Positive study for Inflectra/Remsima (infliximab- biosimilar)supporting switch from Remicade in RA- Hospira
Hospira has announced the results of a clinical study, showing patients with rheumatic diseases experienced comparable clinical effectiveness and safety after switching from Remicade to Inflectra/ Remsima (infliximab- biosimilar). The study supports the use of Inflectra as a treatment option for people suffering from inflammatory conditions such as rheumatoid arthritis, who are currently receiving stable treatment with reference infliximab.
The data, presented at the European League Against Rheumatism Annual Congress (EULAR 2015), compared outcomes in 39 patients after a mean of four years of treatment with Remicade, with the outcomes of those same patients after a median of 11 months following a switch to Inflectra. Patient symptoms and disease activity were similar before and after the switch between the two treatments, and no immediate safety signals were observed.
In addition, the results of a meta-analysis of 14 randomised controlled trials assessing safety incidences in 1,454 patients were announced at EULAR. The abstract is titled, "Meta-analysis of the safety data between infliximab biosimilar (CT-P13) and innovator infliximab in rheumatoid arthritis and ankylosing spondylitis. Abstract AB0433." This analysis compared the safety profile of Inflectra from clinical trials in RA and AS, with historical safety data from Remicade clinical trials. The results revealed no meaningful differences in safety (infections, serious infections, malignancies/lymphoma, infusion-related reactions) between patients treated with Inflectra and Remicade.
See-Sokka T. Clinical experience with infliximab biosimilar � switch from Remicade. Abstract SAT0174. Presented June 2015 at EULAR, Rome, Italy. Available at https://b-com.mci-group.com/Abstract/Statistics/AbstractStatisticsViewPage.aspx?AbstractID=252112.
Comment: Inflectra is now available in 26 European countries, launching in 13 new markets earlier this year, following the patent expiry of Remicade. Inflectra is also available in Canada, has recently been approved by the regulatory authority, ANVISA, in Brazil, and has been submitted to the FDA for approval.
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