New data in Crohn’s disease patients shows similar efficacy and safety profiles for Inflectra and Remicade

Trial data further supports the existing clinical profile of CT-P13 in inflammatory bowel disease.

The randomized 54-week clinical trial (RCT) in 214 patients met its primary end point demonstrating that, at 6 weeks, Inflectra was similar to Remicade in the treatment of CD thereby meeting the criterion for non-inferiority. The trial evaluated the number of patients experiencing a fall of 70 points or greater in the Crohn’s Disease Activity Index (CDAI-70), a well-established assessment of treatment response in CD. The response rates, 71.4% for Inflectra and 75.2% for Remicade were not statistically significantly different. Inflectra is marketed as Inflectra (infliximab-dyyb) in the US and under other brand names in some countries.

“Today’s presentation of randomized control trial data in patients with Crohn’s disease further supports the existing clinical profile of CT-P13 in inflammatory bowel disease. In addition to existing data from the registration studies, real-world experience and the NOR-SWITCH trial, this data adds to the body of evidence supporting use of CT-P13 across its approved indications,” said Sam Azoulay, Senior Vice President, Chief Medical Officer, Pfizer Essential Health, Pfizer.

Additional disease activity measures used in the trial, clinical remission and CDAI-100 response rates, demonstrated similar and consistent efficacy between the two treatments. Six-week data also showed that Inflectra had a similar safety and tolerability profile as Remicade. The number of patients experiencing at least one adverse event, serious adverse events, and adverse events of special interest (such as infusion reaction and infection) were similar between the two treatment arms. No new safety signals were identified.