CELLTRION-HEALTHCARE

Celltrion Healthcare today announced two 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 United European Gastroenterology (UEG) Week 2021, held virtually from October 3- 5.

The first study investigated clinical impact of switching from intravenous (IV) to subcutaneous (SC) treatment of infliximab in patients with Crohn’s disease (CD) or ulcerative colitis (UC) from the pivotal randomised controlled trial of CT-P13 SC.³ 65 patients (25 CD 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 until week 22. At week 30, patients switched to receive CT-P13 SC every 2 weeks up to week 54 (dose 120 mg or 240 mg for patients < 80 kg or ≥ 80 kg, respectively).¹

Results showed switching from IV to SC infliximab conferred more favourable clinical outcomes in terms of pharmacokinetics, efficacy, and possibly, immunogenicity. There was a significant difference in C_trough pre- and post-switch (median C_trough Levels at 2.05 μg/mL (interquartile range [IQR], 0.10-3.61) and 21.10 μg/mL (IQR, 11.30-26.50) pre- and post-switch, respectively; p<0.0001). The proportion of patients with C_trough exceeding target exposure (5 μg/mL) was significantly higher post-switch (36/41, 87.80%) than pre-switch (8/41, 19.51%; p<0.00001). In terms of efficacy, clinical response rates were comparable at both pre- and post-switch timepoints (40/49 [81.63%] vs 44/49 [89.80%], respectively; p=0.3873). However, faecal calprotectin (FC) levels were significantly lower post-switch compared with pre-switch. Anti-drug antibody (ADA) and neutralising antibody (NAb) positivity were also numerically lower post-switch although statistical significance was not reached.¹

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

Patients with active CD or UC who were tumour necrosis factor (TNF) inhibitor treatment–naïve were enrolled and received induction therapy with CT-P13 5 mg/kg intravenously (IV) at week 0 and week 2, after which they were randomised to continue therapy with CT-P13 IV or receive CT-P13 SC 120 mg (patients<80 kg) or 240 mg (patients ≥80 kg) every 2 weeks from week 6 to week 54. Of 66 patients, 37 and 29 received monotherapy and combination therapy, respectively. The results show there was no significant difference between groups in the number of patients with C_trough level exceeding target exposure with both groups exceeding target exposure throughout the study period (target exposure: 5 μg/mL; monotherapy: 28/29, 96.55%; combination therapy: 23/24, 95.83%; p>0.9999). Clinical response rates in terms of CDAI-100 and partial Mayo response were comparable between arms and there was no difference in immunogenicity between the groups despite the concomitant use of immunomodulators in the combination therapy group.²

Professor Walter Reinisch, Director of Clinical IBD Study Group, Department of Gastroenterology and Hepatology, Medical University of Vienna and the presenting author of the poster presentation said, “The post-hoc analysis indicates that switching from IV to SC infliximab will deliver comparable clinical outcomes for patients with inflammatory bowel disease, including those with Crohn's disease and ulcerative colitis, further highlighting the potential of SC infliximab as an alternative administration route. Infliximab SC offers patients and caregivers the possibility of more convenient care with the potential for in-home use.”

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

- ENDS -

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.⁴ They affect an estimated 5 million people globally.⁵ 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.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 was approved by the EC 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 more than 97 countries (as of September 2021) including the US, Canada, Japan and throughout Europe.

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

Remsima^® IV is usually given as 3 mg per kg/body weight in rheumatoid arthritis (RA) and as 5 mg 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.

About Remsima^® CT-P13 subcutaneous (SC) formulation

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

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 endeavours 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

References

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

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

³ Schreiber S, et al. Randomized Controlled Trial: Subcutaneous vs Intravenous Infliximab CT-P13 Maintenance in Inflammatory Bowel Disease. Gastroenterology. 2021; 160:2340-2353

⁴ 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 September 2021].

⁵ The European Federation of Crohn’s & Ulcerative Colitis Associations. What is 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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