Search in the Abstract Database

Search Abstracts 2016

* = Presenting author

P519 Efficacy and safety of biosimilar of infliximab (Inflectra) in adult patients with Crohn’s disease during 1 year of treatment, followed 6 months of observation: a one-centre retrospective study

M. Kaniewska*1, G. Rydzewska1, 2

1Central Clinical Hospital of the Ministry of Interior, Department of Gastroenterology, Warsaw, Poland, 2Faculty of 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 patients with Crohn’s disease (CD) are still limited. The aim of the study was to assess the efficacy, tolerability, and safety of biosimilar infliximab in comparison to biologics originator (Remicade) and adalimumab (Humira) in CD patients.

Methods

This was a retrospective, 1-centre study including a cohort of 176 consecutive CD patients treated in the last 3 years in the gastroenterology department in Warsaw, Poland. All of them were enrolled to receive either Remicade (77) or Inflectra (52) or Humira (47) based on the same inclusion criteria (CDAI > 300 or active perianal fistula). According to our national regulations, treatment was stopped after 1 year. Disease activity (CDAI) was estimated at the beginning of treatment, after the induction therapy, after 1 year of treatment and during 6 months of follow-up. Calprotectin concentration in stool samples was measured in the end of treatment.

Results

All 3 groups of patients were comparable according to age, sex, concomitant medications, smoking, and duration and type of disease. No statistical differences were observed in CDAI at the beginning of treatment (332, 340, and 326, respectively) and after 1 year (108, 119, and 132, respectively) in patients receiving Remicade, Inflectra, and Humira, respectively. Clinical response rate and remission rate (66.2 vs 75 vs 63.8) were also comparable in 3 observed groups. Calprotectin concentration at the end of treatment was 123.5, 123.3, and 112.06 µg/g of stool in patients receiving Remicade, Inflectra, and Humira, respectively. Relapse was claimed in 6 (8.7%), 3 (13.04%), and 5 (14.29%) patients, respectively, during follow-up (p-value 0,684), and was comparable in 3 observed groups. Allergic reactions that were reported during treatment with both infliximabs (Remicade and Inflectra) were also comparable.

Conclusion

We have shown for the first time efficacy and safety of biosimilar infliximab not only in induction and one year therapy, 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.