Patient registry data supports efficacy and safety of Inflectra

Biosimilars/Research | Posted 03/04/2015 post-comment0 Post your comment

US-based injectables specialist Hospira presented data on 19 February 2015 on the use of its biosimilar version of infliximab, Inflectra, at the 10th Congress of the European Crohn’s and Colitis Organisation (ECCO).

Patient MD002316 V13C05

Hospira received European approval for Inflectra, a treatment for autoimmune diseases, including rheumatoid arthritis, Crohn’s disease (CD), ulcerative colitis (UC) and psoriasis, in September 2013 [1].

The results presented at the conference showed a comparable response in patients treated with Inflectra to that expected with the reference product, Remicade (infliximab), for inducing and maintaining remission in Crohn’s disease and ulcerative colitis. These data add to the body of evidence supporting Inflectra’s use in inflammatory bowel disease (IBD).

Results presented from the ongoing independent, prospective, nationwide study in Hungary show that for the first 90 male patients, (57 with CD and 33 with UC) treated with Inflectra, reductions compared with baseline were seen in validated measures of disease activity after both two and six weeks of treatment. For CD there was a significant reduction in CD Activity Index (CDAI) score after 2 and 6 weeks of treatment, p < 0.001 compared with baseline. For UC there was a significant decrease in the mean partial MAYO (pMAYO) score, from 6.4 (n = 16) to 3.7 (at week 2) and 3.6 (at week 6).

C-reactive protein (CRP), a marker of inflammation, was also decreased during induction therapy for UC. Four of the 90 patients showed an allergic reaction to treatment, all of who had previously received anti-TNF (tumour necrosis factor) medication.

The authors concluded that the interim results showed that ‘a significant decrease of disease activity (CDAI and pMAYO) was observed coupled with a decrease in CRP levels during induction with the infliximab biosimilar’.

Editor’s comment
It should be noted that this study 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.

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1.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Apr 3]. Available from:

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Source: ECCO, Hospira

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