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Work Productivity and General Health Through 2 Years of Guselkumab Treatment in a Phase 3 Randomized Trial of Patients With Active Psoriatic Arthritis.
Curtis, Jeffrey R; McInnes, Iain B; Rahman, Proton; Gladman, Dafna D; Peterson, Steven; Yang, Feifei; Adejoro, Oluwakayode; Kollmeier, Alexa P; Shiff, Natalie J; Han, Chenglong; Shawi, May; Tillett, William; Mease, Philip J.
Afiliação
  • Curtis JR; Division of Clinical Immunology and Rheumatology, Department of Medicine, Immunology and Rheumatology, University of Alabama at Birmingham, Shelby 121, 1825 University Blvd, Birmingham, AL, 35233, USA. jrcurtis@uabmc.edu.
  • McInnes IB; College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.
  • Rahman P; Faculty of Medicine, Division of Rheumatology, Memorial University of Newfoundland, St. Johns, NL, Canada.
  • Gladman DD; Department of Medicine, University of Toronto, Toronto, ON, Canada.
  • Peterson S; Department of Immunology, Janssen Global Services, LLC, Horsham, PA, USA.
  • Yang F; Department of Immunology, Janssen Global Services, LLC, Horsham, PA, USA.
  • Adejoro O; Department of Immunology, Janssen Global Services, LLC, Horsham, PA, USA.
  • Kollmeier AP; Department of Immunology, Janssen Research & Development, LLC, San Diego, CA, USA.
  • Shiff NJ; Janssen Scientific Affairs, LLC, Horsham, PA, USA.
  • Han C; Department of Community Health and Epidemiology, College of Medicine, University of Saskatchewan, Saskatoon, SK, Canada.
  • Shawi M; Patient-Reported Outcomes, Janssen Global Services, LLC, Malvern, PA, USA.
  • Tillett W; Janssen Research & Development, LLC, Titusville, NJ, USA.
  • Mease PJ; Department of Life Sciences, Centre for Therapeutic Innovation, Royal National Hospital for Rheumatic Diseases, Combe Park, Bath, UK.
Rheumatol Ther ; 11(2): 425-441, 2024 Apr.
Article em En | MEDLINE | ID: mdl-38386178
ABSTRACT

INTRODUCTION:

To evaluate the effect of guselkumab on work productivity and nonwork daily activity impairment and general health status through 2 years in patients who were biologic-naïve with active psoriatic arthritis (PsA) in the phase 3 DISCOVER-2 clinical trial.

METHODS:

Adult patients with PsA were randomized to subcutaneous injections of guselkumab 100 mg every 4 weeks (Q4W); at weeks 0, 4, then every 8 weeks (Q8W); or placebo (through week 24 with crossover to guselkumab Q4W). Work productivity and nonwork daily activity impairment were assessed using the Work Productivity and Activity Impairment Questionnaire for PsA (WPAI-PsA) and patient-reported general health status using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index and EQ-Visual Analog Scale (EQ-VAS). Least-squares (LS) mean changes from baseline in WPAI-PsA domains and EQ-5D-5L/EQ-VAS were assessed through week 100. Changes in employment status were utilized to estimate potential indirect savings from improved work productivity.

RESULTS:

Of 739 randomized patients, 738 had available baseline data for the analyses (Q4W 245; Q8W 248; placebo 245). At week 24, greater improvements in work productivity, nonwork daily activity, and EQ-5D-5L/EQ-VAS were observed in the Q4W and Q8W groups versus the placebo group. At week 100, LS mean reductions in work productivity impairment (- 23.8% to - 28.0%) and nonwork daily activity impairment (- 26.6% to - 29.2%) and improvements in EQ-5D-5L/EQ-VAS (0.14 to 0.15/21.2 to 25.0) were maintained in patients receiving guselkumab. Among patients employed at baseline, 12.1-16.4% were not employed at week 100, and 20.0-25.3% shifted from not employed at baseline to employed at week 100. Potential yearly indirect cost savings (USD) from improved work productivity at week 100 ranged from $16,529 to $19,409.

CONCLUSION:

Patients with active PsA treated with guselkumab demonstrated reduced impairment in work productivity and nonwork daily activity, together with improvement in general health status and substantial potential cost savings, over a 2-year period. TRIAL REGISTRATION Clinicaltrials.gov identifier NCT03158285.
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Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2024 Tipo de documento: Article