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Involvement of HLADQA1*05 in Patients with Inflammatory Bowel Disease Treated with Anti-TNF Drugs.
Medicina (Kaunas)
January 2025
Laboratory of Specialistic Pediatry, Department of Public Health and Pediatrics, School of Medicine, University of Turin, 10126 Turin, Italy.
: Over the past decade, TNF inhibitors such as Infliximab and Adalimumab have become central to Inflammatory Bowel Diseases treatment, greatly enhancing patient outcomes. However, immunogenicity-where anti-drug antibodies diminish effectiveness-remains an issue, often requiring dose changes or combination therapies. Pharmacogenomics is increasingly applied in IBD to personalise treatment, especially since genetic factors like the HLA-DQA1*05 variant heighten the immunogenicity risk with IFX.
View Article and Find Full Text PDFSafety, efficacy, and immunogenicity of a novel IgG degrading enzyme (KJ103): results from two randomised, blinded, phase 1 clinical trials.
Gene Ther
January 2025
Shanghai Bao Pharmaceuticals Co., Ltd., No. 28 Luoxin Road, Baoshan, Shanghai, China.
The approved intravenous adeno-associated virus (AAV) therapies are limited by the widespread prevalence of pre-existing anti-AAV antibodies in the general population, which are known to restrict patients' ability to receive gene therapy and limit transfection efficacy in vivo. To address this challenge, we have developed a novel recombinant human immunoglobulin G degrading enzyme KJ103, characterized by low immunogenicity and clinical value for the elimination of anti-AAV antibodies in gene transfer. Herein, we conducted two randomized, blinded, placebo-controlled, single ascending dose Phase I studies in China and New Zealand, to evaluate the pharmacokinetics, pharmacodynamics, safety and immunogenicity of KJ103 in healthy volunteers.
View Article and Find Full Text PDFAdalimumab Autoantibodies in Uveitis Patients: Do We Need Routine Drug Monitoring?
Biomedicines
December 2024
Department of Ophthalmology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Augustenburger Platz 1, 13353 Berlin, Germany.
Background: Adalimumab, an anti-TNF-α biologic agent, has emerged as a principal treatment option for patients with non-infectious uveitis. The influence of adalimumab anti-drug antibodies (AAA) on the efficacy of adalimumab therapy is not yet fully understood. We aim to understand their clinical implications in the context of therapeutic drug monitoring and the factors contributing to the formation of these antibodies.
View Article and Find Full Text PDFBrolucizumab and Platelet Activation and Reactivity.
Curr Eye Res
January 2025
Centre for Ophthalmology, Eberhard-Karls University, Tübingen, Germany.
Purpose: This study explores the potential interaction of brolucizumab with platelets and its effects on platelet activation and reactivity, crucial in retinal vasculitis and retinal vascular occlusion. Safety concerns remain of interest, although brolucizumab showed superior retinal efficacy and reduced injection frequency compared to other licensed anti-VEGF agents.
Methods: Resting and activated platelets of healthy volunteers were pretreated with brolucizumab at the following concentrations 0.
Therapeutic Drug Monitoring in Patients with Ulcerative Colitis on Infliximab: A Cost-Effectiveness Analysis.
Dig Dis Sci
December 2024
Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Stanford, CA, USA.
Background And Aims: Ulcerative colitis (UC) can be treated with infliximab (IFX). Therapeutic drug monitoring (TDM) can yield superior outcomes, but its cost-effectiveness is unknown.
Methods: We used a decision analytic Markov model to conduct a cost-effectiveness analysis comparing proactive TDM, reactive TDM, no TDM, and combinations of proactive and reactive TDM in 25-year-old patients with UC started on IFX.
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