Real-world effectiveness, safety and patient-reported outcomes of sarilumab in patients with rheumatoid arthritis: a 52-week, prospective, open-label, non-interventional, observational, nationwide, large-cohort study in Japan (PROFILE-J).

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Title: Real-world effectiveness, safety and patient-reported outcomes of sarilumab in patients with rheumatoid arthritis: a 52-week, prospective, open-label, non-interventional, observational, nationwide, large-cohort study in Japan (PROFILE-J).
Authors: Tanaka Y; Department of Molecular Targeted Therapeutics, University of Occupational and Environmental Health, Kitakyushu, Japan tanaka@med.uoeh-u.ac.jp., Hanami K; The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan., Miyazaki Y; The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan., Ishigatsubo Y; Yokohama Rheumatology Clinic, Yokohama, Japan., Iwamoto T; Department of Allergy and Clinical Immunology, Graduate School of Medicine, Chiba University, Chiba, Japan., Ushio K; Rheumatology, Ushio Clinic, Osaka, Japan., Okano Y; Division of Rheumatology, Department of Medicine, National Hospital Organisation Tokyo Medical Center, Meguro, Japan., Onobori M; Rheumatology, Onobori Clinic, Tsukuba, Japan., Kawahata K; Department of Rheumatology and Allergology, St Marianna University School of Medicine, Kawasaki, Japan., Saegusa J; Department of Rheumatology and Clinical Immunology, Kobe University Hospital, Kobe, Japan., Nakamura Y; Orthopedic Surgery, Showa Inan General Hospital, Komagane, Japan., Natsumeda M; Rheumatic Disease Center, Mabi Memorial Hospital, Kurashiki, Japan., Nozaki Y; Department of Hematology and Rheumatology, Kindai University Faculty of Medicine Graduate School of Medical Sciences, Osakasayama, Japan., Miyamoto T; Department of Rheumatology, Seirei Hamamatsu General Hospital, Hamamatsu, Japan., Yamanishi Y; Rheumatology, Hiroshima Rheumatology Clinic, Hiroshima, Japan., Ishiguro N; Aichi Developmental Disability Center, Kasugai, Japan., Kumanogoh A; Department of Respiratory Medicine and Clinical Immunology, Osaka University Graduate School of Medicine, Suita, Japan., Takeuchi T; Saitama Medical University, Iruma, Japan.; Keio University School of Medicine, Shinjuku, Japan., Tohma S; National Hospital Organisation Tokyo National Hospital, Kiyose, Japan., Fujino Y; Department of Environmental Epidemiology, University of Occupational and Environmental Health, Kitakyushu, Japan., Kameda H; Division of Rheumatology, Faculty of Medicine, Toho University, Meguro, Japan.
Source: RMD open [RMD Open] 2026 May 12; Vol. 12 (2). Date of Electronic Publication: 2026 May 12.
Publication Type: Journal Article; Observational Study; Multicenter Study
Journal Info: Publisher: BMJ Publishing Group Country of Publication: England NLM ID: 101662038 Publication Model: Electronic Cited Medium: Internet ISSN: 2056-5933 (Electronic) Linking ISSN: 20565933 NLM ISO Abbreviation: RMD Open Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Real-world effectiveness, safety and patient-reported outcomes of sarilumab in patients with rheumatoid arthritis: a 52-week, prospective, open-label, non-interventional, observational, nationwide, large-cohort study in Japan (PROFILE-J).
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  Data: <searchLink fieldCode="AU" term="%22Tanaka+Y%22">Tanaka Y</searchLink>; Department of Molecular Targeted Therapeutics, University of Occupational and Environmental Health, Kitakyushu, Japan tanaka@med.uoeh-u.ac.jp.<br /><searchLink fieldCode="AU" term="%22Hanami+K%22">Hanami K</searchLink>; The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.<br /><searchLink fieldCode="AU" term="%22Miyazaki+Y%22">Miyazaki Y</searchLink>; The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.<br /><searchLink fieldCode="AU" term="%22Ishigatsubo+Y%22">Ishigatsubo Y</searchLink>; Yokohama Rheumatology Clinic, Yokohama, Japan.<br /><searchLink fieldCode="AU" term="%22Iwamoto+T%22">Iwamoto T</searchLink>; Department of Allergy and Clinical Immunology, Graduate School of Medicine, Chiba University, Chiba, Japan.<br /><searchLink fieldCode="AU" term="%22Ushio+K%22">Ushio K</searchLink>; Rheumatology, Ushio Clinic, Osaka, Japan.<br /><searchLink fieldCode="AU" term="%22Okano+Y%22">Okano Y</searchLink>; Division of Rheumatology, Department of Medicine, National Hospital Organisation Tokyo Medical Center, Meguro, Japan.<br /><searchLink fieldCode="AU" term="%22Onobori+M%22">Onobori M</searchLink>; Rheumatology, Onobori Clinic, Tsukuba, Japan.<br /><searchLink fieldCode="AU" term="%22Kawahata+K%22">Kawahata K</searchLink>; Department of Rheumatology and Allergology, St Marianna University School of Medicine, Kawasaki, Japan.<br /><searchLink fieldCode="AU" term="%22Saegusa+J%22">Saegusa J</searchLink>; Department of Rheumatology and Clinical Immunology, Kobe University Hospital, Kobe, Japan.<br /><searchLink fieldCode="AU" term="%22Nakamura+Y%22">Nakamura Y</searchLink>; Orthopedic Surgery, Showa Inan General Hospital, Komagane, Japan.<br /><searchLink fieldCode="AU" term="%22Natsumeda+M%22">Natsumeda M</searchLink>; Rheumatic Disease Center, Mabi Memorial Hospital, Kurashiki, Japan.<br /><searchLink fieldCode="AU" term="%22Nozaki+Y%22">Nozaki Y</searchLink>; Department of Hematology and Rheumatology, Kindai University Faculty of Medicine Graduate School of Medical Sciences, Osakasayama, Japan.<br /><searchLink fieldCode="AU" term="%22Miyamoto+T%22">Miyamoto T</searchLink>; Department of Rheumatology, Seirei Hamamatsu General Hospital, Hamamatsu, Japan.<br /><searchLink fieldCode="AU" term="%22Yamanishi+Y%22">Yamanishi Y</searchLink>; Rheumatology, Hiroshima Rheumatology Clinic, Hiroshima, Japan.<br /><searchLink fieldCode="AU" term="%22Ishiguro+N%22">Ishiguro N</searchLink>; Aichi Developmental Disability Center, Kasugai, Japan.<br /><searchLink fieldCode="AU" term="%22Kumanogoh+A%22">Kumanogoh A</searchLink>; Department of Respiratory Medicine and Clinical Immunology, Osaka University Graduate School of Medicine, Suita, Japan.<br /><searchLink fieldCode="AU" term="%22Takeuchi+T%22">Takeuchi T</searchLink>; Saitama Medical University, Iruma, Japan.; Keio University School of Medicine, Shinjuku, Japan.<br /><searchLink fieldCode="AU" term="%22Tohma+S%22">Tohma S</searchLink>; National Hospital Organisation Tokyo National Hospital, Kiyose, Japan.<br /><searchLink fieldCode="AU" term="%22Fujino+Y%22">Fujino Y</searchLink>; Department of Environmental Epidemiology, University of Occupational and Environmental Health, Kitakyushu, Japan.<br /><searchLink fieldCode="AU" term="%22Kameda+H%22">Kameda H</searchLink>; Division of Rheumatology, Faculty of Medicine, Toho University, Meguro, Japan.
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  Data: <searchLink fieldCode="JN" term="%22101662038%22">RMD open</searchLink> [RMD Open] 2026 May 12; Vol. 12 (2). <i>Date of Electronic Publication: </i>2026 May 12.
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  Data: Journal Article; Observational Study; Multicenter Study
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22BMJ+Publishing+Group%22">BMJ Publishing Group </searchLink><i>Country of Publication: </i>England <i>NLM ID: </i>101662038 <i>Publication Model: </i>Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>2056-5933 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2220565933%22">20565933 </searchLink><i>NLM ISO Abbreviation: </i>RMD Open <i>Subsets: </i>MEDLINE
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        Value: 10.1136/rmdopen-2025-006446
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