An analysis of 100 week data from the KEEPsAKE 1 and 2 trials presented at EULAR 2023 offers insight into the long-term effects of risankizumab use in people with psoriatic arthritis.
An analysis of long-term data related to use of risankizumab in patients with psoriatic arthritis from the European Congress on Rheumatology (EULAR) 2023 is offering clinicians with new insight into the effects of the agent on quality of life and other patient-centric outcomes.
Leveraging data from the KEEPsAKE 1 and 2 trials, results of the study, which included up to 100 weeks of follow-up, suggest the majority of patients treated with risankizumab achieving minimal clinically important differences in patient-reported outcomes at week 24 of the trial maintained these responses through week 100, with results also indicating achieving minimal clinically important differences at week 24 associated with sustained and clinically meaningful changes in health-related quality of life.1
“Patient reported outcomes are really important in rheumatic diseases because we know there's a discrepancy about what we as physicians measure when we look at swollen joints, CRP, and so on, compared to what the patients actually experience and report,” said Lars Erik Kristensen, MD, PhD, chief scientific officer of the Parker Institute, in an interview with HCPLive. “If we want to do patient focused or patient centered care, minding the patient reported outcome is actually one of the most important outcome criteria.”
A 24-week trial, the KEEPsAKE 1 trial was a randomized, placebo-controlled, double-blind trial launched with the intent of exploring whether risankizumab could be an effective treatment in patients with psoriatic arthritis who have inadequate response or intolerance to 1 or more conventional synthetic disease-modifying antirheumatic drugs. The trial enrolled and randomized patients to 150 mg of risankizumab or placebo therapy.2
Results of this trial suggest risankizumab use was associated a significantly greater proportion of patients achieving the primary endpoint of ACR20 (57.3% vs 33.5%; P < .001) compared with placebo therapy, with safety analyses indicating the agent was also well-tolerated.2
Also 24 weeks in length, the KEEPsAKE 2 trial had a similar design to KEEPsAKE 1, but expanded its patient population to include those considered to have an inadequate response to biologic therapy. The trial enrolled 444 patients and results trial indicated a significantly greater proportion of patients receiving risankizumab achieved the primary endpoint of ACR20 (51.3% vs 26.5%; P <.001) as well as all secondary endpoints (P < .05) compared with placebo.3
For the EULAR 2023 study, investigators sought to examine the durability of the treatment response on health-related quality of life and patients-reported outcomes out to 100 weeks.1
Upon analysis, results indicated 54-68% and 31-52% of risankizumab-treated patients and placebo-to-risankizumab patients achieved minimal clinically important differences in patient-reported outcomes at Week 24, respectively, in the KEEPsAKE 1 trial. In the KEEPsAke 2 trial, 44–67% and 33–47% of risankizumab-treated patients and placebo-to-risankizumab patients achieved minimal clinically important differences in patient-reported outcomes at Week 24, respectively.1
Among those achieving minimal clinically important differences from KEEPsAKE 1, a high percentage of patients receiving risankizumab maintained minimal clinically important differences from week 52-100 for Patient’s Global Assessment (risankizumab: 85.3–88.9%; placebo to RZB: 87.2–91.4%), Pain (risankizumab: 84.70-88.4%; placebo to risankizumab, 87.0-90.9%), and HAQ-DI (risankizumab: 87.0-90.8%; placebo to RZB: 82.6-84.3%). A similar trend was observed among those achieving minimal clinically important differences in the KEEPsAKE 2 trial, with high percentages of risankizumab and placebo to risankizumab-treated patients maintained minimal clinically important differences in Patient’s Global Assessment (risankizumab: 77.0-80.5%; placebo to RZB: 78.4-84.0%), pain (risankizumab: 77.2-85.6%; placebo to risankizumab: 84.3-94.2%), and HAQ-disability score (risankizumab: 74.0-83.8%; placebo to risankizumab: 89.6-95.8%).1
With an interest in learning more about the study and its results, our editorial team sat down with Kristensen on-site at EULAR 2023.
Dr. Kristensen reports being a member of the speaker bureau or having received consultant frees from AbbVie, Amgen, Biogen, Bristol Myers Squibb, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer, and UCB.