PROSIT-BIO study supports biosimilar infliximab in Crohns disease and Ulcerative Colitis- Hospira/Pfizer
The PROSIT-BIO study of infliximab biosimilar (Remsima/Infliximab) was conducted at 49 centers in Italy in patients with ulcerative colitis (UC) or Crohn's disease (CD) and data were presented at the Italian Group for the Study of IBD (IG-IBD), VII National Congress, Palermo, Italy.
The study of 397 patients (174 UC and 223 CD) demonstrated that those who were switched from reference infliximab to biosimilar infliximab (93 patients) demonstrated comparable efficacy to those patients receiving a biosimilar who had previously been naïve to anti-TNF alfa (217 patients) and to those receiving a biosimilar who had previously been exposed to one or more biologics (87 patients). Safety was also found to be comparable across the patient groups.
Comment: Further switch data on Remsima are expected from the 'Nor-Switch' study funded by the Norwegian government, with data expected to be reported in 2016. Five hundred patients across all indications will be switched to Remsima from reference infliximab in this study, with occurrence of disease worsening as the primary endpoint.
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