Jeffrey R Curtis1, Iain B McInnes2, Proton Rahman3, Dafna D Gladman4, Steven Peterson5, Prasheen Agarwal6, Feifei Yang5, Alexa P Kollmeier7, Elizabeth C Hsia8,9, Natalie J Shiff10,11, Bei Zhou6, Chenglong Han12, May Shawi13, William Tillett14, Philip J Mease15. 1. Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, 510 20th St South, FOT 802, Birmingham, AL, 35233, USA. jrcurtis@uabmc.edu. 2. College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, UK. 3. Division of Rheumatology, Faculty of Medicine, Memorial University of Newfoundland, St. Johns, NL, Canada. 4. Department of Medicine, University of Toronto, Schroeder Arthritis Institute, Krembil Research Institute, Centre for Prognosis Studies in the Rheumatic Diseases, Toronto Western Hospital, Toronto, ON, Canada. 5. Department of Immunology, Janssen Global Services, LLC, Horsham, PA, USA. 6. Department of Biostatics, Janssen Research & Development, LLC, Spring House, PA, USA. 7. Department of Immunology, Janssen Research & Development, LLC, San Diego, CA, USA. 8. Department of Immunology, Janssen Research & Development, LLC, Spring House, PA, USA. 9. University of Pennsylvania School of Medicine, Philadelphia, PA, USA. 10. Janssen Scientific Affairs, LLC, Horsham, PA, USA. 11. Adjunct, Department of Community Health and Epidemiology, College of Medicine, University of Saskatchewan, Saskatoon, SK, Canada. 12. Patient-Reported Outcomes, Janssen Global Services, LLC, Malvern, PA, USA. 13. Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, USA. 14. Department of Pharmacy and Pharmacology, Centre for Therapeutic Innovation, Royal National Hospital for Rheumatic Diseases, Combe Park, Bath, UK. 15. Department of Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, USA.
Abstract
INTRODUCTION: The phase 3 DISCOVER-2 trial evaluated the effect of guselkumab on impaired work productivity and nonwork activity in biologic-naïve patients with psoriatic arthritis (PsA). METHODS: Adults with active PsA were randomized (1:1:1) to guselkumab 100 mg every 4 weeks (Q4W), guselkumab 100 mg at weeks 0 and 4 and then every 8 weeks (Q8W), or placebo (with crossover to guselkumab Q4W at week 24). Least squares mean change from baseline in Work Productivity and Activity Impairment Questionnaire for PsA (WPAI-PsA) domains and employment were assessed by treatment group. Multivariate analysis of data from weeks 0 through 24 assessed independent associations between PsA clinical features and WPAI-PsA domains. RESULTS: In total, 738 patients were evaluated (guselkumab Q4W n = 245; guselkumab Q8W n = 248; placebo n = 245). At week 24, improvements (reduced impairment) in presenteeism (Q4W -20.1%, Q8W -19.6%, placebo -10.5%), work productivity (Q4W -20.1%, Q8W -19.2%, placebo -10.6%), and nonwork activity (Q4W -20.5%, Q8W -21.2%, placebo -9.9%) were greater in guselkumab-treated versus placebo-treated patients. At week 52, following placebo crossover at week 24, improvements were similar among groups. Baseline absenteeism was minimal and did not change in any group. By week 52, 23.1-25.9% of guselkumab-treated patients who were unemployed at baseline were employed. All WPAI-PsA domains were positively associated with C-reactive protein level, fatigue, and pain. All domains except absenteeism were positively associated with enthesitis and Psoriasis Area and Severity Index score. Age was negatively associated with presenteeism and work productivity loss, female sex and tender joint count were positively associated with nonwork activity impairment, and dactylitis was positively associated with presenteeism. CONCLUSION: Both guselkumab regimens reduced work productivity loss and nonwork activity impairment in patients with active PsA. Association of work productivity loss and nonwork activity impairment with PsA joint and skin features suggests that improvement in both features is beneficial for optimizing improved work productivity loss and nonwork activity impairment. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT03158285.
INTRODUCTION: The phase 3 DISCOVER-2 trial evaluated the effect of guselkumab on impaired work productivity and nonwork activity in biologic-naïve patients with psoriatic arthritis (PsA). METHODS: Adults with active PsA were randomized (1:1:1) to guselkumab 100 mg every 4 weeks (Q4W), guselkumab 100 mg at weeks 0 and 4 and then every 8 weeks (Q8W), or placebo (with crossover to guselkumab Q4W at week 24). Least squares mean change from baseline in Work Productivity and Activity Impairment Questionnaire for PsA (WPAI-PsA) domains and employment were assessed by treatment group. Multivariate analysis of data from weeks 0 through 24 assessed independent associations between PsA clinical features and WPAI-PsA domains. RESULTS: In total, 738 patients were evaluated (guselkumab Q4W n = 245; guselkumab Q8W n = 248; placebo n = 245). At week 24, improvements (reduced impairment) in presenteeism (Q4W -20.1%, Q8W -19.6%, placebo -10.5%), work productivity (Q4W -20.1%, Q8W -19.2%, placebo -10.6%), and nonwork activity (Q4W -20.5%, Q8W -21.2%, placebo -9.9%) were greater in guselkumab-treated versus placebo-treated patients. At week 52, following placebo crossover at week 24, improvements were similar among groups. Baseline absenteeism was minimal and did not change in any group. By week 52, 23.1-25.9% of guselkumab-treated patients who were unemployed at baseline were employed. All WPAI-PsA domains were positively associated with C-reactive protein level, fatigue, and pain. All domains except absenteeism were positively associated with enthesitis and Psoriasis Area and Severity Index score. Age was negatively associated with presenteeism and work productivity loss, female sex and tender joint count were positively associated with nonwork activity impairment, and dactylitis was positively associated with presenteeism. CONCLUSION: Both guselkumab regimens reduced work productivity loss and nonwork activity impairment in patients with active PsA. Association of work productivity loss and nonwork activity impairment with PsA joint and skin features suggests that improvement in both features is beneficial for optimizing improved work productivity loss and nonwork activity impairment. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT03158285.