Persistence and safety of anti-TNF biosimilars versus originators in immune-mediated inflammatory diseases: an observational study on the French National Health Data System
Authors' conclusion
Our study shows reassuring results regarding the persistence and safety of biosimilar tumour necrosis factor-alpha inhibitors compared with originators in all licensed indications.
Study context
- Population
- Infliximab, etanercept and adalimumab initiators in all licensed indications (IMIDs), French National Health Data System, from biosimilar launch to 30 June 2021; followed 1 year
- Participants
- 86,776 participants
- Exposure
- Anti-TNF biosimilars vs originators
- Biosimilarn = 49,752
- Outcome
- Treatment persistence (duration without treatment discontinuation or modification)
- Follow-up
- 1 year
Methodological detailsnationwide claims database (SNDS), inverse probability of treatment weighting, Cox regression, analyses by molecule, disease and biosimilar product
- Nationwide claims database (SNDS)
- Inverse probability of treatment weighting
- Cox regression
- Analyses by molecule, disease and biosimilar product
Main finding
As reported in the abstract
Treatment discontinuation, all pathologies and products together
Each group vs originatorEstimate (CI)
Biosimilar
HR (infliximab) 0.88(0.80–0.97)
Biosimilar
HR (etanercept) 0.85(0.81–0.90)
Biosimilar
HR (adalimumab) 0.96(0.91–1.00)
Observational data: associations, not effects.
Safety
| Outcome | Estimate | |
|---|---|---|
| Severe infection · 1 yearBiosimilarvs Originator | HR (infliximab) 0.97 (CI 0.78–1.21) | |
| Severe infection · 1 yearBiosimilarvs Originator | HR (etanercept) 1.04 (CI 0.81–1.33) | |
| Severe infection · 1 yearBiosimilarvs Originator | HR (adalimumab) 0.98 (CI 0.83–1.16) | |
| All-cause hospitalisation · 1 yearBiosimilarvs Originator | HR (infliximab) 1.08 (CI 0.96–1.23) | |
| All-cause hospitalisation · 1 yearBiosimilarvs Originator | HR (etanercept) 0.99 (CI 0.87–1.11) | |
| All-cause hospitalisation · 1 yearBiosimilarvs Originator | HR (adalimumab) 0.91 (CI 0.83–0.99) | |
| 0.512Ratio (log scale) |
Original publication
Persistence and safety of anti-TNF biosimilars versus originators in immune-mediated inflammatory diseases: an observational study on the French National Health Data System. RMD Open. Published 6 March 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →