• Presented today at EULAR 2022, data from a new post-hoc analysis show a statistically significant difference in clinical outcomes with subcutaneous (SC) infliximab compared to intravenous (IV) infliximab at week 30, using conservative missing imputation methods
• Data also show that differences in efficacy outcomes between SC and IV infliximab groups reduced at week 54, after the IV group switched to SC, suggesting improved responses after switching from IV to SC infliximab

INCHEON, South Korea--(BUSINESS WIRE)--A new post-hoc analysis of a pivotal phase III randomised controlled clinical trial shows that the subcutaneous (SC) formulation of infliximab, Remsima^� (CT-P13), is associated with significantly greater improvements in clinical outcomes compared to the intravenous (IV) formulation of infliximab at week 30, in patients with rheumatoid arthritis (RA). Between-group (SC vs. IV) differences were reduced at week 54, suggesting improved responses after switching from IV to SC infliximab.¹ The data were presented today at the Annual European Congress of Rheumatology (EULAR 2022).

�It�s important for people living with rheumatoid arthritis to effectively control their disease, and when there are signs one�s RA treatment is not working as well as it used to, one might need to consider re-evaluating the treatment strategy. Today, many medications have changed the treatment landscape of rheumatology, allowing low disease activity and remission to be achieved in people with RA,� said Professor Arnaud Constantin, Rheumatologist at Rheumatology Department, Purpan University Hospital and Toulouse III � Paul Sabatier University, Toulouse, France. �Switching to medications such as the SC formulation of infliximab could allow patients to have better control of their treatment and improved quality of life.�

The post-hoc study investigated whether the numerical advantage of SC infliximab compared to IV, shown in most efficacy parameters at weeks 30 and 54, was statistically significant. This was achieved using conservative imputation methods, such as non-responder imputation (NRI) and last observation carried forward (LOCF), in 343 patients who were randomised at week six into two treatment arms (165 patients received SC 120mg bi-weekly and 174 patients received IV 3mg/kg every 8 weeks).

Results showed a statistically significant difference in favour of SC compared to IV-treated patients at week 30 in almost all clinical variables, including low disease activity rates and remission rate. In addition, after switching at week 30 to SC infliximab, the proportion of RA patients achieving either low disease activity rates or a �good response�, as measured by EULAR CRP, was increased at week 54, suggesting improved responses after switching from IV to SC.

�The results presented today at EULAR provide further evidence to the efficacy of SC infliximab, as switching from IV to SC infliximab was associated with improvements in clinical response. The positive outcomes following switching from IV to SC infliximab provide reassurance to patients and the healthcare professionals who treat them,� said Kevin Byoung Seo Choi, Senior Vice President and Head of Marketing Division at Celltrion Healthcare.

- ENDS -

Notes to Editors:

About rheumatoid arthritis^2,3,4,5

Rheumatoid arthritis (RA) is a chronic inflammatory disease that causes pain, swelling and stiffness in joints. Approximately 1% of the population worldwide suffer from RA, however, the cause of it remains unknown. Symptoms of RA develop due to a faulty immune system that attacks healthy cells, but it is currently unknown why the immune system behaves in this way. Although there's no cure for rheumatoid arthritis, early treatment such as disease-modifying anti-rheumatic drugs (DMARDs) and biological treatments can reduce the risk of joint damage and limit the impact of the condition.

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 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 US Food and Drug Administration (FDA) approved CT-P13 in April 2016 under the trade name Inflectra^�. CT-P13 is approved in more than 98 countries (as of May 2022) including the US, Canada, Japan and throughout Europe.

About Remsima^� intravenous (IV) formulation⁶

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 including IBD. 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^� 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.⁶ 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.^7,8

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 Current Good Manufacturing Practice (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 Arnaud Constantin, et al. Efficacy of Subcutaneous Infliximab (CT-P13 SC) Compared with Intravenous Infliximab in Rheumatoid Arthritis: A Post-hoc Analysis of a Phase 3 Randomized Controlled Trial.

² Arthritis Research UK. Rheumatoid arthritis. Available at https://www.versusarthritis.org/about-arthritis/conditions/rheumatoid-arthritis [Last accessed as of May 2022]

³ Allan Gibofsky. Overview of Epidemiology, Pathophysiology, and Diagnosis of Rheumatoid Arthritis. American Journal of Managed Care. 2012;18:S295-302.

⁴ Arthritis Foundation. Rheumatoid Arthritis. Available at https://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/ [Last accessed as of May 2022].

⁵ NHS UK. Treatment Available at https://www.nhs.uk/conditions/rheumatoid-arthritis/treatment/ [Last accessed as of May 2022]

⁶ 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 as of May 2022].

⁷ 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.

⁸ 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.

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