{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T13:14:38Z","timestamp":1791983678338,"version":"4.4.0"},"reference-count":20,"publisher":"BMJ","issue":"1","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["RMD Open"],"accepted":{"date-parts":[[2017,2,24]]},"published-print":{"date-parts":[[2017,3]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To assess the efficacy and safety of modified-release (MR) versus immediate-release (IR) prednisone in newly diagnosed glucocorticoid (GC)-na\u00efve patients with polymyalgia rheumatica (PMR).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients were randomised to double-blind MR prednisone (taken at approximately 22:00) or IR prednisone (taken in the morning), 15\u2005mg\/day for 4\u2005weeks. The primary end point was complete response rate (\u226570% reduction in PMR visual analogue scale, duration of morning stiffness and C reactive protein (CRP) (or CRP &lt;2\u00d7 upper limit of normal (ULN))) at week 4. Non-inferiority was decided if the lower 95% confidence limit (MR vs IR prednisone) was above \u221215%. 400 patients were planned but only 62 were enrolled due to difficulties in recruiting GC-na\u00efve patients with PMR with CRP \u22652\u00d7ULN.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The percentage of complete responders at week 4 was numerically greater for MR prednisone (53.8%) than for IR prednisone (40.9%). Non-inferiority of MR versus IR prednisone was not proven in the primary analysis on the per protocol population (N=48; treatment difference: 12.22%; 95% CI \u221215.82% to 40.25%). However, sensitivity analysis on the full analysis population showed an evident trend favouring MR prednisone (N=62; treatment difference: 15.56%; 95% CI \u22129.16% to 40.28%). Adverse events were generally mild and transient with no unexpected safety observations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The study showed a clear trend for favourable short-term efficacy of MR prednisone versus IR prednisone in early treatment of PMR. Further studies are warranted.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>EudraCT number 2011-002353-57; Results.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/rmdopen-2016-000426","type":"journal-article","created":{"date-parts":[[2017,3,18]],"date-time":"2017-03-18T20:10:21Z","timestamp":1489867821000},"page":"e000426","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":27,"title":["Modified-release prednisone for polymyalgia rheumatica: a multicentre, randomised, active-controlled, double-blind, parallel-group study"],"prefix":"10.1136","volume":"3","author":[{"given":"Maurizio","family":"Cutolo","sequence":"first","affiliation":[{"name":"Research Laboratories and Academic Division of Clinical Rheumatology, University of Genova, Genova, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Hopp","sequence":"additional","affiliation":[{"name":"Mundipharma Research GmbH & Co. KG, Limburg, Hessen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan","family":"Liebscher","sequence":"additional","affiliation":[{"name":"Mundipharma Research GmbH & Co. KG, Limburg, Hessen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bhaskar","family":"Dasgupta","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Southend University Hospital, Westcliff-on-Sea, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank","family":"Buttgereit","sequence":"additional","affiliation":[{"name":"Department of Rheumatology and Clinical Immunology, Charit\u00e9 University Medicine, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2017,3,18]]},"reference":[{"key":"2025090313064263000_3.1.e000426.1","doi-asserted-by":"publisher","DOI":"10.1002\/art.23176"},{"key":"2025090313064263000_3.1.e000426.2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra011913"},{"key":"2025090313064263000_3.1.e000426.3","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-139-6-200309160-00015"},{"key":"2025090313064263000_3.1.e000426.4","doi-asserted-by":"publisher","DOI":"10.1001\/archinternmed.2009.352"},{"key":"2025090313064263000_3.1.e000426.5","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2015-207492"},{"key":"2025090313064263000_3.1.e000426.6","doi-asserted-by":"crossref","first-page":"2569","DOI":"10.1002\/art.39333","article-title":"2015 recommendations for the management of polymyalgia rheumatica: a European League Against Rheumatism\/American College of Rheumatology collaborative initiative","volume":"67","author":"Dejaco","year":"2015","journal-title":"Arthritis Rheumatol"},{"key":"2025090313064263000_3.1.e000426.7","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.091283"},{"key":"2025090313064263000_3.1.e000426.8","doi-asserted-by":"crossref","first-page":"28","DOI":"10.3109\/03009742.2011.566438","article-title":"How should impaired morning function in rheumatoid arthritis be treated?","volume":"125","author":"Buttgereit","year":"2011","journal-title":"Scand J Rheumatol Suppl"},{"key":"2025090313064263000_3.1.e000426.9","doi-asserted-by":"crossref","first-page":"174","DOI":"10.1186\/s13075-016-1072-4","article-title":"Circadian variations in clinical symptoms and concentrations of inflammatory cytokines, melatonin, and cortisol in polymyalgia rheumatica before and during prednisolone treatment: a controlled, observational, clinical experimental study","volume":"18","author":"Galbo","year":"2016","journal-title":"Arthritis Res Ther"},{"key":"2025090313064263000_3.1.e000426.10","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(08)60132-4"},{"key":"2025090313064263000_3.1.e000426.11","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2009.126888"},{"key":"2025090313064263000_3.1.e000426.12","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2011-201067"},{"key":"2025090313064263000_3.1.e000426.13","doi-asserted-by":"publisher","DOI":"10.1002\/acr.20347"},{"key":"2025090313064263000_3.1.e000426.14","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2011-200329"},{"key":"2025090313064263000_3.1.e000426.15","doi-asserted-by":"publisher","DOI":"10.1002\/art.34356"},{"key":"2025090313064263000_3.1.e000426.16","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.110977"},{"key":"2025090313064263000_3.1.e000426.17","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/39.6.624"},{"key":"2025090313064263000_3.1.e000426.18","doi-asserted-by":"publisher","DOI":"10.1002\/art.22106"},{"key":"2025090313064263000_3.1.e000426.19","doi-asserted-by":"publisher","DOI":"10.1007\/s00296-012-2583-1"},{"key":"2025090313064263000_3.1.e000426.20","first-page":"498","article-title":"Efficacy of the switch to modified-release prednisone in rheumatoid arthritis patients treated with standard glucocorticoids","volume":"31","author":"Cutolo","year":"2013","journal-title":"Clin Exp Rheumatol"}],"container-title":["RMD Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/rmdopen-2016-000426","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,3]],"date-time":"2025-09-03T20:06:48Z","timestamp":1756930008000},"score":1,"resource":{"primary":{"URL":"https:\/\/rmdopen.bmj.com\/lookup\/doi\/10.1136\/rmdopen-2016-000426"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,3]]},"references-count":20,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2017,3,18]]},"published-print":{"date-parts":[[2017,3]]}},"alternative-id":["10.1136\/rmdopen-2016-000426"],"URL":"https:\/\/doi.org\/10.1136\/rmdopen-2016-000426","relation":{},"ISSN":["2056-5933"],"issn-type":[{"value":"2056-5933","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,3]]}}}