BARCELONA--(BUSINESS WIRE)--Today at the 12th Congress of the European Crohn’s and Colitis Organisation (ECCO), Celltrion Healthcare presented the primary outcome from its pivotal randomised controlled trial (RCT) of CT-P13 (biosimilar infliximab) in Crohn’s disease. The data indicate that the safety and efficacy of CT-P13 in patients with moderate-to-severe Crohn’s disease (CD) is comparable to those treated with reference infliximab.1
The Phase III RCT in 220 patients with CD examined whether CT-P13 is comparable to reference infliximab as determined by the Crohn’s Disease Activity Index (CDAI), a measurement used to quantify the symptoms of CD patients. According to the 6 week and 30 week data, similar clinical remission, CDAI-70 and CDAI-100 response rates were observed in both CT-P13 and reference infliximab treatment groups.1
Leading expert Jørgen Jahnsen, Professor of Gastroenterology at the University of Oslo, Norway commented on the study, “This is the first RCT to examine the use of a biosimilar in inflammatory bowel disease. While we already have a wealth of extrapolated and real-world data for CT-P13, gastroenterologists have for some time wanted the reassurance of an RCT and it’s encouraging to see such positive data from Celltrion’s RCT trial.”
Celltrion Healthcare also presented data from two observational studies. The first study evaluated the efficacy and safety of CT-P13 in 74 paediatric patients with CD (naïve patients: 26, switch patients: 25) or ulcerative colitis (UC) (naïve patients: 16, switch patients: 7). The data show that CT-P13 is effective in both treatment-naïve and switch paediatric patients over 30 weeks and is well-tolerated.2
The second study examined 204 CD patients (fistulising CD: 24, CD patients: 180) in South Korea from July 2012-2016. CT-P13 was found to be clinically consistent to reference infliximab and well tolerated up to six months in patients with moderate-to-severe CD and those with fistulising CD.3
CT-P13 has delivered significant health savings across Europe
Real-world cost savings associated with the use of CT-P13 across all indications were studied in five European countries from the beginning of 2015 to the first half of 2016. According to the data presented at ECCO, total cost savings observed for Germany, Italy, Spain and the UK amounted to €32.4 million and the findings suggest that this could allow an additional 5,428 patients a year access to this important biologic therapy. There were no cost savings in France, as the price of biosimilar and reference infliximab were the same, however despite this, use of CT-P13 has gradually increased in this country.4
Man Hoon Kim, President and CEO of Celltrion Healthcare, said, “At Celltrion, we are committed to addressing the needs of the clinical community through robust scientific exploration. A pivotal RCT in Crohn’s disease is an important example of this, and the results from this pivotal trial are consistent with our other RCTs and many real-world IBD studies that have been conducted. More broadly, it’s rewarding to see the changes that CT-P13 is making in financially-constrained health systems in Europe.”
Notes to editors:
About inflammatory bowel disease
Inflammatory bowel diseases (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), are chronic disabling gastrointestinal disorders that impact every aspect of a patient’s life.5 They affect an estimated 2.5-3 million people in Europe;6 CD affects about three people per 1,000 and UC about 5 people per 1,000.5
IBDs account for substantial costs to the healthcare system and society; the direct healthcare costs of IBDs are estimated to be €4.6-5.6 billion per year.6
About Celltrion Healthcare
Celltrion Healthcare conducts the worldwide marketing, sales and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries. Celltrion Healthcare’s products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US Food and Drug Administration (FDA) cGMP guidelines and the EU GMP guidelines. For more information please visit: http://www.celltrionhealthcare.com/
About CT-P13 3.4 CD RCT
The study is a randomised, double-blind, parallel- group, phase Ⅲ study to investigate efficacy and safety between CT-P13 and reference infliximab with CD patients. Out of 220 patients randomised in 58 study centres across 16 countries, 214 patients completed up to week 6 for the primary analysis, and 180 patients completed up to week 30. The study was funded equally by Celltrion and Pfizer.
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 Medicines Agency (EMA). It is indicated for the treatment of eight autoimmune diseases including rheumatoid arthritis and inflammatory bowel disease. It was approved by the EMA under the trade name Remsima® in September 2013 and launched in Europe in early 2015. The US FDA approved Celltrion’s CT-P13 in April 2016 under the trade name Inflectra™. Celltrion’s CT-P13 is approved in more than 79 (as of January 2017) countries including the US, Canada, Japan and throughout Europe.
1 Kim, Y.H. et al. Phase Ⅲ Randomised, Double-blind, Controlled Trial to Compare Biosimilar Infliximab (CT-P13) with innovator Infliximab (INX) in Patients with Active Crohn’s Disease: Early Efficacy and Safety Results. Congress of the European Crohn’s and Colitis Organisation (ECCO) 2017. DOP061
2 Choe, Y.H. et al. Effectiveness and Safety of CT-P13 under Routine Care in Paediatric Patients with Inflammatory Bowel Disease. Congress of the European Crohn’s and Colitis Organisation (ECCO) 2017. P487
3 Choe, Y.H. et al. Effectiveness and Safety in Crohn’s Disease Patients Who Were Treated with CT-P13. Congress of the European Crohn’s and Colitis Organisation (ECCO) 2017.P500.
4 Han, S. et al. The pharmacoeconomic impact of biosimilar infliximab (CT-P13) in Europe from January 2015 to June 2016. Congress of the European Crohn’s and Colitis Organisation (ECCO) 2017. P582
5 Molodecky NA, et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012; 142(1)46–54. Available at www.gastrojournal.org/article/S0016-5085(11)01378-3/pdf [Last accessed January 2017].
6 Burisch J, et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis (2013)7,322-337.