A5087619596- Inflammatory Bowel Disease
- Microscopic Colitis
- Biosimilars and Bioanalytical Methods
- Eosinophilic Esophagitis
- Celiac Disease Research and Management
- Pharmaceutical studies and practices
- Health Systems, Economic Evaluations, Quality of Life
- Esophageal and GI Pathology
- Pregnancy and Medication Impact
- Gastrointestinal disorders and treatments
- Gastrointestinal Bleeding Diagnosis and Treatment
- Helicobacter pylori-related gastroenterology studies
- Colorectal Cancer Screening and Detection
- Reproductive System and Pregnancy
- Immunodeficiency and Autoimmune Disorders
- Advanced Causal Inference Techniques
- Acute Lymphoblastic Leukemia research
- Liver Disease and Transplantation
- Lymphoma Diagnosis and Treatment
- Colorectal Cancer Treatments and Studies
- Autoimmune Bullous Skin Diseases
- Pharmacogenetics and Drug Metabolism
- Gastroesophageal reflux and treatments
- Veterinary medicine and infectious diseases
- Statistical Methods in Clinical Trials
Takeda (United States)
2019-2022
UMass Memorial Medical Center
2015-2022
Children's Medical Center
2014-2022
Deerfield (United States)
2019-2020
Walsh University
2016
University of Massachusetts Chan Medical School
2015
Children's Hospital & Medical Center
2014
University of Nebraska Medical Center
2014
Biologic therapies are widely used in patients with ulcerative colitis. Head-to-head trials of these inflammatory bowel disease lacking.
Summary Background Vedolizumab, a gut‐selective α 4 β 7 integrin antibody, is approved for moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD). Aim To report the final results from vedolizumab GEMINI long‐term safety (LTS) study. Methods The phase 3, open‐label LTS study (initiated May 2009) enrolled patients with UC or CD four prior clinical trials vedolizumab‐naïve patients. Vedolizumab was evaluated; efficacy patient‐reported outcomes were exploratory endpoints....
To date, there are no systematic pharmacokinetic [PK] data on vedolizumab in paediatric inflammatory bowel disease [IBD]. We report results from HUBBLE, a dose-ranging, phase 2 trial evaluating the PK, safety and efficacy of intravenous for IBD.Enrolled patients [aged 2-17 years] with moderate to severe ulcerative colitis [UC] or Crohn's [CD] body weight ≥10 kg were randomized by receive low- high-dose [≥30 kg, 150 300 mg; <30 100 200 mg] Day 1 Weeks 2, 6 14. Week 14 assessments included...
Wireless capsule endoscopy (CE) was introduced in 2000 as a less invasive method to visualize the distal small bowel adults. Because this technology has advanced it been adapted for use pediatric gastroenterology. Several studies have described its clinical use, utility, and various training methods but literature regarding CE is limited. This report developed by Endoscopic Procedures Committee of North American Society Pediatric Gastroenterology, Hepatology Nutrition outlines current...
Despite a growing number of new therapeutic options for inflammatory bowel disease (IBD), no clinical studies to date have directly compared two biologic agents. We performed head-to-head study the efficacy and safety vedolizumab (VDZ) adalimumab (ADA) treatment over 52 weeks in adults with moderately severely active ulcerative colitis (UC). This was phase 3b, double-blind, double-dummy, multi-centre, active-controlled trial enrolling patients UC (Mayo score 6 12 endoscopic sub-score ≥2) who...
Abstract Patients in the GEMINI 1 or 2 study (NCT00790933; Eudra CT2008‐002784‐14) with ulcerative colitis Crohn disease had low immunogenicity rates after vedolizumab treatment for up to 52 weeks. We report from long‐term safety (LTS) using a new drug‐tolerant electrochemiluminescence assay, including analyses patients who received continuous induction and maintenance long term safety, placebo followed by re‐treatment (treatment interruption). were enrolled 1, 2, 3, as de novo...
Vedolizumab (VDZ), a gut-selective, humanised, α4β7 integrin monoclonal antibody, was approved in 2014 the USA and EU to treat moderately severely active ulcerative colitis (UC) Crohn's disease (CD). GEMINI long-term safety (LTS) is longest VDZ continuous treatment study date provides unique data for therapeutic profiling. We report final LTS efficacy findings. multi-national, multi-centre, open-label, Phase 3 (NCT00790933/EudraCT 2015-000480-14). Patients with UC or CD received 300 mg IV...
Missing data is common in clinical trials. Depending on the volume and nature of missing data, it may reduce statistical power for detecting treatment difference, introduce potential bias invalidate conclusions. Non-responder imputation (NRI), where patients with information to determine endpoint status are considered as failures, widely used handle dichotomous efficacy endpoints inflammatory bowel disease (IBD) However, does not consider mechanisms leading can potentially underestimate...
The safety of inflammatory bowel disease medications during lactation is significant relevance to women childbearing potential. Available data regarding the transfer biologic agents for via breast milk are limited case reports. objective this prospective postmarketing study was assess vedolizumab concentrations in from lactating vedolizumab-treated with disease. Breast serially collected throughout dosing interval 11 patients receiving established intravenous 300-mg maintenance therapy every...
With recent advances in machine learning, we demonstrated the use of supervised learning to optimize prediction treatment outcomes vedolizumab through iterative optimization using VARSITY and VISIBLE 1 data patients with moderate-to-severe ulcerative colitis. The analysis was carried out elastic net regularized regression following a 2-stage training process. model performance assessed AUROC, specificity, sensitivity, accuracy. generalizable predictive patterns suggest that easily obtained...
Abstract Background In VARSITY, the first head-to-head randomized controlled trial of biologics, vedolizumab (VDZ) was superior vs adalimumab (ADA) in achieving clinical remission (CR) at Week 52 patients (pts) with moderate to severe ulcerative colitis (UC).1 Current treatment goals UC are based on symptoms and endoscopy, histologic improvement considered an aspirational goal.2-4 pts CR greater differences between VDZ ADA were seen endoscopic response. Here, data from VARSITY used define...
Abstract Background Vedolizumab is a gut-selective anti-lymphocyte trafficking agent approved for the treatment of moderate to severely active inflammatory bowel disease (IBD: ulcerative colitis [UC] and Crohn’s [CD]). Methods A systematic literature review (SLR) real-world studies was conducted assess effectiveness dose escalation vedolizumab every 8 weeks (Q8W) during maintenance achieve response in patients who were either responders experiencing secondary loss (SLOR) or non-responders....
As previously reported in the pivotal GEMINI 1 (NCT00783718) and 2 (NCT00783692) trials, vedolizumab therapy for ≤ 52 weeks induced low rates of immunogenicity patients with ulcerative colitis (UC) or Crohn’s disease (CD), respectively. [1] [2] We report long-term enrolled (CD) followed by safety (LTS) study (NCT00790933/EudraCT 2015-000480-14), including on placebo re-treated LTS. received 300 mg intravenously at Weeks 0 as induction therapy; Week 6 responders were randomised to every 8 4...
BACKGROUND: Vedolizumab (VDZ) is a gut-selective, humanized monoclonal antibody approved for moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). Although VDZ efficacy safety are well established, there limited publications on longer-term (>3 years) treatment persistence. This study evaluated persistence up 5 years in GEMINI long-term (LTS) de novo cohort. METHODS: All patients LTS (NCT00790933) were treated with every 4 weeks. A post hoc analysis of data from...
Vedolizumab (VDZ) is a safe and effective treatment for moderately to severely active ulcerative colitis (UC) Crohn’s disease (CD); however, effects on surgical rates have not yet been evaluated. This study aimed (1) compare the incidence of VDZ placebo (PLA) in GEMINI I (UC; NCT00783718) II (CD; NCT00783692); (2) describe through year 5 from LTS trial (UC CD; NCT00790933). Data were pooled Week 6 induction responders who randomised or PLA maintenance (intent-to-treat [ITT] populations) I1...