Integrated safety analysis of filgotinib treatment for rheumatoid arthritis in patients from Japan over a median of 1.5 years

Naoki Ishiguro, Yoshiya Tanaka, Tsukasa Matsubara, Tatsuya Atsumi, Koichi Amano, Eiji Sugiyama, Kunihiro Yamaoka, Kevin Winthrop, Alan Kivitz, Gerd R. Burmester, Jacques Eric Gottenberg, Mark C. Genovese, Franziska Matzkies, Ying Guo, Deyuan Jiang, Beatrix Bartok, Alena Pechonkina, Akira Kondo, Robin Besuyen, Tsutomu Takeuchi

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

OBJECTIVE: Characterize safety of the Janus kinase-1 preferential inhibitor filgotinib (FIL) in Japanese patients with moderately to severely active rheumatoid arthritis (RA). METHODS: Data from three Phase 3 trials (NCT02889796, NCT02873936, and NCT02886728) and a long-term extension (NCT03025308) through September 2019 were integrated; patients received ≥1 dose of FIL 200 (FIL200) or 100 mg (FIL100) daily, or placebo (PBO). We calculated exposure-adjusted incidence rates (EAIRs) per 100 patient-years FIL exposure (100PYE) for treatment-emergent adverse events (TEAEs) and adverse events of special interest. RESULTS: Among 3691 total patients and 6080.7 PYE, 229 Japanese patients received FIL for 311.4 PYE (median 1.5, maximum 2.5 years). During the 12-week PBO-controlled period, serious TEAEs and TEAEs leading to study drug disruption were comparable between FIL and PBO. Serious infection rates were 1.9%, 0%, and 2% for FIL200, FIL100, and PBO during the PBO-controlled period; long-term FIL200 and FIL100 EAIRs were 3.8 and 2.1/100PYE. No herpes zoster (HZ) or major adverse cardiovascular events (MACEs) occurred during the PBO-controlled period; long-term FIL200 and FIL100 EAIRs were 3.0 and 2.1/100PYE (HZ) and 0.6 and 0/100PYE (MACE). CONCLUSION: Long-term FIL treatment (median 1.5, maximum 2.5 years exposure) was well tolerated at 100- and 200-mg doses in Japanese patients with RA.

Original languageEnglish (US)
Pages (from-to)64-72
Number of pages9
JournalModern Rheumatology
Volume33
Issue number1
DOIs
StatePublished - Jan 3 2023

Keywords

  • Filgotinib
  • Janus kinase
  • Japanese
  • Phase 3 clinical trials
  • rheumatoid arthritis

ASJC Scopus subject areas

  • Medicine(all)

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