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Master Thesis

Les biosimilaires en rhumatologie : de la prescription à l’acceptation

Abstract : Objectives: Although biologic therapies have revolutionized the care of patients with chronic inflammatory rheumatic diseases (CIRD), their high costs have emerged as a burden to health care systems. Biosimilars which have demonstrated identical efficacy/safety and are marketed at prices 30% lower than the originator, represent an opportunity to lower health care costs. Methods: we conducted two real-life studies in Bordeaux University Hospital. 1) The first evaluated the acceptance and treatment maintenance of the switch from Rémicade® to CT-P13 (Inflectra®) in patient with CIRD. Treatment maintenance was compared to two control cohorts : one historical cohort of patients treated with Rémicade® and one prospective cohort of infliximab-naïve patients beginning CT-P13. 2) The second study evaluated the acceptance of the switch from Enbrel® to SB4 (Benepali®) in rheumatology consults, as well as the sociological determinants of the acceptance. Results: the first study included 100 patients whom 89 (89%) accepted the switch. After a median follow-up of 33 weeks, treatment retention was significantly lower in the switch cohort compared to control cohorts (p < 0.001). Among the 25 CT-P13 failures, 11 (44%) patients did not present objective signs of disease activity, and exclusion of this subgroup from the analysis abrogated the differences with the control cohorts. In the second study, 52 patients were offered information on the switch to Enbrel® biosimilar, and 48 (92%) accepted the switch. The patients refusing the switch were more likely to report a bad opinion of generics, to be older with a longer disease evolution. Conclusion: the acceptance of biosimilar is high in rheumatology practice when a positive information is delivered. However, 10-15% of patients switched to a biosimilar develop subjective symptoms which are related to a nocebo effect. Training health care professionals to deliver positive information to patients who are offered the switch appear to be essential to promote a wide diffusion of biosimilars.
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Master Thesis
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Contributor : Bu Carreire Université de Bordeaux <>
Submitted on : Thursday, September 12, 2019 - 3:41:32 PM
Last modification on : Sunday, October 25, 2020 - 7:04:54 AM
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  • HAL Id : dumas-02285201, version 1


Marc Scherlinger. Les biosimilaires en rhumatologie : de la prescription à l’acceptation. Médecine humaine et pathologie. 2018. ⟨dumas-02285201⟩



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