Impact of Proactive Therapeutic Drug Monitoring on Infliximab Maintenance Therapy and Clinical Outcomes in Pediatric Inflammatory Bowel Disease: A Randomized Controlled Trial and Review of Literature.

Background and Aims: Despite potential benefits of anti-TNF proactive therapeutic drug monitoring (pTDM), few randomized controlled trials have assessed the impact of maintenance therapy in children with inflammatory bowel disease. Methods: This single-center randomized controlled trial assessed pTDM in pediatric patients receiving infliximab maintenance therapy. Patients aged 5-21 years, diagnosed with moderate to severe Crohn's disease or ulcerative colitis, were enrolled. Following optimization to target infliximab concentrations, participants were randomized to either the standard of care (SOC) group, with treatment adjustments based on clinical presentation alone, or to pTDM, where management additionally incorporated infliximab levels regardless of clinical status. Clinical outcomes were monitored over 52 weeks. All authors had access to the study data and reviewed and approved the final manuscript. Results: Fifty-one patients enrolled in the study, and 39 completed the trial; 72.5% required dose optimization prior to randomization, improving Pediatric Ulcerative Colitis Activity Index/Pediatric Crohn's Disease Activity Index scores from 9.13 to 6.31( Conclusion: pTDM was associated with reduced need for rescue therapy compared to SOC. Although not statistically significant, these findings are clinically relevant, supporting potential benefits of pTDM in pediatric inflammatory bowel disease patients on infliximab maintenance therapy. Further investigation is required to refine the timing and optimal strategies for implementation.