Safety and efficacy of filgotinib in patients with rheumatoid arthritis: final results of the DARWIN 3 long-term extension study
Authors' conclusion
Filgotinib was well tolerated in patients with RA for up to 8 years. Safety and efficacy profiles were maintained in patients previously receiving either filgotinib plus methotrexate or filgotinib monotherapy.
Study context
- Population
- Patients with rheumatoid arthritis (RA) completing the 24-week DARWIN 1 (filgotinib plus MTX) and DARWIN 2 (filgotinib monotherapy) trials3706.3 patient-years of exposure (PYE)
- Participants
- 739 patients
- Comparison
- Filgotinib 200 mg vs Filgotinib 100 mg
- Filgotinib 100 mgn = 15
- Primary endpoint
- Safety and tolerability, assessed by incidence of TEAEs
Methodological detailsopen-label extension, mean exposure duration 259.8 weeks
- Open-label extension
- Mean exposure duration 259.8 weeks
Primary result
As reported in the abstract
TEAEs, EAIR /100 PYE
Exposure-adjusted incidence rate (EAIR) of treatment-emergent adverse events (TEAEs) /100 PYE
67
95% CI 62 to 72.2
EAIR of serious TEAEs /100 PYE
3.8
95% CI 3.2 to 4.5
Further findings
ACR20/50/70 response rates (non-responder imputation) · week 396
- ACR20
- 26.9%
- ACR50
- 20.2%
- ACR70
- 14.7%
- Response plateaued at long-term extension (LTE) week 12 before slowly declining
Safety
Infections, EAIR /100 PYE
- Infections
- 23.3 (95% CI 21.2 to 25.6)
- Serious infections
- 1.3 (95% CI 0.9 to 1.7)
- Herpes zoster
- 1.3 (95% CI 0.9 to 1.7)
MACE and malignancies, EAIR /100 PYE
- MACE
- 0.19 (95% CI 0.8 to 0.39)
- Malignancies
- 0.6 (95% CI 0.4 to 0.9)
Original publication
Safety and efficacy of filgotinib in patients with rheumatoid arthritis: final results of the DARWIN 3 long-term extension study. RMD Open. Published 30 January 2025. doi:10.
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