Infliximab Biosimilar Is Noninferior to Remicade in Phase 3 Crohn’s Disease Study

Treatments show similar efficacy, safety, and tolerability profiles

A 54-week, phase 3 trial has met its primary endpoint, demonstrating that, at six weeks, the efficacy and safety of treatment with Inflectra (infliximab-dyyb, Pfizer/Celltrion Healthcare) was similar to that of treatment with Remicade (infliximab, Janssen) in patients with moderate-to-severe Crohn’s disease (CD), thereby meeting the criterion for noninferiority. The data were presented at the 12th Congress of the European Crohn’s and Colitis Organisation (ECCO).

The randomized, double-blind, parallel-group trial evaluated the number of patients among a total of 214 who experienced a reduction of 70 points or greater in the Crohn’s Disease Activity Index (CDAI-70). The response rates were not significantly different between Inflectra and Remicade (71.4% vs. 75.2%, respectively).

Other disease-activity measures––clinical remission and CDAI-100 response rates––also demonstrated similar efficacy between the two treatments. Moreover, six-week data showed that Inflectra and Remicade had similar safety and tolerability profiles.

From week 30, patients treated with Remicade will be randomly assigned to either continue on the same treatment or switch to Inflectra, while patients receiving Inflectra will be randomly assigned to either continue on the same treatment or switch to Remicade. Further results will be collected and reported at 54 weeks.

Inflectra (infliximab-dyyb) can cause serious adverse effects, such as lowering a patient’s ability to fight infections. Some patients, especially those 65 years of age and older, have had serious infections caused by viruses, fungi, or bacteria, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Unusual cancers have been reported in children and teenage patients being treated with tumor necrosis factor (TNF)-blocking drugs. Hepatosplenic T-cell lymphoma, a rare form of fatal lymphoma, has occurred mostly in teenage or young adult males with CD or ulcerative colitis who were receiving infliximab products and azathioprine or 6-mercaptopurine. The chances of developing lymphoma or other cancers may increase in children and adults receiving TNF blockers, including Inflectra,

Source: Pfizer; February 17, 2017.