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Effect of filgotinib, a selective JAK 1 inhibitor, with and without methotrexate in patients with rheumatoid arthritis: patient-reported outcomes

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Genovese M1,2, Westhovens R3, Meuleners L4, Van der Aa A4, Harrison P4, Tasset C4, Kavanaugh A5. Arthritis Res Ther. 2018 Mar 23;20(1):57. doi: 10.1186/s13075-018-1541-z.


Author information

1 Division of Immunology and Rheumatology, Stanford School of Medicine, Stanford, CA, USA. genovese@stanford.edu.

2 Division of Immunology and Rheumatology, Stanford School of Medicine, 1000 Welch RD #203, Palo Alto, CA, 94304, USA. genovese@stanford.edu.

3 Department of Development and Regeneration KU Leuven, Skeletal Biology and Engineering Research Center; Rheumatology, University Hospitals Leuven, Leuven, Belgium.

4 Galapagos NV, Mechelen, Belgium.

5 University of California San Diego, La Jolla, CA, USA.


BACKGROUND: The aim was to assess patient-reported outcomes (PROs) in patients with rheumatoid arthritis(RA) treated with filgotinib during two phase 2b, 24-week, randomized, placebo-controlled studies.

METHODS: Patients with moderate-to-severe active RA and an inadequate response to methotrexate (MTX) were randomized to daily placebo or filgotinib 50 mg, 100 mg, or 200 mg as add-on therapy to MTX (NCT01888874) or as monotherapy (NCT01894516). At week 12, nonresponders receiving filgotinib 50 mg in both studies or placebo in the add-on study, and all patients receiving placebo as monotherapy, were re-assigned to filgotinib 100 mg. PROs were measured using the Health Assessment Questionnaire - Disability Index (HAQ-DI) including Patient Pain assessed by visual analog scale, and the Patient Global Assessment of Disease Activity (Patient Global), the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale (Version 4), and the 36-Item Short Form Health Survey (SF-36).

RESULTS: At week 12, improvements in all PROs, apart from the SF-36 mental component in the add-on study, were statistically better with filgotinib than placebo; some improvements were noted as early as the first assessment time point (week 1 or week 4). Filgotinib improved HAQ-DI by 0.58-0.84 points, FACIT-Fatigue by 6.9-11.4 points, Patient Global by 25.2-35.6 mm, and Pain by 24.2-37.9 mm; scores were maintained or improved to week 24. Across all PROs, more patients achieved minimal clinically important differences and normative values with filgotinib 200 mg than placebo. Patients re-assigned to filgotinib 100 mg at week 12 experienced improvements in PROs between weeks 12 to 24.

CONCLUSIONS: Filgotinib as MTX add-on therapy or as monotherapy demonstrated rapid and sustained (to 24 weeks) improvements in health-related quality of life and functional status in patients with active RA.

TRIAL REGISTRATION: MTX add-on study: ClinicalTrials.gov , NCT01888874 .