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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

Celltrion Healthcare
Posted on: 06 Nov 17

6 November 2017.  San Diego, California. 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).[i]

 

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.[ii]

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.”

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 06/11/2017

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