CT-P13 SC for the treatment of rheumatoid arthritis

ABSTRACT

Introduction

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.

Area covered

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.

Expert Opinion

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.

KEYWORDS:

• Biosimilars
• CT-P13
• infliximab
• rheumatoid arthritis
• subcutaneous

Information resources

• Westhovens R, Wiland P, Zawadzki M et al. Efficacy, pharmacokinetics and safety of subcutaneous versus intravenous CT-P13 in rheumatoid arthritis: a randomized phase I/III trial. Rheumatology (Oxford). 14 May 2021;60(5):2277-2287.

• https://www.ema.europa.eu/en/documents/product-information/remsima-epar-product-information_en.pdf

Article highlights

• CT-P13 SC is a biological recently approved for adults with rheumatoid arthritis and other immune-mediated inflammatory diseases based on a different formulation and a different way of administration compared to IV CT-P13 biosimilar.

• CT-P13 SC 120 mg fixed dose offers improved and more stable infliximab serum levels over time and demonstrates, in a 1 year pivotal phase I/III trial in Rheumatoid Arthritis add on to methotrexate, non-inferiority at 22 weeks compared to CT-P13 IV 3 mg/kg and no new safety issues. Switching of IV to SC CT-P13 is also shown to be possible.

• This new drug for SC use is not associated with more anti-drug antibodies over time, and its administration by self-injection is very feasible, which might be an advantage for patients on the long term and has potential to improve the availability of biologicals overall.

Disclosure statement

R Westhovens acted as an advisor, speaker, and principal investigator for Celltrion and Gilead/Galapagos. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

This paper was not funded.