ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1813

Clinical Characteristics & Outcomes Associate with Work Productivity in Bio-naïve Patients with Active Psoriatic Arthritis Through Week 24 of the DISCOVER-2 Study

Jeffrey Curtis1, Iain McInnes2, Proton Rahman3, Dafna Gladman4, Feifei Yang5, Steven Peterson6, Prasheen Agarwal7, Alexa Kollmeier8, Elizabeth Hsia9, Chenglong Han9, May Shawi10, William Tillett11 and Philip Mease12, 1Division of Clinical Immunology and Rheumatology, Department of Medicine, Department of Epidemiology, University of Alabama at Birmingham, Birmingham, AL, 2University of Glasgow, School of Medicine, Glasgow, Scotland, United Kingdom, 3Department of Medicine, Eastern Health and Memorial University of Newfoundland, St John's, NL, Canada, 4Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada, 5Janssen Immunology Global Commercial Strategy Organization, Horsham, PA, 6Janssen Immunology Global Commercial Strategy Organization, Raritan, NJ, 7Department of Biostatics, Janssen Research & Development, LLC, Spring House, Spring House, PA, 8Janssen Research & Development, LLC, La Jolla, CA, 9Janssen Research & Development, LLC, Spring House, PA, 10Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada, 11Royal National Hospital for Rheumatic Diseases, Bath, United Kingdom, 12Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA

Meeting: ACR Convergence 2021

Keywords:

Session Information

Date: Tuesday, November 9, 2021

Title: Spondyloarthritis Including PsA – Treatment Poster III: Psoriatic Arthritis II (1801–1835)

Session Type: Poster Session D

Session Time: 8:30AM-10:30AM

Background/Purpose: PsA, a chronic inflammatory disease characterized by peripheral arthritis, axial inflammation, dactylitis, enthesitis and skin/nail psoriasis, causes impaired physical function, disability, and loss of work productivity. We evaluated associations between PsA clinical characteristics and outcomes including fatigue and work productivity using Work Productivity & Activity Impairment Questionnaire: PsA (WPAI-PsA).

Methods: Phase 3 DISCOVER-2 trial assessed guselkumab (GUS), an anti-IL-23p19-subunit human mAb, in bio-naïve adults with active PsA (swollen joint count [SJC] ≥5, tender joint count [TJC] ≥5, CRP ≥0.6 mg/dL) despite standard therapies.1 Patients (Pts) were randomized 1:1:1 to GUS 100 mg every 4 weeks (Q4W); GUS 100 mg at Week (W)0, W4, then Q8W; or placebo (PBO). WPAI-PsA assesses PsA-related work time missed (absenteeism), impairment while working (presenteeism), productivity loss (absenteeism+presenteeism), and daily activity during previous week. Spearman correlation testing evaluated relationships between pt demographics & PsA disease characteristics and WPAI domain scores based on observed values at baseline. Univariate linear regression assessed associations between WPAI, and these variables based on observed data at W0 and W24. Variables with p< 0.10 were included in a multivariate analysis employing a mixed-effects model for repeated measures, controlling for all other variables; resulting p-values < 0.05 were considered statistically significant.

Results: As reported,2 least-squares mean % changes from baseline at W24 were -3.8/‑19.5/-20.0/-20.5 for GUS Q4W, -3.1/-19.4/-19.7/-21.5 for GUS Q8W, and -3.5/-10.2/-10.9/-10.3 for PBO for absenteeism, presenteeism, absenteeism+presenteeism, and daily activity impairment, respectively. Among 738 pts, WPAI domain scores were moderately to strongly correlated (ie, ≥0.4) with pt-reported pain (0-10 visual analog scale), physical function (Health Assessment Questionnaire-Disability Index [HAQ-DI]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F] scale) and 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) score, but weakly correlated with other variables (Figure). Based on univariate analyses and evaluation of collinearity between variables, attributes included in multivariate models were age, BMI, gender, CRP, FACIT-F, pain, Psoriasis Area Severity Index (PASI), TJC, SJC, enthesitis and dactylitis. In final model, CRP, FACIT-F, and pain were statistically significantly associated with all WPAI domains (Table). Presence of enthesitis and higher PASI score were significantly associated with higher loss of work productivity and activity outside work.

Conclusion: In PsA pts, extra-articular symptoms, fatigue, pain, and elevated CRP were significantly associated with WPAI-assessed work and activity impairment. Treating all major clinical manifestations of PsA is needed to improve work and activity impairment. GUS effectively treats all major clinical manifestations1 and improves work and activity impairment in PsA.2

1. Mease P. Lancet 2020;395:1126-36

2. Curtis J. ACR 2020; Poster 0332

Disclosures: J. Curtis, AbbVie, 2, Amgen, 2, 5, Bristol-Myers Squibb, 2, Janssen, 2, Eli Lilly, 2, Myriad, 2, Pfizer Inc, 2, 5, Roche/Genentech, 2, UCB, 2, CorEvitas, 2, 5, Crescendo Bio, 5; I. McInnes, Bristol Myers Squibb, 2, 5, Celgene, 2, 5, Eli Lilly, 2, 5, Janssen, 2, 5, Novartis, 2, 5, UCB, 2, 5, Gilead, 2, AbbVie, 2, AstraZeneca, 5, Boehringer Ingelheim, 2, Amgen, 2, 5, 6, Pfizer, 2, 5, 6; P. Rahman, Janssen, 2, 5, 6, Novartis, 2, 5, 6, AbbVie, 2, 6, Amgen, 2, 6, Bristol Myers Squibb, 2, 6, Celgene, 2, 6, Eli Lilly, 2, 6, Pfizer, 2, 6, UCB, 2, 6, Merck, 2, 6; D. Gladman, AbbVie, 2, 5, Amgen, 2, 5, Eli Lilly, 2, 5, Galapagos, 2, 5, Gilead, 2, 5, Janssen, 2, 5, Novartis, 2, 5, Pfizer, 2, 5, UCB, 2, 5, Celgene, 2, 5, Bristol Myers Squibb, 2, 5; F. Yang, Janssen Research & Development, LLC (a subsidiary of Johnson & Johnson), 3, 11; S. Peterson, Janssen, 3, 11; P. Agarwal, Janssen Research & Development, LLC (a subsidiary of Johnson & Johnson), 3, 11; A. Kollmeier, Janssen Research & Development, LLC (a subsidiary of Johnson & Johnson), 3, 11; E. Hsia, Janssen Research & Development, LLC (a subsidiary of Johnson & Johnson), 3, 11; C. Han, Janssen Research & Development, LLC (a subsidiary of Johnson & Johnson), 3, 11; M. Shawi, Janssen Global Services, LLC (a subsidiary of Johnson & Johnson), 3, 11; W. Tillett, AbbVie, 1, 2, 6, Amgen, 1, 2, 6, Celgene, 1, 2, 6, Eli Lilly, 1, 2, 6, Janssen, 1, 2, 6, Novartis, 1, 2, 6, MSD, 1, 2, 6, Pfizer, 1, 2, 6, UCB, 1, 2, 6, Merck Sharp & Dohme, 2; P. Mease, AbbVie, 2, 5, 6, Amgen, 2, 5, 6, Bristol-Myers Squibb, 2, 5, Eli Lilly, 2, 5, 6, Galapagos, 2, 5, Celgene, 2, Boehringer Ingelheim, 2, Genentech, 2, 5, 6, Janssen, 2, 5, 6, Gilead Sciences, 2, 5, 6, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, Sun Pharma, 2, 5, UCB Pharma, 2, 6, GSK, 2.

To cite this abstract in AMA style:

Curtis J, McInnes I, Rahman P, Gladman D, Yang F, Peterson S, Agarwal P, Kollmeier A, Hsia E, Han C, Shawi M, Tillett W, Mease P. Clinical Characteristics & Outcomes Associate with Work Productivity in Bio-naïve Patients with Active Psoriatic Arthritis Through Week 24 of the DISCOVER-2 Study [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/clinical-characteristics-outcomes-associate-with-work-productivity-in-bio-naive-patients-with-active-psoriatic-arthritis-through-week-24-of-the-discover-2-study/. Accessed .

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