CelltrionHealthcare

Data at 54 weeks showed that the subcutaneous (SC) formulation of CT-P13 was comparable in terms of the efficacy and safety when investigated against intravenous (IV) formulation of CT-P13 (biosimilar infliximab) in rheumatoid arthritis (RA).

•The novel SC formulation of CT-P13 may enhance treatment options for the use of infliximab biosimilar by providing high consistency in drug exposure and a convenient method of administration.

•In a separate study, a five-year analysis of medical records showed that long-term treatment with CT-P13 was safe and efficacious based on drug survival, disease activity measurements and adverse events.

June 11, 2019 06:01 PM Eastern Daylight Time

MADRID--(BUSINESS WIRE)--Celltrion Healthcare today presented new findings at the Annual European Congress of Rheumatology (EULAR 2019) from a two-part study investigating the pharmacokinetics, efficacy and overall safety of CT-P13 SC in patients with RA during the treatment period of one year. The second part of the study demonstrated the non-inferiority of the efficacy and compared safety profiles of CT-P13 SC to CT-P13 IV in people with RA over 30 weeks.

Part one of the study enrolled 50 patients of which 48 patients were randomly assigned at week six into four cohorts in a 1:1:1:1 ratio. The IV cohort received CT-P13 IV 3mg/kg every eight weeks and the SC cohorts received CT-P13 SC 90mg, 120mg or 180mg, respectively, every two weeks up to week 54. Overall, the efficacy results of CT-P13 SC up to week 54 were comparable to those of CT-P13 IV. Disease improvement was assessed using the DAS28 (CRP), a disease activity score, and ACR20 score for RA. Results demonstrated that DAS28 (CRP) and ACR20 were comparable across all four cohorts, regardless of the route of administration or dosage of CT-P13. The safety profiles at week six in CT-P13 SC were comparable to CT-P13 IV and were similar to those previously reported for IV infliximab.1

This study was followed by a phase I/III randomised controlled trial. A total of 362 RA patients were enrolled, of whom 348 were randomised at week six into two treatment arms in a 1:1 ratio (169 and 179 patients in SC 120mg bi-weekly or IV 3mg/kg arms every 8 weeks, respectively). The aim of the study was to compare the safety profiles and demonstrate the non-inferiority of efficacy of CT-P13 SC and CT-P13 IV in people with RA over 30 weeks. The trial showed that the mean change of DAS28 (CRP) from baseline to week 22 was similar between the two arms. The lower limit of the 95% CI (0.03) for the treatment difference in the change of DAS28 (CRP) from baseline was greater than the pre-specified non-inferiority margin (-0.6) indicating non-inferiority of CT-P13 SC compared to CT-P13 IV. ACR responses were also similar between the two treatment arms up to week 22. The safety profile at week six in the SC 120mg arm was comparable to the IV 3mg/kg arm.2

Professor Rieke Alten, Head of the Department of Internal Medicine, Rheumatology, Clinical Immunology and Osteology at Schlosspark-Klinik, Teaching Hospital of Charité, Berlin, Germany said, “Despite improvements in treating RA, there is still a significant way to go to help patients and reduce the burden of the disease. Today, pain, fatigue and the psychological issues connected with RA really impact patients on a daily basis, and with frequent visits to hospitals, it is crucial that we find an effective treatment option for patients. The SC formulation of biosimilar infliximab, CT-P13, could address unmet needs in maintenance therapy and provide an affordable, convenient, and personalised treatment option. The results seen to-date demonstrate CT-P13 SC has the potential to be an innovative biosimilar treatment – improving convenience and allowing patients to have more control of their treatment and enjoy life again.”

In a separate study, Celltrion investigated the long-term safety and efficacy of CT-P13 up to five years in people with RA and ankylosing spondylitis (AS), including patients who switched from reference infliximab to CT-P13. The study collected and analysed data from 491 patients (154 RA and 337 AS), including 19 and 118 switched patients with RA and AS, respectively. The probability of drug survival at year five for patients with RA was 0.42 and 0.53, respectively for naïve and switched patients. The probability of drug survival at year five for patients with AS was 0.64 and 0.72, respectively for naïve and switched patients. This five-year analysis of medical records showed that long term treatment with CT-P13 was safe and efficacious based on drug survival, disease activity measurements and adverse events. Drug survival was similar between patients who were naïve at the start of CT-P13 treatment and switched from reference to CT-P13.

Mr Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare said, “We at Celltrion Healthcare are proud to be leading in the biosimilar space, providing physicians with accessible treatment options that suit the individual needs and preferences of their patients, whether that is intravenous or subcutaneous, is important to us. Such innovations in drug administration are shown to really benefit patients and so, being able to offer CT-P13 SC, with the new pharmaco-economic value expected with dual formulation of infliximab, could offer patients a more convenient treatment option reducing the time spent in hospitals.”

+++

Notes to Editors

About CT-P13 (biosimilar infliximab)

CT-P13 is developed and manufactured by Celltrion, Inc. and was the world’s first monoclonal antibody biosimilar approved by the European Commission (EC). It is indicated for the treatment of eight autoimmune diseases including rheumatoid arthritis and IBD. It was approved by the EC under the trade name Remsima® in September 2013 and launched in major EU countries in early 2015. The US FDA approved CT-P13 in April 2016 under the trade name Inflectra®. CT-P13 is approved in more than 89 countries (as of May 2019) including the US, Canada, Japan and throughout Europe.

About Celltrion Healthcare

Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavors to offer high-quality cost-effective solutions through an extensive global network that spans more than 120 different countries. For more information please visit: http://www.celltrionhealthcare.com/

1 Yoo DH, et al. A Novel Formulation of CT-P13 (Infliximab Biosimilar) for Subcutaneous Administration: One Year Results from Part One of a Phase I/III Randomised Controlled Trial in Patients with Rheumatoid Arthritis. Poster Presented at the Annual European Congress of Rheumatology (EULAR 2019).

2 Westhovens R, et al. A Novel Formulation of CT-P13 (Infliximab Biosimilar) for Subcutaneous Administration: 30-week Results from Part Two of a Phase I/III Randomised Controlled Trial in Patients with Rheumatoid Arthritis Poster Presented at the Annual European Congress of Rheumatology (EULAR 2019).