Q&A: One-Year Efficacy, Safety of Risankizumab in Patients with Psoriatic Arthritis

In patients with psoriatic arthritis (PsA) and an inadequate response or intolerance to biologic therapies or conventional synthetic disease-modifying antirheumatic drugs (DMARDs), risankizumab (Skyrizi, Abbvie) was well tolerated and improved symptoms out to 1 year. This is according to a follow-up study published in Rheumatology.¹

In this Q&A, corresponding author Andrew Östör, MD, of Monash University in Melbourne and the Australian National University in Canberra, Australia, discussed the research and its findings.

In the ongoing, phase 3, KEEPsAKE 2 trial, the 52-week efficacy and safety of risankizumab 150 mg was assessed in patients with active PsA who had previous inadequate response or intolerance to 1 or 2 biologic therapies, such as tumor necrosis factor (TNF) inhibitors, or 1 or more conventional synthetic DMARDs.

Patients were randomly assigned to receive subcutaneous risankizumab or at weeks 0, 4 and 16.² At week 24, those initially randomized to receive placebo were switched to risankizumab, and all patients received risankizumab every 12 weeks from weeks 28 to 208. The primary endpoint was the proportion of patients who achieved ≥20% American College of Rheumatology (ACR20) score improvement.

At week 24, American College of Rheumatology (ACR) 20% improvement was achieved by 51.3% of the risankizumab group compared with 26.5% of the placebo group (P < .001). At week 52, ACR20 was achieved by 58.5% of patients who received continuous risankizumab and 55.7% of those who switched from placebo to risankizumab at week 24. No new safety signals were identified at week 52, and the safety profile reported with long-term treatment was generally consistent with that observed at 24 weeks.

What inspired your team to conduct this study?

Although we have made great strides in the management of PsA over the last 20 years, there remains an unmet need as many patients do not respond to currently available therapies.

Interleukin-23 p19 subunit (IL-23p19) is a critical cytokine driving PsA and therefore blocking this represents an opportunity to improve outcomes in this condition.

Were there any findings that were particularly surprising?

Apart from the consistent efficacy across a variety of outcomes, the surprise was how well risankizumab works in patients who have failed on anti-TNF therapy. Furthermore, the adverse event profile was similar to placebo.

What is the clinical significance of the results?

The findings are highly relevant to daily practice. We need effective and safe therapies to treat a spectrum of patients with PsA.

What is the current practice and how could these findings possibly change things?

Traditional DMARDs and currently available biologics such as anti-TNF and anti-IL17 agents do not work for all patients and side effects can be troubling. Risankizumab represents another option for patients with PsA to optimize their management and improve their quality of life.
What are the takeaway points for clinicians?

Risankizumab showed efficacy in a variety of patients including in those who had failed anti-TNF agents. It also showed a consistent benefit across a range of outcomes, including patient reported outcomes, and a highly favorable safety profile.

Reference:

^{1. Östör A, Van den Bosch F, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 2 study. Rheumatology (Oxford). 2023;62(6):2122-2129. doi:10.1093/rheumatology/keac605}

^{2. 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. doi:10.1136/annrheumdis-2021-221048}