Celltrion Healthcare Presents Positive Data on Replacement and Monotherapy with Remsima® SC in Patients with Inflammatory Bowel Disease During Virtual UEG Week 2021

INCHEON, South Korea – (COMMERCIAL THREAD) – Celltrion Healthcare today announced two datasets regarding the use of the subcutaneous formulation of infliximab, Remsima® SC (CT-P13 SC), in inflammatory bowel disease (IBD) in a poster presentation at the United European Gastroenterology Week (UEG) 2021, held virtually from October 3-5.

The first study examined the clinical impact of switching from intravenous (IV) to subcutaneous (SC) treatment of infliximab in patients with Crohn’s disease (CD) or ulcerative colitis (UC). pivotal randomized controlled trial of CT-P13 SC.3 65 patients (25 MC patients, 40 UC patients) were included in the CT-P13 IV arm in which patients received CT-P13 5 mg / kg IV every 8 weeks from week 6 to week 22. At Week 30, patients switched to receiving CT-P13 SC every 2 weeks through week 54 (dose 120 mg or 240 mg for patients 1

The results showed that switching from IV infliximab to SC conferred more favorable clinical results in terms of pharmacokinetics, efficacy and possibly immunogenicity. There was a significant difference in Chollow pre- and post-switching (median Chollow Levels at 2.05 μg / mL (interquartile range [IQR], 0.10-3.61) and 21.10 μg / mL (IQR, 11.30-26.50) before and after switching, respectively; p hollow exceeding the target exposure (5 g / mL) was significantly higher after the change (36/41, 87.80%) than before the change (8/41, 19.51%; p 1

The second study presented examined the comparable efficacy of subcutaneous (SC) infliximab as monotherapy versus combination therapy with immunomodulators using data from the pivotal randomized controlled trial of CT-P13 SC in CD. or the active CU.3

Patients with CD or active UC naïve to tumor necrosis factor (TNF) inhibitor treatment were included and received induction therapy with CT-P13 5 mg / kg intravenously (IV) weekly 0 and at week 2, after which they were randomized to continue treatment with IV CT-P13 or receive 120 mg CT-P13 SC (patients hollow level exceeding the target exposure, both groups exceeding the target exposure throughout the study period (target exposure: 5 g / mL; monotherapy: 28/29, 96.55%; combined therapy: 23/24 , 95.83%; p> 0.9999). The clinical response rates in terms of CDAI-100 and partial Mayo response were comparable between the arms and there was no difference in immunogenicity between the groups despite the concomitant use of immunomodulators in the therapy group. combined.2

“Post hoc analysis indicates that switching from IV infliximab to SC infliximab will produce comparable clinical outcomes for patients with inflammatory bowel disease, including those with Crohn’s disease and ulcerative colitis , further highlighting the potential of infliximab SC as an alternative route of administration. Infliximab SC offers patients and caregivers the possibility of more convenient care with the possibility of home use.

Professor Shomron Ben-Horin, MD, Department of Gastroenterology, Chaim Sheba Medical Center in Israel, and lead author of the poster presentation said:These exploratory results suggest that infliximab SC monotherapy may provide clinical results and immunogenicity comparable to those of combination therapy with immunomodulators, thus advancing the concept of infliximab SC monotherapy as a viable treatment option for patients with the disease. of MII.

ENDS

Notes to Editors:

About inflammatory bowel disease

Inflammatory bowel disease (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), are chronic disabling gastrointestinal disorders that affect all aspects of a patient’s life.4 They affect around 5 million people around the world.5 ITNs represent substantial costs to the health system and to society – the direct healthcare costs of ITNs are estimated at 4.6-5.6 billion euros per year.6

About CT-P13 (biosimilar infliximab)

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 rheumatoid arthritis (RA) and IBD. It has been approved by the CE under the trade name Remsima® in September 2013 and launched in major EU countries in early 2015. The US FDA approved CT-P13 in April 2016 under the trade name Inflectra®. CT-P13 is approved in over 97 countries (as of September 2021), including the United States, Canada, Japan, and across Europe.

About Remsima® (CT-P13) intravenous (IV) formulation7

Remsima® IV is usually given at a dose of 3 mg per kg / body weight in rheumatoid arthritis (RA) and 5 mg per kg / body weight for other indications. IV infliximab 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.

About Remsima® Subcutaneous (SC) formulation CT-P13

A fixed dose of 120 mg of Remsima® SC has obtained marketing authorization in the EU, in adults, regardless of body weight, in all indications previously approved in adults for the IV formulation. Remsima® SC has three devices available; via a pre-filled pen (auto-injector), a pre-filled syringe or a pre-filled syringe with needle shield.7 The SC formulation has the potential to improve treatment options for infliximab use by providing high consistency in drug exposure and a convenient method of administration.

About Celltrion Santé

Celltrion Healthcare is committed to providing innovative and affordable medicines to promote patient access to advanced therapies. Its products are manufactured in state-of-the-art mammalian cell culture facilities designed and built to comply with US FDA cGMP guidelines and EU GMP guidelines. Celltrion Healthcare strives to deliver high quality cost effective solutions through an extensive global network that spans over 110 different countries. For more information, please visit: https://www.celltrionhealthcare.com

The references

1 Stefan Schreiber, et al. Switching from intravenous infliximab to subcutaneous infliximab in patients with active inflammatory bowel disease: post-hoc analysis of pre- / post-passage results of a multicenter randomized controlled pivotal trial. Poster (P0472). Presented at UEG Week Virtual 2021.

2 Geert D’Haens, et al. Comparison of the combination of subcutaneous infliximab and an immunomodulator versus subcutaneous infliximab in monotherapy: post-hoc analysis of a randomized clinical trial. Poster (P0467). Presented at UEG Week Virtual 2021.

3 Schreiber S, et al. Randomized controlled trial: Infliximab CT-P13 subcutaneously vs maintenance intravenous in inflammatory bowel disease. Gastroenterology. 2021; 160: 2340-2353

4 Molodecky, NA, et al. (2012). Increased incidence and prevalence of inflammatory bowel disease over time, based on a systematic review. Gastroenterology, 142 (1), 46-54. Retrieved from: www.gastrojournal.org/article/S0016-5085(11)01378-3/pdf [Last accessed September 2021].

5 The European Federation of Crohn’s and Ulcerative Colitis Associations. What is the IBD? Science. Retrieved from www.efcca.org/en/science [Last accessed September 2021].

6 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 September 2021].

7 European Medicines Agency Summary of Product Characteristics (SmPC). Infliximab. Available at https://www.ema.europa.eu/en/documents/product-information/remsima-epar-product-information_en.pdf [Last accessed September 2021].

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