1. Association of Early Postinduction Adalimumab Exposure With Subsequent Clinical and Biomarker Remission in Children with Crohn’s Disease
- Author
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Amanda Ricciuto, Anne M. Griffiths, Firas Rinawi, Eileen Crowley, Karen Frost, Thomas D. Walters, and Peter C Church
- Subjects
0301 basic medicine ,medicine.medical_specialty ,Gastroenterology ,Likelihood ratios in diagnostic testing ,03 medical and health sciences ,0302 clinical medicine ,Crohn Disease ,Internal medicine ,Adalimumab ,Dose escalation ,Humans ,Immunology and Allergy ,Medicine ,Prospective Studies ,Child ,Crohn's disease ,business.industry ,Remission Induction ,Area under the curve ,medicine.disease ,Clinical trial ,Treatment Outcome ,030104 developmental biology ,Biomarker (medicine) ,Tumor Necrosis Factor Inhibitors ,030211 gastroenterology & hepatology ,Calprotectin ,business ,Biomarkers ,medicine.drug - Abstract
Background Data on the association between early postinduction serum adalimumab (ADA) trough levels (TLs) and objective outcomes are scarce. The aim of this study was to investigate whether early ADA TLs at weeks 4 and 8 are associated with clinical and biomarker remission at week 24 in pediatric Crohn’s disease (CD). Methods Adalimumab TLs at weeks 4 and 8 were prospectively measured in anti-TNF-naïve children initiating treatment with ADA monotherapy for luminal inflammatory CD. The primary outcome was combined clinical and biomarker remission at week 24, defined as achieving steroid-free clinical remission (Pediatric CD activity index Results Among 65 patients, 39 (60%) achieved combined clinical/biomarker remission at week 24 without dose escalation. Adalimumab TLs at both weeks 4 and 8 were significantly higher in remitters vs nonremitters at week 24 (P Conclusion Greater early ADA exposure is associated with superior clinical/biomarker outcomes at week 24.
- Published
- 2020