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* = Presenting author

P645 Efficacy and safety of biosimilar of infliximab in rescue therapy in adult patients with severe ulcerative colitis

M. Kaniewska*1, G. Rydzewska1, 2

1Central Clinical Hospital of the Ministry of Interior, Department of Gastroenterology, Warsaw, Poland, 2Faculty of Medicine and Health Science, Jan Kochanowski University, Kielce, Poland

Background

Biosimilar infliximab (Inflectra) has been shown to be equivalent to infliximab (IFX) and has been approved in Poland for the same indication as its IFX counterpart. However, data with respect to the drug’s efficacy and safety in rescue therapy in ulcerative colitis are still very limited. The aim of the study was to assess the efficacy, tolerability, and safety of biosimilar infliximab in comparison to biologics originator (Remicade) in rescue therapy in ulcerative colitis.

Methods

This was a retrospective, one centre study including a cohort of 67 consecutive UC patients treated in the last 2 years in a gastroenterology department in Warsaw, Poland. All of them were enrolled to receive either Remicade (32) or Inflectra (35) based on the same inclusion criteria (total Mayo score > 6). Disease activity was estimated at the beginning of treatment and after the induction therapy, and during 6 months of follow-up. At the end of treatment sigmoidoscopy was performed in all patients.

Results

Both groups of patients were comparable according to age, sex, and duration and type of disease, concomitant medications and smoking. Clinical response after 3 induction doses was 68% with Remicade, and 79% with biosimilar (NS), surgery rate was 12.5% and 8.5%, respectively. Endoscopic remission (Mayo score 0) was obtained in 9 patients (29.03 %) treated with Remicade and 8 patients (23.53 %) treated with Inflectra (p = 0.45). Mayo scores > 2 were found in 13 patients in the Remicade group (41.93%) and in 21 patients treated with Inflectra (61,7%) (NS). During 6 months of follow-up, 2 relapse after original IFX and 2 after biosimilar IFX treatment was noted. The rate of adverse events was comparable in both groups.

Conclusion

We have shown efficacy and safety of biosimilar infliximab not only in rescue therapy of UC, but also during 6 months of follow-up. Further prospective studies with long-term follow-up periods will be needed to confirm the biosimilarity of this product.