{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,19]],"date-time":"2026-07-19T06:43:37Z","timestamp":1784443417110,"version":"3.55.0"},"reference-count":34,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2023,7,12]],"date-time":"2023-07-12T00:00:00Z","timestamp":1689120000000},"content-version":"vor","delay-in-days":8,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,3,28]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>The aim of this article is to investigate the efficacy and safety of tocilizumab in Japanese patients with systemic sclerosis.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Post hoc subgroup analysis of a global, randomised, controlled trial in patients treated with weekly tocilizumab 162\u2009mg or placebo subcutaneously in a 48-week double-blind period (tocilizumab and placebo groups) followed by tocilizumab for 48\u2009weeks in an open-label extension (continuous-tocilizumab and placebo-tocilizumab groups).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Among 20 patients, 12 were randomised to tocilizumab (all had interstitial lung disease) and eight were randomised to placebo (six had interstitial lung disease). The modified Rodnan skin score improved in both treatment groups. The mean change in percent-predicted forced vital capacity was 3.3% [95% confidence interval (CI), \u22122.5 to 9.0] for tocilizumab and \u22123.8% (95% CI, \u22129.9 to 2.2) for placebo in the double-blind period and 2.0% (95% CI, \u22120.7 to 4.6) for continuous-tocilizumab and \u22121.4% (95% CI, \u22126.7 to 4.0) for placebo-tocilizumab in the open-label extension. Rates of serious adverse events per 100 patient-years were 19.3 for tocilizumab and 26.8 for placebo in the double-blind period and 0.0 for continuous-tocilizumab and 13.6 for placebo-tocilizumab in the open-label period.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The efficacy and safety of tocilizumab in patients with systemic sclerosis were consistent between the Japanese subpopulation and the global trial population.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/mr\/road068","type":"journal-article","created":{"date-parts":[[2023,7,12]],"date-time":"2023-07-12T15:54:30Z","timestamp":1689177270000},"page":"530-540","source":"Crossref","is-referenced-by-count":8,"title":["Efficacy and\u00a0safety of\u00a0tocilizumab in\u00a0Japanese patients with systemic sclerosis and\u00a0associated interstitial lung disease: A subgroup analysis of\u00a0a global, randomised, controlled Phase 3 trial"],"prefix":"10.1093","volume":"34","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8352-6136","authenticated-orcid":false,"given":"Masataka","family":"Kuwana","sequence":"first","affiliation":[{"name":"Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuhiko","family":"Takehara","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University , Ishikawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0807-7139","authenticated-orcid":false,"given":"Yoshiya","family":"Tanaka","sequence":"additional","affiliation":[{"name":"The First Department of Internal Medicine, University of Occupational and Environmental Health , Fukuoka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katsuhisa","family":"Yamashita","sequence":"additional","affiliation":[{"name":"Chugai Pharmaceutical Co., Ltd , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyoko","family":"Katsumata","sequence":"additional","affiliation":[{"name":"Chugai Pharmaceutical Co., Ltd , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mai","family":"Takata","sequence":"additional","affiliation":[{"name":"Chugai Pharmaceutical Co., Ltd , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2523-2938","authenticated-orcid":false,"given":"Yoshihito","family":"Shima","sequence":"additional","affiliation":[{"name":"Laboratory of Thermo-therapeutics for Vascular Dysfunction\/Clinical Immunology, Osaka University Graduate School of Medicine , Osaka, 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