Integrated safety analysis of filgotinib in patients with moderate-to-severe rheumatoid arthritis over a treatment duration of up to 8.3 years

Integrated safety analysis of filgotinib in patients with moderate-to-severe rheumatoid arthritis over a treatment duration of up to 8.3 years

OBJECTIVES: To update the long-term safety profile of filgotinib, a Janus kinase-1 preferential inhibitor, in patients with moderate-to-severe rheumatoid arthritis. METHODS: Data from seven trials were integrated (NCT01888874, NCT01894516, NCT02889796, NCT02873936, NCT02886728, NCT02065700 and NCT03...

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Veröffentlicht in:ANNALS OF THE RHEUMATIC DISEASES 2024-08, Vol.83 (9)
Hauptverfasser: Burmester, Gerd R, Gottenberg, Jacques-Eric, Caporali, Roberto, Winthrop, Kevin L, Tanaka, Yoshiya, Omoruyi, Edmund V. Ekoka, Rajendran, Vijay, Van Hoek, Paul, Van Beneden, Katrien, Takeuchi, Tsutomu, Westhovens, Rene, Aletaha, Daniel
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Sprache:eng
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Zusammenfassung:OBJECTIVES: To update the long-term safety profile of filgotinib, a Janus kinase-1 preferential inhibitor, in patients with moderate-to-severe rheumatoid arthritis. METHODS: Data from seven trials were integrated (NCT01888874, NCT01894516, NCT02889796, NCT02873936, NCT02886728, NCT02065700 and NCT03025308). Patients received once-daily filgotinib 100 mg or 200 mg. Exposure-adjusted incidence rates (EAIRs)/100 patient-years of exposure (PYE) were calculated for treatment-emergent adverse events (TEAEs). Post hoc analyses assessed patients aged
ISSN:0003-4967