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Abstract Number: 0143

Filgotinib Improved Work Productivity and Activity Impairment in Patients with Rheumatoid Arthritis Who Are Methotrexate-naïve: Results from the FINCH-3 Study

Zobair Younossi1, Maria Stepanova2, Lynn Gerber1, Susan Lee3, Ken Hasegawa3, Thijs Hendrikx4, Annelies Boonen5, Bernard Combe6, David Walker7 and Rieke Alten8, 1Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA, 2Center for Outcomes Research in Liver Disease, Washington, DC, 3Gilead Sciences, Inc., Foster City, CA, 4Galapagos BV, Leiden, Netherlands, 5Maastricht University Medical Center, Maastricht, Netherlands, 6University of Montpellier, Montpellier, France, 7Northumbria Healthcare Trust, North Shields, United Kingdom, 8Schlosspark-Klinik, Universitätsmedizin, Berlin, Germany

Meeting: ACR Convergence 2020

Keywords: clinical trial, Patient reported outcomes, rheumatoid arthritis, work

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Session Information

Date: Friday, November 6, 2020

Title: Patient Outcomes, Preferences, & Attitudes Poster I: RA, Spondyloarthritis, & OA

Session Type: Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose: Filgotinib (FIL) is a potent oral selective janus kinase 1 inhibitor currently being investigated as an agent to treat rheumatoid arthritis (RA). In the FINCH 3 study (NCT02886728), FIL in combination with methotrexate (MTX), demonstrated rapid and significant improvements in the signs and symptoms of RA vs MTX monotherapy in patients who were MTX-naïve. Chronic inflammatory diseases such as RA substantially affects a broad range of aspects of patient health related quality of life, including work participation.1 The objective of this post-hoc analysis was to evaluate the rate and magnitude of treatment response on work productivity and activity scores in RA patients from the FINCH 3 study.

Methods: Patients with active RA and MTX-naïve were randomized 2:1:1:2 received FIL 200 mg + MTX, FIL 100 mg + MTX, FIL 200 mg (+ PBO), or MTX (+ PBO) for up to 52 weeks. The activity impairment, work productivity impairment, presenteeism, and absenteeism in the past 7 days were evaluated at baseline and at weeks 4, 12, 24, 36 and 52 on treatment, using the self-administered 6-item Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI:RA). The WPAI-RA contains the activity impairment as a single item score evaluated among all subjects, while work productivity impairment (employed patients only) absenteeism and presenteeism. The 4 subscale scores ranged from 0%-100%, with higher scores indicating greater impairment. Percentage changes from baseline in WPAI: RA score were analyzed using mixed effect models for repeated measures (MMRM), and missing data were not imputed. All analyses were exploratory without multiplicity adjustment, and nominal P values are reported.

Results: Baseline characteristics were similar across all treatment group. Patients were (mean ± SD) 53 ± 14 years old, 80% female, and 42% employed. Statistically significantly greater improvement in work productivity, presenteeism and activity from baseline was reported as early as week 4 with all FIL treatment group compared to MTX alone (Table 1). This improvement over baseline persisted through week 12 for both doses of FIL + MTX and throughout 52 weeks of treatment for FIL 200mg + MTX compared to MTX alone. At week 52, both doses of FIL + MTX resulted in 33.4-39.9% improvement in work productivity, presenteeism, and activity.

Conclusion: FIL monotherapy or with concomitant MTX led to earlier improvements in activity impairment, overall work productivity impairment and presenteeism in RA patients who were naïve to MTX compared to MTX alone.

Reference:

  1. Kim et al. J Rheumatol. 2017;44(8):1112-1117.


Disclosure: Z. Younossi, Gilead, 5, Terns, 5, Viking, 5, Intercept, 5, Novo Nordisk, 5, Merck, 5, Abbvie, 5, Novartis, 5, BMS, 5, Shionogi, 5, Siemens, 5; M. Stepanova, None; L. Gerber, None; S. Lee, Gilead Sciences, Inc., 3; K. Hasegawa, Gilead Sciences, Inc., 1, 3; T. Hendrikx, Galapagos, 1, 3; A. Boonen, AbbVie, 2, Galapagos, 5, Lilly, 5, Celgene, 2, UC, 5; B. Combe, AbbVie, 5, 8, Janssen, 5, Eli Lilly, 2, 5, 8, Novartis, 2, Gilead Sciences, Inc., 5, 8, Roche-Chugai, 5, 8, Sanofi, 5, Pfizer, 2, 8, MSD, 8, Bristol-Myers Squibb, 8; D. Walker, Gilead, 2, 5, Lilly, 5, 8, Pfizer, 5, 8, Novartis, 5, 8; R. Alten, Pfizer, 2, 8, Gilead Sciences, Inc., 2, Novartis, 2, AbbVie, 2, 5, Bristol-Myers Squibb, 2, 5, Lilly, 2, 5, UCB, 2, 5.

To cite this abstract in AMA style:

Younossi Z, Stepanova M, Gerber L, Lee S, Hasegawa K, Hendrikx T, Boonen A, Combe B, Walker D, Alten R. Filgotinib Improved Work Productivity and Activity Impairment in Patients with Rheumatoid Arthritis Who Are Methotrexate-naïve: Results from the FINCH-3 Study [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/filgotinib-improved-work-productivity-and-activity-impairment-in-patients-with-rheumatoid-arthritis-who-are-methotrexate-naive-results-from-the-finch-3-study/. Accessed .
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