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Explore This IssueFebruary 2021
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In both studies, significantly more patients receiving treatment with risankizumab than placebo achieved the primary endpoint—a 20% improvement in disease activity defined by the ACR20 criteria at week 24, that is:
- A 20% improvement in the number of tender and number of swollen joints, and
- A 20% improvement in three of the following five criteria:
- Patient global assessment;
- Physician global assessment;
- Functional ability measure;
- Visual analog pain scale; and
- Erythrocyte sedimentation rate or C-reactive protein.
Ranked secondary endpoints for the studies included change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) and at least a 90% improvement on the Psoriasis Area Severity Index (PASI 90).
KEEPsAKE-1 examined PsA patients (N=964) with an intolerance to at least one disease modifying anti-rheumatic drug (DMARD) or who had had an inadequate response to at least one DMARD. KEEPsAKE-2 examined patients (N=443) who had an inadequate response or intolerance to biologic therapy and/or DMARDs. Patients were randomized to receive 150 mg of subcutaneous risankizumab or placebo.
Results: In KEEPsAKE-1 and KEEPsAKE-2, 57% and 51% of risankizumab-treated patients, respectively, achieved an ACR20 response at week 24 compared with 34% and 27%, respectively, of placebo-treated patients (P<0.001). The results of the ranked secondary endpoints at week 24 showed significant improvements in skin clearance, measured by PASI 90; physical function, measured by the HAQ-DI; and disease activity.
Additionally, in KEEPsAKE-1, the ranked secondary endpoint—the PsA Sharp/van der Heijde Score—was 0.23 in the risankizumab-treated and 0.32 placebo-treated groups (P=0.496). The lower score signifies less radiographic progression.
Rates of serious infections were similar between treatment groups, and no new safety signals were identified.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.