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Rationale, Design and Methods of the Filgotinib Initial Response Study in Rheumatoid Arthritis (FIRST-RA).

Georg Pongratz1, Rieke Alten2, Torsten Witte3

  • 1Abteilung für Rheumatologie und Klinische Immunologie, Krankenhaus Barmherzige Brüder, Regensburg und Fakultät für Medizin, Universität Regensburg, Regensburg, Germany.

Rheumatology and Therapy
|January 12, 2026
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Summary
This summary is machine-generated.

The FIRST-RA study investigates early treatment effects of filgotinib in rheumatoid arthritis (RA) patients. Real-world data show rapid improvements in pain, fatigue, and function within 4 weeks of starting this Janus kinase 1 (JAK1) inhibitor.

Keywords:
FilgotinibJAK inhibitorsPainPatient-reported outcomesRAID scoreReal-world evidence

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Area of Science:

  • Rheumatology
  • Pharmacology
  • Clinical Trials

Background:

  • Filgotinib is an oral JAK1 inhibitor for moderate-to-severe active rheumatoid arthritis (RA).
  • Real-world data on early filgotinib treatment effects are limited.
  • The FIRST-RA study addresses this gap under routine care.

Purpose of the Study:

  • To evaluate very early treatment effects of filgotinib in RA patients.
  • To assess improvements in pain, fatigue, and function within 4 weeks.
  • To support personalized RA management and clarify filgotinib use.

Main Methods:

  • Prospective, multicentre, non-interventional cohort study in Germany and Austria.
  • Enrollment of ~300 adult RA patients newly starting filgotinib.
  • Follow-up for 24 weeks with clinical assessments and patient-reported outcomes (PROs).

Main Results:

  • Primary endpoint: change in RAID pain score from baseline to week 4.
  • Secondary endpoints: fatigue, disease activity, morning stiffness, satisfaction, and tolerability.
  • Analysis of early symptom changes and effectiveness across advanced therapy (AT) subgroups.

Conclusions:

  • FIRST-RA is the first real-world study capturing very early symptomatic responses to filgotinib.
  • Integrating PROs with clinical outcomes supports personalized RA management.
  • The study aims to clarify filgotinib's role in current clinical practice.