News | October 10, 2020

New Data Presented At UEG Week Virtual 2020 Show Positive Association Between Remsima SC Pre-Dose Level With Efficacy Outcomes

INCHEON, SOUTH KOREA--(BUSINESS WIRE)--

Celltrion Healthcare today announced two new data sets relating to the use of the subcutaneous formulation of infliximab, Remsima® SC (CT-P13 SC), in inflammatory bowel disease (IBD) at a poster presentation at UEG Week Virtual 2020.

The first study investigated the association between the pre-dose serum of infliximab concentrations, with clinical efficacy and fecal calprotectin (FC) response.1 The results show a positive association between CT-P13 SC exposure with both efficacy and FC outcomes in patients with Crohn’s disease (CD) and ulcerative colitis (UC).1

Among 54 patients in the SC arm who have completed the CT-P13 SC maintenance treatment up to Week 54, 42 (77.8%) patients achieved clinical remission at Week 54. 1 Upon subgrouping patients according to quartiles of drug level exposure, the analysis shows that as a proportion, patients with the highest infliximab exposure (>26.7 μg/mL) achieved highest efficacy outcomes.1

The second study presented investigated the accuracy of the use of FC in monitoring mucosal change in a controlled trial of CT-P13 SC and IV for patients with moderate to severe UC.2 The results of this trial demonstrate that FC levels are associated with changes in status of mucosal inflammation, and specifically with improved endoscopic activity in UC patients who are treated with CT-P13 SC.2

A total of 68 UC patients were included in the multicentre, randomised controlled pivotal trial with 33 patients in the SC arm and 35 in the IV arm.2 At baseline, the median FC level in the entire cohort was 880 µg/g (786 µg/g and 978 µg/g in the SC and IV arms, respectively). 59 of 68 (86.8%) patients achieved FC level > 250 µg/g overall. In the SC arm, this accounted for 29 of 33 patients (87.9%), and in the IV arm, 30 of 35 patients (85.7%). The proportion of patients with FC level > 250 µg/g decreased to 39.0% (23/59) overall at week 22; with 44.4% (12/27) in the SC arm, and 34.4% (11/32) in the IV arm.2

Professor Walter Reinisch, Director of Clinical IBD Study Group, Department of Gastroenterology and Hepatology, Medical University of Vienna said, “These promising results support the use of the subcutaneous formulation of Remsima® in inflammatory bowel disease as an alternative option for eligible patients with UC and CD. In addition, the use of FC for monitoring the mucosal response to infliximab SC presents a viable, non-invasive choice for monitoring treatment – providing patients and clinicians with greater flexibility to suit their needs.”

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Notes to editors:

About inflammatory bowel disease

Inflammatory bowel diseases (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), arechronic 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

References

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].

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