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Remicade trough levels lower in acute severe vs. moderately severe ulcerative colitis
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Remicade trough levels 2 weeks after infusion were significantly lower in patients with acute severe ulcerative colitis vs. patients with moderately severe ulcerative colitis, according to the results of a multicenter retrospective study.
“Recent evidence suggests that patients with increased fecal loss of infliximab [Remicade, Janssen) are at greater risk of being nonresponders to infliximab induction protocol,” Bella Ungar, MD, from the department of gastroenterology, Sheba Medical Center and Sackler School of Medicine, Tel-Aviv University, Israel, and colleagues wrote. “However, correlation with serum levels of infliximab was not clearly established. The goal of the present study was to compare infliximab trough levels during induction among hospitalized acute severe UC patients and moderately severe UC outpatients.”
Ungar and colleagues evaluated infliximab trough drug and antibody levels on day 14 before the second infusion in 16 acute severe, steroid-refractory UC patients who were hospitalized between 2010 and 2015 and treated with infliximab 5 mg/kg salvage therapy, and compared them with 16 moderately severe UC outpatient controls. They also compared trough levels between primary responders and nonresponders (n = 7).
“Day 14 trough level was chosen as it is a standard time-point that most closely reflects the effects of inflammatory burden and clearance of the first dose, before emergence of other factors such as immunogenicity,” the researchers wrote.
Mean infliximab trough levels at day 14 were significantly lower in patients with acute severe UC compared with moderately-severe UC patients (7.15 ± 5.3 vs. 14.4 ± 11.2 µg/mL; P = .007), “possibly due to a higher inflammatory burden and/or increased drug clearance,” Ungar told Healio Gastroenterology. “However, drug levels at day 14 were not lower among non-responders compared to responders, whereas week 2 median [infliximab-antibody] levels were numerically higher among primary non-responders.”
These findings indicate that patients with severe acute UC have increased infliximab clearance compared with patients with more benign disease, but also suggest that despite lower drug levels in patients with acute severe UC, “this lower level may still be within the therapeutic window and was not instrumental in the mechanism of primary nonresponse,” the researchers wrote.
The researchers also acknowledged that their small sample size limits the generalizability of their observations.
“Controlled trials are warranted to examine whether an a priori intensified infliximab induction protocol will lead to an improved outcome in acute severe UC,” Ungar said. – by Adam Leitenberger
Disclosure: Ungar reports no relevant financial disclosures. Please see the full study for a list of all other researchers’ relevant financial disclosures.
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