Rupatadine improves quality of life in mastocytosis: a randomized, double-blind, placebo-controlled trial

Authors

  • F. Siebenhaar,

    Corresponding author
    • Department of Dermatology and Allergy, Interdisciplinary Mastocytosis Center Charité, Charité - Universitätsmedizin Berlin, Berlin, Germany
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  • A. Förtsch,

    1. Department of Dermatology and Allergy, Interdisciplinary Mastocytosis Center Charité, Charité - Universitätsmedizin Berlin, Berlin, Germany
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  • K. Krause,

    1. Department of Dermatology and Allergy, Interdisciplinary Mastocytosis Center Charité, Charité - Universitätsmedizin Berlin, Berlin, Germany
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  • K. Weller,

    1. Department of Dermatology and Allergy, Interdisciplinary Mastocytosis Center Charité, Charité - Universitätsmedizin Berlin, Berlin, Germany
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  • M. Metz,

    1. Department of Dermatology and Allergy, Interdisciplinary Mastocytosis Center Charité, Charité - Universitätsmedizin Berlin, Berlin, Germany
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  • M. Magerl,

    1. Department of Dermatology and Allergy, Interdisciplinary Mastocytosis Center Charité, Charité - Universitätsmedizin Berlin, Berlin, Germany
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  • P. Martus,

    1. Department of Medical Biostatistics, Universitätsklinikum Tübingen, Tübingen, Germany
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  • M. K. Church,

    1. Department of Dermatology and Allergy, Interdisciplinary Mastocytosis Center Charité, Charité - Universitätsmedizin Berlin, Berlin, Germany
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  • M. Maurer

    1. Department of Dermatology and Allergy, Interdisciplinary Mastocytosis Center Charité, Charité - Universitätsmedizin Berlin, Berlin, Germany
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  • Edited by: Thomas Bieber
  • This study was financially supported by the urticaria network e.V. (UNEV, www.urtikaria.net) and an unrestricted grant from J. Uriach y Compania., S.A. Barcelona, Spain.

Correspondence

Dr. Frank Siebenhaar, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany.

Tel.: +49-30-450-518043

Fax: +49-30-450-518972

E-mail: frank.siebenhaar@charite.de

Abstract

Background

Mastocytosis is frequently associated with mast cell-mediated symptoms which require relieving medication. While second generation antihistamines (sgAHs) are the first line therapeutic strategy to treat mast cell mediator-related symptoms, controlled clinical trials on how they improve quality of life have not been performed.

Methods

This randomized, double-blind, placebo-controlled, cross-over trial assessed rupatadine 20 mg daily in the treatment of mastocytosis symptoms in 30 adult patients. Symptoms were assessed by a visual analogue scale (VAS) and symptom specific quality of life questionnaire (ItchyQoL).

Results

The mean ItchyQoL total score and VAS symptom score were significantly improved in the rupatadine treatment phase compared with placebo. There were also significant reductions from placebo in the severity of itch, wheal and flare, flushing, tachycardia and headache but not gastrointestinal symptoms.

Conclusions

In this first comprehensive trial of a sgAH in mastocytosis, rupatadine 20 mg daily for 4 weeks significantly controlled symptoms and improved patients' quality of life.

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