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 . 
Registered on 28 June 2013. Monotherapy study: ClinicalTrials.gov , NCT01894516 
. Registered on 10 July 2013.