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Celltrion Healthcare Presents Phase III Switching Data Supporting the Long-Term Efficacy and Safety of Truxima® (CT-P10, Biosimilar Rituximab) in Rheumatoid Arthritis Patients

2017年11月06日 AM08:01
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SAN DIEGO

New data presented at the 2017 American College of Rheumatology (ACR) Annual Meeting show that CT-P10 is comparable to reference rituximab in terms of efficacy, pharmacodynamics (PD) and safety profile, over a sustained period of time after switching from reference rituximab in patients with rheumatoid arthritis (RA).1

A total of 295 patients participated in the extension period of the phase III, randomised controlled trial after completing treatment up to 48 weeks with CT-P10 or reference rituximab. Patients with RA in both groups during this main period demonstrated equivalent efficacy and similar pharmacokinetic (PK) and safety profiles.2

During the extension period, patients who previously received reference rituximab either maintained treatment or were switched to CT-P10. Efficacy, PD, safety and immunogenicity were evaluated for a further 24-weeks. CT-P10 showed long term effectiveness and tolerability throughout, and the DAS28-CRP improvement, ACR and EULAR response rates, all clinically recognised measurements of efficacy, were comparable between patients switched to CT-P10 and those in the maintained group.1

Professor Alten, Director of the Rheumatology Research Centre at the Teaching Hospital of the Charité, Berlin said: “In the field of rheumatology, whether to switch patients to biosimilars is a pressing question among physicians. Therefore, it is important to see results from studies such as this one, which shows comparable long-term efficacy and safety of CT-P10, a biosimilar for rituximab following switching.”

Man Hoon Kim, President and CEO of Celltrion Healthcare, said: “The study shows the comparability of our biosimilar rituximab, CT-P10, to the reference rituximab after switching over a sustained period of time. This adds to the increasing wealth of long-term data in support of CT-P10 in rheumatoid arthritis, demonstrating its continuous effective use, which should help physicians feel confident in switching their patients to this biosimilar rituximab.”

— Ends—

Notes to editors:

About CT-P10 (biosimilar rituximab)

CT-P10 is a monoclonal antibody that targets CD20, a transmembrane protein found on the surface of most B cells. By binding specifically to CD20, CT-P10 depletes B cells by three main mechanisms: Induction of apoptosis, Stimulation of CDC (complement-dependent cytotoxicity), Stimulation of ADCC (antibody-dependent cell-mediated cytotoxicity).

CT-P10 is approved in the EU for the treatment of patients with Non-Hodgkin lymphoma, chronic lymphocytic leukaemia, RA, granulomatosis with polyangiitis and microscopic polyangiitis. Further details of the approved indications and safety information for CT-P10 are available in the summary of product characteristics (SmPC).3

About rheumatoid arthritis

In Europe, more than 2.9 million people have rheumatoid arthritis (RA), many of whom are of working age. On average, every third person with RA becomes work disabled and up to 40 per cent leave work completely within 5 years of diagnosis.4 Although there is no cure for RA, there are many treatments that can reduce inflammation and ease pain. As with all rheumatic diseases early diagnosis and intervention is key.

About Celltrion Healthcare

Celltrion Healthcare conducts the worldwide marketing, sales and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries. Celltrion Healthcare’s products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US Food and Drug Administration (FDA) cGMP guidelines and the EU GMP guidelines. For more information please visit: http://www.celltrionhealthcare.com/

References

1 Shim et al. Efficacy and safety of rituximab biosimilar, CT-P10, after a single switch from innovator rituximabs in patients with rheumatoid arthritis: Results from phase 3 randomised controlled trial over 72 week. American College of Rheumatology (ACR). 2017. 2445.
2 Suh et al. Randomised double-blind study shows comparable long-term efficacy and safety between rituximab biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: 48 week results. Annual European Congress of Rheumatology (EULAR). 2017. SAT0146
3 Truxima concentrate for solution for infusion summary of product characteristics [last accessed November 2017]. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004112/WC500222694.pdf.
4 NRAS, European Fit for Work Report. Available at www.nras.org.uk/european-fit-for-work-report. [Last accessed November 2017].

View source version on businesswire.com: http://www.businesswire.com/news/home/20171105005020/en/

CONTACT

For Celltrion Healthcare
Emma Gorton
egorton@hanovercomms.com
+44
203 817 6591
or
Suru Douglas
sdouglas@hanovercomms.com
+44
203 817 6586

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