POS0658 GEOGRAPHIC VARIATION OF EFFICACY IN THE FILGOTINIB RHEUMATOID ARTHRITIS PROGRAM

2021 
Background: The Janus kinase-1 preferential inhibitor filgotinib (FIL) improved signs and symptoms of rheumatoid arthritis (RA) in the FIL clinical program.1–3 Objectives: To assess FIL safety across regions. Methods: This was an analysis of patients (pts) meeting 2010 ACR/EULAR RA criteria in pooled phase (P)2 DARWIN 1–2 (D1–2), P3 FINCH 1–3 (F1–3), and long-term extension studies (DARWIN 3, FINCH 4). Data were analyzed by region: North America, South and Central America, Western Europe, Eastern Europe, Asia, South East (SE) Asia, and Other. Week (W)12 placebo (PBO)-controlled analysis included data from pts receiving once-daily FIL 100 mg (FIL100), FIL 200 mg (FIL200), or PBO for ≤12W (D1–2, F1–2); long-term as-treated data included pts from all 7 studies receiving FIL100 or FIL200; data after rerandomization were included and contributed to treatment received. Data presented as exposure-adjusted incidence rates (EAIRs)/100 patient-years of exposure (PYE) of treatment-emergent (TE) adverse events (TEAEs). Results: Table 1 shows EAIRs of TEAEs in PBO-controlled analysis. EAIRs/100 PYE of all TEAEs in Western Europe, Asia, and Other were higher than in remaining regions and for PBO vs FIL arms; EAIRs for FIL200/FIL100 in North America and SE Asia were higher vs PBO. EAIRs/100 PYE of TE serious AEs were higher in SE Asia for FIL100 and for FIL200/FIL100 in Other, with high PBO EAIRs in Western Europe. EAIRs/100 PYE of TEAEs leading to study discontinuation were higher in FIL arms vs PBO in Western Europe and Other (FIL200); in Asia and SE Asia, EAIRs were higher for PBO vs FIL200/FIL100. EAIRs for SI were highest in Other for FIL200 and SE Asia for FIL100. While VTE EAIRs were low, pts in 5/7 regions had VTE. HZ EAIRs were highest in Asia. Conclusion: Although EAIR of TEAEs varied between regions, no consistent trend was reflected in any particular region. References: [1]Genovese et al. JAMA. 2019;322:315–25. [2]Westhovens et al. Ann Rheum Dis. 2021; online first. [3]Combe et al. Ann Rheum Dis. 2021; online first. Disclosure of Interests: Bernard Combe Speakers bureau: BMS; Eli Lilly & Co.; Gilead Sciences, Inc.; MSD; Pfizer; Roche-Chugai; and UCB, Consultant of: AbbVie; Eli Lilly & Co.; Gilead Sciences, Inc.; Janssen; Pfizer; Roche-Chugai; and Sanofi, Grant/research support from: Novartis, Pfizer, and Roche-Chugai, Tsukasa Matsubara Speakers bureau: Pfizer Japan, Nichi-Iko, Astellas, Meiji Seika, Bristol-Myers Squibb, AbbVie GK, Janssen, Chugai, Eisai, AYUMI, Alena Pechonkina Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., YingMeei Tan Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Zhaoyu Yin Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Jaehyung Hong Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Robin Besuyen Shareholder of: Galapagos, BV, Employee of: Galapagos, BV, Antonio Gomez-Centeno Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly & Co., Gebro, Janssen, Menarini, Merck Sharp & Dohme, Pfizer, Roche, Rubio, Sanofi, and UC, Consultant of: AbbVie, Biogen, Bristol-Myers Squibb, Celgene, Eli Lilly & Co., Gebro, Gilead Sciences, Inc., Hospira, Merck Sharp & Dohme, Pfizer, Roche, Rubio, Sandoz, Sanofi, Grant/research support from: Boehringer Ingelheim, Celltrion, Eli Lilly & Co., Galapagos NV, Gilead Sciences, Inc., Novartis, Pfizer, Roche, Sanofi, UCB, YL Biologics, Maya H Buch Speakers bureau: AbbVie; Eli Lilly and Company; Gilead Sciences, Inc.; Merck-Serono; Pfizer; Roche; Sandoz; Sanofi; and UCB, Consultant of: AbbVie; Eli Lilly and Company; Gilead Sciences, Inc.; Merck-Serono; Pfizer; Roche; Sandoz; Sanofi; and UCB, Grant/research support from: AbbVie; Eli Lilly and Company; Gilead Sciences, Inc.; Merck-Serono; Pfizer; Roche; Sandoz; Sanofi; and UCB
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