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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.

Publication ,  Journal Article
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 ...
Published in: Ann Rheum Dis
June 2021

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.

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Published In

Ann Rheum Dis

DOI

EISSN

1468-2060

Publication Date

June 2021

Volume

80

Issue

6

Start / End Page

727 / 738

Location

England

Related Subject Headings

  • Triazoles
  • Treatment Outcome
  • Pyridines
  • Methotrexate
  • Humans
  • Finches
  • Drug Therapy, Combination
  • Double-Blind Method
  • Arthritis, Rheumatoid
  • Arthritis & Rheumatology
 

Citation

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MLA
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Westhovens, R., Rigby, W. F. C., van der Heijde, D., Ching, D. W. T., Stohl, W., Kay, J., … 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. Ann Rheum Dis, 80(6), 727–738. https://doi.org/10.1136/annrheumdis-2020-219213
Westhovens, René, William F. C. Rigby, Désirée van der Heijde, Daniel W. T. Ching, William Stohl, Jonathan Kay, Arvind Chopra, 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 80, no. 6 (June 2021): 727–38. 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 Jun;80(6):727–738.

Published In

Ann Rheum Dis

DOI

EISSN

1468-2060

Publication Date

June 2021

Volume

80

Issue

6

Start / End Page

727 / 738

Location

England

Related Subject Headings

  • Triazoles
  • Treatment Outcome
  • Pyridines
  • Methotrexate
  • Humans
  • Finches
  • Drug Therapy, Combination
  • Double-Blind Method
  • Arthritis, Rheumatoid
  • Arthritis & Rheumatology