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CT-P39 Compared With Reference Omalizumab in Chronic Spontaneous Urticaria: Results From a Double-Blind, Randomized, Active-Controlled, Phase 3 Study.
Allergy
January 2025
St John's Institute of Dermatology, Guy's Hospital, London, UK.
Background: This study compared the therapeutic equivalence of CT-P39 (an omalizumab biosimilar) and EU-approved reference omalizumab (ref-OMA) in patients with chronic spontaneous urticaria.
Methods: This double-blind, randomized, active-controlled Phase 3 study (NCT04426890) included two 12-week treatment periods (TPs). In TP1, patients received CT-P39 300 mg, ref-OMA 300 mg, CT-P39 150 mg, or ref-OMA 150 mg.
Chronic urticaria treatment challenges in children.
Rev Paul Pediatr
January 2025
Universidade Federal de São Paulo, São Paulo, SP, Brazil.
Objective: This paper aims to review the efficacy and safety of current chronic urticaria (CU) treatment in children and the existing patient-reported outcome measures (PROMs) used in this age group.
Data Source: Since there are few studies of CU in children, the authors performed a non-systematic review of published articles in English, Spanish, and Portuguese in the PubMed database in the last decade. Keywords used were (antihistamines OR omalizumab OR cyclosporine OR treatment) AND (chronic urticaria) AND (children OR adolescents).
EXtending Omalizumab Treatment Intervals in patients with Chronic spontaneous urticaria (EXOTIC): protocol of a multicentre, randomised, open-label, non-inferiority trial.
BMJ Open
January 2025
Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark.
Introduction: Omalizumab, an anti-IgE monoclonal antibody, is effective in treating antihistamine-refractory chronic spontaneous urticaria (CSU). However, tapering strategies for omalizumab are currently not well-studied, and patients may be treated longer than needed. Here, we present the rationale and design of the EXtending Omalizumab Treatment Intervals in patients with Chronic spontaneous urticaria trial, a multicentre, randomised, open-label, non-inferiority clinical trial.
View Article and Find Full Text PDFPredicting the effectiveness of omalizumab in patients with refractory chronic rhinosinusitis with nasal polyps comorbid with asthma based on inflammatory biomarkers.
World Allergy Organ J
January 2025
Department of Otolaryngology Head and Neck Surgery, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.
Background: The treatment of refractory chronic rhinosinusitis with nasal polyps (CRSwNP) with omalizumab has been well studied based on clinical evaluation. Nevertheless, ideal quantitative or qualitative biomarkers for predicting a different response to biologics urgently need to be explored. We aim to identify potential biomarkers for predicting a good or poor response in patients with refractory CRSwNP.
View Article and Find Full Text PDFComparison of the characteristics of patients with chronic urticaria receiving standard- or high-dose omalizumab.
Eur Ann Allergy Clin Immunol
January 2025
Division of Allergy and Clinical Immunology, Faculty of Medicine, Hacettepe University, Ankara, Turkey.
In patients whose chronic urticaria (CU) cannot be controlled with omalizumab 300 mg and antihistamines, the dose can be increased up to 600 mg. The study aimed to compare the clinical characteristics of patients receiving 300 mg versus higher doses of omalizumab, and to evaluate baseline predictors for updosing. A total of 159 patients who have been followed up at a tertiary care allergy center and received omalizumab for at least 12 months were included.
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