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Filgotinib versus placebo or adalimumab in patients with rheumatoid arthritis and inadequate response to methotrexate: a phase III randomised clinical trial.

Publication ,  Journal Article
Combe, B; Kivitz, A; Tanaka, Y; van der Heijde, D; Simon, JA; Baraf, HSB; Kumar, U; Matzkies, F; Bartok, B; Ye, L; Guo, Y; Tasset, C; Nash, P ...
Published in: Ann Rheum Dis
July 2021

OBJECTIVE: To evaluate the efficacy and safety of the Janus kinase-1-preferential inhibitor filgotinib versus placebo or tumour necrosis factor-α inhibitor therapy in patients with active rheumatoid arthritis (RA) despite ongoing treatment with methotrexate (MTX). METHODS: This 52-week, multicentre, double-blind, placebo-controlled and active-controlled phase III trial evaluated once-daily oral filgotinib in patients with RA randomised 3:3:2:3 to filgotinib 200 mg (FIL200) or filgotinib 100 mg (FIL100), subcutaneous adalimumab 40 mg biweekly, or placebo (through week 24), all with stable weekly background MTX. The primary endpoint was the proportion of patients achieving 20% improvement in American College of Rheumatology criteria (ACR20) at week 12. Additional efficacy outcomes were assessed sequentially. Safety was assessed from adverse events and laboratory abnormalities. RESULTS: The proportion of patients (n=1755 randomised and treated) achieving ACR20 at week 12 was significantly higher for FIL200 (76.6%) and FIL100 (69.8%) versus placebo (49.9%; treatment difference (95% CI), 26.7% (20.6% to 32.8%) and 19.9% (13.6% to 26.2%), respectively; both p<0.001). Filgotinib was superior to placebo in key secondary endpoints assessing RA signs and symptoms, physical function and structural damage. FIL200 was non-inferior to adalimumab in terms of Disease Activity Score in 28 joints with C reactive protein ≤3.2 at week 12 (p<0.001); FIL100 did not achieve non-inferiority. Adverse events and laboratory abnormalities were comparable among active treatment arms. CONCLUSIONS: Filgotinib improved RA signs and symptoms, improved physical function, inhibited radiographic progression and was well tolerated in patients with RA with inadequate response to MTX. FIL200 was non-inferior to adalimumab. TRIAL REGISTRATION NUMBER: NCT02889796.

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Published In

Ann Rheum Dis

DOI

EISSN

1468-2060

Publication Date

July 2021

Volume

80

Issue

7

Start / End Page

848 / 858

Location

England

Related Subject Headings

  • Triazoles
  • Pyridines
  • Middle Aged
  • Methotrexate
  • Male
  • Humans
  • Female
  • Drug Therapy, Combination
  • Double-Blind Method
  • Arthritis, Rheumatoid
 

Citation

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Chicago
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Combe, B., Kivitz, A., Tanaka, Y., van der Heijde, D., Simon, J. A., Baraf, H. S. B., … Nash, P. (2021). Filgotinib versus placebo or adalimumab in patients with rheumatoid arthritis and inadequate response to methotrexate: a phase III randomised clinical trial. Ann Rheum Dis, 80(7), 848–858. https://doi.org/10.1136/annrheumdis-2020-219214
Combe, Bernard, Alan Kivitz, Yoshiya Tanaka, Désirée van der Heijde, J Abraham Simon, Herbert S. B. Baraf, Uma Kumar, et al. “Filgotinib versus placebo or adalimumab in patients with rheumatoid arthritis and inadequate response to methotrexate: a phase III randomised clinical trial.Ann Rheum Dis 80, no. 7 (July 2021): 848–58. https://doi.org/10.1136/annrheumdis-2020-219214.
Combe B, Kivitz A, Tanaka Y, van der Heijde D, Simon JA, Baraf HSB, et al. Filgotinib versus placebo or adalimumab in patients with rheumatoid arthritis and inadequate response to methotrexate: a phase III randomised clinical trial. Ann Rheum Dis. 2021 Jul;80(7):848–58.
Combe, Bernard, et al. “Filgotinib versus placebo or adalimumab in patients with rheumatoid arthritis and inadequate response to methotrexate: a phase III randomised clinical trial.Ann Rheum Dis, vol. 80, no. 7, July 2021, pp. 848–58. Pubmed, doi:10.1136/annrheumdis-2020-219214.
Combe B, Kivitz A, Tanaka Y, van der Heijde D, Simon JA, Baraf HSB, Kumar U, Matzkies F, Bartok B, Ye L, Guo Y, Tasset C, Sundy JS, Jahreis A, Genovese MC, Mozaffarian N, Landewé RBM, Bae S-C, Keystone EC, Nash P. Filgotinib versus placebo or adalimumab in patients with rheumatoid arthritis and inadequate response to methotrexate: a phase III randomised clinical trial. Ann Rheum Dis. 2021 Jul;80(7):848–858.

Published In

Ann Rheum Dis

DOI

EISSN

1468-2060

Publication Date

July 2021

Volume

80

Issue

7

Start / End Page

848 / 858

Location

England

Related Subject Headings

  • Triazoles
  • Pyridines
  • Middle Aged
  • Methotrexate
  • Male
  • Humans
  • Female
  • Drug Therapy, Combination
  • Double-Blind Method
  • Arthritis, Rheumatoid