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

Lars Erik Kristensen; Ahmed M Soliman; Kim Papp; Douglas White; Lisa Barcomb; Wenjing Lu; Ann Eldred; Frank Behrens

doi:10.1093/rheumatology/keac342

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

Rheumatology (Oxford). 2023 Feb 1;62(2):629-637. doi: 10.1093/rheumatology/keac342.

Authors

Lars Erik Kristensen¹, Ahmed M Soliman², Kim Papp³, Douglas White^{4

5}, Lisa Barcomb², Wenjing Lu², Ann Eldred², Frank Behrens⁶

Affiliations

¹ The Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen, Denmark.
² AbbVie Inc., North Chicago, IL, USA.
³ K Papp Clinical Research and Probity Medical Research, Waterloo, Ontario, Canada.
⁴ Rheumatology Department, Waikato Hospital, Hamilton.
⁵ Waikato Clinical School, University of Auckland, Auckland, New Zealand.
⁶ Rheumatology, Fraunhofer Institute Translational Medicine and Pharmacology ITMP & Cluster of Excellence CIMD, Goethe University, Frankfurt, Germany.

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).

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Antirheumatic Agents* / therapeutic use
Arthritis, Psoriatic* / drug therapy
Double-Blind Method
Fatigue / drug therapy
Fatigue / etiology
Humans
Pain / drug therapy
Patient Reported Outcome Measures
Quality of Life
Treatment Outcome

Substances

risankizumab
Antirheumatic Agents

Associated data

ClinicalTrials.gov/NCT03675308