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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.
Diminished Diversities and Clonally Expanded Sequences of T-Cell Receptors in Patients with Chronic Spontaneous Urticaria.
Immunotargets Ther
December 2024
Chengdu ExAb Biotechnology, LTD, Chengdu, People's Republic of China.
Objective: Studies establish a link between autoimmune factors and chronic spontaneous urticaria (CSU). T cells are crucial in immune-mediated diseases like CSU, and T-cell receptor (TCR) diversity could be pivotal in autoimmune responses. The clinical relevance of TCR variations in CSU is unknown, but understanding them may offer insights into CSU's pathogenesis and treatment.
View Article and Find Full Text PDFPredictive cytokines of omalizumab in the treatment of chronic spontaneous urticaria.
Cytokine
January 2025
Department of Allergy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Institute of Allergy and Clinical Immunology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.. Electronic address:
Background: Omalizumab, an anti-IgE biological agent, is commonly prescribed as a second-line therapy for Chronic Spontaneous Urticaria (CSU). However, there is a lack of biomarkers to predict which CSU patients will respond favorably to omalizumab.
Objective: Our study aims to identify cytokine markers associated with the efficacy of omalizumab in treating CSU.
Biologics in allergology and clinical immunology: Update on therapies for atopic diseases, urticaria, and angioedema and on safety aspects focusing on hypersensitivity reactions.
Allergol Select
November 2024
Institute of Allergology, Charité Universitätsmedizin Berlin und Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Allergology and Immunology, Berlin.
Article Synopsis
- Targeted therapies using biologics for atopic diseases, urticaria, and angioedema are advancing quickly, with several new antibodies developed, tested, and approved for clinical use, like omalizumab and dupilumab.
- There is ongoing research into combining different biologics for enhanced treatment efficacy, expanding their applications to conditions like food allergies and eosinophilic esophagitis.
- There are emerging concerns about unexpected side effects and hypersensitivity reactions associated with these therapies, raising important questions about their safety and mechanisms, particularly in specific patient groups like children.
Therapies for Chronic Spontaneous Urticaria: Present and Future Developments.
Pharmaceuticals (Basel)
November 2024
Department of Pathophysiology and Transplantation, Internal Medicine, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, 20122 Milan, Italy.
Chronic spontaneous urticaria (CSU) is a complex dermatological condition characterized by recurrent wheals and/or angioedema lasting for more than six weeks, significantly impairing patients' quality of life. According to European guidelines, the first step in treatment involves second-generation H1-antihistamines (sgAHs), which block peripheral H1 receptors to alleviate symptoms. In cases with inadequate responses, the dose of antihistamines can be increased by up to fourfold.
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