CELLTRION-HEALTHCARE

At the European E-Congress of Rheumatology 2020 (The European League Against Rheumatism (EULAR) 2020 E-Congress), Celltrion Healthcare today showcased three sets of data relating to a subcutaneous formulation of infliximab, Remsima^® SC.

The first study demonstrated no impact of body mass index (BMI) on clinical response to CT-P13 SC in patients with active rheumatoid arthritis (RA).¹ The post-hoc study investigated the impact of BMI on clinical response to CT-P13 SC in part 2 of a phase I/III randomised controlled trial (RCT) in 165 patients throughout a 1-year treatment period.¹ Patients were categorized into 3 groups; under/normal weight (<25kg>2 ), overweight (≥25kg/m² , <30kg>2 ), and obesity (≥30kg/m² ) based on the WHO BMI classification. The three groups received at least one full dose of CT-P13 SC (after IV induction) in the initial treatment stage before week 30. The data show that the mean change from baseline of DAS28 (CRP) (-3.3, -3.1, -3.3 at week 54), duration of low disease activity (LDA) up to Week 54 (26.2, 29.2, 27.9 weeks), and the good or moderate EULAR responder rates (84.1%, 80.3%, 90.2% at week 54) were all comparable among all groups and there were no statistically significant differences.¹

Rene Westhovens, rheumatologist and one of the lead investigators of the trial, Emeritus Professor at the KU Leuven, Belgium said, “The post-hoc results showed that there was no impact of BMI on the clinical responses of CT-P13 SC 120 mg biweekly in RA patients. Therefore, Remsima^® SC could be a promising therapeutic option regardless of BMI in RA patients.”

The second study presented contained 1-year data from a multicenter, randomised, controlled, pivotal trial evaluating correlation between the magnitude of anti-drug antibody (ADA) positivity and clinical outcomes in RA patients. The results indicated that clinical analysis of both ADA positivity and titer are clinically meaningful in the prediction of pharmacokinetic (PK) profile and clinical response. CT-P13 SC administration did not result in a greater incidence of ADA compared to CT-P13 IV and there were no clinical differences between the formulations.²

A third study presented at EULAR, assessing budget impact analysis (BIA) data, indicated that the introduction of CT-P13 SC could lead to substantial cost savings for healthcare systems. The analysis compared a market scenario where a proportion of patients were treated with CT-P13 SC, to an alternative scenario where CT-P13 SC was not available and all patients were treated with IV formulations.³

The data show that introduction of CT-P13 SC resulted in potential cost savings of £39.6 million in the UK over a 5-year period, equating to 4,466 additional patients who could be treated with the SC formulation. In a second scenario which took into account IV dose-escalation up to 5mg/kg to reflect the real-world setting, the savings increased to £279.6 million over a 5-year period, equating to 30,839 additional patients able to be treated with CT-P13 SC.³

“Self-injection will significantly reduce the burden on healthcare delivery allowing resource to be spent elsewhere,” said Dr. Martin Perry at Royal Alexandra Hospital, United Kingdom. “With the pressure of meeting patient need and the increasing burden on healthcare systems, there is a greater demand than ever to deliver new and innovative treatment options that enable patients to live more independently, reduce the time spent in hospitals and in turn, lessen the pressures put on healthcare systems.”

“Remsima^® SC has the potential to offer patients a more convenient method of administration, whilst retaining the same clinical benefits found in the IV formulation of Remsima^® ,” said Mr. Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. “This should not only bring improvements to quality of life for patients, but also to healthcare systems who we anticipate could experience both time and cost savings by enabling home administration of Remsima^® SC.”

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Notes to Editors

About CT-P13 (biosimilar infliximab)^4,5,6

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 inflammatory bowel disease (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 June 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 has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and EU marketing authorisation for the treatment of people with RA. Celltrion has submitted a further variation to the marketing authorisation of CT-P13 SC to extend the indication to other disease areas including inflammatory bowel disease. In the United States, CT-P13 SC will be reviewed through the new drug pathway with the expectation of receiving US Food and Drug Administration (FDA) approval 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 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/en-us

References

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¹ Yoo DH, Westhovens R et al. Impacts of Body Mass Index on Clinical Response of Novel Subcutaneous Infliximab (CT-P13 SC) in Patients with Active Rheumatoid Arthritis: 1-Year Results from a Part 2 of Phase I/III Randomized Controlled Trial. Poster. Presented at EULAR 2020 E-Congress.

² Westhovens R, Yoo DH et al. Clinical Evaluation of the Immunogenicity to CT-P13 for Subcutaneous Use in Patients with Active Rheumatoid arthritis: 1-Year Clinical Results from a Multicenter, Randomized Controlled Pivotal Trial. Poster. Presented at EULAR 2020 E-Congress.

³ Perry M and Chung SI. Budget Impact Analysis of Introducing subcutaneous infliximab CT-P13 SC from the UK payer perspective. Poster. Presented at EULAR 2020 E-Congress.

⁴ 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.

⁵ 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.

⁶ 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 May 2020].

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