Biosimilar Switching Not for All Remicade Patients

April 11, 2016

ARD study recommends against biosimilar switching for patients positive for anti-infliximab (Remicade) antibodies.

With Inflectra (infliximab-dyyb), a biosimilar to Remicade, recently approved in the U.S. by the Food and Drug Administration, questions linger about whether it is safe to switch the drug from the brand name version to the biosimilar.

While most studies show there are no significant differences in response between the two versions, some physicians and patient advocacy groups are concerned about interchangeability.

A study published in the March 10 online issue of the Annals of the Rheumatic Diseases, recommends against switching for patients who test positive for anti-infliximab (Remicade) antibodies because the antibodies cross-react with the infliximab biosimilar, CT-P13. Switching could lead to a loss of therapeutic response, the researchers reported. [[{"type":"media","view_mode":"media_crop","fid":"47601","attributes":{"alt":"©ChaowalitSeeneha/Shutterstock.com","class":"media-image media-image-right","id":"media_crop_9367120409276","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"5620","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","style":"font-size: 13.008px; line-height: 1.538em; float: right;","title":"©ChaowalitSeeneha/Shutterstock.com","typeof":"foaf:Image"}}]]

“Antibody positive patients treated with Remicade should not be switched to the biosimilar, since antibodies will interact with the new drug and potentially lead to loss of response,” the authors wrote. “This finding supports the utility for therapeutic drug monitoring before a switching strategy is considered.”

Led by Daniel Nagore, Ph.D., of Progenika Biopharma in Spain, the study included 250 rheumatoid arthritis and spondyloarthritis patients undergoing infliximab treatment and 77 control patients.

The authors used three separate bridging ELISA assays to assess concentrations of anti-infliximab antibodies. Half (50.4%) of patients tested positive for anti-infliximab antibodies, and 100% of those who tested positive for anti-infliximab antibodies also exhibited antibody reactivity against CT-PI3.

“Our results showed that all antibodies developed in patients treated with Remicade did cross-react with either infliximab or Remicade,” researchers wrote.

The authors call for more studies to better assess the potentially different immunogenic responses associated with biologics.

CT-P13 was approved by the FDA on April 5 for rheumatoid arthritis and other conditions. It was approved in 2013 by the European Medicines Agency for all indications.

 

 

 

Disclosures:

Six of the study’s 13 authors, including corresponding coauthor Daniel Nagore, PhD, are employees of the Spanish gene-testing firm Progenika Biopharma.

References:

Ruiz-Arguello MB, Maguregui A, del Agua AR, et al. “Antibodies to infliximab in Remicade-treated rheumatic patients show identical reactivity towards biosimilars,” Ann Rheum Dis. 2016. Published online March 10, 2016 ahead of print. DOI: 10.1136/annrheumdis-2015-208684.