Proactive monitoring of the levels of Remicade (infliximab) in patients with inflammatory bowel disease (IBD) may help promote patients’ health and decrease their hospital visits, according to scientists from the Center for Inflammatory Bowel Disease at the Beth Israel Deaconess Medical Center (BIDMC) and the University of Pennsylvania.
The study, “Proactive Compared to Reactive Therapeutic Drug Monitoring for Optimizing Infliximab Maintenance Therapy is Associated with Less IBD-Related Surgery and Hospitalization,” was published in the journal Clinical Gastroenterology and Hepatology.
Janssen’s Remicade is a common first-line therapy used to treat IBD, but up to half the patients eventually stop responding to the drug. At this stage, clinicians often start to monitor patients’ blood to assess the drug concentration.
In their study, researchers observed that continuous monitoring of patients treated with Remicade is associated with improved long-term outcomes compared to patients who started monitoring only after the drug lost its effectiveness.
“IBD can lead to serious complications and a high rate of surgery despite medical therapy,” Adam S. Cheifetz, MD, the study’s lead author and director of the Center for Inflammatory Bowel Disease at the BIDMC, said in a press release.
“We demonstrated that proactive drug monitoring is associated with better clinical outcomes, including less treatment failure, serious infusion reactions, and less need for IBD-related surgery or hospitalization, when compared to reactive drug monitoring,” he said.
Remicade improves IBD patients’ symptoms by targeting a key factor that promotes inflammation, called tumor necrosis factor (TNF). Despite its initial effectiveness, eventually up to half the patients treated with Remicade fail to respond to the drug. One of the mechanisms underlying this phenotype is that patients begin to develop antibodies against the drug.
Previous work by the research team and others hinted at the potential benefits of monitoring drug levels prior to loss of effectiveness. Now, they performed a multicenter retrospective study, which enrolled 264 patients with IBD taking Remicade maintenance therapy at either BIDMC or University of Pennsylvania hospitals.
Half the patients were monitored proactively, before they showed any signs of failure to respond to treatment, while the other half underwent reactive drug monitoring – monitored after they exhibited treatment failure.
The results showed that in the group submitted to proactive monitoring, only 13 percent of the patients experienced a treatment failure, defined as loss of response to Remicade or when patients required IBD-related surgery. In comparison, treatment failure was detected in 66 percent of patients undergoing reactive monitoring.
The analysis also showed that patients being proactively monitored had lower probability of requiring hospital visits. In fact, only 7 percent of these patients had to visit the hospital, in clear contrast to the 25 percent of patients undergoing reactive monitoring. Even if they required a hospital visit, patients undergoing proactive monitoring stayed on average 37 days, compared to 189 days for the reactive group.
“Prolonging [Remicade’s] efficacy and avoiding surgery and hospitalization is very important for patients with IBD,” said Cheifetz, who also is an associate professor of medicine at Harvard Medical School. “Proactive monitoring is the standard of care in my practice and that of [co-senior author] Mark Osterman, MD, and I think it would benefit the vast majority of patients on [Remicade] and similar biologic medications.”
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