Background: Risankizumab (RZB) has been approved in the UK and Europe for the treatment of adults with active PsA. Patient-reported outcomes (PROs) are important tools for understanding a therapy’s efficacy from the patient’s perspective.

Objectives: This study evaluated the impact of RZB versus placebo on health-related quality of life (HRQoL), fatigue, and work productivity in patients with psoriatic arthritis (PsA) and inadequate response to 1 or 2 biologics and/or ≥1 conventional synthetic DMARDs in two Phase 3 trials (KEEPsAKE 1&2).

Methods: Eligible patients with active PsA (n=1402) were randomized (1:1) to receive risankizumab 150 mg (n=706) or placebo (n=696). Patient-reported outcomes assessed were 36-Item Short-Form Health Survey (SF-36), Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-Fatigue), EQ-5D-5L, and Work Productivity and Activity Impairment–PsA questionnaire. Least squares (LS) mean changes from baseline at Week 24 were compared between risankizumab versus placebo by mixed-effects repeated regression modeling.

Results: At Week 24, risankizumab- versus placebo-treated patients reported greater improvements in LS mean changes with between-group differences (all nominal P <0.001) in SF-36 physical component score (mean difference=3.5, 95% confidence interval [CI] 2.7, 4.2) and mental component score (mean difference=1.8, 95% CI 0.9, 2.6), FACIT-Fatigue (mean difference=2.5, 95% CI 1.5, 3.4), EQ-5D-5L index score (mean=0.07, 95% CI 0.05, 0.09), and EQ-5D-5L visual analogue scale score (mean difference=5.8, 95% CI 3.6, 8.0). In addition, risankizumab- versus placebo-treated patients reported greater reductions with between-group differences (all nominal P <0.001) in overall work impairment (mean difference= −8.9%, 95% CI −13.1, −4.7), activity impairment (mean difference= −7.7%, 95% CI −10.3, −5.2), and presenteeism (mean difference= −9.8%, 95% CI −13.3, −6.3).

Conclusion: Compared to placebo, risankizumab resulted in greater improvements in HRQoL, fatigue, and work productivity among patients with PsA.

Acknowledgements: This work/study was funded by AbbVie Inc. AbbVie participated in the study design, research, data collection, analysis and interpretation of data. No honoraria or payments were made for authorship. Medical writing services provided by Natalie Mitchell of Fishawack Facilitate Ltd, part of Fishawack Health, and funded by AbbVie.

Disclosure of Interests: Lars Erik Kristensen Speakers bureau: AbbVie, Amgen, Biogen, Bristol Myers Squibb, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer, and UCB; and received research grants from AbbVie, Biogen, Eli Lilly, Janssen Pharmaceutical, Novartis, Pfizer, and UCB., Consultant of: AbbVie, Amgen, Biogen, Bristol Myers Squibb, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer, and UCB; and received research grants from AbbVie, Biogen, Eli Lilly, Janssen Pharmaceutical, Novartis, Pfizer, and UCB., Ahmed M. Soliman Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Kim Papp Speakers bureau: AbbVie, Amgen, Astellas, Baxalta, Baxter, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Coherus, Dermira, Eli Lilly, Forward Pharma, Galderma, Genentech, GlaxoSmithKline, Janssen, Kyowa-Hakko Kirin, LEO Pharma, MedImmune, Merck-Serono, Merck Sharp & Dohme, Novartis, Pfizer, Regeneron, Roche, Sanofi-Genzyme, Stiefel, Sun Pharma, Takeda, UCB, and Valeant., Consultant of: AbbVie, Amgen, Astellas, Baxalta, Baxter, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Coherus, Dermira, Eli Lilly, Forward Pharma, Galderma, Genentech, GlaxoSmithKline, Janssen, Kyowa-Hakko Kirin, LEO Pharma, MedImmune, Merck-Serono, Merck Sharp & Dohme, Novartis, Pfizer, Regeneron, Roche, Sanofi-Genzyme, Stiefel, Sun Pharma, Takeda, UCB, and Valeant., Grant/research support from: AbbVie, Amgen, Astellas, Baxalta, Baxter, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Coherus, Dermira, Eli Lilly, Forward Pharma, Galderma, Genentech, GlaxoSmithKline, Janssen, Kyowa-Hakko Kirin, LEO Pharma, MedImmune, Merck-Serono, Merck Sharp & Dohme, Novartis, Pfizer, Regeneron, Roche, Sanofi-Genzyme, Stiefel, Sun Pharma, Takeda, UCB, and Valeant., Lisa Barcomb Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Ann Eldred Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Zailong Wang Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Douglas White Speakers bureau: AbbVie, Novartis, and Roche., Consultant of: AbbVie, Novartis, and Roche., Frank Behrens Speakers bureau: AbbVie, Amgen, BMS, Boehringer, Celgene, Chugai, Genzyme, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, Sandoz, and UCB, Consultant of: AbbVie, Amgen, BMS, Boehringer, Celgene, Chugai, Genzyme, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, Sandoz, and UCB, Grant/research support from: AbbVie, Chugai, Janssen, Pfizer, and Roche