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Clinical and biological predictors of response to standardised paediatric colitis therapy (PROTECT): A multicentre inception cohort study

The Lancet Apr 03, 2019

Hyams JS, et al. - In this inception cohort study, researchers examined whether pretreatment clinical, transcriptomic, and microbial factors could predict disease course in children who are newly diagnosed with ulcerative colitis. Four hundred sixty-seven pediatric patients aged 4–17 years were recruited from 29 centers in the USA and Canada. Of these, 428 started medical therapy; of these, 400 (93%) were evaluable at 52 weeks and 386 (90%) completed the study period with no protocol violations. Initially, standardized mesalazine or corticosteroids were provided to patients, with pre-established criteria for escalation to immunomodulators (ie, thiopurines) or anti-tumor necrosis factor-α (TNFα) therapy. Findings support that initial clinical activity and treatment response by 4 weeks could be used to determine week 52 corticosteroid-free remission with mesalazine alone in these children. Ulcerative colitis therapeutic decisions could be made via developing a personalised clinical and biological signatures, a promising approach.
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