33236 Impact of risankizumab on improving symptoms and health-related quality of life and reducing fatigue and pain among psoriatic arthritis patients with moderate-to-severe skin involvement: Evidence from 2 phase III trials

Abstract

Introduction: Psoriatic arthritis (PsA) greatly affects patient-reported health-related quality of life (HRQoL). This analysis integrated efficacy data from 2 phase III clinical trials (KEEPsAKE-1 and KEEPsAKE-2) to assess the impact of risankizumab (RZB) on patient-reported outcomes (PROs) in patients with high skin burden. Methods: Adult patients with PsA with inadequate response or intolerance to disease-modifying antirheumatic drugs were randomized 1:1 to receive RZB (150 mg) or placebo (PBO). Improvement from baseline in PROs (Patient’s Global Assessment of Disease Activity [PtGA] by visual analog scale [VAS], Short-Form 36 Health Questionnaire physical and mental component summary scores [SF-36 PCS and MCS], Health Assessment Questionnaire–Disability Index [HAQ-DI], EQ-5D 5-Level questionnaire [EQ-5D-5L] index and by VAS, Functional Assessment of Chronic Illness Therapy–Fatigue [FACIT-Fatigue], and pain by VAS) were assessed at Week 24 in patients with high skin burden (body surface area involvement ≥3% and Psoriasis Area Severity Index >10). Least squares mean (LSM) difference (95% confidence interval [CI]) between RZB and PBO groups based on mixed-model repeated measures regression is reported. Results: RZB- vs PBO-treated patients demonstrated greater improvements in PROs with notable LSM differences (95% CI) between groups (P < .01) in PtGA (-18.7 [-25.1, -12.2]), SF-36 PCS (6.3 [4.2, 8.4]) and MCS (4.4 [2.3, 6.6]), HAQ-DI (-0.4 [-0.5, -0.3]), EQ-5D-5L index (0.1 [0.1, 0.2]) and VAS (8.2 [2.5,13.9]), FACIT-Fatigue (4.9 [2.7, 7.2]), and pain (18.9 [-25.1, -12.7]). Conclusions: In patients with PsA with high skin burden, 24 weeks of RZB treatment, as compared with PBO, improved patients’ HRQoL, including fatigue and pain.