{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T13:26:39Z","timestamp":1792761999552,"version":"4.5.0"},"reference-count":34,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2017,12,12]],"date-time":"2017-12-12T00:00:00Z","timestamp":1513036800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clin Experimental Allergy"],"published-print":{"date-parts":[[2018,2]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Omalizumab has been shown to be effective in treating chronic spontaneous urticaria (<jats:styled-content style=\"fixed-case\">CSU<\/jats:styled-content>). The reduction in Fc\u03b5<jats:styled-content style=\"fixed-case\">RI<\/jats:styled-content> receptor density on the surface of basophils and mast cells is thought to play a major role in its effectiveness. We conducted a double\u2010blind, randomized, placebo\u2010controlled trial to investigate the mode of action of omalizumab in patients with antihistamine\u2010resistant <jats:styled-content style=\"fixed-case\">CSU<\/jats:styled-content>.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Thirty patients were randomized in a 2:1 ratio to receive either 300\u00a0mg omalizumab or placebo. Four monthly applications of omalizumab\/placebo were followed up with a visit 2\u00a0months after the last injection. The primary endpoint was the Fc\u03b5<jats:styled-content style=\"fixed-case\">RI<\/jats:styled-content> receptor density change on basophils.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Omalizumab led to a significant reduction in Fc\u03b5<jats:styled-content style=\"fixed-case\">RI<\/jats:styled-content> receptor density on basophils as soon as 1\u00a0week after the first injection: baseline omalizumab vs placebo group, 80.31\u00a0\u00b1\u00a047.18\u00a0\u00d7\u00a010\u00b3 vs 78.29\u00a0\u00b1\u00a045.09\u00a0\u00d7\u00a010\u00b3 receptors\/basophil\u00a0\u00b1\u00a0<jats:styled-content style=\"fixed-case\">SD<\/jats:styled-content>; 1\u00a0week, 72.89\u00a0\u00b1\u00a047.79\u00a0\u00d7\u00a010\u00b3 vs 27.83\u00a0\u00b1\u00a020.87\u00a0\u00d7\u00a010\u00b3, <jats:italic>P<\/jats:italic>\u00a0=\u00a0.001. This effect continued during the treatment phase and persisted for 2\u00a0months after the last injection: 93.81\u00a0\u00b1\u00a056.50\u00a0\u00d7\u00a010\u00b3 vs 21.09\u00a0\u00b1\u00a015.23\u00a0\u00d7\u00a010\u00b3, <jats:italic>P<\/jats:italic>\u00a0=\u00a0.002. Values for basophil \u201creleasability\u201d and the basophil activation test (<jats:styled-content style=\"fixed-case\">CU<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">BAT<\/jats:styled-content>) of patient serum using donor basophils were unchanged despite treatment: <jats:styled-content style=\"fixed-case\">CU<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">BAT<\/jats:styled-content>,<jats:styled-content style=\"fixed-case\"> CD<\/jats:styled-content>63 10.75% (7.35) in the placebo group vs 8.35% (15.20) in the omalizumab group, <jats:italic>P<\/jats:italic>\u00a0=\u00a0.778.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>We demonstrated a rapid reduction of Fc\u03b5<jats:styled-content style=\"fixed-case\">RI<\/jats:styled-content> receptor density on basophils following treatment with omalizumab. Because <jats:styled-content style=\"fixed-case\">CU<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">BAT<\/jats:styled-content> using well\u2010characterized, omalizumab\u2010na\u00efve donor basophils did not change during the treatment phase, autoreactive serum factors seem to remain unaltered. This points towards a cellular effect of omalizumab on basophils. To predict the omalizumab response time and to monitor disease, Fc\u03b5<jats:styled-content style=\"fixed-case\">RI<\/jats:styled-content> density and <jats:styled-content style=\"fixed-case\">CU<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">BAT<\/jats:styled-content> might be promising cellular\u2010based assays.<\/jats:p><\/jats:sec>","DOI":"10.1111\/cea.13066","type":"journal-article","created":{"date-parts":[[2017,11,22]],"date-time":"2017-11-22T08:59:01Z","timestamp":1511341141000},"page":"196-204","source":"Crossref","is-referenced-by-count":56,"title":["Double\u2010blind placebo\u2010controlled trial of the effect of omalizumab on basophils in chronic urticaria patients"],"prefix":"10.1111","volume":"48","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1512-4279","authenticated-orcid":false,"given":"L.","family":"J\u00f6rg","sequence":"first","affiliation":[{"name":"Department of Rheumatology, Immunology and Allergology, Inselspital Bern University Hospital University of Bern Bern Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T.","family":"Pecaric\u2010Petkovic","sequence":"additional","affiliation":[{"name":"Adverse Drug Reactions, Analysis and Consulting ADR\u2010AC GmbH Bern Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Reichenbach","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Immunology and Allergology, Inselspital Bern University Hospital University of Bern Bern Switzerland"},{"name":"Clinical Trial Unit University of Bern Bern Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Coslovsky","sequence":"additional","affiliation":[{"name":"Clinical Trial Unit University of Bern Bern Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"O.","family":"Stalder","sequence":"additional","affiliation":[{"name":"Clinical Trial Unit University of Bern Bern Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W.","family":"Pichler","sequence":"additional","affiliation":[{"name":"Adverse Drug Reactions, Analysis and Consulting ADR\u2010AC GmbH Bern Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"O.","family":"Hausmann","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Immunology and Allergology, Inselspital Bern University Hospital University of Bern Bern Switzerland"},{"name":"Adverse Drug Reactions, Analysis and Consulting ADR\u2010AC GmbH Bern Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2017,12,12]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2230.2010.03840.x"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2014.02.036"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1067\/mjd.2003.142"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2009.11.047"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.iac.2004.01.003"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2011.06.010"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2011.04.038"},{"key":"e_1_2_7_9_1","doi-asserted-by":"crossref","first-page":"924","DOI":"10.1056\/NEJMoa1215372","article-title":"Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria","volume":"7","author":"Maurer M","year":"2013","journal-title":"N Engl J Med"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/all.12313"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1189\/jlb.70.2.207"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2004.06.032"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.2340\/00015555-2654"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.7150\/thno.18304"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2003.11.044"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.coi.2008.09.005"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1067\/mai.2001.115484"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199306033282204"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1067\/mai.2000.104939"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2006.02.016"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0091-6749(98)70176-9"},{"key":"e_1_2_7_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2011.07.021"},{"key":"e_1_2_7_23_1","doi-asserted-by":"crossref","first-page":"1059","DOI":"10.1016\/j.jaci.2016.07.047","article-title":"Serum autoreactivity predicts time to response to omalizumab therapy in chronic spontaneous urticaria","volume":"139","author":"Gericke J","year":"2016","journal-title":"J Allergy Clin Immunol"},{"key":"e_1_2_7_24_1","doi-asserted-by":"crossref","first-page":"1300","DOI":"10.1016\/j.jaci.2010.12.1085","article-title":"Omalizumab is effective in non\u2010autoimmune urticaria","volume":"127","author":"Sanz ML","year":"2011","journal-title":"J Allergy Clin Immunol"},{"key":"e_1_2_7_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-1759(99)00087-3"},{"key":"e_1_2_7_26_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2133.2006.07205.x"},{"key":"e_1_2_7_27_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1398-9995.2008.01726.x"},{"key":"e_1_2_7_28_1","doi-asserted-by":"publisher","DOI":"10.1093\/biomet\/80.1.27"},{"key":"e_1_2_7_29_1","volume-title":"Stata Statistical Software: Release 13","author":"StataCorp","year":"2013"},{"key":"e_1_2_7_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2014.04.036"},{"key":"e_1_2_7_31_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2013.04.056"},{"key":"e_1_2_7_32_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.12693"},{"key":"e_1_2_7_33_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2222.2003.01589.x"},{"key":"e_1_2_7_34_1","first-page":"1107e13","article-title":"Basophil recruitment and activation in inflammatory skin diseases","volume":"66","author":"Ito Y","year":"2011","journal-title":"Allergy"},{"key":"e_1_2_7_35_1","doi-asserted-by":"crossref","first-page":"284e92","DOI":"10.1016\/j.clim.2004.10.007","article-title":"Chronic idiopathic urticaria: infiltrating cells and related cytokines in autologous serum\u2010induced wheals","volume":"114","author":"Caproni M","year":"2005","journal-title":"Clin Immunol"}],"container-title":["Clinical &amp; Experimental Allergy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fcea.13066","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cea.13066","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,27]],"date-time":"2023-09-27T12:14:06Z","timestamp":1695816846000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/cea.13066"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,12,12]]},"references-count":34,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2018,2]]}},"alternative-id":["10.1111\/cea.13066"],"URL":"https:\/\/doi.org\/10.1111\/cea.13066","archive":["Portico"],"relation":{},"ISSN":["0954-7894","1365-2222"],"issn-type":[{"value":"0954-7894","type":"print"},{"value":"1365-2222","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,12,12]]}}}