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Winthrop KL, Tanaka Y, Takeuchi T, et al. Integrated safety analysis of filgotinib in patients with moderately to severely active rheumatoid arthritis receiving treatment over a median of 1.6 years. Ann Rheum Dis. 2021;doi: 10.1136/annrheumdis-2021-221051.
Winthrop, K. L., Tanaka, Y., Takeuchi, T., Kivitz, A., Matzkies, F., Genovese, M. C., Jiang, D., Chen, K., Bartok, B., Jahreis, A., Besuyen, R., Burmester, G. R., & Gottenberg, J. E. (2021). Integrated safety analysis of filgotinib in patients with moderately to severely active rheumatoid arthritis receiving treatment over a median of 1.6 years. Annals of the rheumatic diseases, . https://doi.org/10.1136/annrheumdis-2021-221051
Winthrop, Kevin L, et al. "Integrated safety analysis of filgotinib in patients with moderately to severely active rheumatoid arthritis receiving treatment over a median of 1.6 years." Annals of the rheumatic diseases vol. (2021). doi: https://doi.org/10.1136/annrheumdis-2021-221051
Winthrop KL, Tanaka Y, Takeuchi T, Kivitz A, Matzkies F, Genovese MC, Jiang D, Chen K, Bartok B, Jahreis A, Besuyen R, Burmester GR, Gottenberg JE. Integrated safety analysis of filgotinib in patients with moderately to severely active rheumatoid arthritis receiving treatment over a median of 1.6 years. Ann Rheum Dis. 2021 Nov 05; doi: 10.1136/annrheumdis-2021-221051. Epub 2021 Nov 05. PMID: 34740884.
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Ann Rheum Dis. 2021 Nov 05; doi: 10.1136/annrheumdis-2021-221051. Epub 2021 Nov 05.

Integrated safety analysis of filgotinib in patients with moderately to severely active rheumatoid arthritis receiving treatment over a median of 1.6 years.

Annals of the rheumatic diseases

Kevin L Winthrop, Yoshiya Tanaka, Tsutomu Takeuchi, Alan Kivitz, Franziska Matzkies, Mark C Genovese, Deyuan Jiang, Kun Chen, Beatrix Bartok, Angelika Jahreis, Robin Besuyen, Gerd R Burmester, Jacques-Eric Gottenberg

Affiliations

  1. Oregon Health & Science University, Portland, Oregon, USA [email protected].
  2. The First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.
  3. Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan.
  4. Altoona Research, Duncansville, Pennsylvania, USA.
  5. Gilead Sciences, Inc, Foster City, California, USA.
  6. Galapagos BV, Leiden, The Netherlands.
  7. Charité University Hospital Berlin, Berlin, Germany.
  8. Strasbourg University Hospital, Strasbourg, France.

PMID: 34740884 DOI: 10.1136/annrheumdis-2021-221051

Abstract

OBJECTIVE: To characterise safety of the Janus kinase-1 preferential inhibitor filgotinib in patients with moderately to severely active rheumatoid arthritis.

METHODS: Data were integrated from seven trials (NCT01668641, NCT01894516, NCT02889796, NCT02873936, NCT02886728, NCT02065700, NCT03025308). Results are from placebo (PBO)-controlled (through week (W)12) and long-term, as-treated (all available data for patients receiving ≥1 dose filgotinib 200 (FIL200) or 100 mg (FIL100) daily) datasets. We calculated exposure-adjusted incidence rates (EAIRs)/100 patient-years filgotinib exposure (100PYE) for treatment-emergent adverse events (TEAEs).

RESULTS: 3691 patients received filgotinib for 6080.7 PYE (median 1.6, maximum 5.6 years). During the PBO-controlled period, TEAEs, including those of grade ≥3, occurred at comparable rates with filgotinib or PBO; long-term EAIRs of TEAEs grade ≥3 were 6.4 and 7.6/100PYE for FIL200 and FIL100. EAIRs for deaths were 0.6/100PYE for FIL200, FIL100 and PBO; long-term EAIRs were 0.5 and 0.3/100PYE for FIL200 and FIL100. EAIRs for serious infection were 3.9, 3.3 and 2.4/100PYE for FIL200, FIL100 and PBO; long-term EAIRs were 1.6 and 3.1/100PYE for FIL200 and FIL100. EAIRs for herpes zoster were 0.6, 1.1, and 1.1/100PYE for FIL200, FIL100 and PBO; long-term EAIRs were 1.8 and 1.1/100PYE for FIL200 and FIL100. EAIRs for major adverse cardiovascular events were 0, 1.7 and 1.1/100PYE for FIL200, FIL100 and PBO; long-term EAIRs were 0.4 and 0.6/100PYE for FIL200 and FIL100. No venous thromboembolism occurred during the PBO-controlled period; long-term EAIRs were 0.2 and 0/100PYE for FIL200 and FIL100.

CONCLUSIONS: Over a median of 1.6 and maximum of 5.6 years of exposure, safety/tolerability of FIL200 and FIL100 were similar, with a lower incidence of infections with FIL200 among the long-term, as-treated dataset.

© 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; rheumatoid arthritis; therapeutics

Conflict of interest statement

Competing interests: KLW reports receiving grant/research support from AbbVie, Bristol Myers Squibb, and Pfizer and serving as a consultant for AbbVie, Bristol Myers Squibb, Eli Lilly and Co., Galapag

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