33.7% with RZB and 34.7% with PBO/RZB. In patients with psoriasis affecting ≥ 3% of their body surface area at baseline, a ≥ 90% improvement from baseline in the Psoriasis Area and Severity Index was achieved by 64.5% of patients with RZB and 59.9% of patients with PBO/RZB (Table 1). In patients with nail psoriasis at baseline, the modified Nail Psoriasis Severity Index and the Physician’s Global Assessment of Fingernail Psoriasis scores least squares (LS) mean improvements from baseline were 14.7 points and 1.6 points with RZB and 14.7 points and 1.5 points with PBO/RZB, respectively. In patients with enthesitis at baseline, resolution was achieved by 59.9% with RZB and 60.7% with PBO/RZB. For patients with dactylitis at baseline, 73.6% in the RZB group and 72.8% in the PBO/RZB group achieved resolution. The LS mean change from baseline in Psoriatic Arthritis modified Total Sharp Score (PSA-mTSS) was 0.9 with RZB and 2.1 with PBO/RZB; 88.4% of patients receiving RZB and 80.7% of patients receiving PBO/RZB showed no radiographic progression (PSA-mTSS change from baseline ≤ 0). In patients with axial spondylitis at baseline, the LS mean change from baseline in the modified Bath Ankylosing Spondylitis Disease Activity Index was –2.2 with RZB and –2.4 with PBO/RZB. Patient-reported measures of quality of life and fatigue maintained improvements from baseline. Rates of TEAEs (119.0 events/100 person-years [E/100PY]), serious TEAEs (7.6 E/100PY), and TEAEs leading to discontinuation of study drug (1.8 E/100PY) remained stable and were comparable to rates in the double-blind period (Table 2).

Conclusion: The 244-week results of the ongoing KEEPsAKE 1 trial demonstrate the durable efficacy of RZB 150 mg in treating clinical manifestations of PsA, sustaining bone structure, and improving quality of life for patients with PsA who are csDMARD-IR. RZB continues to be well tolerated, with no new safety signals identified.

Figure 1. Achievement of ACR Responses and MDA at Week 244

Table 1. Efficacy Outcomes at Week 244

Table 2. Safety Overview

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/long-term-efficacy-and-safety-of-risankizumab-for-csdmard-ir-patients-with-active-psoriatic-arthritis-244-week-results-from-the-keepsake-1-trial/