Evaluation of the nocebo effect after switching from etanercept or adalimumab originator to a biosimilar: a retrospective study of patients with inflammatory rheumatism
Authors' conclusion
The occurrence of a NE after switching to a biosimilar remains acceptable.
Study context
- Population
- Patients with RA or SpA in remission under adalimumab or etanercept originators before switching to biosimilars, 4 hospitals in Normandy, France, January 2018–July 2022
- Participants
- 183 patients
- Exposure
- Switch from adalimumab or etanercept originator to biosimilar; before vs after switching
- Outcome
- Nocebo effect: biosimilar not maintained at 12 months with a subjective AE
- Follow-up
- 12 months
Methodological detailsmulticentre (4 hospitals)
- Multicentre (4 hospitals)
Main finding
As reported in the abstract
Nocebo effect
Patients with a nocebo effect
13.1%
Observational data: associations, not effects.
Further findings
Morning stiffness duration before vs after switch (SpA)
- Significantly different before and after the switch in the SpA group
- P = 0.01
Risk factors for nocebo effect
- No risk factors associated with the occurrence of a nocebo effect within the limits of the studied parameters
Safety
Objective adverse event (AEs)
- Rheumatism reactivation
- 15.3%
- Intolerance
- 8.2%
- Infection
- 1.6%
- Allergic reactions
- 0.5%
Original publication
Evaluation of the nocebo effect after switching from etanercept or adalimumab originator to a biosimilar: a retrospective study of patients with inflammatory rheumatism. Clin Exp Rheumatol. Published 17 January 2024. doi:10.
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