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Efficacy and safety of biosimilar infliximab in children with IBD Posted 30/09/2016

Researchers from Birmingham Children’s Hospital presented results from a study of the use of the infliximab biosimilar CT-P13 (Remsima/Inflectra) in children with inflammatory bowel disease (IBD) [1].

The European Medicines Agency (EMA) approved its first monoclonal antibody (mAb) biosimilar, infliximab (Inflectra, Remsima), in July 2013 for the same indications as the originator product Remicade [2]. The indications cover a range of autoimmune diseases, such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. However, no clinical trials were carried out in IBD indications and specifically not in a paediatric population.

The results were presented at the 11th European Crohn’s and Colitis Organisation (ECCO) conference, which was held in Amsterdam, The Netherlands on 16−19 March 2016.

Biosimilar infliximab (Inflectra) has been used in Birmingham Children’s hospital since July 2015. From this date all new starters on infliximab treatment have been started on Inflectra. Prior to this date, all patients received the originator infliximab Remicade. The authors collected clinical and laboratory data from January 2015 to February 2016 and compared the safety and efficacy of the biosimilar versus the originator.

A total of 24 patients (18 Crohn’s disease, 6 ulcerative colitis) were started on Inflectra. Whereas 17 patients (14 Crohn’s disease, 3 ulcerative colitis) were started on Remicade between January 2015 and July 2015. Patients on Inflectra had 72 infusions compared to 96 infusions for patients on Remicade, with an average of three infusions per patient.

Safety was similar between the biosimilar and originator infliximab. Major infusion reactions requiring a switch to adalimumab were observed in one patient receiving Inflectra and one patient receiving Remicade.

With respect to efficacy, 5/18 (28%) of patients with Crohn’s disease being treated with Inflectra required dose or frequency escalation of infusions. This compares to 3/14 (21%) of patients being treated with Remicade. Clinical remission was achieved in 5/8 (63%) of patients being treated with Inflectra compared to 10/14 (71%) of children with Crohn’s disease receiving Remicade. Children with ulcerative colitis achieved clinical remission in 2/5 (40%) of patients being treated with Inflectra and in 2/3 (67%) of patients being treated with Remicade.

The authors concluded that ‘the efficacy and safety of biosimilar infliximab (Inflectra) is comparable to the originator infliximab’. Considering that the cost of Inflectra in the UK is approximately GBP210 compared to GBP350 for Remicade, the authors pointed out that there are therefore ‘significant cost savings’ to be made with the use of biosimilar infliximab.

Conflict of interest
The authors of the abstract [1] did not provide any conflict of interest statement.

Editor’s comment
It should be noted that data of the study presented in this article was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

Related articles
Safety and efficacy of Remsima in IBD patients in clinical practice

Inflectra shows comparable results in IBD patients

1. Muhammed R, et al. Comparison of efficacy and safety of biosimilar infliximab to originator infliximab in children with inflammatory bowel disease. 11th Congress of ECCO, Amsterdam, The Netherlands; 16–19 March 2016.
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 30]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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