14.02.2020 - 16:05 Uhr

Celltrion Healthcare showcases positive 1-year results for novel subcutaneous formulation of infliximab in patients with active Crohn’s disease and ulcerative colitis presented at The European Crohn's and Colitis Organisation annual congress

Celltrion Healthcare today announced new 1-year data from a randomised controlled trial to evaluate the pharmacokinetics (PK), efficacy and safety of CT-P13 subcutaneous (SC) formulation compared to the CT-P13 intravenous (IV) formulation in patients with active Crohn’s disease (CD) and ulcerative colitis (UC). Results presented at The European Crohn's and Colitis Organisation (ECCO) 2020 annual congress in Vienna, Austria demonstrated that the SC formulation of CT-P13 was comparable to the IV formulation of CT-P13 in terms of efficacy and safety throughout the 1-year treatment period.1

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4 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 February 2020].
5 Yoo DH, Jaworski J, Matyska-Piekarska E et al. 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.
6 Westhovens R, Wiland P, Zawadzki M et al. 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.
7 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 February 2020].