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Utility of serum biomarkers in real-world practice for predicting response to omalizumab therapy in patients with chronic spontaneous urticaria.

J Allergy Clin Immunol Glob

February 2025

Department of Internal Medicine, Division of Rheumatology, Allergy and Immunology, Cincinnati, Ohio.

Background: Omalizumab (OMA), a recombinant humanized IgG monoclonal anti-IgE antibody, is approved for treatment for chronic spontaneous urticaria (CSU) refractory to second-generation H-antihistamine (SGAH) therapy. However, currently, there are no validated serum biomarkers to reliably predict response to OMA treatment.

Objective: We explored the real-world clinical utility of using serum biomarkers for predicting response to OMA for CSU patients with disease refractory to high-dose SGAH therapy.

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Chronic rhinosinusitis with nasal polyps (CRSwNP) is a chronic inflammatory condition of the nasal passages and sinuses, often characterized by nasal congestion, loss of smell, facial pressure, and nasal discharge. Conventional treatments, such as corticosteroids and endoscopic sinus surgery (ESS), often provide only temporary relief, with frequent recurrence of symptoms. For patients with severe, refractory CRSwNP, biologic therapies have emerged as a promising treatment option.

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Background: Gut microbial involvement has been speculated in chronic spontaneous urticaria (CSU). The aim of the study was to compare the gut microbiome composition and diversity in CSU patients uncontrolled with second-generation antihistamines (sgAHs) and healthy individuals, as well as to explore any association between gut microbiome and disease characteristics.

Methods: A cross-sectional case-control study including 20 CSU patients unresponsive to standard doses of sgAHs, and 15 age-and-sex matched healthy controls was conducted.

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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.

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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).

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