Similar Outcomes for IBD Patients Who Switch from Biosimilar to Originator

In a prospective observational study, patients who switched from treatment with a biosimilar to originator infliximab (Remicade) had outcomes comparable to those who had only been treated with Remicade.

“There is evidence that it is safe and effective for patients with inflammatory bowel diseases (IBD) to switch from maintenance therapy with an original infliximab drug to a biosimilar, but little is known about outcomes of reverse switches and/or multiple switches,” according to the researchers.

The study included 174 consecutive IBD patients—136 with Crohn’s disease (CD) and 38 with ulcerative colitis (UC)—who were being treated with the biosimilar and switched to Remicade in September 2017; 8% (n = 14) of patients had previous exposure to Remicade. Patient data were gathered on the day of the switch and at 16 and 24 weeks. Clinical remission for CD patients was defined as a CD activity index < 150 points or no fistula drainage, and for UC patients was defined as a partial Mayo score < 3 points.

The percent of patients in clinical remission did not largely differ before the switch (82.5% with CD and 82.9% with UC), at baseline (80.6% with CD and 81.6% with UC), at week 16 (77.5% with CD and 83.7% with UC), or at week 24 (CD 76.3% with CD and 84.9% with UC) (CD patient groups, P = .60; UC patient groups, P = .98). Baseline and week 16 mean serum trough infliximab levels were not significantly different (5.33±4.70 μg/ml at baseline and 5.69±4.94 μg/ml at week 16, P = .71); anti-drug antibody prevalence also remained similar (16.2% at baseline and 16.9% at week 16, P = .87).

“No significant changes were observed in remission, trough levels, or antidrug antibodies in patients switched from the biosimilar to Remicade,” the study authors wrote. “No new safety signals were detected.”

Outcomes of Patients With Inflammatory Bowel Diseases Switched from Maintenance Therapy with a Biosimilar to Remicade

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Source: Clinical Gastroenterology and Hepatology