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Biosimilar CT-P13 matches infliximab in improving ankylosing spondylitis disease activity
Date:6/11/2014

New data presented today at the European League Against Rheumatism Annual Congress (EULAR 2014) show that the newly-approved infliximab biosimilar CT-P13 achieves statistically similar improvements in disease activity, disability and mobility in patients with Ankylosing Spondylitis (AS) compared to its original reference product infliximab (INX).1

CT-P13 is the world's first biosimilar monoclonal antibody to receive a positive opinion from an advanced and developed nations' regulatory body. According to Dr Won Park, Inha University Hospital, Korea, and lead investigator of the PLANETAS* study, "the challenge for biosimilars is to demonstrate similarity in therapeutic effectiveness, safety and immunogenicity to their reference product, not just biochemical and pharmacokinetic equivalence."

"By demonstrating comparable efficacy and safety, the results of our clinical trials should give physicians confidence in using CT-P13 as an alternative treatment option to INX in AS patients," Dr Park added. "This is good news for patients who may previously have had limited access to costly antibody biopharmaceuticals."

AS is a type of chronic arthritis affecting an estimated 1.4 million patients in Europe.2 In AS, inflammation in the joints and ligaments causes pain and stiffness in the neck, back and buttocks. The cause of AS is unknown, and there is no known cure, so the current aim of treatment is to reduce pain and stiffness and to keep the spine flexible.3

These new data captured clinical measures of disease activity via ASAS20/40 and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), disability via the Bath Ankylosing Spondylitis Functional Index (BASFI) and mobility via the Bath Ankylosing Spondylitis Metrology Index (BASMI). In addition, the Student's t test was used to compare mean change of three indices from baseline in both treatment groups.

At week 54, BASDAI improved significantly from baseline in both tre
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Contact: EULAR Press Office
eularpressoffice@cohnwolfe.com
44-078-801-73209
European League Against Rheumatism
Source:Eurekalert

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