Predicting Response to Standardized Pediatric Colitis Therapy

This multicenter open-label study was designed to evaluate the safety and efficacy of standardized initial therapy using either mesalamine or corticosteroids then mesalamine for the treatment of children and adolescents newly diagnosed with ulcerative colitis. The study investigated the hypothesis that response to the initial 4 weeks of therapy as well as specific clinical, genetic, and immune parameters determined during the initial course of therapy predicted severe disease as reflected by need for escalation of medical therapy or surgery.

Participants were assigned to one of two initial therapeutic plans (mesalamine only or prednisone/liquid equivalent prednisolone followed by mesalamine) depending upon initial disease severity determined by the validated multi-dimensional Pediatric Ulcerative Colitis Activity Index (PUCAI). Biospecimens were obtained at diagnosis, and subsequently following the initiation of therapy at weeks 4, 12, and 52 (blood and stool at weeks 4 and 12; blood, stool, and colonic tissue at week 52). Follow-up clinic visits were conducted for a minimum of 1 year to a maximum of 5 years depending on when the participant enrolled. Adherence to mesalamine dosing was monitored using a state of the art electronic Medication Event Monitoring System (MEMS®).

The primary publication associated with the PROTECT study can be found here: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6501846/">Clinical and Biological Predictors of Response to Standardised Paediatric Colitis Therapy: A Multicentre Inception Cohort Study</a>.