Impact of the interchangeability of infliximab biosimilars on the efficacy in patients followed for chronic inflammatory bowel disease within the gastroenterology department of CHU Mustapha Pacha.

Introduction. Infliximab (IFX) is a monoclonal antibody used in the treatment of chronic inflammatory bowel disease (IBD). Interchangeability is the medical practice of replacing one drug with another that is expected to produce the same clinical effect. Products intended for the treatment of inflammatory bowel diseases, such as infliximab, are dispensed according to the availability of products at the level of the central hospital pharmacy, which imposes interchangeability at the level of the user department. The lack of clinical data on this practice prompted us to evaluate the impact of the interchangeability of different infliximab molecules (originator and biosimilars) on efficacy, tolerability and the occurrence of adverse events in patients with IBD in the Gastroenterology Department of the MUSTAPHA PACHA CHU. Methods and materials. This is a monocentric observational study with retrospective data collection, carried out in the Gastroenterology Department of UNIVERSITY HOSPITAL OF MUSTAPHA PACHA using a data collection sheet filled from the patient's medical record and/or EXCEL file in collaboration with clinicians. Significance was calculated using the Fisher exact statistical test and the MC'namer test for assessment of maintenance of clinical and biological response before and after treatment interchangeability. Significance was assessed at P < 0,05. Results: The study compared the clinical and biological response of patients with chronic inflammatory bowel disease (IBD) before and after interchangeability. Results showed that there was no significant difference in the clinical status of Crohn's disease patients (p =0,527), and that the four patients with ulcerative colitis in remission maintained the same profile after interchangeability. The Fisher exact test also showed that the variation in CRP value (P = 0,133) and Hb level (P = 0,167) were not significant. Conclusion. Interchangeability has no impact on the clinical and biological status of IBD patients.