Data presented today at the 11th Congress of European Crohn’s and Colitis Organisation (ECCO) adds to the growing body of real-world evidence that supports switching patients from reference infliximab to biosimilar infliximab. In total, data for 589 patients who were switched from reference infliximab to biosimilar infliximab in ten independent studies from across eight countries was presented at the congress.1–10 This comprised switch data from 325 patients with Crohn’s disease (CD), 128 patients with ulcerative colitis (UC) and 136 patients where the type of IBD was not specified.1–10
One study which included 74 IBD (56 CD and 18 UC) patients found comparable efficacy and safety after switching patients with IBD from the reference infliximab to biosimilar infliximab.2 Lead researcher, Professor Martin Kolár, Charles University, Prague, noted that between week 0 and week 24, there was no significant difference in C-reactive protein levels (4.3±8.0mg/l versus 3.6±4.5; p=0.78) or faecal calprotectin (135±153µg/g versus 226±297; p=0.44) observed. Likewise, no increase in immunogenicity was found (IFX trough levels: 3.4±3.8 µg/ml versus 3.8±3.3, p=0.23; anti-drug antibodies positivity: 9.5% versus 10%, p=0.79) and disease activity was stable until the end of follow up (remission at week 0 versus week 24: 72% versus 78%).2 In addition, the frequency and type of adverse events were similar to that observed during treatment with the reference infliximab.2
The largest single cohort of patient switch data was from a study by Southampton General Hospital in the UK, which included 134 IBD patients. The service outcome evaluation reported that there was no significant change in drug persistence between patients treated with the biosimilar and those treated with the reference product (p=0.49) and there was a similar incidence of expected side effects before and after switch.1 Furthermore, the IBD team concluded that switching to a lower cost biologic could offer considerable cost savings to healthcare systems and therefore investment in clinical services.1
Co-author of the study, Dr Fraser Cummings, Southampton General Hospital, UK, comments: “We worked with our commissioning team to develop a switch programme that enabled us to invest some of the savings made by using biosimilars to improve patient care in the department. These ‘gain share’ agreements allowed us to distribute the savings gained between the different stakeholders in the hospital and thus to directly fund a new IBD nurse, as well as clerical, pharmacist and dietetic support. Through this, we have made considerable improvements to the care we are able to offer our patients.”
Further data from a survey conducted by ECCO were also presented, which demonstrate the rapid evolution of IBD specialists’ thinking in favour of biosimilars since 2013 when research was last undertaken by the organisation. The survey of 118 IBD healthcare professionals found that most experts (92.4%) regarded potential cost savings as the main advantage of biosimilars.11 The survey also found that:11
- Only a quarter (25%) of those asked would not extrapolate data across IBD classifications
- 75% felt that medical societies should promote information on biosimilars
- Just under half (44%) of respondents considered the reference product and biosimilar to be interchangeable
- Only 19.5% of physicians felt little or no confidence in the use of biosimilars
- Only 35% of physicians agreed that biosimilars should carry distinct International Non-proprietary Names
Lead researcher Professor Silvio Danese, Humanitas Clinical and Research Center, Italy, comments: “This research demonstrates that IBD specialists are generally informed and well educated about biosimilars and it’s evident that physician confidence in biosimilars has grown since 2013. There are fewer concerns and increased confidence about the use of biosimilars in clinical practice.”
Mundipharma International Limited and its independent associated companies have distribution rights from Celltrion Healthcare Hungary Kft for Remsima® in Germany, Italy, UK, Netherlands, Belgium and Luxembourg.
References:
- Bettey M et al. (2016) ‘DOP029 Outcomes of a managed switching programme changing IBD patients established on originator infliximab to biosimilar infliximab’ Abstract presented at the 11th Congress of ECCO, 16-19 March, Amsterdam, Netherlands.
- Kolar M et al. (2016) ‘DOP032 Switching of patients with inflammatory bowel disease from original infliximab (Remicade®) to biosimilar infliximab (Remsima®) is effective and safe’ Abstract presented at the 11th Congress of ECCO, 16-19 March, Amsterdam, Netherlands.
- Smits, L et al. (2016) ‘DOP030 Elective switching from Remicade® to biosimilar CT-P13 in inflammatory bowel disease patients: a prospective observational cohort study’ Abstract presented at the 11th Congress of ECCO, 16-19 March, Amsterdam, Netherlands.
- Hamanaka S et al. (2016) ‘P329 Infliximab biosimilar in the treatment of inflammatory bowel disease: a Japanese single-cohort observational study’ Abstract presented at the 11th Congress of ECCO, 16-19 March, Amsterdam, Netherlands.
- Diaz Hernández L et al. (2016) ‘P449 Efficacy and safety of switching between originator and biosimilar infliximab in patients with inflammatory bowel disease in practical clinic: results to 6 months’ Abstract presented at the 11th Congress of ECCO, 16-19 March, Amsterdam, Netherlands.
- Guerra Veloz MF et al. (2016) ‘P452 Safety and efficacy of infliximab biosimilar (Remsima®) in Crohn’s disease patients in clinical practice: results after 6 months of treatment’ Abstract presented at the 11th Congress of ECCO, 16-19 March, Amsterdam, Netherlands.
- Fiorino G et al. (2016) ‘P544 Prospective observational study on inflammatory bowel disease patients treated with infliximab biosimilars: preliminary results of the PROSIT-BIO cohort of the IG-IBD’ Abstract presented at the 11th Congress of ECCO, 16-19 March, Amsterdam, Netherlands.
- Guerra Veloz MF et al. (2016) ‘P600 Safety and efficacy of infliximab biosimilar (Remsima®) in ulcerative colitis disease patients in clinical practice: results after 6-months treatment’ Abstract presented at the 11th Congress of ECCO, 16-19 March, Amsterdam, Netherlands.
- Sieczkowska J et al. ‘P617 Immunogenicity after switching from reference infliximab to biosimilar in children with Crohn’s disease’ Abstract presented at the 11th Congress of ECCO, 16-19 March, Amsterdam, Netherlands.
- Hlavaty T et al. (2016) ‘P655 Biosimilar infliximab CT-P13 treatment in patients with inflammatory bowel diseases: a 1-year, single-centre retrospective study’ Abstract presented at the 11th Congress of ECCO, 16-19 March, Amsterdam, Netherlands.
- Danese S et al. (2016) ‘P312 Has IBD specialists’ awareness of biosimilar monoclonal antibodies changed? Results from a survey amongst ECCO members’ Abstract presented at the 11th Congress of ECCO, Amsterdam, Netherlands.
- Remsima SPC: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002576/WC500150871.pdf.
