Adrenal insufficiency is a contraindication for omalizumab therapy in mast cell activation disease: risk for serum sickn
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REVIEW ARTICLE
Adrenal insufficiency is a contraindication for omalizumab therapy in mast cell activation disease: risk for serum sickness G. J. Molderings 1 & F. L. Dumoulin 2 & J. Homann 2 & B. Sido 3 & J. Textor 4 & M. Mücke 5 & G. J. Qagish 6 & R. Barion 7 & M. Raithel 8 & D. Klingmüller 9 & V. S. Schäfer 10 & H. J. Hertfelder 11 & D. Berdel 12 & G. Tridente 13 & L. B. Weinstock 14 & L. B. Afrin 15 Received: 31 March 2020 / Accepted: 24 April 2020 # The Author(s) 2020
Abstract Omalizumab is an effective therapeutic humanized murine IgE antibody in many cases of primary systemic mast cell activation disease (MCAD). The present study should enable the clinician to recognize when treatment of MCAD with omalizumab is contraindicated because of the potential risk of severe serum sickness and to report our successful therapeutic strategy for such adverse event (AE). Our clinical observations, a review of the literature including the event reports in the FDA AE Reporting System, the European Medicines Agency Eudra-Vigilance databases (preferred search terms: omalizumab, Xolair®, and serum sickness) and information from the manufacturer’s Novartis database were used. Omalizumab therapy may be more likely to cause serum sickness than previously thought. In patients with regular adrenal function, serum sickness can occur after 3 to 10 days which resolves after the antigen and circulating immune complexes are cleared. If the symptoms do not resolve within a week, injection of 20 to 40 mg of prednisolone on two consecutive days could be given. However, in MCAD patients whose adrenal cortical function is completely suppressed by exogenous glucocorticoid therapy, there is a high risk that serum sickness will be masked by the MCAD and evolve in a severe form with pronounced damage of organs and tissues, potentially leading to death. Therefore, before the application of the first omalizumab dose, it is important to ensure that the function of the adrenal cortex is not significantly limited so that any occurring type III allergy can be self-limiting. Keywords Omalizumab . Mast cell activation disease . Serum sickness . Complement activation . Serum sickness therapy
Electronic supplementary material The online version of this article (https://doi.org/10.1007/s00210-020-01886-2) contains supplementary material, which is available to authorized users. * G. J. Molderings [email protected] 1
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Malteser Waldkrankenhaus St. Marien, Medical Clinic II, Erlangen, Germany
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Institute of Human Genetics, University Hospital Bonn, Venusberg-Campus 1, D-53127 Bonn, Germany
Department of Endocrinology, University Hospital Bonn, Bonn, Germany
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Department of Internal Medicine, Gemeinschaftskrankenhaus Bonn, Bonn, Germany
Department of Rheumatology and Clinical Immunology, Clinic for Internal Medicine III, University Hospital Bonn, Bonn, Germany
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Department of General and Visceral Surgery, Gemeinschaftskrankenhaus Bonn, Bonn, Germany
Institute of Experimental Hematology and Transfusion Medicine, University Hospital
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