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Inflectra (infliximab) patient registry reports interim results in the treatment of inflammatory bowel disease

Data have been presented today on the use of Hospira’s Inflectra (infliximab), the world’s first approved biosimilar monoclonal antibody (mAb), at the European Crohn’s and Colitis Organisation (ECCO-ibd) conference. Results show a comparable response in patients treated with Inflectra to that expected with the reference product, Remicade (infliximab), for inducing and maintaining remission in Crohn’s disease (CD) and ulcerative colitis (). These data add to the body of evidence supporting Inflectra’s use in (IBD).

Results presented from the ongoing independent, prospective, nationwide study in Hungary show that for the first 90 patients, (57 with CD and 33 with UC) treated with Inflectra, reductions compared with baseline were seen in validated measures of disease activity after both two and six weeks of treatment.1* C-reactive protein (CRP), a marker of inflammation, was also decreased during induction therapy for UC.1 Four of the 90 patients showed an allergic reaction to treatment, all of who had previously received anti-TNF medication.1 The abstract can be found at: P314 Biosimilar infliximab in inflammatory bowel diseases: first interim results from a prospective nationwide observational cohort.

Professor Peter Lakatos, one of the founders and leader of the Hungarian IBD Study Group said, “The results of this study thus far have been deeply informative to confirm the clinical efficacy and safety of biosimilar infliximab following its introduction to the Hungarian market last year. The induction and maintenance of remission in patients prescribed Inflectra are exactly as we would expect to see with Remicade.”

Another abstract presented at ECCO-ibd by Kim A et al. reports that the introduction of biosimilar infliximab for the treatment of CD alone could lead to savings of between €76 million and €336 million across the United Kingdom, Italy and France within five years.2 The abstract can be found at: P137 5 year budget impact analysis of CT-P13 (Infliximab) for the treatment of Crohn’s Disease in UK, Italy and France. Biologic medicines have transformed the lives of people living with debilitating inflammatory diseases such as CD and UC, chronic conditions that affect more than 2.2 million people in Europe.3 However, these medicines are expensive and many eligible patients across Europe have been unable to access the treatments they need to fight the disease.4 Biosimilar medicines provide a more affordable alternative to high-cost originator biologic medicines while maintaining the same quality, efficacy and safety.5

Dr. Paul Audhya, vice president, Medical Affairs, Europe, Middle East and Africa, Hospira, said, “The introduction of biosimilars provides an opportunity to reduce the high cost of biologic treatment, giving patients access to more affordable care without compromising on quality, safety or efficacy. The dataset collected under the nationwide registry in Hungary further validates the long-established biosimilar regulatory pathway in the EU, and in particular the principle of extrapolation, which is fundamental to the biosimilar concept.”

The data reported is derived from a network of centres across Hungary and has been compiled since Inflectra entered the Hungarian market in May 2014. The study will follow individual patients with CD for a period of 108 weeks, and patients with UC for a period of 54 weeks, following induction with Inflectra.1

The Hungarian registry will continue to enrol patients, adding to the evaluation of Inflectra’s use in IBD in a number of ongoing studies assessing safety, adherence, long-term outcomes and cost. Additional abstracts are being presented on the use of biosimilar infliximab (CT-P13) in IBD at the ECCO-ibd conference, in total assessing 272 patients, and can be found at:https://www.ecco-ibd.eu/index.php/publications/congress-abstract-s/abstracts-2015.html

Infliximab is a cornerstone treatment for many inflammatory diseases, with more than 15 years of clinical data and experience.6 Inflectra is a biosimilar version of the anti-TNF? blockbuster Remicade (infliximab), and is the first biosimilar mAb to be assessed and licensed by the European Commission (EC). A biosimilar developed in-line with EU requirements can be considered a therapeutic alternative to an existing biologic.[5] Inflectra was licensed by the European Commission in September 2013 for all indications of its reference product. Inflectra is licensed in adults for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PsO), Crohn’s disease (CD) and ulcerative colitis (UC). Inflectra is also licensed in children and adolescents aged between six and 17 years for CD and UC.7 Inflectra is available in 24 European countries.


*For CD: reduction in CD Activity Index (CDAI) score, p?0.001 compared with baseline; for UC: reduction in partial MAYO (pMAYO) score, from 6.4 to 3.7 (at week 2) and 3.6 (at week 6).

1. Gecse K, et al. Biosimilar infliximab in inflammatory bowel disease: first interim results from a prospective nationwide observational cohort. Abstract P314. Presented February 2015 at ECCO-ibd, Barcelona, Spain.

2. Kim J, et al. 5 year budget impact analysis of CT-P13 (infliximab) for the treatment of Crohn’s disease in UK, Italy and France. Abstract P137. Presented February 2015 at ECCO-ibd, Barcelona, Spain.

3. The European Federation of Crohn’s and Ulcerative Colitis Associations. What is IBD? Available at: http://www.efcca.org/index.php/about-efcca/what-are-ibd. Last accessed February 2015.

4. Putrik P, Ramiro S, Kvien TK et al. Inequities in access to biologic and synthetic DMARDs across 46 European countries. Ann Rheum Dis. 2014. Jan; 73(1): 198-206.

5. Weise M. et al. Biosimilars: what clinicians should know. Blood. 2012; 120: 5111-5117.

6. Danese S, Colombel J, Reinisch W et al. Review article: infliximab for Crohn’s disease treatment – shifting therapeutic strategies after 10 years of clinical experience. Alimentary Pharmacology and Therapeutics. 2011; 33: 857-869.

7. EMA. Inflectra European Public Assessment Report – Summary for the public. EMA/402688/2013. Available at http://www.ema.europa.eu/ema/index.jsp?curl=/pages/medicines/human/medicines/002778/human_med_001677.jsp. Last accessed January 2015.

Source: Hospira, Inc.