Major adverse cardiovascular, thromboembolic and malignancy events in the filgotinib rheumatoid arthritis and ulcerative colitis clinical development programmes
Authors' conclusion
Data are consistent with previous overall safety analyses demonstrating low rates of AEI in the overall study population.
Study context
- Population
- Patients with rheumatoid arthritis (RA) and ulcerative colitis (UC) in filgotinib phase II and III trials>12,500 (RA) and >2800 (UC) patient-years of exposure (PYE)
- Comparison
- Filgotinib 100 mg vs 200 mg once daily
- Outcome
- Adverse events of interest: MACE, VTE and malignancies
Main finding
As reported in the abstract
Adverse events of interest:
- MACE
- VTE
- Malignancies
- Incidences of adverse events of interest (AEI) in the integrated analysis population were low
- Modest numerical increases in incidence rates in patients aged ≥65 years: Major adverse cardiovascular events (MACE) (RA), malignancies excluding non-melanoma skin cancer (NMSC) and NMSC (RA or UC)
Further findings
MACE in RA patients aged ≥65 years
- Incidence rates identical between filgotinib 100 mg and 200 mg
Malignancies and NMSC in RA patients aged ≥65 years
- Rates numerically higher with 200 mg vs 100 mg
Safety
- Venous thromboembolism (VTE) in RA patients aged ≥65 years, exposure-adjusted incidence rate — Filgotinib 200 mg
- 0.3 (95% CI 0.1–0.8) /100 PYE
VTE in UC patients aged ≥65 years
- No VTE events
Original publication
Major adverse cardiovascular, thromboembolic and malignancy events in the filgotinib rheumatoid arthritis and ulcerative colitis clinical development programmes. RMD Open. Published 4 March 2025. doi:10.
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