Celltrion Healthcare presents Phase III switching data for Truxima (rituximab) in rheumatoid arthritis patients

November 10, 2017 6:56 AM

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).

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.

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.

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.”

 

Source: Celltrion Healthcare press release

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