Effectiveness and safety of filgotinib in rheumatoid arthritis patients: data from the GISEA registry
Authors' conclusion
In an Italian real-life setting, filgotinib is confirmed to be safe and with a good effectiveness profile both in monotherapy and without glucocorticoids.
Study context
- Population
- Rheumatoid arthritis (RA) patients in the Italian GISEA registry starting filgotinib (female 89%, 57.6±12.2 years old), mostly as second (22%) or further (43.9%) b/tsDMARD line
- Participants
- 246 patients
- Outcome
- Effectiveness (disease activity scores and patient-reported outcomes (PROs)) and safety of filgotinib
- Follow-up
- 12-month follow-up
Methodological detailsreal-life, Kaplan-Meier retention, Cox regression
- Real-life
- Kaplan-Meier retention
- Cox regression
Main finding
As reported in the abstract
CDAI-based remission · 3 and 12 months
CDAI remission at 3 months
18.8%
CDAI remission at 12 months
27.5%
VAS pain ≤20 at 3 months
30.1%
VAS pain ≤20 at 12 months
37.7%
Observational data: associations, not effects.
Further findings
Filgotinib discontinuation (Cox regression)
| HR (95% CI) | ||
|---|---|---|
| b/tsDMARD naiveLowest HR | 0.29 (0.14–0.64) | |
| D2T-RAHighest HR | 1.82 (1.01–3.3) | |
| 0.10.31310Hazard ratio (log scale) |
Filgotinib survival (retention) rate · 6 and 12 months
- Survival rate at 6 months
- 84.5%
- Survival rate at 12 months
- 75.8%
- Comparable in monotherapy or combination therapy, and irrespective of GC intake
Safety
| Outcome | Values |
|---|---|
| Discontinuation due to adverse events | Filgotinib 3.3% |
Original publication
Effectiveness and safety of filgotinib in rheumatoid arthritis patients: data from the GISEA registry. Clin Exp Rheumatol. Published 5 September 2023. doi:10.
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