{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,3]],"date-time":"2026-07-03T21:26:14Z","timestamp":1783113974338,"version":"3.54.6"},"reference-count":10,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2017,3,13]],"date-time":"2017-03-13T00:00:00Z","timestamp":1489363200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008322","name":"CSL Behring","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008322","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004330","name":"GlaxoSmithKline","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004330","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004336","name":"Novartis","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004336","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004337","name":"Roche","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004337","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Allergy"],"published-print":{"date-parts":[[2017,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The Icatibant Outcome Survey (<jats:styled-content style=\"fixed-case\">IOS<\/jats:styled-content>) is an observational study monitoring safety and effectiveness of icatibant in the real\u2010world setting. We analyzed safety data from 3025 icatibant\u2010treated attacks in 557 patients (enrolled between July 2009 and February 2015). Icatibant was generally well tolerated. Excluding off\u2010label use and pregnancy, 438 patients (78.6%) did not report adverse events (<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s). The remaining 119 (21.4%) patients reported 341 <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s, primarily gastrointestinal disorders (19.6%). Of these, 43 <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s in 17 patients (3.1%) were related to icatibant. Serious <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s (<jats:styled-content style=\"fixed-case\">SAE<\/jats:styled-content>s) occurred infrequently. A total of 143 <jats:styled-content style=\"fixed-case\">SAE<\/jats:styled-content>s occurred in 59 (10.6%) patients; only three events (drug inefficacy, gastritis, and reflux esophagitis) in two patients were considered related to icatibant. Notably, no <jats:styled-content style=\"fixed-case\">SAE<\/jats:styled-content>s related to icatibant occurred in patients with cardiovascular disease, nor in those using icatibant at a frequency above label guidelines. Additionally, no major differences were noted in <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s occurring in on\u2010label <jats:italic>vs<\/jats:italic> off\u2010label icatibant users.<\/jats:p>","DOI":"10.1111\/all.13103","type":"journal-article","created":{"date-parts":[[2016,12,7]],"date-time":"2016-12-07T22:13:11Z","timestamp":1481148791000},"page":"994-998","source":"Crossref","is-referenced-by-count":16,"title":["Long\u2010term safety of icatibant treatment of patients with angioedema in real\u2010world clinical practice"],"prefix":"10.1111","volume":"72","author":[{"given":"A.","family":"Zanichelli","sequence":"first","affiliation":[{"name":"Department of Biomedical and Clinical Sciences Luigi Sacco University of Milan ASST Fatebenefratelli Sacco Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Maurer","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Allergy Charit\u00e9\u2013Universit\u00e4tsmedizin Berlin Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W.","family":"Aberer","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Venerology Medical University of Graz Graz Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T.","family":"Caballero","sequence":"additional","affiliation":[{"name":"Department of Allergy Hospital La Paz Institute for Health Research (IdiPaz) Biomedical Research Network on Rare Diseases (CIBERER, U754) Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H. J.","family":"Longhurst","sequence":"additional","affiliation":[{"name":"Department of Immunology Barts Health NHS Trust London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Bouillet","sequence":"additional","affiliation":[{"name":"National Reference Centre for Angioedema Internal Medicine Department Grenoble University Hospital Grenoble France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"V.","family":"Fabien","sequence":"additional","affiliation":[{"name":"Shire Zug Switzerland at time of data analysis; now with Vifor Pharma, Glattbrugg, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"I.","family":"Andresen","sequence":"additional","affiliation":[{"name":"Shire Zug Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the IOS Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2017,3,13]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0906393"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.anai.2011.08.015"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/cei.12358"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/all.12303"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/all.12244"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.112.118117"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1089\/hum.2011.123"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0053773"},{"key":"e_1_2_9_10_1","unstructured":"Firazyr\u00ae(icatibant) summary of product characteristics. Available at:http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_-_Product_Information\/human\/000899\/WC500022966.pdf(accessed 9 September 2016)."},{"key":"e_1_2_9_11_1","volume-title":"Firazyr\u00ae (icatibant) [package insert]. Shire Orphan Therapies, LLC","year":"2015"}],"updated-by":[{"DOI":"10.1111\/all.13259","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2018,8,30]],"date-time":"2018-08-30T00:00:00Z","timestamp":1535587200000}}],"container-title":["Allergy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fall.13103","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/all.13103","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,3]],"date-time":"2023-10-03T15:32:56Z","timestamp":1696347176000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/all.13103"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,3,13]]},"references-count":10,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2017,6]]}},"alternative-id":["10.1111\/all.13103"],"URL":"https:\/\/doi.org\/10.1111\/all.13103","archive":["Portico"],"relation":{"correction":[{"id-type":"doi","id":"10.1111\/all.13259","asserted-by":"object"}]},"ISSN":["0105-4538","1398-9995"],"issn-type":[{"value":"0105-4538","type":"print"},{"value":"1398-9995","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,3,13]]}}}