Safety and Efficacy of Switching Infliximab to Biosimilar in IBD
Switching irritable bowel syndrome (IBD) patients from infliximab (Remicade) to an infliximab biosimilar (Inflectra) in routine care contributes no difference in drug levels and disease activity, according to a new study conducted in a controlled setting. The findings have been published in Alimentary Pharmacology & Therapeutics.
Researchers examined a cohort of 133 IBD patients with 64% having Crohn's disease (CD) and 36% having ulcerative colitis (UC) from 2 hospitals who were treated with infliximab innovator for a median of 52 months. Before switching, 40% of CD patients and 27% of UC patients had infliximab levels within the therapeutic range (3–7μg/mL). This constitutes a broad range of disease activity despite empirical therapy optimization. A reason for may be that the cohort did not include patients with high disease activity.
Patients were told about the switch from Remicade to Inflectra, which was described as a different brand that studies had shown to be highly similar. Blood samples were taken before the first, second, fourth and seventh infusion of biosimilar.
Results showed that disease activity scores before and after switching were not statistically significantly different (Crohn's disease activity index: P=0.5657 and Truelove-Witts disease activity index: P=0.7609). The therapy was discontinued by 35 patients (26%), mostly due to higher disease activity (12; 9%) and adverse events (13; 9.8%). The authors indicated that 8 of the discontinuing patients for higher disease activity were "possibly switch-related," 2 were probable and another were "not switch-related." The discontinuation rate could also be impacted by the non-blinded nature of the study and the nocebo effect of changing to the biosimilar.
Biosimilar use could greatly decrease costs for IBD patients, as it is estimated to be 40% less expensive. The author's conclusion is that biosimilar switching is, "safe and effective", finding no differences in drug levels and disease activity between infliximab biosimilar and innovator. "Switching to biosimilar and performing therapeutic drug monitoring as part of routine care can optimize infliximab therapy efficiently and make it more cost-effective,” they wrote.
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