Long-Term Survival of Subcutaneous Biosimilar Tumor Necrosis Factor Inhibitors Compared to Originators: Results From a Multicenter Prospective Registry
Main finding · DiscontinuationResult — go to the resultAdjusted hazard ratio 0.84 95% CI 0.75–0.95Authors' conclusion
No significant differences were found between treatments in long-term survival due to inefficacy or AEs.
Study context
- Population
- Patients with rheumatic diseases in BIOBADASER (Spain) starting etanercept (ETN) or ADA, January 2016 to October 2023treatment courses in 4162 patients
- Participants
- 4,723 patients
- Exposure
- Subcutaneous biosimilar TNFi vs originators
- Biosimilarsn = 4,001
- Originatorsn = 722reference
- Outcome
- Long-term survival (retention) of biosimilar vs originator TNFi
Methodological detailsmulticenter prospective registry (BIOBADASER), Kaplan-Meier, Cox regression
- Multicenter prospective registry (BIOBADASER)
- Kaplan-Meier
- Cox regression
Main finding
Discontinuation
Adjusted hazard ratio
0.84
95% CI 0.75–0.95
By group
Biosimilarsvs Originators
aHR 0.84 (95% CI 0.75–0.95)
As reported in the abstract
Observational data: associations, not effects.
Further findings
Cause-specific discontinuation (inefficacy or AEs), excluding nonmedical switching
- No significant differences in retention between biosimilars and originators (crude and adjusted)
Main reason for discontinuation: inefficacy
- Inefficacy
- 60.35%
Factors associated with discontinuation
- Female sex, obesity, second or later treatment lines increased risk of discontinuation
- Disease duration and concomitant MTX associated with greater survival
Original publication
Long-Term Survival of Subcutaneous Biosimilar Tumor Necrosis Factor Inhibitors Compared to Originators: Results From a Multicenter Prospective Registry. J Rheumatol. Published 1 June 2024. doi:10.
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