{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T15:11:11Z","timestamp":1787670671030,"version":"build-2736575974"},"reference-count":18,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2022,4,28]],"date-time":"2022-04-28T00:00:00Z","timestamp":1651104000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,3,2]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>This subgroup analysis of the randomized, double-blind, Phase 3 ADVOCATE study evaluated the efficacy and safety of avacopan compared with tapered prednisone in Japanese patients with antineutrophil cytoplasmic antibody-associated vasculitis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients with microscopic polyangiitis (MPA) or granulomatosis with polyangiitis (GPA) received either avacopan 30\u2009mg twice daily for 52\u2009weeks plus prednisone-matching placebo or tapered prednisone over 20\u2009weeks plus avacopan-matching placebo for 52\u2009weeks. The two primary efficacy endpoints were clinical remission at Week 26 and sustained remission at Week 52.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Compared with the overall population (N\u2009=\u2009330), Japanese patients (N\u2009=\u200921) were older and had worse renal function, and a higher proportion were female and had MPA. The proportion of Japanese patients with clinical remission at Week 26 was 9\/11 (81.8%) with avacopan vs. 7\/10 (70.0%) with prednisone (overall population: 72.3% vs. 70.1%) and with sustained remission at Week 52 was 8\/11 (72.7%) vs. 4\/10 (40.0%), respectively (overall population: 65.7% vs. 54.9%). The safety profile of avacopan was similar in Japanese patients and the overall study population.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The efficacy and safety of avacopan in Japanese patients with MPA or GPA were comparable to that observed in the overall ADVOCATE study population.<\/jats:p><\/jats:sec>","DOI":"10.1093\/mr\/roac037","type":"journal-article","created":{"date-parts":[[2022,4,28]],"date-time":"2022-04-28T16:46:47Z","timestamp":1651164407000},"page":"338-345","source":"Crossref","is-referenced-by-count":20,"title":["Efficacy and safety of avacopan in Japanese patients with antineutrophil cytoplasmic antibody-associated vasculitis: A subanalysis of a randomized Phase 3 study"],"prefix":"10.1093","volume":"33","author":[{"given":"Masayoshi","family":"Harigai","sequence":"first","affiliation":[{"name":"Division of Rheumatology, Department of Internal Medicine, Tokyo Women\u2019s Medical University School of Medicine , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinya","family":"Kaname","sequence":"additional","affiliation":[{"name":"Department of Nephrology and Rheumatology, Kyorin University School of Medicine , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1729-2954","authenticated-orcid":false,"given":"Naoto","family":"Tamura","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Rheumatology, Juntendo University Faculty of Medicine , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroaki","family":"Dobashi","sequence":"additional","affiliation":[{"name":"Division of Hematology, Rheumatology and Respiratory Medicine, Department of Internal Medicine, Faculty of Medicine, Kagawa University , Kagawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinichi","family":"Kubono","sequence":"additional","affiliation":[{"name":"Medical Research Department, Kissei Pharmaceutical Co., Ltd. , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takumitsu","family":"Yoshida","sequence":"additional","affiliation":[{"name":"Clinical Projects Management Department, Kissei Pharmaceutical Co., Ltd. , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2022,4,28]]},"reference":[{"key":"2023030304341779300_","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1002\/art.37715","article-title":"2012 Revised International Chapel Hill Consensus Conference nomenclature of vasculitides","volume":"65","author":"Jennette","year":"2013","journal-title":"Arthritis 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