Six posters on clinical experience with biosimilar mAb infliximab presented at ECCO 10th annual congress

Celltrion Healthcare has announced data demonstrating that the world’s first biosimilar monoclonal antibody (mAb) infliximab is an effective treatment option for patients with the chronic debilitating autoimmune diseases, Crohn’s disease (CD) and ulcerative colitis (UC). Clinical experience of biosimilar infliximab in 332 patients with inflammatory bowel disease (IBD) is being presented in six posters and a satellite symposium at ECCO 2015 showing that the treatment is effective and safe in these patients.

Celltrion Healthcare has announced data demonstrating that the world’s first biosimilar monoclonal antibody (mAb) infliximab is an effective treatment option for patients with the chronic debilitating autoimmune diseases, Crohn’s disease (CD) and ulcerative colitis (UC). Clinical experience of biosimilar infliximab in 332 patients with inflammatory bowel disease (IBD) is being presented in six posters and a satellite symposium at ECCO 2015 showing that the treatment is effective and safe in these patients.

The safety and efficacy of biosimilar infliximab in rheumatoid arthritis (RA) and ankylosing spondylitis (AS) have previously been demonstrated in two pivotal clinical trials, PLANETAS and PLANETRA. Biosimilar infliximab, developed by Celltrion, Inc., is approved by the EMA for treatment of eight autoimmune diseases, including adult and paediatric CD and UC.

Six posters show clinical experience with biosimilar mAb infliximab. Data from six prospective observational trials, totalling 258 patients from Europe and South Korea, show that the biosimilar infliximab is an effective and well-tolerated treatment for patients with CD and UC. (1,2)

In one study of 106 patients with CD or UC, the clinical response to the treatment at eight weeks was ≥87% in patients who had not been treated with anti-tumour necrosis factor (anti-TNF) therapy before and ≥67% in patients who had switched from another anti-TNF therapy. (1) Another study, in which data was collected prospectively on 90 patients with CD or UC, demonstrated decreases in internationally recognised scores of disease activity after six weeks of treatment with the biosimilar mAb infliximab (CRP level [from 23l5mg/L to 11.3mg/l at two weeks and 15.3mg/l at week six], CDAI [compared to baseline p<0.001, ANOVA-Scheffe] and pMAYO score [from 6.4 to 3.7 at week two and 3.6 at week six]). (2)

Case report from Norway
At a satellite symposium session, Jørgen Jahnsen, Professor of Gastroenterology at the University of Oslo, Norway, reported on his clinical experience of treating CD and UC patients with biosimilar mAb infliximab. A reduction in disease activity at week 14 was reported in 74 IBD patients (44 CD and 30 UC): after three infusions of biosimilar infliximab, there was a significant reduction in HBI, calprotectin and CRP in CD patients, and in partial MAYO score, Simple AI, calprotectin and CRP in UC patients.

Stanley Hong, President of Celltrion Healthcare, said: “The data presented at ECCO’s 2015 congress support the EMA’s decision to approve the biosimilar infliximab for the treatment of Crohn’s disease and ulcerative colitis in the EU based on extrapolation of the clinical data in rheumatologic diseases which demonstrated comparable efficacy and safety to its reference medicinal product. We are conducting prospective observational and registry trials as part of pharmacovigilance in the EU and South Korea to monitor the safety of the biosimilar infliximab.”

Biosimilar mAb infliximab posters at ECCO
The following abstracts relating to the efficacy and safety of the biosimilar infliximab in CD and UC are being presented at ECCO 2015:

• Suk JY et al. Efficacy and safety of infliximab’s biosimilar (Remsima) for IBD. P540.
• Gecse K et al. Biosimilar infliximab in inflammatory bowel diseases: first interim Results from a prospective nationwide observational cohort. P314.
• Jarzebicka D et al. Preliminary assessment of efficacy and safety of switching between originator and biosimilar infliximab in paediatric Crohn disease patients. P295.
• Sieczkowska J et al. Assessment of safety and efficacy of biosimilar infliximab in children with Crohn disease: a preliminary report. P430.
• Jarzebicka D et al. First observations of the use of biosimilar infliximab for treatment of ulcerative colitis in paediatric population. P456.
• Molnar T et al. Efficacy of the new infliximab biomarker CT-P13 induction therapy on mucosal healing in ulcerative colitis patients. P603.

Celltrion Healthcare satellite symposium
Satellite symposium 3a: Remsima™, the 1st biosimilar monoclonal antibody, **Friday 20 February 07:15–08:15

• Real world experience in IBD, Jørgen Jahnsen, Professor of Medicine and Gastroenterology at the University of Oslo

References:

1. Suk JY et al. Efficacy and safety of infliximab’s biosimilar (Remsima) for IBD. European Crohn’s and Colitis Organisation (ECCO) 10th annual congress 2015; P450.
2. Gecse K et al. Biosimilar infliximab in inflammatory bowel diseases: first interim results from a preopsective nationwide observational cohort. European Crohn’s and Colitis Organisation (ECCO) 10th annual congress 2015; P314.
3. Yoo DH et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis 2013;72(10):1613–20. Available at: http://ard.bmj.com/content/early/2013/05/20/annrheumdis-2012-203090.full.pdf. [Last accessed February 2015].
4. Park W et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis 2013;72(10):1605–12. Available at: http://ard.bmj.com/content/early/2013/05/16/annrheumdis-2012-203091.full. [Last accessed February 2015].
5. European Medicines Agency. Remsima. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002576/WC500150872.pdf. [Last accessed February 2015].
6. Jarzebicka D et al. Preliminary assessment of efficacy and safety of switching between originator and biosimilar infliximab in paediatric Crohn disease patients. European Crohn’s and Colitis Organisation (ECCO) 10th annual congress 2015; P295.
7. Sieczkowska J et al. Assessment of safety and efficacy of biosimilar infliximab in children with Crohn disease: a preliminary report. European Crohn’s and Colitis Organisation (ECCO) 10th annual congress 2015; P430.
8. Jarzebicka D et al. First observations of the use of biosimilar infliximab for treatment of ulcerative colitis in paediatric population. European Crohn’s and Colitis Organisation (ECCO) 10th annual congress 2015; P456.
9. Molnar T et al. Efficacy of the new infliximab biomarker CT-P13 induction therapy on mucosal healing in ulcerative colitis patients. European Crohn’s and Colitis Organisation (ECCO) 10th annual congress 2015; P603.
10. 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 http://www.gastrojournal.org/article/S0016-5085(11)01378-3/pdf [Last accessed February 2015].
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13. World Health Organisation. Access to biotherapeutic products including similar biotherapeutic products and ensuring their quality, safety and efficacy. 2014. WHA67.21. Available at: http://apps.who.int/gb/ebwha/pdf_files/WHA67/A67_R21-en.pdf. [Last accessed February 2015].
14. European Commission. What you need to know about biosimilar medicinal products. Available at: http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/biosimilars_report_en.pdf [Last accessed February 2015].
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