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.
Therapeutic TNF antibodies revolutionized care of patients with IBD but is costly. Plevris et al describe their experience with a biosimilar to TNF antibody infliximab, concluding that safety & efficacy are similar to those of infliximab at a lower cost. https://t.co/1OAqjc584B pic.twitter.com/WP2lE2VYzv
— Digestive Diseases and Sciences (@DDS_Journal) January 11, 2019
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.
Celltrion reports that its biosimilar product has captured 56% of the infliximab market in Europe as of the third quarter of 2018. https://t.co/ijCDjOBLOE
— CenterForBiosimilars (@BiosimCenter) January 11, 2019
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.”