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Master Thesis

A 12-month real life efficacy and safety study of IBD patients under stable steroid free clinical and biological remission switched from adalimumab originator Humira® to one of its biosimilars: Amgevita®, Hulio®, Hyrimoz® or Imraldi®: Rhoneswitch Study

Abstract : Background: Anti-TNF are effective drugs in induction and maintenance treatment of moderate to severe inflammatory bowel diseases (IBD) and are an undeniable progress. The patent for adalimumab fell into the public domain in 2018, leading to the arrival of several biosimilars, representing potential health-cost saving and research reinvestment. While studies of non-inferiority have proven similar efficacy and safety to Humira® in psoriasis notably, real-life data in IBD are expected. Reducing the nocebo effect (NE) of a switch is also a challenge. Objective: One-year observational prospective multicentric real-life study evaluating IBD patients in remission who switch Humira® for one of its biosimilars. Main objective: to assess the magnitude of the NE. Secondary objectives: maintaining efficacy, safety and 1-year adherence factors to switch. Materials and methods : 200 quiescient IBD patients for 3 months under Humira® are proposed to switch to one of its biosimilars after receiving information and signing the consent. They are clinically and biologically monitored every 3 months for one year, and fill-up 3 questionnaires (BMQ, SATMED-Q, IBD Disk) at each appointment. Results: Primary endpoint: percentage of patients who switch back to Humira® without any objective markers of inflammation during 1 year. Secondary endpoints: percentage of clinical remission, biological, clinical response, loss of response and adverse effects at one year. Risk factors for an NE are assess by the questionnaires every 3 months. Conclusion: First real-life French data evaluating the one-year impact of Adalimumab originator switch to one of its biosimilars in IBD patients in remission.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-02309721
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Submitted on : Wednesday, October 9, 2019 - 3:02:09 PM
Last modification on : Wednesday, July 15, 2020 - 8:58:04 AM

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  • HAL Id : dumas-02309721, version 1

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Loïc Cabon. A 12-month real life efficacy and safety study of IBD patients under stable steroid free clinical and biological remission switched from adalimumab originator Humira® to one of its biosimilars: Amgevita®, Hulio®, Hyrimoz® or Imraldi®: Rhoneswitch Study. Human health and pathology. 2019. ⟨dumas-02309721⟩

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