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Westhovens R, Rigby WFC, van der Heijde D, et al. Filgotinib in combination with methotrexate or as monotherapy versus methotrexate monotherapy in patients with active rheumatoid arthritis and limited or no prior exposure to methotrexate: the phase 3, randomised controlled FINCH 3 trial. Ann Rheum Dis. 2021;doi: 10.1136/annrheumdis-2020-219213.
Westhovens, R., Rigby, W. F. C., van der Heijde, D., Ching, D. W. T., Stohl, W., Kay, J., Chopra, A., Bartok, B., Matzkies, F., Yin, Z., Guo, Y., Tasset, C., Sundy, J. S., Jahreis, A., Mozaffarian, N., Messina, O. D., Landewé, R. B., Atsumi, T., & Burmester, G. R. (2021). Filgotinib in combination with methotrexate or as monotherapy versus methotrexate monotherapy in patients with active rheumatoid arthritis and limited or no prior exposure to methotrexate: the phase 3, randomised controlled FINCH 3 trial. Annals of the rheumatic diseases, . https://doi.org/10.1136/annrheumdis-2020-219213
Westhovens, René, et al. "Filgotinib in combination with methotrexate or as monotherapy versus methotrexate monotherapy in patients with active rheumatoid arthritis and limited or no prior exposure to methotrexate: the phase 3, randomised controlled FINCH 3 trial." Annals of the rheumatic diseases vol. (2021). doi: https://doi.org/10.1136/annrheumdis-2020-219213
Westhovens R, Rigby WFC, van der Heijde D, Ching DWT, Stohl W, Kay J, Chopra A, Bartok B, Matzkies F, Yin Z, Guo Y, Tasset C, Sundy JS, Jahreis A, Mozaffarian N, Messina OD, Landewé RB, Atsumi T, Burmester GR. Filgotinib in combination with methotrexate or as monotherapy versus methotrexate monotherapy in patients with active rheumatoid arthritis and limited or no prior exposure to methotrexate: the phase 3, randomised controlled FINCH 3 trial. Ann Rheum Dis. 2021 Jan 15; doi: 10.1136/annrheumdis-2020-219213. Epub 2021 Jan 15. PMID: 33452004; PMCID: PMC8142453.
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Ann Rheum Dis. 2021 Jan 15; doi: 10.1136/annrheumdis-2020-219213. Epub 2021 Jan 15.

Filgotinib in combination with methotrexate or as monotherapy versus methotrexate monotherapy in patients with active rheumatoid arthritis and limited or no prior exposure to methotrexate: the phase 3, randomised controlled FINCH 3 trial.

Annals of the rheumatic diseases

René Westhovens, William F C Rigby, Désirée van der Heijde, Daniel W T Ching, William Stohl, Jonathan Kay, Arvind Chopra, Beatrix Bartok, Franziska Matzkies, Zhaoyu Yin, Ying Guo, Chantal Tasset, John S Sundy, Angelika Jahreis, Neelufar Mozaffarian, Osvaldo Daniel Messina, Robert Bm Landewé, Tatsuya Atsumi, Gerd R Burmester

Affiliations

  1. Department of Development and Regeneration, Skeletal Biology and Engineering Research Center, KU Leuven, Leuven, Flanders, Belgium [email protected].
  2. Division of Rheumatology, University Hospitals KU Leuven, Leuven, Flanders, Belgium.
  3. Geisel School of Medicine at Dartmouth, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
  4. Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
  5. Timaru Medical Specialists Limited, Timaru, New Zealand.
  6. University of Southern California Keck School of Medicine, Los Angeles, California, USA.
  7. Division of Rheumatology, Department of Medicine, UMass Memorial Medical Center, Worcester, Massachusetts, USA.
  8. Division of Rheumatology, Department of Medicine, University of Massachusetts Medical School, Worcester, Massachusetts, USA.
  9. Centre for Rheumatic Diseases, Pune, India.
  10. Gilead Sciences, Foster City, California, USA.
  11. Galapagos NV, Mechelen, Belgium.
  12. Department of Medicine, Duke University Medical Center, Durham, North Carolina, USA.
  13. Ichnos Sciences, New York, New York, USA.
  14. Cosme Argerich Hospital, Buenos Aires, Argentina.
  15. Investigaciones Reumatologicas y Osteologicas SRL IRO, Buenos Aires, Argentina.
  16. Department of Rheumatology & Clinical Immunology, Amsterdam University Medical Center, Amsterdam, The Netherlands.
  17. Department of Rheumatology, Zuyderland Hospital, Heerlen, The Netherlands.
  18. Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
  19. Department of Rheumatology and Clinical Immunology, Charité University Hospital, Berlin, Germany.
  20. Free University and Humboldt University, Berlin, Germany.

PMID: 33452004 PMCID: PMC8142453 DOI: 10.1136/annrheumdis-2020-219213

Abstract

OBJECTIVES: To investigate efficacy and safety of the Janus kinase-1 inhibitor filgotinib in patients with active rheumatoid arthritis (RA) with limited or no prior methotrexate (MTX) exposure.

METHODS: This 52-week, phase 3, multicentre, double-blind clinical trial (NCT02886728) evaluated once-daily oral filgotinib in 1252 patients with RA randomised 2:1:1:2 to filgotinib 200 mg with MTX (FIL200 +MTX), filgotinib 100 mg with MTX (FIL100 +MTX), filgotinib 200 mg monotherapy (FIL200), or MTX. The primary endpoint was proportion achieving 20% improvement in American College of Rheumatology criteria (ACR20) at week 24.

RESULTS: The primary endpoint was achieved by 81% of patients receiving FIL200+ MTX versus 71% receiving MTX (p<0.001). A significantly greater proportion treated with FIL100+ MTX compared with MTX achieved an ACR20 response (80%, p=0.017) at week 24. Significant improvement in Health Assessment Questionnaire-Disability Index was seen at week 24; least-squares mean change from baseline was -1.0 and -0.94 with FIL200+MTX and FIL100+MTX, respectively, versus -0.81 with MTX (p<0.001, p=0.008, respectively). Significantly higher proportions receiving FIL200+MTX (54%) and FIL100+MTX (43%) achieved DAS28(CRP) <2.6 versus MTX (29%) (p<0.001 for both) at week 24. Hierarchical testing stopped for comparison of ACR20 for FIL200 monotherapy (78%) versus MTX (71%) at week 24 (p=0.058). Adverse event rates through week 52 were comparable between all treatments.

CONCLUSIONS: FIL200+MTX and FIL100+MTX both significantly improved signs and symptoms and physical function in patients with active RA and limited or no prior MTX exposure; FIL200 monotherapy did not have a superior ACR20 response rate versus MTX. Filgotinib was well tolerated, with acceptable safety compared with MTX.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Keywords: antirheumatic agents; arthritis; rheumatoid; therapeutics

Conflict of interest statement

Competing interests: RW reports grant/research support from and serving as a consultant for Celltrion, Galapagos, and Gilead Sciences. WFCR reports serving as a consultant for Gilead Sciences. DvdH re

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