A5078075638- Inflammatory Bowel Disease
- Microscopic Colitis
- Immunodeficiency and Autoimmune Disorders
- Eosinophilic Esophagitis
- Pharmaceutical studies and practices
- Adolescent and Pediatric Healthcare
- Diagnosis and treatment of tuberculosis
- Autoimmune and Inflammatory Disorders
- Liver Disease and Transplantation
- Chronic Lymphocytic Leukemia Research
- Gastroesophageal reflux and treatments
- Liver Diseases and Immunity
- Anorectal Disease Treatments and Outcomes
- Acute Lymphoblastic Leukemia research
- Liver Disease Diagnosis and Treatment
- Colorectal Cancer Surgical Treatments
- Celiac Disease Research and Management
- Diverticular Disease and Complications
- Colorectal and Anal Carcinomas
- Gastrointestinal Tumor Research and Treatment
- Colorectal Cancer Treatments and Studies
- Gastrointestinal Bleeding Diagnosis and Treatment
- Pelvic floor disorders treatments
- Health Systems, Economic Evaluations, Quality of Life
- Systemic Sclerosis and Related Diseases
Janssen (United States)
2019-2024
Janssen Scientific Affairs (United States)
2019-2024
Ben-Gurion University of the Negev
2021
Hudson Dermatology
2014
Graduate Hospital
2005-2006
Drexel University
2006
University of Pennsylvania
2006
Temple University Hospital
2004
We evaluated the real-world effectiveness and safety of ustekinumab (UST) in patients with Crohn's disease (CD).This study used a retrospective, multicenter, multinational consortium UST-treated CD patients. Data included patient demographics, phenotype, activity, treatment history, concomitant medications. Cumulative rates clinical, steroid-free, endoscopic, radiographic remissions were assessed using time-to-event analysis, clinical predictors by multivariate Cox proportional hazard...
Abstract Background We studied the efficacy and safety of ustekinumab (UST) vs adalimumab (ADA) through 1 year in biologic-naïve patients (pts) with moderate-to-severe Crohn’s disease. Methods SEAVUE was a multicenter, randomized, blinded, parallel-group, active-controlled study adults CD Activity Index (CDAI) scores ≥220/≤450. Biologic-naïve pts failing/intolerant to conventional therapy any size ulcer on baseline (BL) ileocolonoscopy were eligible. Pts randomized 1:1 UST (⁓6mg/kg IV at BL...
Abstract Background Inflammatory bowel disease (IBD), including Crohn’s (CD) and ulcerative colitis (UC), affects an estimated 1.6 million US adults, results in humanistic economic burden even among mild patients, which grows with increasing activity. Methods Gastroenterologists their IBD patients provided real-world data via Disease Specific Programmes 2014–2018. Patients physician- patient-reported completing a Work Productivity Activity Impairment questionnaire were categorized by...
Abstract Background Perianal fistulas are common and cause significant quality of life impairment in patients (pts) with Crohn’s disease (CD). In previous phase 2/3 studies, ustekinumab (UST) showed some evidence efficacy on fistula resolution, no clear dose-response relationship. Additional studies needed to evaluate the role UST perianal treatment. Here, we report data from two recent CD, SEAVUE STARDUST. Methods SEAVUE, biologic-naïve pts moderate-to-severe CD were randomized receive...
Ustekinumab is an effective treatment of Crohn's disease (CD). Of interest to patients knowing how soon symptoms may improve. We analyzed ustekinumab response dynamics from the CD trials.
To estimate long-term persistence among bio-naïve patients with CD initiated on ustekinumab or adalimumab.Adults initiating adalimumab (index date, between September 23, 2016 and August 1, 2019) were sampled from the IBM MarketScan Commercial Database. Patients without CD-indicated biologics (bio-naïve) no diagnoses for other autoimmune diseases 12 months pre-index date (baseline) included. Cohorts balanced baseline characteristics inverse probability of treatment weighting. Persistence was...
Chronic corticosteroid use is common in ulcerative colitis (UC); however, real-world evidence of its burden to the health care system limited.
Our hypothesis states that variceal pressure and wall tension increase dramatically during esophageal peristaltic contractions. This in is a natural consequence of the anatomy physiology esophagus venous plexus. The purpose this study was to evaluate hemodynamics contraction. A simultaneous ultrasound probe manometry catheter placed distal nine patients with varices. Simultaneous luminal images varices were recorded Maximum cross-sectional area pressures at which varix flattened, closed,...
In UNITI-1 and 2, pivotal induction studies of ustekinumab (UST) in patients with CD, 467 non-responders to UST 130 mg or ~6 mg/kg IV received 90 SC at Week 8. Overall, 50.5% achieved response 16 (delayed responders, DR).1 We sought characterise DR population induced identify predictors for delayed response. 2 who were UST~6 had a dose 8 included this post hoc analysis classified as 8-responders (ER), (no 8/response 16) (NR, no Weeks 16). Levels CRP FeCal 6 described. Pearson Spearman...
<h3>Introduction</h3> Perianal fistulas are common and cause significant quality of life impairment in patients (pts) with Crohn's disease (CD). We report data on fistula closure from the SEAVUE STARDUST studies. <h3>Methods</h3> In SEAVUE, biologic-naïve pts moderately-to-severely active CD were randomized to blinded UST (∽6 mg/kg IV at baseline then 90mg SC q8w) or adalimumab (ADA; 160/80 mg baseline/W2, 40mg q2w). STARDUST, biologic-naïve+biologic-failure received open-label ∽6 W8...
Background/Objective: This study evaluated emergency department (ED) visit trends, subsequent inpatient admissions for patients with inflammatory bowel disease (IBD) diagnosis and IBD-related abdominal pain (AP), hospital-level variation in admission rates the USA (US).Methods: population-based, cross-sectional included data from Nationwide Emergency Department Sample (NEDS, 2006─2013) database. Patients ≥18 years of age primary ED IBD/IBD-related AP were included. Variables demographics,...
Abstract Background In the UNIFI study of ustekinumab (UST) in ulcerative colitis (UC), patients who achieved histo-endoscopic mucosal healing (HEMH; ie, both histologic and endoscopic improvement mucosa) after induction had higher clinical remission corticosteroid-free rates through 1 year than those either or alone.1 Here, we report effect achieving HEMH on long-term symptomatic outcomes 3 years. Methods Patients were response 8 wks IV with UST 130mg ~6mg/kg (wk responders) randomized to...
INTRODUCTION: Measuring Patient-Reported Outcomes (PROs) is important in understanding how ulcerative colitis (UC) patients perceive their own health status and emotional well-being. This study aims to establish the association between PROs disease severity measured by partial Mayo score (PMS) using real-world data. METHODS: Data were drawn from Adelphi Disease Specific Programme (a survey of gastroenterologist-completed retrospective chart review patient self-completion questionnaires)...
INTRODUCTION: Measuring Patient-Reported Outcomes (PROs) is important in understanding how Crohn's disease (CD) patients perceive their own health status and emotional well-being. This study aims to establish the association between PROs Disease Activity Index (CDAI) using real-world data. METHODS: Data were drawn from Adelphi Specific Programme, a survey of gastroenterologist-completed retrospective chart reviews patient self-completed questionnaires conducted US 2015 2017. CD form...
Abstract Background Entry criteria and outcome measures of Crohn’s disease (CD) clinical trials have evolved. Patients are now required to active inflammation on screening endoscopy, with some studies requiring moderate-severe SES-CD scores. Recent endoscopic response as a co-primary endpoint remission (ER) deep (DR) major secondary endpoints. Pivotal CD maintenance typically examine only responders induction. The SEAVUE study ≥1 ulceration any size (SES-CD≥3) at baseline had treat-through...
DEVELOP is a multicenter, prospective, observational registry of the long-term safety and clinical status 6070 pediatric patients with inflammatory bowel disease (IBD; Crohn’s [CD]: 4122, ulcerative colitis [UC]: 1643, IBD-unclassified[IBD-U]: 305; median age at enrollment 13.0 years) treated originator infliximab (REM) and/or other medical therapies for IBD as part routine care. has sites in United States, Canada EU enrolled from 2007 to 2017. The labelled maintenance dose interval REM...