New data presented at UEG Week Virtual 2020 show positive association between Remsima® SC pre-dose level with efficacy outcomes
- Data show positive association between subcutaneous infliximab (Remsima® SC / CT-P13 SC) exposure with efficacy and fecal calprotectin (FC) outcomes in patients with active Crohn’s disease (CD) and ulcerative colitis (UC)1
- These findings suggest that higher SC infliximab pre-dose levels may be associated with better clinical outcomes compared to intravenous (IV) infliximab1
Notes to editors:
About inflammatory bowel disease
Inflammatory bowel diseases (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), are chronic disabling gastrointestinal disorders that impact every aspect of a patient’s life.3 They affect an estimated 5 million people globally.4 IBDs account for substantial costs to the healthcare system and society - the direct healthcare costs of IBDs are estimated to be €4.6-5.6 billion per year.5
About CT-P13 (biosimilar infliximab)6,7,8
CT-P13 is developed and manufactured by Celltrion, Inc. and was the world’s first monoclonal antibody biosimilar approved by the European Commission (EC). It is indicated for the treatment of eight autoimmune diseases including RA and IBD. It was approved by the EC under the trade name Remsima® in September 2013 and launched in major EU countries in early 2015. The U.S. Food and Drug Administration approved CT-P13 in April 2016 under the trade name Inflectra®. CT-P13 is approved in more than 94 countries (as of October 2020) including the US, Canada, Japan and throughout Europe.
CT-P13 IV is usually given as 3mg per kg/body weight in RA and as 5mg per kg/body weight for the other indications. Infliximab IV is given as an infusion over two hours. All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards. Celltrion has also developed a subcutaneous (SC) formulation of infliximab that has three administration options; via a pre-filled pen (auto injector), pre-filled syringe or pre-filled syringe with needle safeguard. The SC formulation has the potential to enhance treatment options for the use of infliximab biosimilar by providing high consistency in drug exposure and a convenient method of administration.
CT-P13 SC received EU marketing authorisation for the treatment of people with RA and IBD in November 2019 and July 2020, respectively. In the United States, Remsima® SC will be reviewed through the new drug pathway by the US Food and Drug Administration (FDA) with the outcome expected by 2022.
About Celltrion Healthcare
Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavors to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us
1 Ye, B.D., et al. (2020). Exposure-response relationship of subcutaneous infliximab (CT-P13 SC) in patients with active Crohn’s disease and ulcerative colitis: analysis from a multicentre, randomized controlled pivotal trial. Moderated Poster Presentation (P0482). Presented at UEG Week Virtual 2020.
2 Reinisch, W., et al. (2020). Evaluation of clinical relationship between fecal calprotectin and endoscopic findings in ulcerative colitis patients treated with infliximab (ct-p13) subcutaneous and intravenous therapy: results from a multicenter, randomized, controlled pivotal trial. E-Poster Presentation (P0593). Presented at UEG Week Virtual 2020.
3 Molodecky, N. A, et al. (2012). Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology, 142(1), 46-54. Retrieved from: www.gastrojournal.org/article/S0016-5085(11)01378-3/pdf [Last accessed October 2020].
4 The European Federation of Crohn’s & Ulcerative Colitis Associations. (n.d). What is IBD? Science. Retrieved from www.efcca.org/en/science [Last accessed October 2020].
5 Burisch, J, et al. (2013). The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis, 7(4), 322-337.Retrieved from: https://www.sciencedirect.com/science/article/pii/S1873994613000305?via%3Dihub [Last accessed October 2020].
6Yoo DH, Jaworski J, Matyska-Piekarska E et al. (2019). A Novel Formulation of CT-P13 (Infliximab Biosimilar) for Subcutaneous Administration: One Year Results from Part One of a Phase I/III Randomised Controlled Trial in Patients with Rheumatoid Arthritis. Poster (FRI0128). Presented at EULAR 2019.
7 Westhovens R, Wiland P, Zawadzki M et al. (2019). A Novel Formulation of CT-P13 (Infliximab Biosimilar) for Subcutaneous Administration: 30-week Results from Part Two of a Phase I/III Randomised Controlled Trial in Patients with Rheumatoid Arthritis. Poster (SAT0170). Presented at EULAR 2019.
8 European Medicines Agency Summary of Product Characteristics (SmPC). CT-P13. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/002576/WC500150871.pdf [Last accessed October 2020].