Division of Pediatric Gastroenterology, Hepatology & Nutrition, Cincinnati Children's Hospital Medical Center, MLC 2010, 3333 Burnet Avenue, Cincinnati, OH 45229, USA.
Division of Pediatric Gastroenterology, Hepatology & Nutrition, Cincinnati Children's Hospital Medical Center, MLC 2010, 3333 Burnet Avenue, Cincinnati, OH 45229, USA; Department of Pediatrics, University of Cincinnati School of Medicine, Cincinnati, OH, USA.
Gastroenterol Clin North Am. 2023 Sep;52(3):549-563. doi: 10.1016/j.gtc.2023.05.002. Epub 2023 Jun 9.
The use of biologic therapies has changed the treatment landscape for children with inflammatory bowel disease. While the novel biologics have improved clinical outcomes, there remains a significant gap in achieving endoscopic remission, prolonged steroid-free remission, and drug durability. Contributing to this gap is the paucity of real-world pharmacokinetic studies in children and a failure to dose optimize therapy during induction. Emerging data from a pediatric clinical trial and several observational studies have shown that the combination of proactive therapeutic drug monitoring and achievement of early therapeutic concentrations is effective in achieving improved outcomes. The next steps will be to leverage these past studies to develop more innovative clinical trials to properly assess the safety and effectiveness of proactive therapeutic drug monitoring in children.
生物制剂的应用改变了儿童炎症性肠病的治疗格局。虽然新型生物制剂改善了临床结局,但在实现内镜缓解、延长无类固醇缓解和药物持久性方面仍存在显著差距。导致这一差距的原因是儿童人群中缺乏真实世界的药代动力学研究,以及在诱导治疗期间未能优化剂量。来自儿科临床试验和几项观察性研究的新数据表明,积极的治疗药物监测与早期治疗浓度的实现相结合,可有效改善结局。下一步将利用这些既往研究制定更具创新性的临床试验,以正确评估积极治疗药物监测在儿童中的安全性和有效性。