Multinational Drug Survival Study of Omalizumab in Patients With Chronic Urticaria and Potential Predictors for Discontinuation.

Autor:	Soegiharto R; Department of Dermatology/Allergology, University Medical Centre Utrecht, Utrecht University, Utrecht, Netherlands., Alizadeh Aghdam M; Department of Dermatology/Allergology, University Medical Centre Utrecht, Utrecht University, Utrecht, Netherlands., Sørensen JA; Department of Dermato-Venereology and Wound Healing Centre, University of Copenhagen, Bispebjerg Hospital, Copenhagen, Denmark., van Lindonk E; Department of Dermatology, Erasmus MC, Netherlands., Bulut Demir F; Department of Dermatology, Marmara University School of Medicine, Fevzi Cakmak Mah, İstanbul, Turkey., Porras NM; Department of Dermatology, Hospital del Mar-Institut d'Investigacions Mèdiques Universitat Pompeu Fabra de Barcelona, Barcelona, Spain., Matsuo Y; Department of Dermatology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan., Kiefer L; Urticaria Center of Reference and Excellence (UCARE), Institute of Allergology, Charité, Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.; Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Allergology and Immunology, Berlin, Germany., Knulst AC; Department of Dermatology/Allergology, University Medical Centre Utrecht, Utrecht University, Utrecht, Netherlands., Maurer M; Urticaria Center of Reference and Excellence (UCARE), Institute of Allergology, Charité, Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.; Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Allergology and Immunology, Berlin, Germany., Ritchie C; Secciones Alergia Adultos y Pediátrica, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina., Rudenko M; London Allergy and Immunology Centre, London, United Kingdom., Kocatürk E; Urticaria Center of Reference and Excellence (UCARE), Institute of Allergology, Charité, Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.; Department of Dermatology, Koç University School of Medicine, Istanbul, Turkey., Criado RFJ; Department of Dermatology, Faculdade de Medicina do ABC, Bairro Sacadura Cabral, Santo André, Brazil., Gregoriou S; First Department of Dermatology and Venereology, National and Kapodistrian University of Athens A Syggros Hospital, Athens, Greece., Bobylev T; Clinic for Dermatology, Elbe Klinikum Buxtehude, Buxtehude, Germany., Kleinheinz A; Clinic for Dermatology, Elbe Klinikum Buxtehude, Buxtehude, Germany., Takahagi S; Department of Dermatology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan., Hide M; Department of Dermatology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.; Department of Dermatology, Hiroshima City Hiroshima Citizens Hospital, Naka-ku, Hiroshima, Japan., Giménez-Arnau AM; Department of Dermatology, Hospital del Mar-Institut d'Investigacions Mèdiques Universitat Pompeu Fabra de Barcelona, Barcelona, Spain., Salman A; Department of Dermatology, Marmara University School of Medicine, Fevzi Cakmak Mah, İstanbul, Turkey.; Department of Dermatology, Acibadem Mehmet Ali Aydinlar University School of Medicine, Istanbul, Turkey., Kara RO; Department of Dermatology, Sakarya University Faculty of Medicine, Korucuk, Sakarya, Turkey., Sevimli Dikicier B; Department of Dermatology, Sakarya University Faculty of Medicine, Korucuk, Sakarya, Turkey., van Doorn MBA; Department of Dermatology, Erasmus MC, Netherlands.; Centre for Human Drug Research, Leiden, Netherlands., Thomsen SF; Department of Dermato-Venereology and Wound Healing Centre, University of Copenhagen, Bispebjerg Hospital, Copenhagen, Denmark., van den Reek JMPA; Department of Dermatology, Radboud University Medical Centre, Nijmegen, Netherlands., Röckmann H; Department of Dermatology/Allergology, University Medical Centre Utrecht, Utrecht University, Utrecht, Netherlands.
Jazyk:	angličtina
Zdroj:	JAMA dermatology [JAMA Dermatol] 2024 Sep 01; Vol. 160 (9), pp. 927-935.
DOI:	10.1001/jamadermatol.2024.2056
Abstrakt:	Importance: Treating patients with chronic urticaria using omalizumab has been shown to be safe and effective in randomized clinical trials. Multinational studies on long-term omalizumab performance in chronic urticaria in clinical practice settings are lacking, especially on drug survival. Drug survival, which refers to the length of time that patients are treated with a specific drug, is a comprehensive outcome covering effectiveness, safety, and patient and physician preferences. Furthermore, little is known about the reasons and potential predictors for omalizumab discontinuation. Objective: To investigate omalizumab drug survival as well as reasons and potential predictors for discontinuation in a large, diverse population. Design, Setting, and Participants: This international multicenter cohort study was conducted at 14 Urticaria Centers of Reference and Excellence in 10 countries, including all patients with chronic urticaria from these centers who were ever treated with omalizumab. Main Outcomes and Measures: Drug survival analysis was performed to assess time to discontinuation. Patient characteristics and treatment protocols were investigated by Cox regression analysis to identify potential predictors for omalizumab discontinuation. Results: In 2325 patients with chronic urticaria who started omalizumab between June 2009 and July 2022, the mean (SD) age of the cohort was 42 (6) years, and 1650 participants (71%) were female. Overall omalizumab survival rates decreased from 76% to 39% after 1 to 7 years, respectively (median survival time, 3.3 [95 % CI, 2.9-4.0] years), primarily due to discontinuation from well-controlled disease in 576 patients (65%). Ineffectiveness and adverse effects were reasons for discontinuation in a far smaller proportion of patients, totaling 164 patients (18%) and 31 patients (4%), respectively. Fast treatment response was associated with higher rates of omalizumab discontinuation due to well-controlled disease (hazard ratio, 1.45 [95% CI, 1.20-1.75]), and disease duration of more than 2 years was associated with lower rates of discontinuation due to well-controlled disease (HR, 0.81 [95% CI, 0.67-0.98]). Immunosuppressive cotreatment at the start of omalizumab and autoimmune disease was associated with a higher risk for discontinuation due to ineffectiveness (HR, 1.65 [95% CI, 1.12-2.42]). The presence of spontaneous wheals (HR, 0.62 [95% CI, 0.41-0.93]) and access to higher dosages (HR, 0.40 [95% CI, 0.27-0.58) were both associated with a lower risk for discontinuation of omalizumab due to ineffectiveness. Conclusion and Relevance: This multinational omalizumab drug survival cohort study demonstrated that treatment of chronic urticaria with omalizumab in a clinical setting is effective and safe, and well-controlled disease is the main reason for treatment discontinuation. These findings on omalizumab drug survival rates and reasons and potential predictors for discontinuation may guide patients and physicians in clinical decision-making and expectation management. These results may call for the identification of biomarkers for chronic urticaria remission in complete responders to omalizumab treatment.
Databáze:	MEDLINE
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