Celltrion Healthcare, a biopharmaceutical company, recently announced data from a study further investigating efficacy, safety, immunogenicity & pharmacokinetics of CT-P13 SC, over a period of 1-year treatment. The study focuses on the results achieved  after substituting from CT-P13 IV with CT-P13 SC, in people with RA (rheumatoid arthritis). The data was put forward at the American College of Rheumatology (ACR) annual meeting.

A previous study compared the pharmacokinetics, efficacy & and safety profiles of both CT-P13 IV and CT-P13 SC in people with rheumatoid arthritis over 30 weeks. This study demonstrated the non-inferiority of CT-P13 SC as compared to CT-P13 IV.

Rene Westhovens, Professor of Rheumatology, University Hospitals KU Leuven, Belgium, was reportedly quoted saying that non-inferiority for CT-P13 SC to CT-P13 IV was supported by the change from baseline CRP (DAS28) at Week 22. Up to Week 54, serum concentration of CT-P13 SC was well retained. Over the study period, safety outcomes of CT-P13 SC exhibited comparable profiles to CT-P13 IV.

Westhovens added that CT-P13 SC indicated lower ADA than CT-P13 IV, which implies high trough level possibly leading to better PK pattern, as well as, positive efficacy profile. The findings show that the new SC formulation of CT-P13 through pre-filled syringe could provide advantageous benefits to people with an alternative convenient way of administration.

 Hyoung-Ki Kim, V.C., Celltrion Healthcare, stated that with CT-P13 SC at the disposal, patients can now be treated utilizing infliximab SC before switching over to other costly antibodies with a different mechanism of action such as JAK-inhibitors. For the second-line treatment of rheumatoid arthritis, Celltrion Healthcare is looking forward to target CT-P13 SC as the desired agent. With the medical formulation of CT-P13 and the development of the biosimilar adalimumab, CT-P17, has immense potential in improving access to treatment as well as expanding treatment options worldwide.

Hyoung-Ki Kim further added that the pharmaceutical company remains highly committed to developing biosimilar portfolio in order to deliver value to patients and healthcare providers.
 

Source Credit: https://finance.yahoo.com/news/data-show-non-inferiority-efficacy-213000945.html