Improving Post-Induction Anti-Tumor Necrosis Factor Therapeutic Drug Monitoring in Pediatric Inflammatory Bowel Disease.

Abstract

OBJECTIVES Adequate serum drug levels of tumor necrosis factor-alpha inhibitors (anti-TNF) have been shown to improve outcomes in patients with inflammatory bowel disease (IBD). We aim to describe the quality improvement (QI) methods used at our institution to improve post-induction therapeutic drug monitoring (TDM) in children initiating anti-TNF therapy (infliximab and adalimumab) and describe the frequency of subtherapeutic anti-TNF levels. METHODS Beginning in February 2016, all patients initiating anti-TNF therapy were identified and tracked. Interventions to improve TDM, including the initiation of therapy plans for infliximab, real-time reminders for practitioners, and scheduling modifications for those initiating anti-TNF therapies were implemented using the Institute for Healthcare Improvement (IHI) Plan-Do-Study-Act (PDSA) cycle approach. Statistical process control charts were used to demonstrate improvement over time. Anti-TNF levels and presence of anti-drug antibodies were also recorded. RESULTS Using QI methodology, we improved post-induction anti-TNF TDM from a baseline of 43% in 2015 to > 80% by the end of 2017, with sustained improvement. Infliximab post-induction TDM improved from a baseline of 59% to 82% while adalimumab post-induction TDM improved from baseline of 14% to 79%. In total, 36% of all anti-TNF post-induction levels were less than 5 μg/mL, with nearly 60% of post-induction infliximab levels being less than 5 μg/mL. CONCLUSIONS Through incremental QI approaches, we improved the utilization of anti-TNF post-induction TDM with sustained improvement, approaching our goal of 90%. Subtherapeutic post-induction infliximab levels were common, indicating a strong need for anti-TNF TDM and an opportunity for dose optimization.