Integrated safety analysis of filgotinib in patients with moderate-to-severe rheumatoid arthritis over a treatment duration of up to 8.3 years
Authors' conclusion
In the overall population, TEAEs of interest were stable over time and similar between filgotinib 100 mg and 200 mg dose groups, except for herpes zoster. A dose-dependent relationship between malignancies and all-cause mortality was suggested in patients ≥65 years old.
Study context
- Population
- Patients with moderate-to-severe RA
- Participants
- 3,691 patients7 trials
- Comparison
- Filgotinib 100 mg vs 200 mg once daily
- Outcome
- Exposure-adjusted incidence rates (EAIRs)/100 PYE of treatment-emergent adverse events (TEAEs)
Methodological detailspost hoc analyses by age (<65 and ≥65 years)
- Post hoc analyses by age (<65 and ≥65 years)
Main finding
As reported in the abstract
TEAEs of interest (serious infections, malignancies, MACE, VTE)
- Rates stable over time and comparable between doses
- Median (maximum) exposure 3.8 (8.3) years; 12 541 patient-years of exposure (PYE)
Further findings
All-cause mortality, EAIR/100 PYE (aged ≥65 years) · numerically lower · post hoc
Patients aged ≥65 vs <65 years (post hoc)
- Incidence of serious infections, herpes zoster, major adverse cardiovascular events (MACE), malignancies and all-cause mortality higher in ≥65 vs <65 years
Safety
Herpes zoster, EAIR/100 PYE (overall population) · numerically lower
NMSC, EAIR/100 PYE (aged ≥65 years) · numerically lower · post hoc
Malignancies excluding NMSC, EAIR/100 PYE (aged ≥65 years) · numerically lower · post hoc
Original publication
Integrated safety analysis of filgotinib in patients with moderate-to-severe rheumatoid arthritis over a treatment duration of up to 8.3 years. Ann Rheum Dis. Published 27 August 2024. doi:10.
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