Pfizer and Celltrion on Friday announced Phase III study data at the Congress of the European Crohn's and Colitis Organisation (ECCO) showing that the safety and efficacy of Inflectra (infliximab CT-P13) in patients with moderate-to-severe Crohn's disease is comparable to those treated with Johnson & Johnson and Merck & Co.'s reference drug Remicade (infliximab). Sam Azoulay, chief medical officer at Pfizer Essential Health, said the latest data "further support the existing clinical profile of [Inflectra] in inflammatory bowel disease," and that the results also add "to the body of evidence supporting use of [Inflectra] across its approved indications."
In the ongoing 54-week study, 214 patients with moderate-to-severe Crohn's disease were randomised to treatment with Inflectra or Remicade. The trial's primary endpoint was the proportion of patients who experienced a decline of at least 70 points in the Crohn's Disease Activity Index (CDAI-70) at six weeks.
Results showed that CDAI-70 response rates were 71.4 percent in the Inflectra arm and 75.2 percent for Remicade-treated patients, "thereby meeting the criterion for non-inferiority," the companies said. Pfizer and Celltrion noted that other disease activity measures used in the study, clinical remission and CDAI-100 response rates, demonstrated "similar and consistent" efficacy between the two treatments. The six-week data also revealed similar tolerability and safety profiles between the drugs.
As of week 30, patients enrolled in the study's Remicade arm will be randomised to either continue on the same treatment or switch to Inflectra, while those in the Inflectra group will be randomised to either continue on the biosimilar or switch to Remicade. The companies said they plan to release longer-term efficacy and safety data from the study later this year.
Inflectra was approved in Europe in 2013 and in the US last year. Pfizer obtained rights to the therapy, which was developed by Celltrion under the terms of a 2009 agreement with Hospira, as part of its $17-billion acquisition of Hospira in 2015.
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