Efficacy and Safety of Omalizumab (Xolair) for Cholinergic Urticaria in Patients Unresponsive to a Double Dose of Antihistamines: A Randomized Mixed Double-Blind and Open-Label Placebo-Controlled Clinical Trial.

Abstract

BACKGROUND:

Cholinergic urticaria (UCOL) is a highly disabling inducible urticaria triggered by an increase in core body temperature.

OBJECTIVE:

To explore the safety and efficacy of omalizumab in controlling UCOL.

METHODS:

We conducted a multicenter randomized mixed double-blind and open-label (first 4 months blinded followed by 8 months open-label) placebo-controlled clinical trial in 22 patients suffering from UCOL who were unresponsive to a double dose of antihistamines. We performed an exercise challenge test during each visit as our main outcome variable.

RESULTS:

The overall rate of exercise challenge test negative at week 48 was 31.3%, with an average increase in exercise challenge test negative rate of 2.9% points (95% CI, 1.5-4.2) per visit. Statistically significant differences in the negative exercise challenge test rate between the placebo and active intervention groups were not observed during the blinded period (first 4 months of the study). However, from the fourth dose, a progressive improvement was observed. When comparing before and after treatment, statistically significant improvements in all secondary outcome measures were noted after 4 doses (UCOL score: P = .0015; visual analog scale score: P = .0108; days with symptoms: P = .0125) and after 8 doses (UCOL score: P = .0005; chronic urticaria quality of life questionnaire: P = .0105; visual analog scale score: P = .0008; and days with symptoms: P = .0144). In the follow-up visit after the cessation of treatment, the symptoms reappeared, with positive exercise challenge test result and significant increases in all variables. Only 4 of 22 patients remained asymptomatic after 3 months of no treatment. No adverse effects were reported.

CONCLUSIONS:

This randomized mixed double-blind and open-label placebo-controlled trial showed evidence of the safety and potential efficacy of omalizumab in patients with UCOL.

• Authors: Gabriel Gastaminza, Julian Azofra, Jorge M Nunez-Cordoba, Maria Luisa Baeza, Susana Echechipía, Pere Gaig, Blanca Esther García, Moises Labrador-Horrillo, Ana Sala-Cunill, Marina Sabaté Brescó, Ana Beristain, Dolores Quiñones, Carmen Díaz Donado, José Manuel Zubeldia, Marta Ferrer
• Journal: The journal of allergy and clinical immunology. In practice (J Allergy Clin Immunol Pract) 2019 May - Jun Vol. 7 Issue 5 Pg. 1599-1609.e1 ISSN: 2213-2201 [Electronic] United States
• PMID: 30654196 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2019 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Chemical References

• Anti-Allergic Agents
• Histamine H1 Antagonists, Non-Sedating
• Omalizumab
• Cetirizine

Topics

• Adult
• Anti-Allergic Agents (therapeutic use)
• Body Temperature
• Cetirizine (administration & dosage)
• Chronic Urticaria (drug therapy, etiology)
• Double-Blind Method
• Exercise Test
• Female
• Histamine H1 Antagonists, Non-Sedating (administration & dosage)
• Hot Temperature (adverse effects)
• Humans
• Male
• Middle Aged
• Omalizumab (therapeutic use)
• Quality of Life
• Treatment Failure
• Treatment Outcome
• Young Adult