{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T03:51:24Z","timestamp":1780372284297,"version":"3.54.1"},"reference-count":13,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2023,12,4]],"date-time":"2023-12-04T00:00:00Z","timestamp":1701648000000},"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":[[2024,8,20]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>To investigate the 2\u2009year safety and effectiveness of denosumab 60\u2009mg in patients with rheumatoid arthritis (RA) in clinical practice in Japan.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This 2\u2009year, prospective, observational cohort study included patients who initiated treatment with denosumab 60\u2009mg for the progression of bone erosion associated with RA. Key endpoints were adverse drug reactions (ADRs), progression of bone erosion, and 28-joint Disease Activity Score based on C-reactive protein or erythrocyte sedimentation rate. Univariate and multivariate analyses were conducted to determine the risk factors for ADRs and the progression of bone erosion.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>In the safety analysis set (n\u2009=\u20091239), the incidence of ADRs was 3.0%; the most common ADRs were hypocalcaemia (1.2%) and osteonecrosis of jaw-related events (0.6%). A history of any drug allergy was a statistically significant risk factor associated with the occurrence of ADRs. In the effectiveness analysis set (n\u2009=\u2009815), the incidence of progression of bone erosion was 8.7%. Steinbrocker stage and initial steroid dose were statistically significant risk factors associated with the progression of bone erosion.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>Denosumab demonstrated safety and effectiveness over a 2\u2009year period in RA patients without any new safety concerns.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/mr\/road108","type":"journal-article","created":{"date-parts":[[2023,11,29]],"date-time":"2023-11-29T08:37:19Z","timestamp":1701247039000},"page":"927-935","source":"Crossref","is-referenced-by-count":2,"title":["Safety and\u00a0effectiveness of\u00a0denosumab in\u00a0Japanese patients with rheumatoid arthritis: A 2-year post-marketing surveillance study"],"prefix":"10.1093","volume":"34","author":[{"given":"Yoshiya","family":"Tanaka","sequence":"first","affiliation":[{"name":"First Department of Internal Medicine, Faculty of Medicine, University of Occupational and Environmental Health , Kitakyushu,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hideki","family":"Mizutani","sequence":"additional","affiliation":[{"name":"Post Marketing Study Department, Daiichi Sankyo Co., Ltd. , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kunimitsu","family":"Fujii","sequence":"additional","affiliation":[{"name":"Post Marketing Study Department, Daiichi Sankyo Co., Ltd. , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naoki","family":"Okubo","sequence":"additional","affiliation":[{"name":"Biostatistics & Data Management Department, Daiichi Sankyo Co., Ltd. , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2023,12,4]]},"reference":[{"key":"2024101507121373800_R1","doi-asserted-by":"crossref","DOI":"10.1038\/nrdp.2018.1","article-title":"Rheumatoid arthritis","volume":"4","author":"Smolen","year":"2018","journal-title":"Nat Rev Dis Primers"},{"key":"2024101507121373800_R2","doi-asserted-by":"crossref","first-page":"1047","DOI":"10.1136\/ard.61.12.1047","article-title":"Receptor activator NF-kappaB ligand (RANKL) expression in\u00a0synovial tissue from patients with rheumatoid arthritis, spondyloarthropathy, osteoarthritis, and\u00a0from normal patients: semiquantitative and\u00a0quantitative analysis","volume":"61","author":"Crotti","year":"2002","journal-title":"Ann Rheum Dis"},{"key":"2024101507121373800_R3","doi-asserted-by":"crossref","first-page":"106","DOI":"10.1007\/s00774-020-01159-1","article-title":"RANKL as a therapeutic target of\u00a0rheumatoid arthritis","volume":"39","author":"Tanaka","year":"2021","journal-title":"J Bone Miner Metab"},{"key":"2024101507121373800_R4","article-title":"New Drugs Approved in\u00a0FY 2012","author":"Pharmaceuticals and Medical Devices Agency","year":"2013"},{"key":"2024101507121373800_R5","article-title":"New Drugs Approved in\u00a0FY 2017","author":"Pharmaceuticals and Medical Devices Agency","year":"2017"},{"key":"2024101507121373800_R6","doi-asserted-by":"crossref","first-page":"983","DOI":"10.1136\/annrheumdis-2015-208052","article-title":"Effect of\u00a0denosumab on\u00a0japanese patients with rheumatoid arthritis: a dose\u2013response study of\u00a0AMG 162 (denosumab) in\u00a0patients with rheumatoid arthritis on\u00a0methotrexate to validate inhibitory effect on\u00a0bone erosion (DRIVE)\u2014a 12-month, multicentre, randomised, double-blind, placebo-controlled, phase II clinical trial","volume":"75","author":"Takeuchi","year":"2016","journal-title":"Ann Rheum Dis"},{"key":"2024101507121373800_R7","doi-asserted-by":"crossref","first-page":"899","DOI":"10.1136\/annrheumdis-2018-214827","article-title":"Effects of\u00a0the anti-RANKL antibody denosumab on\u00a0joint structural damage in\u00a0patients with rheumatoid arthritis treated with conventional synthetic disease-modifying antirheumatic drugs (DESIRABLE study): a randomised, double-blind, placebo-controlled phase 3 trial","volume":"78","author":"Takeuchi","year":"2019","journal-title":"Ann Rheum Dis"},{"key":"2024101507121373800_R8","doi-asserted-by":"crossref","first-page":"21","DOI":"10.1093\/mr\/roac017","article-title":"Drug treatment algorithm and\u00a0recommendations from the 2020 update of\u00a0the Japan College of\u00a0Rheumatology clinical practice guidelines for\u00a0the management of\u00a0rheumatoid arthritis-secondary publication","volume":"33","author":"Kawahito","year":"2023","journal-title":"Mod Rheumatol"},{"key":"2024101507121373800_R9","article-title":"Guide to the Use of\u00a0Denosumab for\u00a0Rheumatoid Arthritis","author":"Japan Society of Rheumatology","year":"2020"},{"key":"2024101507121373800_R10","doi-asserted-by":"crossref","first-page":"920","DOI":"10.1016\/j.joms.2022.02.008","article-title":"American Association of\u00a0Oral and\u00a0Maxillofacial Surgeons\u2019 position paper on\u00a0medication-related osteonecrosis of\u00a0the jaws-2022 update","volume":"80","author":"Ruggiero","year":"2022","journal-title":"J Oral Maxillofac Surg"},{"key":"2024101507121373800_R11","doi-asserted-by":"crossref","first-page":"34","DOI":"10.1080\/14397595.2019.1703484","article-title":"Predictors of\u00a0new bone erosion in\u00a0rheumatoid arthritis patients receiving conventional synthetic disease-modifying antirheumatic drugs: analysis of\u00a0data from the DRIVE and\u00a0DESIRABLE studies","volume":"31","author":"Takeuchi","year":"2021","journal-title":"Mod Rheumatol"},{"key":"2024101507121373800_R12","doi-asserted-by":"crossref","first-page":"1663","DOI":"10.3899\/jrheum.201376","article-title":"Effects of\u00a0denosumab in\u00a0Japanese patients with rheumatoid arthritis treated with conventional antirheumatic drugs: 36-month extension of\u00a0a phase III study","volume":"48","author":"Tanaka","year":"2021","journal-title":"J Rheumatol"},{"key":"2024101507121373800_R13","doi-asserted-by":"crossref","first-page":"463","DOI":"10.1007\/s00774-020-01180-4","article-title":"Long-term safety and\u00a0effectiveness of\u00a0denosumab in\u00a0Japanese patients with osteoporosis: 3-year post-marketing surveillance study","volume":"39","author":"Tanaka","year":"2021","journal-title":"J Bone Miner Metab"}],"container-title":["Modern 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