Risankizumab improves symptoms, is well tolerated in psoriatic arthritis through 52 weeks
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Risankizumab improves symptoms and is well tolerated through 52 weeks in patients with psoriatic arthritis who respond inadequately to biologic therapies or conventional synthetic disease-modifying antirheumatic drugs, according to data.
“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 rheumatologic and dermatologic signs and symptoms of the disease for patients who are considered [inadequate responders to one or two biologic therapies (Bio-IR) or one or more conventional synthetic DMARDs (csDMARD-IR)],” Andrew Östör, MD, MA, MBBS, FRACP, FRCP, of Monash University and Cabrini Hospital, in Melbourne, Australia, and colleagues wrote in Rheumatology.
“Risankizumab is a humanized immunoglobulin G1 monoclonal antibody that specifically inhibits interleukin 23 by binding to its p19 subunit, which is approved in many countries to treat moderate-to-severe plaque psoriasis and active PsA,” they added.
To report on the 52-week efficacy and safety of risankizumab (Skyrizi, AbbVie) in patients with PsA who have had an inadequate response to biologic therapies or conventional synthetic DMARDs, Östör and colleagues conducted a follow-up analysis to the ongoing, phase 3 KEEPsAKE 2 trial. In that trial, patients were randomized 1:1 to receive subcutaneous rizankizumab 150 mg or placebo at weeks 0, 4 and 16. During the second phase of the trial, all patients received rizankizumab 150 mg every 12 weeks through 208 weeks.
Patients were eligible for inclusion if they were aged 18 years or older and had an active diagnosis of PsA, with 6 or more months since symptom onset. Additionally, patients were required to meet the Classification Criteria for Psoriatic Arthritis for 6 or more months. Lastly, patients needed to demonstrate poor responses or intolerance to conventional synthetic DMARDs or biologic therapy.
Endpoints included the proportion of patients who achieved ACR20, ACR50 and ACR70. In addition, the researchers assessed changes from baseline in the Health Assessment Questionnaire-Disability Index, as well as the proportion of patients who achieved minimal disease activity. Safety evaluations monitored for adverse events.
The current analysis included 224 patients who received risankizumab and 220 in the placebo group.
According to the researchers, 51.3% of patients who received risankizumab achieved ACR20, compared with 26.5% in the placebo group, through 24 weeks (P < .001). At week 52, 58.5% of patients who were randomized to receive continuous risankizumab achieved ACR20, while 55.7% of patients who started receiving risankizumab at week 24 achieved ACR20. The researchers reported similar trends for other efficacy measures. Regarding safety, rates of serious treatment-emergent adverse events, as well as events leading to treatment discontinuation, were stable through week 52. There were no reported deaths.
“These efficacy and safety data from the ongoing phase 3 KEEPsAKE 2 study in patients who experienced Bio-IR or csDMARD-IR demonstrate robust and durable long-term efficacy of risankizumab through 52 weeks of treatment,” Östör and colleagues. “No new safety signals were identified, and the safety profile observed with long-term treatment was generally consistent with previously reported 24-week results.”
References:
- Kristensen LE, et al. Rheumatology. 2022;doi:10.1093/rheumatology/keac607.
- Skyrizi (risankizumab-rzaa) [prescribing information]. https://www.rxabbvie.com/pdf/skyrizi_pi.pdf. Nov 2, 2022.
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Evan L. Siegel, MD, FACP, FACR
Östör and colleagues report the results of the 52-week extension of KEEPsAKE 2, an evaluation of risankizumab (Skyrizi, AbbVie) in psoriatic arthritis.
Results were somewhat as expected. Initial reports of the 24-week data showed significant efficacy in all evaluated domains of PsA (spondylitis was not studied). ACR 20/50/70 responses were a respectable 51%, 26% and 12%, respectively, at 24 weeks and continued to improve to 58.5%, 32% and 16.5% at week 52. Enthesitis and dactylitis also responded nicely with complete resolution at 24 weeks in 43% and 72.5%, respectively, with maintenance of that response at 52 weeks.
This is somewhat more robust than when data were combined with KEEPsAKE 1, which included only patients with an inadequate response (IR) to conventional synthetic DMARDs.
Skin responded beautifully as had been seen in the prior psoriasis trials and has been seen across the IL-23 mechanism of action.
Perhaps most importantly, 25.6% of patients reached minimal disease activity (MDA) at 24 weeks, maintained at 27.2% at 52 weeks. Of those initially on placebo, 33.8% reached MDA at 52 weeks.
Safety profiles have been excellent with this agent, with very little in the way of major adverse cardiac events and only one non-skin malignancy. There were non-melanoma skin cancers as expected in a psoriasis population. Infections were minimal, including opportunistic infections. No safety signals appeared that were not previously seen in this study or in the previous large psoriasis trials.
Risankizumab has shown itself to be another excellent tool in the PsA armamentarium, now with documented prolonged efficacy and an excellent safety profile, even in the more difficult to treat biologic-IR population. Although joint efficacy is similar to other biologic agents, patients with more significant skin burden and those who prefer or require a more prolonged dosing schedule (every 12 weeks) may find this agent advantageous.
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