Efficacy of risankizumab across GRAPPA domains in psoriatic arthritis: a pooled analysis of patients from the phase 3 KEEPsAKE 1 and 2 studies

Abstract

Objective: To assess the efficacy of long-term treatment with risankizumab across the updated Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) domains and key related conditions of psoriatic arthritis (PsA).

Methods: This post hoc analysis primarily used data from the phase 3 KEEPsAKE 1 trial of adult patients with PsA, with data from KEEPsAKE 2 pooled for prespecified outcomes. Outcomes measuring risankizumab efficacy across key GRAPPA-recognised domains of PsA (peripheral arthritis, enthesitis, dactylitis, skin and nail psoriasis, axial disease) and PsA-related conditions such as inflammatory bowel disease (IBD) and uveitis were assessed over 100 weeks of treatment (~2 years). Statistical approaches included non-responder imputation (as-observed with imputation) for categorical variables and mixed-effect model for repeated measures for continuous variables including as-observed measurements at all visits. PsA-related conditions were evaluated via adverse events through 100 weeks.

Results: Overall, in KEEPsAKE 1 and KEEPsAKE 2, 412/483 (85.3%) and 181/224 (80.8%) of patients randomised to risankizumab completed treatment to week 100. Risankizumab demonstrated efficacy across all GRAPPA-defined domains through 100 weeks, including swollen and tender joint counts, enthesitis, dactylitis, skin and nail outcomes, and axial disease. In KEEPsAKE 1, 42.4% of patients had achieved a Disease Activity in Psoriatic Arthritis measurement of low disease activity and 62.9% had reached a minimal clinically important difference in pain at week 100. Rates of new onset or flare of IBD and uveitis were low.

Conclusions: Treatment with risankizumab provides durable improvement in the signs and symptoms of PsA across all GRAPPA disease domains and related conditions.

Trial registration: ClinicalTrials.gov NCT03675308, NCT03671148.

Keywords: Arthritis, Psoriatic; Biological Therapy; DMARD.