Biomarker Predictors of Clinical Efficacy of the Anti-IgE Biologic, Omalizumab, in Severe Asthma in Adults: Results of the SoMOSA Study
Conclusions This is the first discovery of omics biomarkers that predict improvement to a biologic for asthma. Their prospective validation and development for clinical use is justified.PMID:38635834 | DOI:10.1164/rccm.202310-1730OC (Source: Am J Respir Crit Car...)
Source: Am J Respir Crit Car... - April 18, 2024 Category: Intensive Care Authors: Ratko Djukanovi ć Paul Brinkman Johan Kolmert Cristina Gomez James Schofield Joost Brandsma Andy Shapanis Paul J S Skipp Anthony Postle Craig Wheelock Sven-Erik Dahlen Peter J Sterk Thomas Brown David J Jackson Adel Mansur Ian Pavord Mitesh Patel Christo Source Type: research

The OUtMATCH study: treating multiple allergies
It is recognised that of those children who do have allergies (about 8% of the population), 30–80% have responses to multiple foods. A double blind, placebo-controlled, randomised clinical trial, the Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen Oral Immunotherapy in Food Allergic Participants (OUtMATCH) study is a three phase study comparing omalizumab to placebo in children with multiple food allergies and is in its first phase. The study then goes on to phase two, a longer-term (52 weeks) treatment with omalizumab with oral immunotherapy and then the third stage will assess the introduction of...
Source: Archives of Disease in Childhood - April 18, 2024 Category: Pediatrics Tags: Miscellanea Source Type: research

Omalizumab-induced ocular myasthenia gravis?
Can J Ophthalmol. 2024 Apr 14:S0008-4182(24)00100-5. doi: 10.1016/j.jcjo.2024.03.018. Online ahead of print.NO ABSTRACTPMID:38631494 | DOI:10.1016/j.jcjo.2024.03.018 (Source: Canadian Journal of Ophthalmology)
Source: Canadian Journal of Ophthalmology - April 17, 2024 Category: Opthalmology Authors: Hanru Wang Devaraj Supramaniam Sudha Cugati Celia Chen Source Type: research

A Practical Guide for Implementing Omalizumab Therapy for Food Allergy
The recent approval of omalizumab for the treatment of IgE-mediated food allergy is an important step forward for the millions of food allergy patients in the US. Through the depletion of circulating IgE and the subsequent reduction of FC εR1 on key effector cells, patients increase their tolerance to food allergens. However, omalizumab does not permit patients to eat foods that they are allergic to with impunity. Rather, it protects them from most accidental exposures. In addition, omalizumab does not cure food allergy and has not demonstrated true immunomodulation. (Source: Journal of Allergy and Clinical Immunology)
Source: Journal of Allergy and Clinical Immunology - April 8, 2024 Category: Allergy & Immunology Authors: Thomas B. Casale, Alessandro Fiocchi, Matthew Greenhawt Source Type: research

Pharmacokinetics of Monoclonal Antibodies Throughout Pregnancy: A Systematic Literature Review
ConclusionAvailable information suggests that the anatomical and physiological changes throughout pregnancy may have meaningful effects on the PK of mAbs. For most mAbs (not IFX), modestly higher dosing (per mg) maybe needed during pregnancy to sustain a similar serum exposure compared to pre-pregnancy. (Source: Clinical Pharmacokinetics)
Source: Clinical Pharmacokinetics - April 7, 2024 Category: Drugs & Pharmacology Source Type: research

A Randomized, Single ‐Dose, Parallel‐Controlled Phase 1 Clinical Comparison of an Omalizumab Biosimilar Candidate with Reference Omalizumab in Healthy Chinese Male Volunteers
This study evaluated the bioequivalence of omalizumab, a humanized monoclonal antibody against immunoglobulin-E (IgE), with one of its biosimilar candidates. The study was designed as a randomized, double-blind, parallel-controlled trial. A total of subjects who met the inclusion criteria and did not meet the exclusion criteria were dynamically randomly assigned to receive the test drug or the reference drug with a single subcutaneous injection of 150  mg by the minimization method. The test group and the reference group had similar demographic characteristics and baseline characteristics of total IgE. The 90% confidence ...
Source: Clinical Pharmacology in Drug Development - April 4, 2024 Category: Drugs & Pharmacology Authors: Jie Cheng, Chenguang Wang, Jin Xu, Chunyang Zhao, Rong Song, Yijun Wang, Yang Zou, Xunmin Zhang, Yong Shan, Jian Zhou, Jing ‐Ying Jia Tags: Original Article Source Type: research

Clinical Impacts of Omalizumab on the Psychiatric Comorbidities of Chronic Spontaneous Urticaria: A Systematic Review and Meta-Analysis
J Drugs Dermatol. 2024 Apr 1;23(4):e116-e117. doi: 10.36849/JDD.7919.NO ABSTRACTPMID:38564395 | DOI:10.36849/JDD.7919 (Source: Journal of Drugs in Dermatology)
Source: Journal of Drugs in Dermatology - April 2, 2024 Category: Dermatology Authors: Marcus G Tan Adrian M J Bailey Brian Dorus Mark G Kirchhof Source Type: research