{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T03:42:20Z","timestamp":1740109340894,"version":"3.37.3"},"reference-count":18,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2022,11,8]],"date-time":"2022-11-08T00:00:00Z","timestamp":1667865600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"National Institute of Biomedical Innovation, Health and Nutrition"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,11,1]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>We conducted a Phase 3, multicentre, randomised, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of intravenous immunoglobulin (IVIg) in patients with glucocorticoid-refractory neuropathy associated with microscopic polyangiitis.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Patients received immunoglobulin or placebo intravenously for 5 consecutive days at baseline and after 4 weeks. The IVIg and placebo groups received IVIg and placebo, respectively, after 8 weeks. The primary and major secondary end-points were the least squares mean of the change in the manual muscle test (MMT) sum score after 8 and 4 weeks, respectively.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>A total of 37 patients were randomised into two groups (IVIg [19] and placebo [18]). The least squares mean for the change in the MMT sum score was 9.02 for IVIg and 6.71 for placebo (difference 2.32, 95% confidence interval \u22122.60 to 7.23, p\u2009=\u2009.345) after 8 weeks and 6.81 and 2.83 (difference 3.99, 95% confidence interval \u22121.22 to 9.19, p\u2009=\u2009.129), respectively, after 4 weeks. There were no new safety concerns for IVIg.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>MMT sum scores improved with IVIg compared with placebo after 8 weeks of dosing and two courses of treatment, but the differences were not statistically significant, and the results showed no clear efficacy of IVIg in this patient population. No new safety concerns were raised.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/mr\/roac137","type":"journal-article","created":{"date-parts":[[2022,11,8]],"date-time":"2022-11-08T15:51:02Z","timestamp":1667922662000},"page":"1125-1136","source":"Crossref","is-referenced-by-count":0,"title":["Intravenous immunoglobulin for chronic residual peripheral neuropathy in microscopic polyangiitis: A multicentre randomised double-blind trial"],"prefix":"10.1093","volume":"33","author":[{"given":"Yoshihiro","family":"Arimura","sequence":"first","affiliation":[{"name":"Department of Nephrology and Rheumatology, Kyorin University School of Medicine , Tokyo,","place":["Japan"]},{"name":"Department of Internal Medicine, Kichijoji Asahi Hospital , Tokyo,","place":["Japan"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gen","family":"Sobue","sequence":"additional","affiliation":[{"name":"Aichi Medical University , Aichi,","place":["Japan"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naoki","family":"Hattori","sequence":"additional","affiliation":[{"name":"Department of Neurology, Toyota Kosei Hospital , Aichi,","place":["Japan"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroshi","family":"Takashima","sequence":"additional","affiliation":[{"name":"Department of Neurology and Geriatrics, Kagoshima University Graduate School of Medical and Dental Sciences , Kagoshima,","place":["Japan"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6418-2603","authenticated-orcid":false,"given":"Masayoshi","family":"Harigai","sequence":"additional","affiliation":[{"name":"Division of Rheumatology, Department of Internal Medicine, Tokyo Women\u2019s Medical University School of Medicine , Tokyo,","place":["Japan"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Koichi","family":"Nagata","sequence":"additional","affiliation":[{"name":"Clinical Development Department, Teijin Pharma Limited , Tokyo,","place":["Japan"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hirofumi","family":"Makino","sequence":"additional","affiliation":[{"name":"Okayama University , Okayama,","place":["Japan"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2022,11,8]]},"reference":[{"key":"2024101109362081700_R1","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 Rheum"},{"key":"2024101109362081700_R2","doi-asserted-by":"crossref","first-page":"1366","DOI":"10.1002\/art.41773","article-title":"2021 American College of Rheumatology\/Vasculitis Foundation Guideline for the management of antineutrophil cytoplasmic antibody-associated vasculitis","volume":"73","author":"Chung","year":"2021","journal-title":"Arthritis Rheum"},{"key":"2024101109362081700_R3","doi-asserted-by":"crossref","first-page":"299","DOI":"10.1253\/circj.CJ-19-0773","article-title":"JCS 2017 guideline on management of vasculitis syndrome \u2013 digest version","volume":"84","author":"Isobe","year":"2020","journal-title":"Circ J"},{"key":"2024101109362081700_R4","doi-asserted-by":"crossref","first-page":"20","DOI":"10.1080\/14397595.2018.1500437","article-title":"2017 Clinical practice guidelines of the Japan Research Committee of the Ministry of Health, Labour, and Welfare for intractable vasculitis for the management of ANCA-associated vasculitis","volume":"29","author":"Harigai","year":"2019","journal-title":"Mod Rheumatol"},{"key":"2024101109362081700_R5","first-page":"1408","article-title":"Mortality and morbidity in peripheral neuropathy associated Churg-Strauss syndrome and microscopic polyangiitis","volume":"29","author":"Hattori","year":"2002","journal-title":"J Rheumatol"},{"key":"2024101109362081700_R6","doi-asserted-by":"crossref","first-page":"1916","DOI":"10.1093\/rheumatology\/ker205","article-title":"Comparison of the epidemiology of anti-neutrophil cytoplasmic antibody-associated vasculitis between Japan and the UK","volume":"50","author":"Fujimoto","year":"2011","journal-title":"Rheumatology"},{"author":"Ministry of Health, Labour and Welfare.","key":"2024101109362081700_R7","article-title":"Number of Recipients of Certificates for Specific Medical Care Expenditure (Designated Intractable\u00a0Disease) by Report on Public Health Administration and Services from the Ministry of Health, Labour, and Welfare (as of the Fiscal End of 2020). 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