New data show comparable efficacy and safety to originator infliximab in both biologic-naïve and switch patients
New clinical data indicate no differences in efficacy, adverse events and immunogenicity when patients with inflammatory bowel disease (IBD) are switched to the biosimilar infliximab Remsima® from originator infliximab (the reference medicinal product or RMP). The study results, presented at United European Gastroenterology Week (UEG Week) 2015 in a satellite symposium sponsored by Celltrion Healthcare, add to growing real-world evidence that patients already being treated with the RMP can be appropriately switched to Remsima®, a more cost-effective treatment option.
In the Czech Republic, a total of 74 IBD patients (Crohn's disease [CD]: 56, ulcerative colitis [UC]: 18) in remission on long term treatment with the RMP were switched to Remisma®. After a median follow up of 24 weeks, results from the study showed good efficacy for Remsima® with the same maintenance of remission, minimal adverse events - including immunogenicity - and no difference in allergic reactions compared to the RMP. The same trough levels of infliximab were seen in patients receiving Remsima® compared to historical data for the RMP.1
Speaking at UEG Week, Professor Milan Lukas, IBD department head, Clinical and Research Center for IBD, ISCARE Clinic, Prague, said: "Following the approval of biosimilars in Europe, there has been a lot of discussion about whether it is possible to alternate or switch from the originator product to the biosimilar in clinical practice. Although the follow up period is relatively short and the number of patients is small, we have found biosimilar infliximab to be comparable to the originator in both switch and anti-TNF naïve patients and are encouraged that others around the world are having similar experiences."
Professor Lukas also presented data from a further cohort of 93 anti-TNF naïve IBD patients (CD: 69, UC: 24) from the Czech Republic at the symposium. The study showed that the clinical efficacy of Remsima®, measured by a decrease in inflammatory activity shown in endoscopic assessment of mucosal healing (endoscopy subscore of 0 or 1) for UC or biological remission markers including C-reactive protein, fecal calprotectin and clinical symptomatology for CD, was comparable to a retrospective cohort of the RMP.1
Details of a real-world study of IBD patients from South Korea were also presented at the symposium. In the post-marketing study of 173 patients (CD: 95, UC: 51), both treatment-naïve patients and patients who had previously received the RMP were treated with Remsima® and followed for 30 weeks. The study results published in the September edition of Expert Review of Gastroenterology and Hepatology, show that Remsima® is well tolerated and efficacious in IBD patients. Comparison of the study results with historical data for the RMP suggests that clinical outcomes such as safety and efficacy are comparable for Remsima® and the RMP, reinforcing the clinical similarity of the two treatments.2
Additional real-world data supporting the safety and efficacy of switching to biosimilar infliximab from the RMP were presented at UEG Week in three poster presentations:
- Gecse K, et al. Biosimilar infliximab: efficacy and safety based on interim results from a prospective nationwide cohort in inflammatory bowel diseases: first interim results from a prospective nationwide observational cohort. Abstract P0970, poster sessions, Tuesday, October 27, 09:00 - 17:00; Hall 7
- Sieczkowska J, et al. First experience of switching between originator and biosimilar infliximab in paediatric inflammatory bowel disease patients. Abstract 0P096, poster sessions, Monday, October 26, 16:45 - 16:57; Room A2
- Lovasz B et al. Immunogenicity of the biosimilar infliximab: interim results from a prospective nationwide cohort. Abstract P0351, poster sessions Monday, October 26, 09:00 - 17:00; Hall 7
As the world's first EMA-approved monoclonal antibody biosimilar, Remsima® is singular in terms of the cumulative real-world data available in both treatment-naïve patients and those who have been switched to the biosimilar from the RMP. Clinical experience of biosimilar infliximab in patients with IBD was presented in six posters and a satellite symposium,3,4,5,6,7,8,9 at the 2015 European Crohn's and Colitis Organisation annual meeting, as well as in published case studies.10,11 These earlier data also show that treatment with biosimilar infliximab is effective and well tolerated in patients with UC and CD.
Dr Stanley Hong, President and CEO of Celltrion Healthcare, said: "The new real-world experience with Remsima® in IBD adds to the expanding body of clinical evidence. Biosimilar infliximab can support greater and earlier access to biological therapies while reducing the financial burden on healthcare systems around the world. Switching to biosimilars offers comparable clinical benefits at a lower price, allowing medical communities to realize higher cost-savings. We are committed to ensuring as many IBD patients as possible benefit from this important therapy."
Further data for Remsima® were also presented at UEG Week:
- Jarzebicka D, et al. First observations of the use of biosimilar infliximab for treatment of ulcerative colitis in paediatric population. Abstract P0370 Monday, October 26, 09:00 - 17:00; Hall 7
- Kim Y H. Early effectiveness in inflammatory bowel disease patients who were treated with CT-P13 (biosimilar infliximab). Abstract P1594 Wednesday, October 28, 09:00 - 17:00; Hall 7
- Molnar T, et al. Efficacy of the new infliximab biomarker CT-P13 (biosimilar infliximab) induction therapy on mucosal healing in ulcerative colitis patients. Abstract P1605 Wednesday, October 28, 09:00 - 17:00; Hall 7
- Dreesen E, et al. Anti-Remicade antibodies cross-react with the biosimilars Remsima and Inflectra in patients with inflammatory bowel disease. Abstract OP097 Monday, October 26, 16:57 - 17:09; A2