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 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).
Competing Interests: Thomas Casale is a consultant and speaker bureau member for Genentech, Inc.; consultant for Novartis Pharmaceuticals Corporation. Benjamin Trzaskoma and Michael Holden are employees of Genentech, Inc.; stockholders in Roche. Jonathan Bernstein is a consultant and PI for Genentech, Inc., Novartis, Amgen, GSK, Sanofi-Regeneron, AstraZeneca, Celldex, Allakos, Escient, Teva, Takeda/Shire, CSL Behring, Biocryst, Kalvista, Ionis, Biomarin, Pharming, Jasper. Marcus Maurer is a speaker and/or advisor for and/or has received research funding from Allakos, Alexion, Almirall, Alvotech, Amgen, Aquestive, Arcensus, argenX, AstraZeneca, Astria, BioCryst, Blueprint, Celldex, Celltrion, Clinuvel, Cogent, CSL Behring, Escient, Evommune, Excellergy, Genentech, GSK, Incyte, Jasper, Kashiv, Kalvista, Kyowa Kirin, Leo Pharma, Lilly, Menarini, Mitsubishi Tanabe Pharma, Moxie, Noucor, Novartis, Orion Biotechnology, Pharvaris, Resonance Medicine, Sanofi/Regeneron, Santa Ana Bio, Septerna, Servier, Takeda, Teva, Third HarmonicBio, Valenza Bio, Vitalli Bio, Yuhan Corporation, Zurabio.
(© 2024 The Authors.)