Does Biosimilar Infliximab Have a Role After Secondary Loss of Response to Its Reference?

Results of a small Greek observational study suggest that biosimilar infliximab may be an effective alternative for the treatment of patients with inflammatory bowel disease (IBD) who have active disease and experienced a loss of response to innovator infliximab (Remicade). 
Jackie Syrop
November 15, 2018
Results of a small Greek observational study suggest that biosimilar infliximab may be an effective alternative for the treatment of patients with inflammatory bowel disease (IBD) who have active disease and experienced a loss of response to innovator infliximab (Remicade). 

In a Letter to the Editor of Alimentary Pharmacology & Therapeutics, researchers led by Eleni Orfanoudaki, MD, department of gastroenterology, University Hospital of Heraklion, Heraklion, Greece, reported results of a switch to the biosimilar in 15 patients who failed to respond to other biologics, including the reference infliximab. The patients were switched to the biosimilar at 5 mg/kg on weeks 0, 2, 6, and every 8 weeks thereafter. 

The researchers noted that although there have been several studies on switching from the reference to the biosimilar in patients whose IBD is in remission, there have been no published results to date on the use of the biosimilar in patients with active disease and a history of loss of response to the reference.

Thus, they reported what they called “unexpected results” with the use of the biosimilar in patients with active IBD and secondary loss of response to innovator infliximab:
  • 8 patients (57%) had a clinical response to the biosimilar by a Harvey Bradshaw Index (HBI) or a Simple Clinical Colitis Activity Index (SCAI) reduction of greater than 2 (<.05).
  • Mean (standard error) erythrocyte sedimentation rate decreased from 51 (6) to 31 (3) mm/h (=.19).
  • Mean C-reactive protein decreased from 10.3 (4.7) to 1.5 (0.4) mg/dL (<.05).
There were no available measurements of trough levels and anti-infliximab antibodies, however, and only limited endoscopic data for a few patients. Nonetheless, the results of the small observational study suggest that the biosimilar may be an effective alternative for IBD patients with active disease and loss of response to the reference, the researchers conclude. “The underlying mechanism of action of [the biosimilar] in these cases as well as a further validation of this finding could be assessed by future prospective controlled studies including drug pharmacokinetics," they wrote.

Reference
Orfanoudaki E, Drygiannakis I, Koutroubakis I. Letter: Is there a role for infliximab biosimilar in patients with inflammatory bowel disease with secondary loss of response to infliximab innovator? Aliment Pharmacol Ther.2018. doi:10.1111/apt.14980.
 

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