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Infliximab monitoring, dose adjustment may improve IBD outcomes
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Proactive monitoring of infliximab levels in patients with IBD effectively identified those with low or undetectable trough concentrations and resulted in a greater likelihood of remaining on therapy, according to new research data.
“Currently providers typically only measure infliximab concentrations in the reactive setting, when a patient is having breakthrough symptoms or concern for an antibody-mediated side effect,” Byron P. Vaughn, MD, University of Minnesota Medical Center, told Healio.com/Gastroenterology. “However we propose that proactive therapeutic monitoring (TCM) of infliximab trough concentrations with dose optimization can improve patient outcomes.”
Byron P. Vaughn
This pilot observational study was initiated in 2009 when Adam S. Cheifetz, MD, director of the Center for Inflammatory Bowel Disease at Beth-Israel Deaconess Medical Center, began proactive TCM of his IBD patients’ infliximab levels to improve long-term efficacy and decrease toxicity by gradually adjusting their dosing regimens. Forty-eight patients achieved clinical remission and were evaluated for TCM outcomes by chart review. To evaluate associations between TCM and longer duration of infliximab, and reasons for cessation, patients also were compared with controls (n=78) composed of patients from the hospital’s infusion center who achieved remission but did not have TCM. Median duration of infliximab before TCM was 43 weeks, and 144 weeks overall.
Twenty-nine percent of TCM patients were within the target therapeutic range at baseline, and 35% underwent a dosing change based on TCM results. Twenty-five percent escalated, and 15% de-escalated during the study. Among TCM patients, 75% achieved trough concentrations of at least 5 micrograms/mL. Patients in the TCM group had a greater probability of remaining on infliximab at 5 years compared with controls (86% vs. 52%; HR=0.3; 95% CI, 0.1-0.6). This probability was highest for patients with more than 5 microgram/mL trough concentrations (HR=0.03; 95% CI, 0.01-0.1). Ten percent of TCM patients vs. 31% of controls stopped infliximab (P=.009).
“We found that patients who had proactive trough concentration monitoring and titration of infliximab to a therapeutic window remained on infliximab significantly longer that those who had standard weight-based dosing and reactive testing or empiric dose escalation,” Vaughn said. “Patients who did not have proactive trough monitoring were three times more likely to stop infliximab. The main reasons for this seemed to be less disease recurrence and fewer infusion reactions in the group that underwent proactive [TCM].
“While larger prospective studies are needed, we recommend that all patients have routine monitoring of infliximab concentrations and adjustment of dose even if in remission. The optimal target window is not defined, but our current practice is to routinely measure infliximab trough concentrations after induction and then every 6 to 12 months once the patient has reached a target level of 5 to 10.”
“This would be a huge paradigm shift for patients on [infliximab],” Cheifetz said in a press release, adding that “creating a pathway or algorithm for a provider to follow when prescribing” infliximab is the next step.
Disclosure: See the study for a full list of relevant financial disclosures.
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