{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T14:55:32Z","timestamp":1777560932480,"version":"3.51.4"},"reference-count":30,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2021,1,31]],"date-time":"2021-01-31T00:00:00Z","timestamp":1612051200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Mycoses"],"published-print":{"date-parts":[[2021,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Isavuconazole is a broad\u2010spectrum triazole for the treatment of invasive fungal disease (IFD).<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>To investigate the clinical experience with isavuconazole in Chinese individuals.<\/jats:p><\/jats:sec><jats:sec><jats:title>Patients\/Methods<\/jats:title><jats:p>Participants were Chinese healthy volunteers from a Phase I pharmacokinetics (PK) and safety study of single\/multiple doses of isavuconazole (<jats:italic>n<\/jats:italic>\u00a0=\u00a036) and Chinese patients from the global Phase\u00a0III SECURE study that assessed safety and efficacy of isavuconazole vs voriconazole for IFD treatment (<jats:italic>n<\/jats:italic>\u00a0=\u00a026).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>No clinically relevant differences in PK were found between Chinese and Western participants, although exposure was increased in Chinese volunteers. Treatment\u2010emergent adverse events (TEAEs) were reported in 75.0% of healthy volunteers, many of which were infusion\u2010related. No serious AEs were reported. In SECURE, findings in Chinese patients (<jats:italic>n<\/jats:italic>\u00a0=\u00a026) were similar to the global population. For patients who received \u22651\u00a0dose of study drug, allcause mortality from first dose to Day 42 was 10.0% (1\/10) with isavuconazole and 25.0% (4\/16) with voriconazole (treatment difference [95% confidence interval, CI]: \u221215.0% [\u221243.2%, 13.2%]). Overall response at the end of treatment for patients with proven\/probable IFD was 25.0% and 16.7% with isavuconazole and voriconazole, respectively (treatment difference [95% CI] \u22128.3% [\u221260.2%, 43.5%]). Isavuconazole was associated with lower incidence of hepatobiliary, eye, skin, subcutaneous tissue and psychiatric disorders compared with voriconazole and lower incidence of treatment\u2010related TEAEs, serious TEAES or death overall.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Although further research is required, this study demonstrated a favourable risk\u2013benefit profile of isavuconazole in Chinese patients.<\/jats:p><\/jats:sec>","DOI":"10.1111\/myc.13233","type":"journal-article","created":{"date-parts":[[2020,12,24]],"date-time":"2020-12-24T14:33:13Z","timestamp":1608820393000},"page":"445-456","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Clinical experience with isavuconazole in healthy volunteers and patients with invasive aspergillosis in China, and the results from an exposure\u2013response analysis"],"prefix":"10.1111","volume":"64","author":[{"given":"Jing","family":"Zhang","sequence":"first","affiliation":[{"name":"Institute of Antibiotics, Huashan Hospital Fudan University Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yingyuan","family":"Zhang","sequence":"additional","affiliation":[{"name":"Institute of Antibiotics, Huashan Hospital Fudan University Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Depei","family":"Wu","sequence":"additional","affiliation":[{"name":"Department of Hematology the First Affiliated Hospital of Soochow University Suzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Guoying","family":"Cao","sequence":"additional","affiliation":[{"name":"Institute of Antibiotics, Huashan Hospital Fudan University Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1896-9736","authenticated-orcid":false,"given":"Kamal","family":"Hamed","sequence":"additional","affiliation":[{"name":"Basilea Pharmaceutica International Ltd. Basel Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amit","family":"Desai","sequence":"additional","affiliation":[{"name":"Astellas Pharma Inc Northbrook IL USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5184-1182","authenticated-orcid":false,"given":"Jalal A.","family":"Aram","sequence":"additional","affiliation":[{"name":"Pfizer Inc New York City NY USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xuan","family":"Guo","sequence":"additional","affiliation":[{"name":"Pfizer Inc Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rana","family":"Fayyad","sequence":"additional","affiliation":[{"name":"Pfizer Inc New York City NY USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9599-3137","authenticated-orcid":false,"given":"Oliver A.","family":"Cornely","sequence":"additional","affiliation":[{"name":"University of Cologne, Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Excellence Center for Medical Mycology (ECMM) Cologne Germany"},{"name":"Cologne Excellence Cluster on Cellular Stress Responses in Aging\u2010Associated Diseases (CECAD) Cologne Germany"},{"name":"Clinical Trials Centre Cologne (ZKS K\u00f6ln) Cologne Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,1,31]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.02023-18"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1469-0691.2009.03015.x"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.00062206"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13054-014-0722-7"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13277-014-2649-7"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.bbmt.2015.03.018"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1086\/651262"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0149964"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-3026(15)00028-9"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciw326"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmi.2018.01.002"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/myc.13082"},{"issue":"6","key":"e_1_2_8_14_1","first-page":"453","article-title":"The Chinese guidelines for the diagnosis and treatment of invasive fungal disease in patients with hematological disorders and cancers (the fifth revision)","volume":"56","author":"Chinese Invasive Fungal Disease Working Group","year":"2017","journal-title":"Zhonghua Nei Ke Za Zhi"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01355-13"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.02301-13"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01354-13"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.04055-14"},{"key":"e_1_2_8_19_1","unstructured":"US Food and Drug Administration.Cresemba (isavuconazonium sulfate) prescribing information. 2019 (14 February 2020).https:\/\/www.astellas.us\/docs\/cresemba.pdf. Accessed 11 Aug 2020."},{"key":"e_1_2_8_20_1","unstructured":"European Medicines Agency.Cresemba (isavuconazole);2019.https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/cresemba. Accessed 11 Aug 2020."},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa020191"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(15)01159-9"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1111\/myc.12831"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1111\/myc.12885"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1469-0691.2011.03503.x"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.02819-15"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.1111\/myc.13189"},{"key":"e_1_2_8_28_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.46.8.2546-2553.2002"},{"key":"e_1_2_8_29_1","unstructured":"Pfizer Inc.Vfend full US prescribing information (Pfizer Inc);2019.http:\/\/labeling.pfizer.com\/showlabeling.aspx?id=618. Accessed 11 Aug 2020."},{"key":"e_1_2_8_30_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01034-17"},{"key":"e_1_2_8_31_1","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dky463"}],"container-title":["Mycoses"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/myc.13233","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/myc.13233","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/myc.13233","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,29]],"date-time":"2023-08-29T22:22:07Z","timestamp":1693347727000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/myc.13233"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,1,31]]},"references-count":30,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2021,4]]}},"alternative-id":["10.1111\/myc.13233"],"URL":"https:\/\/doi.org\/10.1111\/myc.13233","archive":["Portico"],"relation":{},"ISSN":["0933-7407","1439-0507"],"issn-type":[{"value":"0933-7407","type":"print"},{"value":"1439-0507","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,1,31]]},"assertion":[{"value":"2020-11-23","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-12-18","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-01-31","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}