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• W4381125695 abstract "<h3>Introduction</h3> Filgotinib (FIL), a once-daily, oral, Janus kinase 1 preferential inhibitor, is approved for the treatment of moderately to severely active rheumatoid arthritis (RA) and ulcerative colitis (UC). To further understand the safety profile of FIL across indications, we evaluated the risk of major adverse cardiovascular events (MACE) and venous thromboembolic events (VTE) in patients treated with FIL 200 mg or 100 mg (FIL200/100). <h3>Methods</h3> Integrated analyses were conducted with RA data from five phase 2/3 trials and two long-term extension (LTE) trials of FIL, and UC data from two phase 2/3 trials and one LTE trial of FIL (herein termed ‘overall’ data). Subgroup analyses by age and cardiovascular (CV) risk factors (excluding age) were conducted. Real-world data were extracted from a systematic literature review. Exposure-adjusted incidence rates (EAIRs) or incidence rates per 100 patient-years of exposure and 95% confidence intervals (CIs) were estimated for MACE and VTE. <h3>Results</h3> MACE and VTE rates were lower in the overall FIL200 and FIL100 arms than in the general UC and RA population. In the UC data, MACE rates were 0.29, 0.35 and 0.87 and VTE rates were 0.08, 0.18 and 0.39 in the overall FIL200 and FIL100 arms and in the general UC population, respectively (<b>figure 1</b>). For both MACE and VTE EAIRs, wide CIs were reported in patients aged ≥65 years and in those with CV risk, owing to low numbers of events and/or patients in these subgroups. In the RA data, higher MACE EAIRs were reported in patients aged ≥65 years vs <65 years. Numerically higher VTE EAIRs with overlapping CIs were seen in patients aged ≥65 years vs <65 years, and in those with vs without CV risk. <h3>Conclusions</h3> No association was identified between FIL200 and an increased risk of MACE or VTE compared with the general UC or RA population. Patients aged ≥65 years or with CV risk had slightly higher rates of MACE and VTE than those in other subgroups; however, overlapping CIs suggested no real difference. Further work should examine real-world data from FIL-treated patients and longer follow-up." @default.
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• W4381125695 date "2023-06-01" @default.
• W4381125695 modified "2023-10-18" @default.
• W4381125695 title "O35 Thromboembolic and major adverse cardiovascular events among patients in the filgotinib clinical trial programme" @default.
• W4381125695 doi "https://doi.org/10.1136/gutjnl-2023-bsg.34" @default.
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