Phase III trial of Inflectra (infliximab CT-P13) meets endpoint in Crohn's disease- Pfizer and Celltrion Healthcare

Data announced by Pfizer and Celltrion Healthcare showed that for patients with moderate-to-severe Crohn’s disease (CD), treatment with Inflectra (infliximab CT-P13) has similar efficacy and safety to treatment with Remicade (infliximab). The randomized 54 week phase III clinical trial (RCT) in 214 patients met its primary end point demonstrating that, at six 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.

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.

Further results on the longer-term safety and efficacy of Inflectra from this ongoing 54-week study in CD are expected later this year. The study is also examining the treatment response and safety profile in patients when switched from Remicade to Inflectra, and from Inflectra to Remicade. Inflectra is marketed as Inflectra (infliximab-dyyb) in the United States and under other brand names in some countries. Data were presented at the 12th Congress of the European Crohn’s and Colitis Organisation (ECCO).