Risankizumab improved health-related quality of life, fatigue, pain and work productivity in psoriatic arthritis: results of KEEPsAKE 1
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Risankizumab improved health-related quality of life, fatigue, pain and work productivity in psoriatic arthritis : results of KEEPsAKE 1. / Kristensen, Lars Erik; Soliman, Ahmed M.; Papp, Kim; White, Douglas; Barcomb, Lisa; Lu, Wenjing; Eldred, Ann; Behrens, Frank.
In: Rheumatology (Oxford, England), Vol. 62, No. 2, 2023, p. 629-637.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Risankizumab improved health-related quality of life, fatigue, pain and work productivity in psoriatic arthritis
T2 - results of KEEPsAKE 1
AU - Kristensen, Lars Erik
AU - Soliman, Ahmed M.
AU - Papp, Kim
AU - White, Douglas
AU - Barcomb, Lisa
AU - Lu, Wenjing
AU - Eldred, Ann
AU - Behrens, Frank
N1 - Publisher Copyright: © The Author(s) 2022. Published by Oxford University Press on behalf of the British Society for Rheumatology.
PY - 2023
Y1 - 2023
N2 - 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.
AB - 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.
KW - biological therapies
KW - DMARDs
KW - outcome measures
KW - patient attitude to health
KW - quality of life
KW - spondyloarthropathies (including psoriatic arthritis)
U2 - 10.1093/rheumatology/keac342
DO - 10.1093/rheumatology/keac342
M3 - Journal article
C2 - 35801915
AN - SCOPUS:85147317913
VL - 62
SP - 629
EP - 637
JO - Rheumatology
JF - Rheumatology
SN - 1462-0324
IS - 2
ER -
ID: 373029812