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Omalizumab in Chronic Spontaneous Urticaria Refractory to Conventional Therapy: An Italian Retrospective Clinical Analysis with Suggestions for Long-Term Maintenance Strategies

INTRODUCTION: Omalizumab is indicated for the treatment of patients affected by chronic spontaneous urticaria (CSU) refractory to antihistamines. The aim of this study was to assess the efficacy, safety, and recurrence of symptoms in a real-life experience of omalizumab as an add-on therapy for H(1)...

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Autores principales: Mandel, Victor D., Guanti, Mario B., Liberati, Serena, Demonte, Antongiulio, Pellacani, Giovanni, Pepe, Patrizia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6002323/
https://www.ncbi.nlm.nih.gov/pubmed/29770909
http://dx.doi.org/10.1007/s13555-018-0240-7
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author Mandel, Victor D.
Guanti, Mario B.
Liberati, Serena
Demonte, Antongiulio
Pellacani, Giovanni
Pepe, Patrizia
author_facet Mandel, Victor D.
Guanti, Mario B.
Liberati, Serena
Demonte, Antongiulio
Pellacani, Giovanni
Pepe, Patrizia
author_sort Mandel, Victor D.
collection PubMed
description INTRODUCTION: Omalizumab is indicated for the treatment of patients affected by chronic spontaneous urticaria (CSU) refractory to antihistamines. The aim of this study was to assess the efficacy, safety, and recurrence of symptoms in a real-life experience of omalizumab as an add-on therapy for H(1)-antihistamine-refractory CSU patients (refractory CSU). METHODS: A retrospective review of the clinical records of all refractory CSU treated with omalizumab at our dermatology center from June 2014 to April 2017 was performed. Patients previously treated with second-generation antihistamines at a fourfold increased dose without clinical responses at 4 weeks of treatment were selected. Omalizumab was administered at a single dosage of 300 mg every 4 weeks for 6 months. Disease severity was assessed using the 7-day Urticaria Activity Score (UAS7). RESULTS: Eighteen patients (14 women; mean age 51 years, range 25–74) were enrolled. Mean UAS7 at baseline was 27.3 (range 15–38). Symptoms improved in all patients at 4 weeks (UAS7 = 16.1, range 0–36). Treatment was completed in 17 patients (94.4%), and among these, a complete response (UAS7 = 0) was registered in 10 patients (58.8%). Adverse events included thrombocytopenia in 1 patient (5.6%) at 16 weeks; therapy was suspended after 20 weeks and the complication was resolved, resulting in a freedom from major adverse events of 94.4%. Symptom recurrence occurred in 3 patients (17.6%) at 4, 5, and 7 months from the end of the primary therapy. Retreatment with omalizumab was successful without any adverse effects. Mean follow-up was 9.5 months (range 1–28). CONCLUSION: Add-on omalizumab therapy for refractory CSU in a real-life setting seems to be effective and safe with a relatively low incidence of symptom recurrence. Further research should investigate personalized omalizumab treatment dosages and administration intervals, and the identification of biomarkers for future treatment algorithms.
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spelling pubmed-60023232018-06-29 Omalizumab in Chronic Spontaneous Urticaria Refractory to Conventional Therapy: An Italian Retrospective Clinical Analysis with Suggestions for Long-Term Maintenance Strategies Mandel, Victor D. Guanti, Mario B. Liberati, Serena Demonte, Antongiulio Pellacani, Giovanni Pepe, Patrizia Dermatol Ther (Heidelb) Original Research INTRODUCTION: Omalizumab is indicated for the treatment of patients affected by chronic spontaneous urticaria (CSU) refractory to antihistamines. The aim of this study was to assess the efficacy, safety, and recurrence of symptoms in a real-life experience of omalizumab as an add-on therapy for H(1)-antihistamine-refractory CSU patients (refractory CSU). METHODS: A retrospective review of the clinical records of all refractory CSU treated with omalizumab at our dermatology center from June 2014 to April 2017 was performed. Patients previously treated with second-generation antihistamines at a fourfold increased dose without clinical responses at 4 weeks of treatment were selected. Omalizumab was administered at a single dosage of 300 mg every 4 weeks for 6 months. Disease severity was assessed using the 7-day Urticaria Activity Score (UAS7). RESULTS: Eighteen patients (14 women; mean age 51 years, range 25–74) were enrolled. Mean UAS7 at baseline was 27.3 (range 15–38). Symptoms improved in all patients at 4 weeks (UAS7 = 16.1, range 0–36). Treatment was completed in 17 patients (94.4%), and among these, a complete response (UAS7 = 0) was registered in 10 patients (58.8%). Adverse events included thrombocytopenia in 1 patient (5.6%) at 16 weeks; therapy was suspended after 20 weeks and the complication was resolved, resulting in a freedom from major adverse events of 94.4%. Symptom recurrence occurred in 3 patients (17.6%) at 4, 5, and 7 months from the end of the primary therapy. Retreatment with omalizumab was successful without any adverse effects. Mean follow-up was 9.5 months (range 1–28). CONCLUSION: Add-on omalizumab therapy for refractory CSU in a real-life setting seems to be effective and safe with a relatively low incidence of symptom recurrence. Further research should investigate personalized omalizumab treatment dosages and administration intervals, and the identification of biomarkers for future treatment algorithms. Springer Healthcare 2018-05-16 /pmc/articles/PMC6002323/ /pubmed/29770909 http://dx.doi.org/10.1007/s13555-018-0240-7 Text en © The Author(s) 2018 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Original Research
Mandel, Victor D.
Guanti, Mario B.
Liberati, Serena
Demonte, Antongiulio
Pellacani, Giovanni
Pepe, Patrizia
Omalizumab in Chronic Spontaneous Urticaria Refractory to Conventional Therapy: An Italian Retrospective Clinical Analysis with Suggestions for Long-Term Maintenance Strategies
title Omalizumab in Chronic Spontaneous Urticaria Refractory to Conventional Therapy: An Italian Retrospective Clinical Analysis with Suggestions for Long-Term Maintenance Strategies
title_full Omalizumab in Chronic Spontaneous Urticaria Refractory to Conventional Therapy: An Italian Retrospective Clinical Analysis with Suggestions for Long-Term Maintenance Strategies
title_fullStr Omalizumab in Chronic Spontaneous Urticaria Refractory to Conventional Therapy: An Italian Retrospective Clinical Analysis with Suggestions for Long-Term Maintenance Strategies
title_full_unstemmed Omalizumab in Chronic Spontaneous Urticaria Refractory to Conventional Therapy: An Italian Retrospective Clinical Analysis with Suggestions for Long-Term Maintenance Strategies
title_short Omalizumab in Chronic Spontaneous Urticaria Refractory to Conventional Therapy: An Italian Retrospective Clinical Analysis with Suggestions for Long-Term Maintenance Strategies
title_sort omalizumab in chronic spontaneous urticaria refractory to conventional therapy: an italian retrospective clinical analysis with suggestions for long-term maintenance strategies
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6002323/
https://www.ncbi.nlm.nih.gov/pubmed/29770909
http://dx.doi.org/10.1007/s13555-018-0240-7
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