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At week 52, 58.5% of patients continuing risankizumab treatment and 55.7% of patients who switched to risankizumab at week 24 achieved ACR20.
Results of the ongoing KEEPsAKE 2 study demonstrated long-term, durable efficacy, a consistent long-term safety profile, and improved psoriatic arthritis (PsA) symptoms in patients with inadequate response or intolerance to 1 or 2 biologic therapies or ≥1 conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) receiving risankizumab 150 mg, according to an article published in Oxford Rheumatology.1
Risankizumab, a humanized immunoglobulin G1 monoclonal antibody, works by binding to the p19 subunit and inhibiting interleukin-23 (IL-23). The drug is approved for the treatment of active PsA and moderate-to-severe plaque psoriasis.2
“Current treatment guidelines for PsA recommend csDMARD (eg methotrexate) as first-line therapy for patients with polyarticular PsA,” wrote Andrew Östör, MD, principle investigator at Emeritus Research, Melbourne, Victoria, Australia, and colleagues. “Although there are several therapeutic options available to treat PsA, there is a need for additional efficacious and well-tolerated, long-term therapies that address the range of rheumatological and dermatological signs and symptoms of the disease.”
The phase 3, global, multicenter KEEPsAKE 2 trial evaluated adult patients with active PsA receiving either subcutaneous risankizumab 150 mg or placebo at weeks 0, 4, and 16. In the second part of the trial, which began at week 24, patients receiving the placebo were switched to risankizumab. They will continue to receive the drug every 12 weeks through week 208.
Eligible patients had ≥5 tender joints and ≥5 swollen joints, fulfilled the Classification Criteria for Psoriatic Arthritis (CASPAR), and had inadequate response or intolerance to biologic therapies or csDMARDs. Efficacy endpoints included the proportion of patients who achieved ≥20%/50%/70% improvement in the American College of Rheumatology criteria (ACR20/ACR50/ACR70), ≥90% reduction in Psoriasis Area and Severity Index (PASI 90), the proportion of patients who achieved minimal disease activity (MDA), and changes in baseline from the Health Assessment Questionnaire-Disability Index (HAQ-DI) and the 36-Iten Short Form Health Survey Physical Component Summary score (SF-36 PCS).
In total, 414 patients were entered into the extension period, of which 84.8% (n = 190/224) continued risankizumab and 80.4% (n = 176/219) were switched to risankizumab treatment at week 24. The most common reason for discontinuing the study in period 2 was withdrawal of consent. Baseline characteristics and demographics were comparable across treatment arms.
At the 24-week mark, 51.3% of patients treated with risankizumab (n = 224) obtained ACR20, compared with 26.5% of patients in the placebo category (n = 220; P <.001). At week 52, 58.5% of patients continuing risankizumab treatment and 55.7% of patients who switched to risankizumab at week 24 achieved ACR20. ACR50 increased from 26.3% at week 24 to 32.1% at week 52, while ACR70 increased from 12.0% to 16.5%, respectively. Comparable trends in other efficacy measures were also observed during this study period.
The rates of serious treatment-emergent adverse events (TEAEs) as well as TEAEs leading to treatment discontinuation between week 24 and 52 remained stable. No new safety signals were identified, and no deaths were reported across treatment arms.
Investigators noted generalizability may be limited due to the homogenous study population. Additionally, the open-label extension period of the study may be biased towards risankizumab responders. Lastly, as the study will continue over a 4-year period, the 52-week analysis could be considered brief.
“As anticipated, patients initially randomized to receive placebo and then switched to risankizumab at week 24 experienced a similar trajectory of improvements in the signs and symptoms of PsA from week 24 through week 52,” investigators concluded. “The KEEPsAKE 2 trial is ongoing, and the long-term efficacy and safety of risankizumab in PsA will continue to be evaluated.”