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

Publication date: Available online 15 January 2019

Source: The Journal of Allergy and Clinical Immunology: In Practice

Author(s): 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

Abstract

Background

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

Objective

We wanted to explore the safety and efficacy of omalizumab in controlling UCOL.

Methods

We conducted a multicenter randomized mixed double-blind and open-label (first four months blinded followed by eight 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 (IC 95%: 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 four 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=0.0015; VAS: p=0.0108; days with symptoms: p=0.0125) and after 8 doses (UCOL score p=0.0005; CU2-QoL: p=0.0105; VAS p=0.0008, and days with symptoms p=0.0144). In the follow-up visit after the cessation of treatment, the symptoms reappeared, with positive exercise challenge test and significant increases in all variables. Only 4 out of 22 patients remained asymptomatic after three months of no treatment. No adverse effects were reported.

Conclusion

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

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