Serum miRNAs Are Pharmacodynamic Biomarkers Associated With Therapeutic Response in Pediatric Inflammatory Bowel Disease

Inflamm Bowel Dis. 2020 Sep 18;26(10):1597-1606. doi: 10.1093/ibd/izaa209.

Abstract

Background: We sought to identify microRNAs (miRNAs) associated with response to anti-TNF-α or glucocorticoids in children with inflammatory bowel disease (IBD) to generate candidate pharmacodynamic and monitoring biomarkers.

Methods: Clinical response was assessed by Pediatric Crohn's Disease Activity Index and Pediatric Ulcerative Colitis Activity Index. Quantitative real-time polymerase chain reaction via Taqman Low-Density Array cards were used to identify miRNAs in a discovery cohort of responders (n = 11) and nonresponders (n = 8). Seven serum miRNAs associated with clinical response to treatment, along with 4 previously identified (miR-146a, miR-146b, miR-320a, miR-486), were selected for further study. Candidates were assessed in a validation cohort of serum samples from IBD patients pre- and post-treatment and from healthy controls. Expression of miRNA was also analyzed in inflamed mucosal biopsies from IBD patients and non-IBD controls.

Results: Discovery cohort analysis identified 7 miRNAs associated with therapeutic response: 5 that decreased (miR-126, miR-454, miR-26b, miR-26a, let-7c) and 2 that increased (miR-636, miR-193b). In the validation cohort, 7 of 11 candidate miRNAs changed in the same direction with response to anti-TNF-α therapies, glucocorticoids, or both. In mucosal biopsies, 7 out of 11 miRNAs were significantly increased in IBD vs healthy controls.

Conclusions: Five candidate miRNAs associated with clinical response and mucosal inflammation in pediatric IBD patients were identified (miR-126, let-7c, miR-146a, miR-146b, and miR-320a). These miRNAs may be further developed as pharmacodynamic and response monitoring biomarkers for use in clinical care and trials.

Keywords: biomarker; inflammatory bowel disease; microRNA; pharmacodynamic.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Adolescent
  • Biomarkers / blood
  • Biopsy
  • Child
  • Child, Preschool
  • Cohort Studies
  • Colitis, Ulcerative / blood*
  • Colitis, Ulcerative / drug therapy
  • Crohn Disease / blood*
  • Crohn Disease / drug therapy
  • Drug Monitoring / methods*
  • Female
  • Humans
  • Intestinal Mucosa / pathology
  • Male
  • MicroRNAs / blood*
  • Real-Time Polymerase Chain Reaction
  • Tumor Necrosis Factor Inhibitors / pharmacokinetics*
  • Young Adult

Substances

  • Biomarkers
  • MicroRNAs
  • Tumor Necrosis Factor Inhibitors

Supplementary concepts

  • Pediatric Crohn's disease
  • Pediatric ulcerative colitis