Publications by authors named "J R Rosh"
Objectives: To assess the efficacy, safety, immunogenicity, and pharmacokinetics through 240 weeks of ustekinumab treatment in paediatric patients from the long-term extension (LTE) of the phase 1, double-blind UniStar trial.
Methods: Paediatric patients with moderately to severely active Crohn's disease (CD) were randomised 1:1 and stratified by body weight (<40 or ≥40 kg) to low- or high-dose intravenous ustekinumab followed by a subcutaneous maintenance dose at Week 8. At Week 16, patients were eligible to enter the LTE at the discretion of the investigator and continued maintenance dosing every 8 weeks up to Week 240.
Article Synopsis
- Most studies on pediatric inflammatory bowel disease (IBD) largely involve adolescents and suggest that adolescent-onset IBD may not differ significantly from adult-onset IBD, challenging the need for delayed drug access for adolescents.
- Researchers analyzed data from 11 randomized clinical trials, focusing on the treatment responses of 6283 participants (both adolescents and adults) to various biologics for Crohn's disease and ulcerative colitis.
- The findings indicate that treatment responses in adolescents are generally similar to those in adults, supporting the idea that efficacy data from adult studies can be used to approve drugs for adolescents more quickly.
A prospective, controlled multisite trial of yoga in pediatric inflammatory bowel disease.
J Pediatr Gastroenterol Nutr
February 2024
Aim: To investigate whether a structured yoga program improves health-related quality of life (HRQOL) and self-efficacy in pediatric patients receiving care for inflammatory bowel disease (IBD).
Methods: IBD patients who were 10-17 years old participated in a 12 week, in-person yoga intervention at two clinical sites. Outcomes were measured at time of consent (T0), start of yoga (T1), and completion of yoga (T2) and 3 months after yoga completion (T3) using the IMPACT-III, Pediatric Quality of Life Inventory (PedsQL), and General Self Efficacy (GSE) scales.
Background & Aims: The evolution of complicated pediatric Crohn's disease (CD) in the era of anti-tumor necrosis factor (aTNF) therapy continues to be described. Because CD progresses from inflammatory to stricturing (B2) and penetrating (B3) disease behaviors in a subset of patients, we aimed to understand the risk of developing complicated disease behavior or undergoing surgery in relation to aTNF timing and body mass index z-score (BMIz) normalization.
Methods: Multicenter, 5-year longitudinal data from 1075 newly diagnosed CD patients were analyzed.