Data announced jointly today by Pfizer Inc. (NYSE:PFE) and Celltrion Healthcare, at the 12th Congress of the European Crohn’s and Colitis Organisation (ECCO), 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).1 The randomized 54 week clinical trial (RCT)2 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,1 were not statistically significantly different. INFLECTRA is marketed as INFLECTRA (infliximab-dyyb) in the UnitedStates (U.S.) 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, M.D., Senior Vice President, Chief Medical Officer, Pfizer Essential Health,Pfizer. 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.1 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.2
About the trial
This is a randomized, double-blind, parallel-group, phase III study being conducted in patients with moderately-to-severe Crohn’s disease to compare overall safety and efficacy between INFLECTRA and REMICADE in terms of Crohn’s Disease Activity Index (CDAI)-70 response rates. The primary endpoint of the 54-week study was collected at week six to demonstrate that INFLECTRA is similar to REMICADE in the treatment of CD. The study used the standard assessment of CDAI-70 as primary endpoint. From Week 30, patients on REMICADE will be randomized to either continue on the same treatment or switch to INFLECTRA while patients on INFLECTRA will be randomized to either continue on the same treatment or switch to the REMICADE. Further results will be collected and reported at 54-weeks.2
Filed Under: Drug Discovery