Poster Session A
Rheumatoid arthritis (RA)
Kevin Winthrop, MD, MPH
Oregon Health & Science University
portland, Oregon, United States
No financial relationships with ineligible companies to disclose
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.2
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). 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). Owing to the study designs, duration of exposure was shorter in the FIL100 (5,202.2 PYE) than in the FIL200 group (8,924.5 PYE); comparisons of EAIRs between treatment groups should therefore be made with caution. Over 312 weeks, the risk of all-cause mortality was similar for FIL100 and FIL200 (Figure).
Conclusion:
In this updated integrated safety analysis, the safety profile of FIL remains stable over time and similar to that from the previous analysis. No new safety information concerning AESIs were identified in the overall rheumatoid arthritis population.
References:
1. Winthrop KL, et al. Ann Rheum Dis 2023;82:721–22
2. Winthrop KL, et al. Ann Rheum Dis 2022;81:184–92
K. Winthrop: AbbVie, 2, AstraZeneca, 2, BMS, 2, 5, Galapagos, 2, Gilead, 2, GSK, 2, Lilly, 2, Novartis, 2, Pfizer, 2, 5, Regeneron, 2, Roche, 2, Sanofi, 2, UCB, 2; D. Aletaha: AbbVie, 2, 5, 6, Galapagos, 2, 5, 6, Gilead, 2, 5, 6, Janssen, 2, 5, 6, Lilly, 2, 5, 6, Merck, 2, 5, 6, Novartis, 2, 5, 6; R. Caporali: AbbVie, 2, 6, Amgen, 2, 6, BMS, 2, 6, Celltrion, 2, 6, Fresenius Kabi, 2, Galapagos, 2, 6, Janssen, 2, 6, Lilly, 2, 6, MSD, 2, 6, Novartis, 2, 6, Pfizer, 2, 6, Roche, 2, Sandoz, 2, 6, UCB, 2, 6; Y. Tanaka: AbbVie, 6, Asahi-kasei, 6, Astellas, 6, AstraZeneca, 6, Boehringer Ingelheim, 5, 6, Chugai, 5, 6, Daiichi Sankyo, 6, Eisai, 6, Gilead, 6, GSK, 6, Lilly, 6, Pfizer, 6, Taisho, 5, 6, UCB, 6; T. Takeuchi: AbbVie, 4, 6, Astellas, 2, 6, Eisai, 4, 6, Eli Lilly Japan, 2, 6, Gilead, 2, 6, Pfizer Japan, 6; V. Modgill: Galapagos, 3, 11; E. Ekoka Omoruyi: Alfasigma, 2, Galapagos, 2, Janssen, 2, UCB, 11; D. de Vries: Galapagos, 3, 11; K. Van Beneden: Alfasigma, 3, Galapagos, 3, 11; J. Gottenberg: AbbVie, 2, BMS, 2, 5, Galapagos, 2, Gilead, 2, Lilly, 2, MSD, 2, Novartis, 2, Pfizer, 2, 5; G. Burmester: AbbVie, 2, Amgen, 2, BMS, 2, Galapagos, 2, Lilly, 2, MSD, 2, Pfizer, 2, Sanofi, 2.