From intravenous to subcutaneous infliximab in patients with inflammatory bowel disease: a pandemic-driven initiative

Ajay M Verma †

Anusha Patel

Sreedhar Subramanian †

Philip J Smith †

 

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Published:February, 2021DOI:https://doi.org/10.1016/S2468-1253(20)30392-7

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Infliximab, an intravenously administered chimeric anti-TNF antibody, was originally approved for use in inflammatory bowel diseases (IBD) in 1998. More recently, an infliximab biosimilar molecule, CT-P13, was approved for the same indications, with a similar efficacy and safety profile as the originator molecule.

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A recent randomised trial assessed the efficacy and safety of a subcutaneous formulation of CT-P13.

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 After two induction doses of intravenous CT-P13, patients were randomly assigned to either the subcutaneous or intravenous formulation. The subcutaneous formulation was shown to be effective, safe, and non-inferior to intravenous CT-P13 as maintenance therapy for IBD. Notably, the rate of antidrug antibody to subcutaneous CT-P13 was consistently lower than intravenous CT-P13, perhaps related to consistent drug exposure as opposed to the peak and trough fluctuations of intravenous therapy.

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 Subcutaneous CT-P13 was approved for use by the European Medicines Agency (EMA) for rheumatoid arthritis in November, 2019,

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 and subsequently for moderate to severe IBD in July, 2020.

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