Biotechnology Journal talks to Prof. Stanley Cohen after his plenary lecture at the International Biotechnology Symposium, Sept 2012, in Daegu, Korea.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1002/biot.201200359 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Pooled safety analysis from the VOLTAIRE clinical trials of adalimumab-adbm and adalimumab reference product in patients with rheumatoid arthritis, Crohn's disease, and chronic plaque psoriasis.
Expert Opin Biol Ther
November 2024
Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
Objectives: This analysis reported the incidence of safety endpoints across five phase 3 randomized controlled clinical trials in patients with rheumatoid arthritis (RA), Crohn's disease (CD), and chronic plaque psoriasis (PsO) who received ≥ 1 dose of adalimumab-adbm or adalimumab reference product (RP).
Methods: Exposure-adjusted incidence rates for safety endpoints were calculated per 100 patient-years and reported by disease indication and treatment arm. Subgroup analyses by patient age and sex were also conducted.
A Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-dose escalation study to evaluate the safety and pharmacokinetics/pharmacodynamics of PF-06835375, a C-X-C chemokine receptor type 5 directed antibody, in patients with systemic lupus erythematosus or rheumatoid arthritis.
Arthritis Res Ther
June 2024
Pfizer Inc, Collegeville, PA, USA.
Background: The objective of this study was to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF‑06835375, a potent selective afucosyl immunoglobulin G1 antibody targeting C-X-C chemokine receptor type 5 (CXCR5) that potentially depletes B cells, follicular T helper (Tfh) cells, and circulating Tfh-like (cTfh) cells, in patients with systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA).
Methods: This first-in-human, multicenter, double-blind, sponsor-open, placebo-controlled Phase 1 study recruited patients aged 18-70 years with SLE or RA. In Part A, patients received single doses of intravenous PF-06835375 (dose range: 0.
Ustekinumab in paediatric patients with moderately to severely active Crohn's disease: UniStar study long-term extension results.
J Pediatr Gastroenterol Nutr
August 2024
Immunology, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.
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.
Outcomes in Adult Inflammatory Bowel Disease Clinical Trials: Assessment of Similarity Among Participants with Adolescent-onset and Adult-onset Disease.
J Crohns Colitis
August 2024
Child Health Innovation Leadership Department, Johnson & Johnson, New Brunswick, NJ, USA.
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.
Correction: Post-Marketing Safety Surveillance of Tofacitinib over 9 Years in Patients with Psoriatic Arthritis and Rheumatoid Arthritis.
Rheumatol Ther
February 2024
Inflammation and Immunology, Pfizer Canada ULC, 17300 Trans-Canada Hwy, Kirkland, QC, H9J 2M5, Canada.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!