The biosimilar therapy Inflectra (infliximab CT-P13) is as good a treatment as Remicade (infliximab) for those with moderate-to-severe Crohn’s disease (CD), according to the results of a clinical trial.
Pfizer and Celltrion Healthcare, which developed Inflectra, presented the results at the 12th Congress of the European Crohn’s and Colitis Organisation (ECCO).
Two hundred fourteen patients with Crohn’s participated in the randomized, double-blind, parallel-group, 54-week Phase 3 clinical trial (NCT02096861). It was designed to assess whether Inflectra was as effective and safe as Remicade, developed by Janssen Immunology.
Biosimilars are close copies of original therapies, but cheaper.
Those making the ECCO presentation indicated that the trial met its primary goal of Inflectra performing as well as Remicade against Crohn’s. The trial assessed the proportion of patients who had a decrease of 70 points or more in the Crohn’s Disease Activity Index (CDAI-70) after six weeks.
The response rates were not statistically significantly different between those treated with Inflectra (71.4 percent) and Remicade (75.2 percent). Other measures of disease activity, such as remission and CDAI-1oo response rates, were also similar.
In addition, Inflectra’s safety and tolerability profile was similar to Remicade’s in the trial. No safety issues arose during treatment. The proportion of patients experiencing adverse reactions, including infection and infusion reactions, was similar between those treated with Inflectra and Remicade. Scientists define infusion reactions as those that occur from unexplained causes.
The clinical study is also assessing the safety profile and treatment response in patients switched from Remicade to Inflectra, and vice versa. Those results are expected later this year.
“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,” Sam Azoulay, M.D., senior vice president and chief medical officer of Pfizer, said in a press release.
Inflectra is an anti-inflammatory medicine that contains the active substance infliximab. It was the first biosimilar monoclonal antibody ever approved.
Initial approval came in September 2013 from the European Medicines Agency (EMA) under the brand name Remsima. The U.S. Food and Drug Administration (FDA) approved infliximab as Inflectra in April 2016. The biosimiliar has now been approved in more than 75 countries.
Inflectra reduces such symptoms of Crohn’s as adult ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, and ankylosing spondylitis.
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