Risankizumab Effective Through 100 Weeks in Improving Signs, Symptoms of Psoriatic Arthritis

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These data suggest risankizumab was both safe and efficacious through 100 weeks for PsA patients, with no new safety signals.

Andrew Östör, MA, MB

Credit: Singapore Society of Rheumatology

Andrew Östör, MA, MB

Credit: Singapore Society of Rheumatology

Psoriatic arthritis (PsA) treatment with risankizumab is efficacious and well-tolerated through 100 weeks, according to recent findings, with most patients maintaining their response as far as signs and symptoms.1

These findings were the conclusion of the KEEPsAKE 2 randomized clinical trial (RCT), a global and phase 3 study on risankizumab’s efficacy and tolerability among individuals with PsA. Those given a placebo in KEEPsAKE 1 and 2 were changed to a new treatment regimen.2,3

Both trials were conducted in parallel. The KEEPsAKE 2 research was led by Andrew Östör, MA, MB, from Monash University’s department of medicine in Clayton, Australia.

“Patients who had initially been randomized to receive placebo in both the KEEPsAKE 1 and KEEPsAKE 2 studies were switched at week 24 to receive risankizumab 150 mg, and at the 52-week analysis, risankizumab demonstrated robust, durable efficacy for patients with csDMARD-IR and/or bDMARD-IR; risankizumab continued to be well tolerated through each of the studies,” Östör and colleagues wrote.

Background and Methods

The prior details, including such data as inclusion and exclusion criteria, had been disclosed for KEEPsAKE 2 previously. The investigators’ period of data collection was terminated at the 100-week mark in March 2022, with eligible subjects havin been adults with active PsA who had shown inadequate response to conventional synthetic DMARDs (csDMARD-IR) or biologic DMARDs (bDMARD-IR).

The research team assessed the bDMARD-IR group separately given the challenges these individuals had in controlling their disease. There were 2 KEEpSAKE 2 phases, the first occurring over 24 weeks with parallel treatment groups and the second commencing at Week 24 and being an open-label trial.

During the initial phase, the team randomly assigned subjects in a 1:1 ratio to receive either placebo or risankizumab 150 mg at the 0, 4, and 16-week mark. During the second phase, those first given the placebo were treated with risankizumab at the 24-week mark and those first on the treatment were swapped to the placebo.

All of the subjects at the Week 28-mark were given open-label risankizumab 150 mg over a course of every 12 weeks. As a result, they were first randomized to risankizumab in the "continuous risankizumab" arm, and the participants who swapped from placebo to the drug made up the "placebo/risankizumab" arm.

Discontinuation criteria was described by the investigators for those not given at least 20% improvement in joint counts by specified visits. Measures of effectiveness included American College of Rheumatology criteria (ACR20) response rates and minimal disease activity (MDA), as well as improvements in other markers of PsA.

Findings

Overall, the team reported that 77.9% of the study subjects continued to be in the study. They found that at Week 100, ACR20 was shown to have been reached by 57.1% and 52.5% in the continuous risankizumab and placebo/risankizumab arms of the study, respectively.

The investigators then noted that by the 52-week mark, the rates ended up being 60.0% and 55.8%, respectively. ACR20 maintenance, among responders at the 52-week mark, was observed by the research team on the 100th week among 74.8% in the continuous arm and 78.7% in the placebo/risankizumab arm.

In their notes on MDA, the team reported that 33.0% and 33.3% were shown to have reported it at the 100-week mark in the respective groups. At the 52-week mark, the rates were 27.2% and 33.8%.

Overall, the investigators found that MDA responders at the 52-week point showed a maintenance of MDA response among an observed percent of 83.6% for continuous and 73.0% for placebo/risankizumab. The drug was confirmed to have been well-tolerated through to 100 weeks.

“Risankizumab has demonstrated an acceptable, stable, long-term safety profile and was generally well tolerated,” they wrote. “The KEEPsAKE 2 study remains ongoing for continued efficacy and safety analysis.”

References

  1. Östör, A., Van den Bosch, F., Papp, K. et al. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 100-Week Results from the KEEPsAKE 2 Randomized Clinical Trial. Rheumatol Ther (2024). https://doi.org/10.1007/s40744-024-00657-2.
  2. Kristensen LE, Keiserman M, Papp K, et al. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 100-Week Results from the Phase 3 KEEPsAKE 1 Randomized Clinical Trial. Rheumatol Ther. Published online March 18, 2024. doi:10.1007/s40744-024-00654-5.
  3. 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;62:2122–9.
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