Risankizumab improved health-related quality of life, fatigue, pain and work productivity in psoriatic arthritis: results of KEEPsAKE 1

Abstract

Objectives: PsA is a heterogeneous disease that impacts many aspects of social and mental life, including quality of life. Risankizumab, an antagonist specific for IL-23, is currently under investigation for the treatment of adults with active PsA. This study evaluated the impact of risankizumab vs placebo on health-related quality of life (HRQoL) and other patient-reported outcomes (PROs) among patients with active PsA and inadequate response or intolerance to conventional synthetic DMARD (csDMARD-IR) in the KEEPsAKE 1 trial.

Methods: Adult patients with active PsA (n = 964) were randomized (1:1) to receive risankizumab 150 mg or placebo. PROs assessed included the 36-Item Short-Form Health Survey (SF-36, v2), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), EuroQoL-5 Dimension-5 Level (EQ-5D-5L), Patient's Assessment of Pain, Patient's Global Assessment (PtGA) of Disease Activity, and Work Productivity and Activity Impairment-PsA (WPAI-PsA) questionnaire. Least squares (LS) mean change from baseline at week 24 was compared between risankizumab and placebo.

Results: At week 24, differences between groups were observed using LS mean changes from baseline in SF-36 physical component summary and mental component summary; FACIT-Fatigue; EQ-5D-5L; Patient's Assessment of Pain; PtGA; all eight SF-36 domains (all nominal P < 0.001); and the WPAI-PsA domains of impairment while working (presenteeism), overall work impairment and activity impairment (all nominal P < 0.01).

Conclusion: Risankizumab treatment resulted in greater improvements in HRQoL, fatigue, pain and work productivity in patients with active PsA who have csDMARD-IR, when compared with placebo.

Trial registration: ClinicalTrials.gov, https://clinicaltrials.gov, NCT03675308.

Keywords: DMARDs; biological therapies; outcome measures; patient attitude to health; quality of life; spondyloarthropathies (including psoriatic arthritis).

Fig. 1

LS mean change and difference (95% CI) in SF-36 component summary and domain scores from baseline at week 24 ^aNominal P < 0.001 for risankizumab vs placebo. BP: bodily pain; GH: general health; LS: least squares; MCS: mental component summary; MH: mental health; PBO: placebo; PCS: physical component summary; PF: physical health; RE: role emotional; RZB: risankizumab; RP: role physical; SF: social functioning; SF-36: 36-Item Short-Form Survey; VT: vitality.

Fig. 2

LS mean change and difference (95% CI) in WPAI-PsA domain scores from baseline at week 24 ^aReported only for patients who were employed. ^bNominal P < 0.001 for risankizumab vs placebo. ^cNominal P < 0.01 for risankizumab vs placebo. LS: least squares; PBO: placebo; RZB: risankizumab; WPAI-PsA: Work Productivity and Activity Impairment.