Observational studyRMD open2024
Persistence and safety of anti-TNF biosimilars versus originators in immune-mediated inflammatory diseases: an observational study on the French National Health Data System.
Observational study in RMD open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 14 citations in OpenAlex.
- Comparative effectiveness and safety of biosimilars versus reference biologics in rheumatoid arthritis during treatment initiation: a systematic review of real-world evidence.International journal of clinical pharmacy · 2025Pooled it
- Mitigating the Nocebo Effect in Biosimilar Use and Switching: A Systematic Review.Pharmaceutical medicine · 2024Pooled it
- Biosimilars in Adult and Pediatric Noninfectious Uveitis.Clinical ophthalmology (Auckland, N.Z.) · 2026Review
- PD-L1 inhibitors combined with chemotherapy for extensive-stage small cell lung cancer: a French nationwide cohort study.The Lancet regional health. Europe · 2025Article
- Real-world efficacy and safety of trastuzumab deruxtecan versus trastuzumab emtansine and tucatinib as second-line and third-line treatments for HER2-positive metastatic breast cancer: two target trial emulation studies.The Lancet regional health. Europe · 2025Article
- Treatment Persistence in Rheumatoid Arthritis Before and After Etanercept Biosimilar Introduction: A Nationwide Australian Real-World Study.Pharmaceutical medicine · 2025Article
- Cycle versus swap strategy after TNFi discontinuation in psoriatic arthritis and axial spondyloarthritis: a quasi-experimental study.RMD open · 2025Article
- The Switch from Reference Biologic Medicines to Biosimilars in France: The Perspective of Patients and Prescribers on Barriers and Needs.Journal of multidisciplinary healthcare · 2025Article
- Article
- Comments on "Development and Validation of a META-Algorithm to Identify the Indications of Use of Biological Drugs Approved for the Treatment of Immune-Mediated Inflammatory Diseases from Claims Databases: Insights from the VALORE Project" [Letter].Clinical epidemiology · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesBiosimilar-originator equivalence has been demonstrated in phase 3 trials in a few indications of infliximab, etanercept and adalimumab. The objective of our study was to compare the persistence and safety of biosimilars versus originators in all the licensed indications of these molecules.
methodsWe used data from the French National Health Data System (SNDS), covering 99% of the French population, to identify infliximab, etanercept and adalimumab initiators from biosimilar launch (January 2015, May 2016 and October 2018, respectively) to 30 June 2021. Patients were then followed for 1 year. Treatment persistence (duration without treatment discontinuation or modification) and safety (including severe infections, all-cause hospitalisation and death) were compared between originator and biosimilar users by Cox regressions weighting the populations on the inverse probability of treatment. Analyses were performed by molecule, by disease and by biosimilar product.
resultsFrom January 2015 to June 2021, 86 776 patients were included in the study: 22 670, 24 442 and 39 664 patients had initiated infliximab, etanercept and adalimumab, respectively; 49 752 (53%) were biosimilar initiators. We did not find any risk of discontinuation (HRs were below or around 1, here all pathologies and products together: infliximab 0.88 (0.80-0.97), etanercept 0.85 (0.81-0.90) and adalimumab 0.96 (0.91-1.00)) or safety event (infection: infliximab 0.97 (0.78-1.21), etanercept 1.04 (0.81-1.33) and adalimumab 0.98 (0.83-1.16); hospitalisation: infliximab 1.08 (0.96-1.23), etanercept 0.99 (0.87-1.11) and adalimumab 0.91 (0.83-0.99)) associated with biosimilar versus originator use.
conclusionsOur study shows reassuring results regarding the persistence and safety of biosimilar tumour necrosis factor-alpha inhibitors compared with originators in all licensed indications.
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