KEEPsAKE 2 trial demonstrates the efficacy and tolerability of risankizumab in treating active psoriatic arthritis

Despite the availability of various treatment modalities, there is a dire need for long-term efficacious and well-tolerated therapies that manage both the rheumatologic and dermatologic signs and symptoms of psoriatic arthritis (PsA). The findings of the ongoing, phase 3, KEEPsAKE 2 trial has shown that the treatment with risankizumab resulted in significant improvements in key disease outcomes in PsA patients. The treatment was found to be well tolerated in patients treated with biological therapies (Bio-IR) and/or conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR).

Risankizumab, a humanized immunoglobulin G1 (IgG1) monoclonal antibody, acts by selectively binding to the p19 subunit of human interleukin 23 (IL-23) cytokine, thereby blocking IL-23-dependent cell signaling and subsequent release of proinflammatory cytokines. The study results published in Rheumatology (Oxford) have shown that the treatment at 24 weeks contributed to ≥20% improvement in American College of Rheumatology criteria (ACR20) in 51.3% of risankizumab-treated patients as opposed to 26.5% of placebo-treated subjects (P < 0.001).  Nearly 58% of the patients randomized to receive risankizumab and 55% of the subjects switched to risankizumab from placebo achieved ACR20 at week 52 and 24 respectively. The researchers have also noted that the rates of serious treatment-emergent adverse events (TEAEs) and the subsequent treatment discontinuation were stable throughout the study period, with no reported mortality.

In concurrence with the present study, the findings of the 76-week phase 2 randomized trial published in Rheumatology Therapy (2022) have shown that the risankizumab treatment resulted in sustained, long-term improvement in joint and skin symptoms in patients with active PsA. The treatment helped in reducing both dermatologic and arthritic manifestations of the disease and inhibiting the progression of joint damage.

The present study has demonstrated, the safety, long-term benefits, and durable efficacy of risankizumab in attaining symptomatic control in PsA. Further corroboration of the findings and its routine use in clinical practice may assist in circumventing the limitations of csDMARDs such as treatment-related adverse events and inadequate response in certain patient subset.

A comprehensive news update on the human leukocyte antigen-B27 status and psoriatic arthritis axial disease has been published on the same RheumaTv platform. For further reading please visit:

Human leukocyte antigen-B27 status is not suggestive of treatment response in psoriatic arthritis axial disease


  1. Östör A, Van den Bosch F, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial. Ann Rheum Dis. 2022;81(3):351-358.
  2. Mease PJ, Kellner H, Morita A, Kivitz AJ, Aslanyan S, Padula SJ, et al. Long-Term Efficacy and Safety of Risankizumab in Patients with Active Psoriatic Arthritis: Results from a 76-Week Phase 2 Randomized Trial. Rheumatol Ther. 2022 Oct 1;9(5):1361–75.