Improved patient-reported outcomes in patients with psoriatic arthritis treated with risankizumab: analysis of the Phase 3 trial KEEPsAKE 2

Abstract

Objectives: Determine the impact of 24-week risankizumab (RZB) versus placebo (PBO) on patient-reported outcomes (PROs) in patients with psoriatic arthritis (PsA) and inadequate response to one or two biologics (Bio-IR) and/or ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR).

Methods: Patients in the Phase 3 trial, KEEPsAKE 2, were randomised (1:1) to RZB 150 mg or PBO by subcutaneous injection. PROs assessed: 36-Item Short-Form Health Survey (SF-36), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), Patient's Assessment of Pain by visual analogue scale (VAS), Patient's global assessment of disease activity (PtGA), EuroQoL-5 Dimension-5 Level (EQ-5D-5L) and Work Productivity and Activity Impairment-PsA (WPAI-PsA). Least squares mean change from baseline at week 24 was compared between RZB versus PBO by mixed-effects repeated regression modelling.

Results: At week 24, RZB versus PBO treatment resulted in significant differences (95% CIs) in mean change from baseline in ranked secondary endpoints SF-36 physical component summary score (3.9 (2.4 to 5.3); p<0.001) and FACIT-Fatigue (2.2 (0.6 to 3.9); p=0.009) and improvements in pain (-8.1 (-12.8 to -3.5)), PtGA (-8.8 (-13.5 to -4.2)) and EQ-5D-5L index (0.08 (0.04 to 0.11)) and VAS (5.9 (1.9 to 9.8)) (all nominal p<0.01). More RZB-treated versus PBO-treated patients reported improvements from baseline at week 24 in 7 of 8 SF-36 subdomains (nominal p<0.05). At week 24, more RZB-treated versus PBO-treated patients reported improvements in 3 of 4 WPAI-PsA domains (nominal p≤0.01).

Conclusion: Overall, RBZ treatment resulted in improvements in pain, fatigue, health-related quality of life and ability to perform work in Bio-IR and/or csDMARD-IR patients with PsA.

Trial registration number: NCT03671148.

Keywords: Arthritis, Psoriatic; Biological Therapy; Patient Reported Outcome Measures.

Conflict of interest statement

Competing interests: AJKO has received honoraria or fees for serving on advisory boards or as a consultant, and grants as an investigator for AbbVie, Bristol Myers Squibb, Gilead, Janssen, Lilly, Novartis, Pfizer, Roche and UCB. AMS, BP, ZW and AE are full-time employees of AbbVie and may hold AbbVie stock and/or stock options. KAP has received honoraria or fees for serving on advisory boards, or as a speaker, or as a consultant, or on a steering committee, or as a scientific officer, and grants as an investigator from AbbVie, Akros, Amgen, Anacor, Arcutis, Astellas, Avillion, Bausch Health/Valeant, Baxalta, Baxter, Boehringer Ingelheim, Bristol Myers Squibb, Can-Fite Biopharma, Celgene, Coherus, Dermavant, Dermira, Dice Pharmaceuticals, Dow Pharma, Eli Lilly, Evelo, Galapogos, Galderma, Genentech, Gilead, GlaxoSmithKline, Incyte, Janssen, Kyowa-Hakko Kirin, LEO Pharma, MedImmune, Meiji Seika Pharma, Merck-Serono, Merck Sharp & Dohme, Mitsubishi Pharma, Moberg Pharma, Novartis, Pfizer, PRCL Research, Regeneron, Roche, Sanofi-Genzyme, Sun Pharma, Takeda, UCB and Xencor. KdV has received honoraria or fees for serving on advisory boards, or as a speaker, or as a consultant, and grants as an investigator from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Pfizer and UCB. A Kivitz received honoraria or fees for serving as a speaker or as a consultant from AbbVie, Boehringer Ingelheim, Celgene, Flexion, Genzyme, Gilead Sciences, Inc, GSK, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Sanofi, SUN Pharma Advanced Research and UCB; and is a shareholder of Amgen, GlaxoSmithKline, Gilead Sciences, Novartis, Pfizer and Sanofi.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

Least squares mean change from baseline in SF-36 Scores at 24 weeks. *Nominal p

Figure 2

Least squares mean percent change from baseline in WPAI Scores at 24 weeks. *Reported only for patients who were employed. †Nominal p