Major adverse cardiovascular, thromboembolic and malignancy events in the filgotinib rheumatoid arthritis and ulcerative colitis clinical development programmes
RMD Open. 2025;11:e005033. doi: 10.1136/rmdopen-2024-005033.
Mariette et al. investigated the long-term safety of filgotinib with regard to MACE, VTE and malignancy across RA and UC clinical trial populations. Rates of these events remained low overall, with some increases observed in patients aged 65 years and older.
This integrated analysis pooled data from seven RA trials and two UC trials evaluating filgotinib 100 mg or 200 mg daily, encompassing >12,500 and >2,800 patient-years of exposure, respectively. AE of interest (AEI) were assessed by age and CV risk profile, with exposure-adjusted incidence rates calculated.
The study aimed to provide clarity on the long-term risk profile of filgotinib, particularly in light of regulatory recommendations for JAK inhibitors in older patients or those with elevated CV or malignancy risk. Results showed no consistent dose effect for AEIs, reinforcing current guidelines for lower starting doses in at-risk populations.
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