Ustekinumab in paediatric patients with moderately to severely active Crohn's disease: UniStar study long-term extension results.

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.

Using multiple imputation of real-world data to estimate clinical remission in pediatric inflammatory bowel disease.

To evaluate the performance of the multiple imputation (MI) method for estimating clinical effectiveness in pediatric Crohn's disease in the ImproveCareNow registry; to address the analytical challenge of missing data. Simulation studies were performed by creating missing datasets based on fully observed data from patients with moderate-to-severe Crohn's disease treated with non-ustekinumab biologics. MI was used to impute sPCDAI remission statuses in each simulated dataset.

Validating the Simplified Endoscopic Mucosal Assessment for Crohn's Disease: A Novel Method for Assessing Disease Activity.

Background: To demonstrate treatment efficacy in Crohn's disease (CD), regulatory authorities require that trials include an endoscopic remission/response end point; however, standardized endoscopic assessment of disease activity, such as the Simple Endoscopic Score for Crohn's Disease (SES-CD), is not typically recorded by clinicians in practice or outside of clinical trials. The novel Simplified Endoscopic Mucosal Assessment for Crohn's Disease (SEMA-CD) was developed to be easy to use in routine clinical practice and as a trial end point. We conducted a study to assess and validate the reliability and feasibility of SEMA-CD as a measure of endoscopic disease activity.

Sugar-sweetened beverage purchases and intake at event arenas with and without a portion size cap.

This is the first real-world study to examine the association between a voluntary 16-ounce (oz) portion-size cap on sugar-sweetened beverages (SSB) at a sporting arena on volume of SSBs and food calories purchased and consumed during basketball games. Cross-sectional survey data from adults exiting a Brooklyn, NY, USA arena (Barclays, n = 464) with a 16-oz portion-size restriction and a Manhattan, NY, USA arena with no portion-size restriction (Madison Square Garden, control, n = 295) after the portion cap policy was put in place from March through June 2014 were analyzed. Linear regression models adjusting for sex, age, BMI, ethnicity, race, marital status, education, and income were used to compare the two arenas during the post-implementation period.