Multicenter Cohort Study of Infliximab Pharmacokinetics and Therapy Response in Pediatric Acute Severe Ulcerative Colitis.

ABSTRACT:

Background & aims

We aimed to model infliximab (IFX) pharmacokinetics (PK) in pediatric acute severe ulcerative colitis (ASUC) and assess the association between PK parameters, including drug exposure, and clinical response.

Methods

We studied a multicenter prospective cohort of hospitalized children initiating IFX for ASUC or IBD-unclassified. Serial IFX serum concentrations over 26 weeks were used to develop a PK model. We tested the association of PK parameter estimates with day 7 clinical response, week 8 clinical remission, week 26 corticosteroid-free clinical remission (CSF-CR) (using the Pediatric Ulcerative Colitis Activity Index), and colectomy-free survival.

Results

Thirty-eight participants received IFX (median initial dose, 9.9 mg/kg). Day 7 clinical respo

SUBMITTER: Whaley KG 

PROVIDER: S-EPMC9968822 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature