Significant Improvements With Risankizumab in Patients With Psoriatic Arthritis

KEEPSAKE 2 is a clinical trial evaluating the efficacy and safety of risankizumab in patients with psoriatic arthritis.

Treatment with risankizumab vs placebo was found to be efficacious and well-tolerated among patients with psoriatic arthritis (PsA) with previous inadequate response to 2 or fewer biologics (Bio-IR) and/or 1 or more conventional synthetic disease-modifying antirheumatic drugs (cs-DMARD-IR), according to study results published in Annals of the Rheumatic Diseases.

There is an unmet need for effective treatment in patients with PsA who do not achieve an adequate response or are intolerant to treatment with csDMARDs or biologics.

In the current phase 3, double-blind, randomized, placebo-controlled study (KEEPSAKE; Identifier: NCT03671148), investigators sought to determine the efficacy and safety of risankizumab in patients with active PsA who were Bio-IR and csDMARD-IR.

All eligible patients were diagnosed with active PsA, defined as 5 or more tender joints and 5 or more swollen joints, who met the Classification Criteria for Psoriatic Arthritis and were Bio-IR and/or csDMARD-IR.

Primary study outcome was the percentage of patients achieving a 20% or more improvement in American College of Rheumatology score (ACR20) at week 24. Researchers also assessed the key domains of PsA and patient-reported outcomes.

The study included 444 patients, with a median age of 53 years; 55.1% were women; and 46.5% of patients were Bio-IR. Patients were randomly assigned 1:1 to receive 150 mg of subcutaneous risankizumab (n=224) or placebo (n=220) at weeks 0, 4 and 16.

Results of the study showed that 51.3% of patients who received treatment with risankizumab and 26.5% who received with placebo achieved ACR20 at week 24 (P <.001). Patients who received risankizumab vs placebo had higher ACR20 response rates, irrespective of whether patients received concomitant csDMARDs (50.4% vs 33.9%, respectively) or risankizumab as monotherapy (53.0% vs 16.0%, respectively). Among patients who were csDMARD-IR and Bio-IR, response rates compared with placebo were 56.3% vs 36.6% and 45.7% vs 14.9%, respectively.

Patient-related outcomes were significantly greater in the risankizumab group compared with the placebo group.

A total of 124 patients receiving risankizumab (55.4%) and 120 patients receiving placebo (54.8%) reported treatment-emergent adverse events. Most adverse events were mild or moderate, with upper respiratory tract infection most frequently reported (risankizumab, 7.6%; placebo, 5.5%).

One study limitation included the relatively short assessment period of 24 weeks.

Researchers concluded, “Overall, treatment with risankizumab demonstrated efficacy in key clinical PsA domains, providing additional evidence that targeting the p19 unit of [interleukin] (IL)-23 is a rational therapeutic approach to treat PsA.”

Disclosure: Some of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures. 


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. Published online November 23, 2021. doi:10.1136/annrheumdis-2021-221048