Remicade Cross-reaction Suggests Switching to Biosimilars Not Optimal for All Patients

Antibodies produced in response to the biological treatment Remicade cross (infliximab; Janssen Biotech) react with antibodies produced by the drug’s biosimilars, suggesting that patients treated with Remicade should not be switched to a biosimilar product, according to data presented at the EULAR 2016 Congress. 

“While most studies show there are no significant differences in clinical response between a biosimilar and the original product, some physicians and patient advocacy groups have expressed concern about how interchangeable they really are, and whether it is safe to switch from the brand name version to the biosimilar,” study author Daniel Nagore, PhD of Progenika Biopharma in Derio, Spain, said in a press release. 

The researchers compared 250 rheumatoid arthritis and spondyloarthritis patients who received Remicade treatment and had been previously treated with a biosimilar product to 77 control group patients. They used assay testing to determine the concentrations of anti-infliximab antibodies. Results showed that 50.4% of patients in the Remicade group tested positive for anti-infliximab antibodies. Furthermore, 100% of these patients also demonstrated antibody reactivity against the biosimilar.

“Our results have shown that all the antibodies that developed in patients being treated with Remicade cross-reacted with the biosimilar,” Nagore said. “The presence of these anti-infliximab antibodies is likely to enhance clearance of the drug from the body, potentially leading to a loss of response, as well as increasing the risk of side effects. Therefore, in patients where biological infliximab is ineffective due to the presence of circulating antibodies, switching to its biosimilar will lead to the same problems.”

Nagore and colleagues also noted that no differences were observed between patients with rheumatoid arthritis and those with spondyloarthritis or those treated with concomitant immunosuppressives. Researchers wrote that these findings support the utility of therapeutic drug monitoring before switching to biosimilars is considered. —David Costill