Subcutaneous Human C1-Inhibitor with Recombinant Human Hyaluronidase for the Prevention of Angioedema Attacks in Patients with Hereditary Angioedema: Results of a Randomized, Double-Blind, Dose-Ranging, Crossover Study

Autor: H. Henry Li, Jennifer Schranz, William R. Lumry, Jonathan A. Bernstein, Hongzi Chen, Marcus Maurer, Marc A. Riedl, Markus Magerl, Murat Bas, Aleena Banerji
Rok vydání: 2015
Předmět:
Zdroj: Journal of Allergy and Clinical Immunology. 135:AB278
ISSN: 0091-6749
DOI: 10.1016/j.jaci.2014.12.1849
Popis: T U E S D A Y 902 The Icatibant Outcome Survey: Trigger Factors and Premonitory Symptoms of Angioedema Attacks in Patients with Hereditary Angioedema Teresa Caballero, Marcus Maurer, Hilary Longhurst, Werner Aberer, Laurence Bouillet, Vincent Fabien, Andrea Zanichelli, MD; Hospital La Paz Institute for Health Research (IdiPaz), Biomedical Research Network on Rare Diseases (CIBERER, U754), Madrid, Spain, Department of Dermatology and Allergy, Allergie-CentrumCharit e, Charit e Universit€atsmedizin Berlin, Berlin, Germany, Department of Immunology, Barts Health NHS Trust, London, United Kingdom, Department of Dermatology and Venereology, Medical University of Graz, Graz, Austria, National Reference Centre for Angioedema, Internal Medicine Department, Grenoble University Hospital, Grenoble, France, Shire, Zug, Switzerland, Dipartimento di Scienze Biomediche e Cliniche Luigi Sacco, Universit a degli Studi di MilanoOspedale Luigi Sacco, Milano, Italy. RATIONALE: Hereditary angioedema (HAE) is a potentially lifethreatening, bradykinin-mediated disease characterized by attacks of non-pruritic, non-pitting, subcutaneous edema with unpredictable frequency and severity. We report the most common triggers and prodromal symptoms of attacks in patients with HAE type I/II in the Icatibant Outcome Survey (IOS). METHODS: IOS (NCT01034969) is an observational study monitoring safety and effectiveness of icatibant in a real-world setting. Patients with HAE reported triggers and prodromes for attacks that occurred before IOS (historical) and those occurring during IOS. Data were collected from July 2009–April 2014. RESULTS: Of 512 patients (59.6% female) with HAE type I/II, 306 reported historical triggers (most common: emotional distress [54.9%], physical trauma [38.9%], infection [20.6%], change in estrogen levels [20.3%]), and 294 reported historical prodromes (most common: tiredness [22.4%], tight/prickling sensation in skin [16.7%], nausea [16.0%], erythema marginatum [15.6%]). During IOS, 314 patients reported 1410 attacks. Of these patients, 109 reported triggers for 324 attacks, and 89 reported prodromes for 329 attacks.Most common triggers were emotional distress (n540 attacks, 19 patients), change in estrogen levels (n523 attacks, 9 patients), and physical trauma (n59 attacks, 9 patients). Most common prodromes were erythema marginatum (n549 attacks, 23 patients), tiredness (n523 attacks, 7 patients), irritability and nausea (both n512 attacks, 9 and 4 patients, respectively). CONCLUSIONS: The most common triggers in IOS were emotional distress, change in estrogen levels and physical trauma. A variety of prodromes, including tiredness and erythema marginatum, were recognized by patients. Understanding triggers and prodromesmay help patients better recognize attack onset.
Databáze: OpenAIRE
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