A5052046238- Inflammatory Bowel Disease
- Microscopic Colitis
- Helicobacter pylori-related gastroenterology studies
- Colorectal Cancer Treatments and Studies
- Immunodeficiency and Autoimmune Disorders
- Biosimilars and Bioanalytical Methods
- Diagnosis and treatment of tuberculosis
- Liver Diseases and Immunity
- Health Systems, Economic Evaluations, Quality of Life
- Chronic Lymphocytic Leukemia Research
- Tuberculosis Research and Epidemiology
- Barrier Structure and Function Studies
- Autoimmune and Inflammatory Disorders
- Eosinophilic Esophagitis
- Mycobacterium research and diagnosis
- Celiac Disease Research and Management
- Drug Transport and Resistance Mechanisms
- Pharmacological Effects of Natural Compounds
- Gastrointestinal motility and disorders
- Acute Lymphoblastic Leukemia research
- Psoriasis: Treatment and Pathogenesis
- Autoimmune and Inflammatory Disorders Research
- Ion Transport and Channel Regulation
- Cancer Immunotherapy and Biomarkers
- Advanced Glycation End Products research
Janssen (United States)
2015-2024
Janssen (Switzerland)
2015-2023
Janssen (Belgium)
2013-2020
Springhouse
2020
Icahn School of Medicine at Mount Sinai
2020
Hôpital Beaujon
2014
Johnson & Johnson (United States)
2011
Mayo Clinic in Arizona
2011
Johnson University
2004
Baylor University Medical Center
2004
The efficacy of ustekinumab, an antagonist the p40 subunit interleukin-12 and interleukin-23, as induction maintenance therapy in patients with ulcerative colitis is unknown.We evaluated ustekinumab 8-week 44-week moderate-to-severe colitis. A total 961 were randomly assigned to receive intravenous dose (either 130 mg [320 patients] or a weight-range-based that approximated 6 per kilogram body weight [322]) placebo (319). Patients who had response 8 weeks after administration again...
<h3>Background and aims:</h3> Infliximab is an effective treatment for ulcerative colitis with over 60% of patients responding to up 30% reaching remission. The mechanism resistance anti-tumour necrosis factor α (anti-TNFα) unknown. This study used colonic mucosal gene expression provide a predictive response signature infliximab in colitis. <h3>Methods:</h3> Two cohorts who received their first refractory were studied. Response was defined as endoscopic histological healing. Total RNA from...
Background & AimsWe analyzed data collected during the Active Ulcerative Colitis Trials (ACT-1 and ACT-2) to assess relationships between serum concentrations of infliximab outcomes adults with moderate-to-severe ulcerative colitis.MethodsWe compared 728 patients moderately-to-severely active colitis who participated in ACT-1 or ACT-2; efficacy were at weeks 8, 30, 54 (for only). Relationships concentration assessed using trend, logistic regression, receiver operating characteristic curve...
BackgroundSafe and effective therapies are needed for pediatric patients with psoriasis.ObjectiveThe purpose of this study was to evaluate ustekinumab in age 12 17 years who had moderate-to-severe psoriasis.MethodsPatients (n = 110) were randomly assigned standard dosing (SD; 0.75 mg/kg [≤60 kg], 45 mg [>60-≤100 90 [>100 kg]) or half-standard (HSD; 0.375 22.5 at weeks 0 4 every placebo crossover SD HSD week 12. Clinical assessments included the proportion achieving a Physician's Global...
The UNIFI long-term extension [LTE] study reports the efficacy and safety of subcutaneous 90 mg ustekinumab through 3 years maintenance therapy.Patients randomised to every 12 weeks [q12w] or 8 [q8w] at baseline [N = 348] ustekinumab-treated patients in LTE 284] were evaluated. Symptomatic remission [Mayo stool frequency 0/1, rectal bleeding 0] was assessed. Safety included all 188 placebo N 457 ustekinumab].Among q12w q8w groups baseline, 54.1% 56.3% achieved symptomatic Week 152,...
Summary Background Benefits and risks of concomitant immunomodulators maintenance infliximab in inflammatory bowel disease (IBD) patients have not been adequately evaluated. Aim To assess the effect immunomodulator therapy using data from four prospective, randomized Phase 3 trials IBD patients. Methods Overall, 1383 ACCENT I II [luminal fistulizing Crohn’s trials] ACT 1 2 [ulcerative colitis were analysed. Patients treated with placebo or 5 10 mg/kg at weeks 0, 6 followed by every‐8‐week...
To assess golimumab pharmacokinetics [PK] and exposure-response [ER] in adults with moderate-to-severe ulcerative colitis [UC] from the Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment [PURSUIT] studies. We analysed PK ER data patients UC PURSUIT-subcutaneous induction [N = 1064] maintenance 464] Induction analyses evaluated serum concentration [SGC] efficacy through Week [wk] 6 following subcutaneous doses at wk0 wk2; assessed wk54 4-weekly dosing....
Janus kinase [JAK] inhibitors have shown efficacy in ulcerative colitis [UC]. We studied the dose-response, efficacy, and safety of peficitinib, an oral JAK inhibitor, patients with moderate-to-severe UC.In this Phase 2b, dose-ranging trial, we evaluated peficitinib at 25 mg once daily [o.d.], 75 o.d., 150 twice versus placebo for 219 UC. The primary outcome was dose-response Week 8, response assessed using Mayo score change from baseline. Secondary endpoints were clinical response,...
Ustekinumab is currently approved globally in Crohn's disease (CD) and psoriatic diseases. Recent phase 3 data demonstrate safety/efficacy ulcerative colitis (UC). UC programs had similar study designs, facilitating integrated safety analyses.Data from 6 ustekinumab 2/3 CD studies were pooled, was evaluated through 1 year. Patients received placebo or (generally 130 mg ~6 mg/kg) intravenous induction, then subcutaneous (90 mg) maintenance every 8/12 weeks. Analyses incorporated all patients...
The efficacy of antibody-based therapeutics depends on their pharmacokinetics. pharmacokinetic and exposure response profiles ustekinumab, a monoclonal antibody against interleukin 12/interleukin 23, are known in patients with Crohn's disease, yet there few data from ulcerative colitis. We characterized ustekinumab's pharmacokinetics, response, optimal serum concentrations colitis.We collected 2 phase 3 trials (1 induction 1 maintenance), which moderate to severe colitis received an...
Abstract Background and Aims Previously published long-term safety data reported a favourable ustekinumab profile for the treatment of inflammatory bowel disease [IBD]. We present final cumulative from pooled IBD phase 2/3 clinical studies through 5 years in Crohn’s [CD] 4 ulcerative colitis [UC]. Methods In 3 studies, patients received single intravenous placebo or [130 mg ~6 mg/kg] induction dose followed by subcutaneous maintenance doses [90 q8w q12w]. Analyses included all who one study...
ABSTRACTObjectives: The long-term effect of infliximab on endoscopic and histologic disease activity expression inflammatory markers was assessed in Crohn's patients who received as episodic or scheduled maintenance therapy over 54 weeks (ACCENT I).Methods: All 5 mg/kg at week 0 2 were then randomized responders nonresponders to placebo (5 10 mg/kg). Patients 6 followed by mg/kg) every 8 episodically loss response. Disease Activity Index (CDAI), Endoscopic Severity (CDEIS), Inflammatory...
Infliximab has been shown to induce clinical response and remission in ulcerative colitis (UC). To characterize the biological of patients infliximab, we analyzed mRNA expression patterns mucosal colonic biopsies taken from UC enrolled Active Ulcerative Colitis Trial 1 (ACT1) study.Biopsies were obtained 48 before treatment with 5 or 10 mg/kg at 8 30 weeks after (n = 113 biopsies). Global gene profiling was performed using Affimetrix GeneChip Human Genome U133 Plus 2.0 arrays. Expression...
Summary Background Tumour necrosis factor alpha ( TNF α)‐antagonism effectively treats ulcerative colitis (UC). The golimumab clinical programme evaluated subcutaneous (SC) and intravenous (IV) induction, SC maintenance regimens, in α‐antagonist‐naïve patients with moderate‐to‐severe active UC despite conventional treatment. Aim To evaluate dose–response relationship, select IV induction doses for continued development, the safety efficacy of selected doses. Methods Adults Mayo scores 6–12...
Ustekinumab induces and maintains histologic improvement in patients with ulcerative colitis (UC). The clinical relevance of this endpoint alone, combination endoscopic improvement, is unknown.Histologic disease activity was evaluated 2630 colonic biopsy samples from UC treated the UNIFI phase 3 studies ustekinumab. We associations between (defined as composite neutrophil infiltration less than 5% crypts no crypt destruction, erosions, ulcerations, or granulation tissue) endpoints at end...
The ongoing UNIFI long-term extension evaluates subcutaneous ustekinumab for moderate-to-severe ulcerative colitis (UC) from weeks 44 through 220.To assess efficacy (through week 92) and safety 96) during the METHODS: Overall, 399 responders to intravenous induction who were randomised maintenance therapy treated in (115 received placebo, 141 90 mg every 12 [q12w], 143 q8w). Placebo treatment was discontinued at unblinding after 44. Partial Mayo scores collected each dosing visit unblinding....
The cytokine tumor necrosis factor-alpha (TNF) increases the frequency of apoptosis in confluent renal epithelial LLC-PK1 cells, an effect that can be blocked by anti-TNFR1 monoclonal antibody. However, there were no visible "holes" cell sheet as a result TNF-induced apoptosis. Instead striking tissue remodeling occurred response to Apoptotic cells became surrounded and engulfed repositioned neighboring distributed distinct "rosette" pattern. cadherin-catenin cell-cell adhesion molecules,...
Rapid symptomatic relief is an important treatment goal for patients with ulcerative colitis (UC). We aimed to characterize early response ustekinumab in moderate-to-severe UC during the initial 16 weeks of treatment.We performed a post hoc analysis data from A Study Evaluate Safety and Efficacy Ustekinumab Induction Maintenance Therapy Participants With Moderately Severely Active Ulcerative Colitis trial. Patients (N = 961) were randomized (1:1:1) receive intravenous 130 mg ustekinumab,...