{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:27:42Z","timestamp":1792787262218,"version":"4.5.0"},"reference-count":24,"publisher":"BMJ","issue":"6","funder":[{"name":"MSD Sharp & Dohme, Haar, Germany"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"published-print":{"date-parts":[[2018,6]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>The Non Interventional Evaluation with Golumimab (GO-NICE) study aimed to document patient and treatment characteristics as well as clinical effectiveness and safety in adult patients newly treated with the tumour necrosis factor inhibitor golimumab (GLM).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Prospective non-interventional study with 24-month observation per patient.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>158 office-based and clinical-based physicians in Germany.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Intervention<\/jats:title>\n                    <jats:p>GLM administered in the 50\u2009mg dose subcutaneously in monthly intervals under real-life conditions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of the 1613 included patients, 1458 patients were eligible for final analysis: 474 patients with rheumatoid arthritis (RA, 54.9\u00b113.4 years, 72.8% women, 64.7% biologic-na\u00efve), 501 with psoriatic arthritis (PsA, 50.5\u00b112.1 years, 54.1% women, 56.5% biologic-na\u00efve) and 483 with ankylosing spondylitis (AS, 43.6\u00b112.3 years, 66.5% men, 61.0% biologic-na\u00efve). 664 patients completed follow-up (2-year retention rate 45.5%). Disease Activity Score 28-joint count erythrocyte sedimentation rate (DAS28-ESR) decreased from 5.0 to 2.9 after 24 months (p&lt;0.0001) in patients with RA, and Bath Ankylosing Spondylitis Disease Index score decreased from 5.1 to 2.4 (p&lt;0.0001) in patients with AS. Response rate calculated in patients with PsA by modified Psoriatic Arthritis Response Criteria was 67.9% after 24 months. Most adverse events were of mild or moderate nature, and no new safety signals were detected. According to the physicians\u2019 clinical assessments, treatment with GLM was successful (no adverse drug reaction and a clear or moderate therapeutic effect in an individual patient) in 55.0%\u201356.6% of patients with RA, PsA and AS, respectively, at month 3, increasing from 74.5% to 76.1% at month 24.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>GLM subcutaneously once monthly led to substantial improvements in clinical effectiveness in patients with various inflammatory rheumatic diseases who could be followed up in a real-life setting in Germany. The treatment was well tolerated, and the safety profile of GLM was consistent with that observed in the previous randomised controlled trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"NCT01313858\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial\">NCT01313858<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2017-021082","type":"journal-article","created":{"date-parts":[[2023,4,5]],"date-time":"2023-04-05T14:05:05Z","timestamp":1680703505000},"page":"e021082","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":30,"title":["Effectiveness and safety of golimumab in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis under real-life clinical conditions: non-interventional GO-NICE study in Germany"],"prefix":"10.1136","volume":"8","clinical-trial-number":[{"clinical-trial-number":"nct01313858","registry":"10.18810\/clinical-trials-gov","type":"preResults"}],"author":[{"given":"Klaus","family":"Kr\u00fcger","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerd R","family":"Burmester","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siegfried","family":"Wassenberg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Bohl-B\u00fchler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthias H","family":"Thomas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2018,6,14]]},"reference":[{"key":"2023040221250604000_8.6.e021082.1","doi-asserted-by":"crossref","first-page":"92","DOI":"10.1016\/j.cyto.2016.07.015","article-title":"Anti cytokine therapy in chronic inflammatory arthritis","volume":"86","author":"Thompson","year":"2016","journal-title":"Cytokine"},{"key":"2023040221250604000_8.6.e021082.2","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2010.09.003"},{"key":"2023040221250604000_8.6.e021082.3","unstructured":"European Agency for the Evaluation of Medicinal Products (EMA). 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Latest renewal of authorisation. http:\/\/www.ema.europa.eu (accessed on 28 Feb 2018)."},{"key":"2023040221250604000_8.6.e021082.4","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2008.099010"},{"key":"2023040221250604000_8.6.e021082.5","doi-asserted-by":"publisher","DOI":"10.1002\/art.24403"},{"key":"2023040221250604000_8.6.e021082.6","doi-asserted-by":"publisher","DOI":"10.1002\/art.23969"},{"key":"2023040221250604000_8.6.e021082.7","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.160420"},{"key":"2023040221250604000_8.6.e021082.8","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.150712"},{"key":"2023040221250604000_8.6.e021082.9","doi-asserted-by":"crossref","first-page":"744","DOI":"10.1002\/acr.22759","article-title":"Efficacy and Safety of Subcutaneous Golimumab in Methotrexate-Naive Patients With Rheumatoid Arthritis: Five-Year Results of a Randomized Clinical Trial","volume":"68","author":"Emery","year":"2016","journal-title":"Arthritis Care Res"},{"key":"2023040221250604000_8.6.e021082.10","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2014-205862"},{"key":"2023040221250604000_8.6.e021082.11","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780380107"},{"key":"2023040221250604000_8.6.e021082.12","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2007.084459"},{"key":"2023040221250604000_8.6.e021082.13","doi-asserted-by":"publisher","DOI":"10.1002\/acr.20577"},{"key":"2023040221250604000_8.6.e021082.14","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780391210"},{"key":"2023040221250604000_8.6.e021082.15","first-page":"2281","article-title":"A new approach to defining functional ability in ankylosing spondylitis: the development of the Bath Ankylosing Spondylitis Functional Index","volume":"21","author":"Calin","year":"1994","journal-title":"J Rheumatol"},{"key":"2023040221250604000_8.6.e021082.16","doi-asserted-by":"crossref","first-page":"108","DOI":"10.1016\/j.semarthrit.2017.01.008","article-title":"Golimumab in real-life settings: 2 Years drug survival and predictors of clinical outcomes in rheumatoid arthritis, spondyloarthritis, and psoriatic arthritis","volume":"47","author":"Iannone","year":"2017","journal-title":"Semin Arthritis Rheum"},{"key":"2023040221250604000_8.6.e021082.17","first-page":"804","article-title":"Two-year retention rate of golimumab in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis: data from the LORHEN registry","volume":"35","author":"Manara","year":"2017","journal-title":"Clin Exp Rheumatol"},{"key":"2023040221250604000_8.6.e021082.18","doi-asserted-by":"crossref","first-page":"987","DOI":"10.1007\/s00296-016-3423-5","article-title":"Treatment persistence among patients with immune-mediated rheumatic disease newly treated with subcutaneous TNF-alpha inhibitors and costs associated with non-persistence","volume":"36","author":"Dal\u00e9n","year":"2016","journal-title":"Rheumatol Int"},{"key":"2023040221250604000_8.6.e021082.19","doi-asserted-by":"crossref","first-page":"210","DOI":"10.1007\/s00393-016-0174-3","article-title":"[The first biologic for rheumatoid arthritis: factors influencing the therapeutic decision]","volume":"76","author":"Pattloch","year":"2017","journal-title":"Z Rheumatol"},{"key":"2023040221250604000_8.6.e021082.20","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.120584"},{"key":"2023040221250604000_8.6.e021082.21","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2012-202035"},{"key":"2023040221250604000_8.6.e021082.22","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2011.154799"},{"key":"2023040221250604000_8.6.e021082.23","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2013-204195"},{"key":"2023040221250604000_8.6.e021082.24","doi-asserted-by":"publisher","DOI":"10.1136\/jech.2003.008466"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2017-021082","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,4,5]],"date-time":"2023-04-05T14:05:15Z","timestamp":1680703515000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2017-021082"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,6]]},"references-count":24,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2018,6,14]]},"published-print":{"date-parts":[[2018,6]]}},"alternative-id":["10.1136\/bmjopen-2017-021082"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2017-021082","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,6]]}}}