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* = Presenting author

P540 Efficacy and safety of infliximab's biosimilar (REMSIMA) for IBD

J. Yoon Suk*1, D.I. Park2, Y.H. Kim3, P.J. Seo4, J.W. Kim5, H.W. Kang6

1Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine , Department of Internal Medicine, Seoul, Korea, Republic of, 2Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Department of Internal Medicine, Seoul, Korea, Republic of, 3Samsung Medical Center, Sungkyunkwan University School of Medicine, Department of Internal Medicine, Seoul, Korea, Republic of, 4Seoul Song Do Colorectal Hospital, Digestive Endoscopic Center, Seoul, Korea, Republic of, 5Seoul National University Boramae Hospital, Department of Internal Medicine, Seoul, Korea, Republic of, 6College of Medicine, Dongguk University Ilsan Hospital , Department of Internal Medicine, Goyang, Korea, Republic of

Background

The biosimilar to infliximab, Remsima have been recently shown to be equivalent to infliximab in efficacy and safety in rheumatologic diseases. However, there are no data for patients with inflammatory bowel disease (IBD). We aimed to assess the efficacy and safety of Remsima in Korean patients with IBD.

Methods

This was a retrospective multicenter study including IBD patients who received at least one Remsima infusion. Both anti-TNF naïve patients and patients who switch from Remicade or Humira to Remsima were included. Short- term clinical outcomes and adverse events of Remsima were evaluated.

Results

A total of 55 Crohn's disease (CD) patients (23 anti-TNF naïve patients and 32 patients who switch to Remsima) and 51 ulcerative colitis (UC) patients (41 anti-TNF naïve patients and 10 patients who switch to Remsima) were included. In anti-TNF naïve CD patients, the rates of clinical response and remission were 91% and 78% at week 8. In anti-TNF naïve UC patients, the rates of clinical response, clinical remission, and mucosal healing were 87%, 31%, and 54% at week 8. Three patients (2.8%) discontinued Remsima because of an adverse event. The efficacy of Remsima was maintained in 86% of patients with CD and in 67% of patients with UC after switching from Remicade.

Conclusion

Remsima showed an excellent short-term clinical response and a good safety in both moderate to severe CD and UC. Further prospective studies with long-term follow up are needed to confirm the efficacy of Remsima.