Abstract
Filgotinib (FIL) is a Janus kinase 1 preferential inhibitor for the treatment of moderate to severe rheumatoid arthritis (RA) approved at doses of 100 mg (FIL100) and 200 mg (FIL200). This integrated safety analysis provides an update on selected treatment-emergent adverse events for FIL up to a median (maximum) exposure of 4.3 (8.3) years.
FIL rheumatoid arthritis data were integrated from 7 clinical trials: the Phase 2 DARWIN studies (NCT01888874, NCT01894516), the Phase 3 FINCH studies (NCT02889796, NCT02873936, NCT02886728), and the long-term extension studies DARWIN 3 (NCT02065700) and FINCH 4 (NCT03025308). Exposure-adjusted incidence rates (EAIRs)/100 patient-years of exposure (PYE), censored at time of first event, were determined for major adverse cardiovascular events (MACE), venous thromboembolism (VTE), arterial systemic thromboembolism (ASTE), nonmelanoma skin cancer (NMSC), malignancies (excluding NMSC), herpes zoster, serious infections and deaths. Data were from completed studies and up until May 8, 2023, for FINCH 4.
In total, 3,691 patients received FIL with a total exposure of 14,127 PYE. Median (maximum) exposure was 4.3 (8.3) years in the pooled FIL group; 3.6 (8.1) years for FIL100 and 4.4 (8.3) years for FIL200. Baseline demographics and disease characteristics were balanced between the dose groups. Incidences of adverse events of special interest (AESIs), including MACE, VTE, ASTE, NMSC, malignancies (excluding NMSC), serious infections, herpes zoster and all-cause mortality, were comparable between the data cut in 2022 and the current analysis (Table 1). The EAIR (95% confidence interval [CI])/100 PYE of serious infections was 2.2 (1.8, 2.6) and 1.7 (1.5, 2.0) in the FIL100 and FIL200 dose groups, respectively. The EAIR (95% CI)/100 PYE of herpes zoster was 1.1 (0.8, 1.4) for FIL100 and 1.4 (1.2, 1.7) for FIL200 (Table 1). Over 312 weeks, the risk of all-cause mortality was similar for FIL100 and FIL200.
In this updated integrated safety analysis, the safety profile of FIL remained stable over time and similar to that from the previous analysis. No new safety information concerning AESIs were identified in the overall RA population.
K.L. Winthrop: Consultancies; Abbvie, AstraZeneca, BMS, Eli Lilly, Galapagos, Gilead, GSK, Novartis, Pfizer, Regeneron, Roche, Sanofi, UCB. Grants/research support; BMS, GSK. D. Aletaha: Consultancies; Abbvie, Eli Lilly, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Sandoz, Sanofi. Member of speakers’ bureau; Abbvie, Eli Lilly, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Sandoz, Sanofi. Grants/research support; Abbvie, Eli Lilly, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Sandoz, Sanofi. R. Caporali: Consultancies; Abbvie, Accord, Eli Lilly, Fresenius Kabi, Galapagos, Janssen, Novartis, Pfizer, UCB. Member of speakers’ bureau; Abbvie, Amgen, BMS, Celltrion, Eli Lilly, Fresenius Kabi, Galapagos, Janssen, MSD, Novartis, Pfizer, UCB. Y. Tanaka: Member of speakers’ bureau; Abbvie, AstraZeneca, BMS, Boehringer Ingelheim, Chugai, Eisai, Eli Lilly, Gilead, GSK, Pfizer, Taiho and Taisho. Grants/research support; Chugai, Eisai, Mitsubishi Tanabe, Taisho. T. Takeuchi: Consultancies; Abbvie, Astellas, Chugai, Eli Lilly, Gilead, Janssen, Mitsubishi Tanabe, Pfizer. Member of speakers’ bureau; Abbvie, AYUMI, BMS, Chugai, Daiichi Sankyo, Eisai, Eli Lilly, Gilead, Janssen, Mitsubishi Tanabe, Pfizer, Sanofi. Grants/research support; Abbvie, Asahi Kasei Pharma, Astellas, AYUMI, Chugai, Daiichi Sankyo, Eisai, Eli Lilly, Mitsubishi Tanabe, Nippon Kayaku, UCB. M. Buch: Consultancies; Abbvie, Arxx Therapeutics, Boehringer Ingelheim, CESAS medical, Galapagos, Gilead, Pfizer. Member of speakers’ bureau; Abbvie. Grants/research support; Galapagos, Gilead. Other; Professor Maya Buch is a non-Author presenter. V. Modgill: Shareholder/stock ownership; Galapagos. Other; Employed by Galapagos. E. Omoruyi: Consultancies; Galapagos, Janssen. Shareholder/stock ownership; UCB. Other; Employed by Galapagos. D. De Vries: Shareholder/stock ownership; Galapagos. Other; Employed by Galapagos. K. Van Beneden: Shareholder/stock ownership; Galapagos. Other; Employed by Galapagos. J. Gottenberg: Consultancies; Abbvie, BMS, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer. Grants/research support; BMS, Pfizer. G. Burmester: Consultancies; Abbvie, BMS, Galapagos, Eli Lilly, MSD, Pfizer. Member of speakers’ bureau; Abbvie, BMS, Galapagos, Eli Lilly, MSD, Pfizer.
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