{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T16:22:33Z","timestamp":1790353353044,"version":"4.1.0"},"reference-count":28,"publisher":"MDPI AG","issue":"18","license":[{"start":{"date-parts":[[2024,9,21]],"date-time":"2024-09-21T00:00:00Z","timestamp":1726876800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Italian Ministry of Health","award":["RC 2024"],"award-info":[{"award-number":["RC 2024"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background: Omalizumab, an anti-IgE monoclonal antibody, is an effective treatment for patients with chronic spontaneous urticaria (CSU) resistant to antihistamines, but about 10% are unresponsive. Our aim was to assess the effectiveness, safety, and drug survival (DS) of omalizumab by considering clinical and laboratory characteristics. Methods: We conducted a retrospective study on 296 patients with severe CSU treated with omalizumab. Disease activity, comorbidities, and serum levels of total IgE and anti-thyroid autoantibodies were evaluated over a period of up to 8 years. DS was analyzed using unadjusted Kaplan\u2013Meier survival curves. When applicable, the risk of discontinuation was assessed using Cox regression analysis. Results: Out of 296 patients, 118 (40.4%) were early responders, 72 (25.0%) were late responders, 76 (26.0%) were partial responders, and 25 (8.6%) were non-responders. Early responders were more likely to be patients without associated inducible urticaria (p = 0.021, \u03c72 = 9.692), without autoimmune thyroiditis (p = 0.007, \u03c72 = 12.037), and those with higher IgE levels (p = 0.039, \u03c72 = 8.385). Overall, DS was 53.5% at 8 years, primarily due to clinical remission. DS due to inefficacy and clinical remission were 83.9% and 62.1%, respectively, at 8 years. No patients discontinued omalizumab due to adverse events. Patients with normal IgE levels (p = 0.012, HR = 4.639, CI: 1.393\u201315.445) and those with autoimmune thyroiditis (p = 0.028, HR = 3.316, CI: 1.128\u20138.718) had a higher risk of discontinuing omalizumab due to inefficacy. Conclusions: This study confirms the long-term effectiveness and safety of omalizumab in the treatment of CSU over a period of up to 8 years. Most patients discontinued omalizumab due to clinical remission, while only 5.1% discontinued it due to ineffectiveness.<\/jats:p>","DOI":"10.3390\/jcm13185610","type":"journal-article","created":{"date-parts":[[2024,9,24]],"date-time":"2024-09-24T08:56:06Z","timestamp":1727168166000},"page":"5610","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Omalizumab for the Treatment of Chronic Spontaneous Urticaria in Adults and Adolescents: An Eight-Year Real-Life Experience"],"prefix":"10.3390","volume":"13","author":[{"given":"Paolo","family":"Calzari","sequence":"first","affiliation":[{"name":"Dermatology Unit, Fondazione IRCCS Ca\u2019 Granda Ospedale Maggiore Policlinico, 20122 Milan, Italy"},{"name":"Department of Pathophysiology and Transplantation, Universit\u00e0 Degli Studi di Milano, 20122 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8028-5453","authenticated-orcid":false,"given":"Alessandra","family":"Chiei Gallo","sequence":"additional","affiliation":[{"name":"Dermatology Unit, Fondazione IRCCS Ca\u2019 Granda Ospedale Maggiore Policlinico, 20122 Milan, Italy"},{"name":"Department of Pathophysiology and Transplantation, Universit\u00e0 Degli Studi di Milano, 20122 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7188-7310","authenticated-orcid":false,"given":"Francesca","family":"Barei","sequence":"additional","affiliation":[{"name":"Dermatology Unit, Fondazione IRCCS Ca\u2019 Granda Ospedale Maggiore Policlinico, 20122 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4486-5084","authenticated-orcid":false,"given":"Eleonora","family":"Bono","sequence":"additional","affiliation":[{"name":"Department of Pathophysiology and Transplantation, Universit\u00e0 Degli Studi di Milano, 20122 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9918-0763","authenticated-orcid":false,"given":"Massimo","family":"Cugno","sequence":"additional","affiliation":[{"name":"Department of Pathophysiology and Transplantation, Universit\u00e0 Degli Studi di Milano, 20122 Milan, Italy"},{"name":"Fondazione IRCCS Ca\u2019 Granda Ospedale Maggiore Policlinico, SC Medicina\u2014Emostasi e Trombosi, 20122 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8160-4169","authenticated-orcid":false,"given":"Angelo Valerio","family":"Marzano","sequence":"additional","affiliation":[{"name":"Dermatology Unit, Fondazione IRCCS Ca\u2019 Granda Ospedale Maggiore Policlinico, 20122 Milan, Italy"},{"name":"Department of Pathophysiology and Transplantation, Universit\u00e0 Degli Studi di Milano, 20122 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6734-1366","authenticated-orcid":false,"given":"Silvia Mariel","family":"Ferrucci","sequence":"additional","affiliation":[{"name":"Dermatology Unit, Fondazione IRCCS Ca\u2019 Granda Ospedale Maggiore Policlinico, 20122 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,9,21]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"734","DOI":"10.1111\/all.15090","article-title":"The international EAACI\/GA2LEN\/EuroGuiDerm\/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria","volume":"77","author":"Zuberbier","year":"2022","journal-title":"Allergy"},{"key":"ref_2","doi-asserted-by":"crossref","unstructured":"Zuberbier, T., Grattan, C., and Maurer, M. 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