Safety and efficacy of Remsima in IBD patients in clinical practice

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Safety and efficacy of Remsima in IBD patients in clinical practice

Biosimilars/Research | Posted 09/09/2016 0 Post your comment

Researchers from Spain presented results from a study of the use of the infliximab biosimilar Remsima in ulcerative colitis disease patients in clinical practice after six months treatment.

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 [1]. 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 inflammatory bowel disease (IBD) indications.

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

The single cohort observatory study was carried out at the Hospital Universitario Virgen Macarena, Seville, Spain in March 2015 and included 40 ulcerative colitis (UC) patients (31 of whom were switched from Remicade to Remsima and 9 were naïve). After six months of treatment, of the 16 patients analysed (15 switch and 1 naïve) 70% continued in remission and 23% of patients without remission when switched reached remission. In 2 patients (5%) mild adverse events (headache) were noted.

The authors concluded that ‘Remsima is safe’, stating that ‘most of the patients with UC who switched from Remicade to Remsima continue in remission after six months of treatment’. They did concede, however, that the follow-up was short and that there was no control group, highlighting the need for further studies.

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.

Reference
1. Guerra Veloz MF, et al. Safety and efficacy of infliximab biosimilar (Remsima) in ulcerative colitis disease patients in clinical practice: results after 6-months treatment. 11th Congress of ECCO, Amsterdam, The Netherlands; 16-19 March 2016.

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