Management of Rheumatoid Arthritis (RA) has improved following the implementation of early intensive treat to target recommendations and the availability of different biologicals. Most experience is with TNF blockers, but challenges remain in the efficacy/safety balance, immunogenicity, and long-term drug survival as well as availability and affordability despite the introduction of biosimilars.
We provide an overview of the development of CT-P13 SC based on infliximab biosimilar CT-P13 IV. The one-year pivotal phase I/III trial in RA showed CT-P13 120 mg SC fixed dose to have favorable pharmacokinetics compared to CT-P13 IV classical weight adapted dosing, similar to lower anti-drug antibodies, similar safety and non-inferiority for efficacy at 6 months.
CT-P13 SC is an additional option in RA treatment and by extension for other inflammatory diseases as Inflammatory Bowel Disease. This new way of administration has the potential to improve long-term drug survival of infliximab, improve patient outcomes, and patient comfort.