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POS0200 (2021)
CLINICAL CHARACTERISTICS & OUTCOMES ASSOCIATE WITH WORK PRODUCTIVITY IN BIO-NAÏVE PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS THROUGH WEEK 24 OF THE DISCOVER-2 STUDY
J. Curtis1, I. Mcinnes2, D. D. Gladman3, F. Yang4, S. Peterson4, P. Agarwal5, A. Kollmeier6, E. C. Hsia7,8, C. Han7, M. Shawi4, W. Tillett9, P. J. Mease10, P. Rahman11
1University of Alabama at Birmingham, Department of Medicine, Immunology and Rheumatology, Birmingham, United States of America
2University of Glasgow, Institute of Infection, Immunity and Inflammation, Glasgow, United Kingdom
3Toronto Western Hospital, Centre for Prognosis in the Rheumatic Diseases, Toronto, Canada
4Janssen Global Services, LLC, Immunology, Horsham, United States of America
5Janssen Research & Development, LLC, Biostatistics, Spring House, United States of America
6Janssen Research & Development, LLC, Immunology, San Diego, United States of America
7Janssen Research & Development, Immunology, Spring House, United States of America
8University of Pennsylvania School of Medicine, Rheumatology, Philadelphia, United States of America
9Royal National Hospital for Rheumatic Diseases, Department of Pharmacy & Pharmacology, Centre for Therapeutic Innovation, Bath, United Kingdom
10Swedish Medical Center/Providence St. Joseph Health and University of Washington, Rheumatology Research, Seattle, United States of America
11Memorial University of Newfoundland, Craig L Dobbin Genetics Research Centre, St. John’s, Canada

Background: Psoriatic arthritis (PsA), a chronic inflammatory disease characterized by peripheral arthritis, axial inflammation, dactylitis, enthesitis & skin/nail psoriasis, causes impaired physical function, disability & loss of work productivity.


Objectives: Evaluate associations between PsA clinical characteristics & outcomes including fatigue & work productivity using Work Productivity & Activity Impairment Questionnaire: PsA (WPAI-PsA).


Methods: The Phase 3 DISCOVER-2 trial assessed guselkumab (GUS), an anti-IL-23p19 subunit monoclonal antibody, in bio-naïve adults with active PsA (swollen joint count [SJC] ≥5 & tender joint count [TJC] ≥5, C-reactive protein [CRP] ≥0.6 mg/dL) despite standard therapies. 1 Patients (Pts) were randomized 1:1:1 to GUS 100 mg Q4W; GUS 100 mg at W0, W4, then Q8W; or placebo (PBO). WPAI-PsA assesses PsA-related work time missed (absenteeism), impairment while working (presenteeism), productivity loss (absenteeism+presenteeism), & daily activity during the previous week. Spearman correlation testing evaluated relationships between pt demographics & disease characteristics of PsA & WPAI domain scores based on observed values at baseline. Univariate linear regression assessed associations between WPAI & these variables based on observed data at W0 & at 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 elsewhere, 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, & -3.5/-10.2/-10.9/-10.3 for PBO for absenteeism, presenteeism, absenteeism+presenteeism, & 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) & 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) score, but weakly correlated with other variables ( Figure 1 ). Based on univariate analyses & evaluation of collinearity between variables, attributes included in multivariate models were age, body mass index (BMI), gender, CRP, FACIT-F, pain, Psoriasis Area Severity Index (PASI), TJC, SJC, enthesitis & dactylitis. In final model, CRP, FACIT-F, & pain were statistically significantly associated with all WPAI domains ( Table 1 ). Presence of enthesitis & higher PASI score were significantly associated with higher loss of work productivity & activity outside work.


Conclusion: In PsA pts, extra-articular symptoms, fatigue, pain & elevated CRP were significantly associated with WPAI-assessed work & activity impairment. Treating all major clinical manifestations of PsA is needed to help pts improve work & activity impairment. GUS effectively treats all major clinical manifestations 1 & improves work & activity impairment in PsA. 2


REFERENCES:

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

[2]Curtis J. ACR 2020; Poster 0332.

Multivariate analysis of clinical characteristics/outcomes & WPAI domains at W0 & W24

Parameter Absenteeism a Presenteeism a Productivity Loss a Activity Impairment b
Estimate p-value Estimate p-value Estimate p-value Estimate p-value
Age -0.05 0.42 -0.27 <0.001 -0.28 <0.001 -0.06 0.17
Female 0.91 0.46 -1.54 0.22 -1.74 0.20 2.38 0.02
CRP 0.73 0.04 0.97 0.01 1.01 0.01 0.89 <0.001
FACIT-F -0.31 <0.001 -0.67 <0.001 -0.73 <0.001 -0.75 <0.001
Pain 1.03 <0.001 4.15 <0.001 4.25 <0.001 4.02 <0.001
PASI 0.06 0.36 0.16 0.02 0.14 0.05 0.15 0.003
SJC 0.08 0.48 -0.05 0.61 -0.05 0.66 0.03 0.75
TJC -0.10 0.13 0.11 0.09 0.09 0.19 0.10 0.04
Dactylitis (Y/N) -1.10 0.39 2.47 0.05 2.58 0.05 0.54 0.57
Enthesitis (Y/N) 1.52 0.20 2.38 0.04 2.99 0.01 2.40 0.01

a Pts working at baseline

b All pts in study


Disclosure of Interests: Jeffrey Curtis Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Eli Lilly, Myriad, Pfizer, Regeneron, Roche, and UCB, Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Eli Lilly, Myriad, Pfizer, Regeneron, Roche, and UCB, Iain McInnes Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, and UCB, Grant/research support from: Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, and UCB, Dafna D Gladman Consultant of: AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer and UCB, Grant/research support from: AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer and UCB, Feifei Yang Shareholder of: Janssen, Employee of: Janssen, Steve Peterson Shareholder of: Janssen, Employee of: Janssen, Prasheen Agarwal Shareholder of: Janssen, Employee of: Janssen, Alexa Kollmeier Shareholder of: Janssen, Employee of: Janssen, Elizabeth C Hsia Shareholder of: Janssen, Employee of: Janssen, Chenglong Han Shareholder of: Janssen, Employee of: Janssen, May Shawi Shareholder of: Janssen, Employee of: Janssen, William Tillett Speakers bureau: AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, MSD, Pfizer, and UCB, Grant/research support from: AbbVie, Celgene, Eli Lilly, Janssen, and Novartis, Philip J Mease Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer, SUN, and UCB, Grant/research support from: AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, SUN, and UCB, Proton Rahman Speakers bureau: AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Roche, and UCB, Consultant of: AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Roche, and UCB, Grant/research support from: Janssen and Novartis


Citation: Ann Rheum Dis, volume 80, supplement 1, year 2021, page 316
Session: PsA treatment: what is new? (Poster Tours)