Does angioedema in patients with chronic spontaneous urticaria impact response to omalizumab?

The presence of angioedema, or deep skin swelling, in addition to hives (wheals) in patients with chronic spontaneous urticaria (CSU) can complicate disease management. There is evidence that omalizumab is effective for patients with CSU with angioedema, but the time to a clinically meaningful respo...

Full description

Bibliographic Details
Published in:World Allergy Organization Journal
Main Authors: Thomas B. Casale, MD, Benjamin Trzaskoma, MS, Michael Holden, MD, Jonathan A. Bernstein, MD, Marcus Maurer, MD
Format: Article
Language:English
Published: Elsevier 2024-08-01
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S1939455124000747
_version_ 1850377784395825152
author Thomas B. Casale, MD
Benjamin Trzaskoma, MS
Michael Holden, MD
Jonathan A. Bernstein, MD
Marcus Maurer, MD
author_facet Thomas B. Casale, MD
Benjamin Trzaskoma, MS
Michael Holden, MD
Jonathan A. Bernstein, MD
Marcus Maurer, MD
author_sort Thomas B. Casale, MD
collection DOAJ
container_title World Allergy Organization Journal
description The presence of angioedema, or deep skin swelling, in addition to hives (wheals) in patients with chronic spontaneous urticaria (CSU) can complicate disease management. There is evidence that omalizumab is effective for patients with CSU with angioedema, but the time to a clinically meaningful response has not been assessed. This post hoc analysis examined data from the phase 3, randomized, double-blind ASTERIA I and ASTERIA II studies: patients with CSU with hives were grouped by presence (n = 216) or absence of angioedema (n = 265) at baseline. The time to minimally important difference (MID, change from baseline of ≥11 points) in weekly Urticaria Activity Score (UAS7) was analyzed using Kaplan-Meier analyses. Median time to MID for omalizumab 300 mg was similar in patients with and without angioedema. Median time to MID for omalizumab 150 mg was similar to 300 mg for patients without angioedema, and was longer for patients with angioedema. Therefore, the response to omalizumab for patients with CSU with angioedema was dose dependent. We recommend that the best approach for clinicians, in line with guidelines, would be initial administration of omalizumab 300 mg every 4 weeks for all patients. Clinical trials registration: Clinicaltrials.gov NCT01287117 (registered 27 January 2011) and NCT01292473 (registered 7 February 2011).
format Article
id doaj-art-37ec73a1f4e641de8d5f4e7ac781d181
institution Directory of Open Access Journals
issn 1939-4551
language English
publishDate 2024-08-01
publisher Elsevier
record_format Article
spelling doaj-art-37ec73a1f4e641de8d5f4e7ac781d1812025-08-19T22:58:39ZengElsevierWorld Allergy Organization Journal1939-45512024-08-0117810094310.1016/j.waojou.2024.100943Does angioedema in patients with chronic spontaneous urticaria impact response to omalizumab?Thomas B. Casale, MD0Benjamin Trzaskoma, MS1Michael Holden, MD2Jonathan A. Bernstein, MD3Marcus Maurer, MD4Division of Allergy and Immunology, University of South Florida, Tampa, FL, USA; Corresponding author. Division of Allergy and Immunology, Joy McCann Culverhouse Clinical Research Center, University of South Florida, 12901 Bruce B. Downs Blvd., MDC 19, Tampa, FL 33612, USA.Genentech, Inc., South San Francisco, CA, USAGenentech, Inc., South San Francisco, CA, USACollege of Medicine, University of Cincinnati, Cincinnati, OH, USAInstitute of Allergology, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany; Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology, Berlin, GermanyThe presence of angioedema, or deep skin swelling, in addition to hives (wheals) in patients with chronic spontaneous urticaria (CSU) can complicate disease management. There is evidence that omalizumab is effective for patients with CSU with angioedema, but the time to a clinically meaningful response has not been assessed. This post hoc analysis examined data from the phase 3, randomized, double-blind ASTERIA I and ASTERIA II studies: patients with CSU with hives were grouped by presence (n = 216) or absence of angioedema (n = 265) at baseline. The time to minimally important difference (MID, change from baseline of ≥11 points) in weekly Urticaria Activity Score (UAS7) was analyzed using Kaplan-Meier analyses. Median time to MID for omalizumab 300 mg was similar in patients with and without angioedema. Median time to MID for omalizumab 150 mg was similar to 300 mg for patients without angioedema, and was longer for patients with angioedema. Therefore, the response to omalizumab for patients with CSU with angioedema was dose dependent. We recommend that the best approach for clinicians, in line with guidelines, would be initial administration of omalizumab 300 mg every 4 weeks for all patients. Clinical trials registration: Clinicaltrials.gov NCT01287117 (registered 27 January 2011) and NCT01292473 (registered 7 February 2011).http://www.sciencedirect.com/science/article/pii/S1939455124000747AngioedemaChronic spontaneous urticariaOmalizumab
spellingShingle Thomas B. Casale, MD
Benjamin Trzaskoma, MS
Michael Holden, MD
Jonathan A. Bernstein, MD
Marcus Maurer, MD
Does angioedema in patients with chronic spontaneous urticaria impact response to omalizumab?
Angioedema
Chronic spontaneous urticaria
Omalizumab
title Does angioedema in patients with chronic spontaneous urticaria impact response to omalizumab?
title_full Does angioedema in patients with chronic spontaneous urticaria impact response to omalizumab?
title_fullStr Does angioedema in patients with chronic spontaneous urticaria impact response to omalizumab?
title_full_unstemmed Does angioedema in patients with chronic spontaneous urticaria impact response to omalizumab?
title_short Does angioedema in patients with chronic spontaneous urticaria impact response to omalizumab?
title_sort does angioedema in patients with chronic spontaneous urticaria impact response to omalizumab
topic Angioedema
Chronic spontaneous urticaria
Omalizumab
url http://www.sciencedirect.com/science/article/pii/S1939455124000747
work_keys_str_mv AT thomasbcasalemd doesangioedemainpatientswithchronicspontaneousurticariaimpactresponsetoomalizumab
AT benjamintrzaskomams doesangioedemainpatientswithchronicspontaneousurticariaimpactresponsetoomalizumab
AT michaelholdenmd doesangioedemainpatientswithchronicspontaneousurticariaimpactresponsetoomalizumab
AT jonathanabernsteinmd doesangioedemainpatientswithchronicspontaneousurticariaimpactresponsetoomalizumab
AT marcusmaurermd doesangioedemainpatientswithchronicspontaneousurticariaimpactresponsetoomalizumab