{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,22]],"date-time":"2025-10-22T10:34:59Z","timestamp":1761129299531},"reference-count":36,"publisher":"The Journal of Rheumatology","issue":"12","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Rheumatol"],"published-print":{"date-parts":[[2015,12]]},"abstract":"<jats:sec><jats:title>Objective.<\/jats:title><jats:p>Using data from a randomized, double-blind, placebo-controlled study, we assessed the capacity of clinical and nonsteroidal antiinflammatory drug (NSAID)-sparing endpoints, alone and in combination, to discriminate between treatment effects in axial spondyloarthritis (axSpA).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods.<\/jats:title><jats:p>Patients with active NSAID-resistant axSpA received etanercept (ETN) 50 mg\/week or placebo for 8 weeks and tapered\/discontinued NSAID. In posthoc logistic regression analyses, OR were calculated that indicated the capacity of the following endpoints to discriminate between the effects of ETN and placebo at Week 8: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50; BASDAI \u2264 3; Assessment of Spondyloarthritis international Society (ASAS) 20; ASAS40; Ankylosing Spondylitis Disease Activity Score (ASDAS) with C-reactive protein (CRP) &lt; 1.3 and ASDAS-CRP &lt; 2.1; \u2265 50% decrease from baseline in ASAS-NSAID score, score &lt; 10, and score = 0; and each clinical and\/or each NSAID measure.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results.<\/jats:title><jats:p>In 90 randomized patients (ETN, n = 42; placebo, n = 48), disease activity was similar between groups at baseline: mean (\u00b1 SD) BASDAI (ETN vs placebo) 6.0 \u00b1 1.6 versus 5.9 \u00b1 1.5. NSAID intake was high: ASAS-NSAID score 98.2 \u00b1 39.0 versus 93.0 \u00b1 23.4. OR ranged from 1.6 (95% CI 0.5\u20135.4) for ASDAS-CRP &lt; 1.3 to 5.8 (95% CI 1.2\u201329.1) for BASDAI50 and NSAID score of 0; most measures (34\/45) reached statistical significance (\u03b1 = 0.05) favoring ETN. Most combined outcome variables using OR were more discriminant than single outcome measures.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion.<\/jats:title><jats:p>These findings suggest that changes in NSAID intake during treatment do not prevent demonstration of clinically relevant effects of biologic treatment, and combined (i.e., clinical with NSAID-sparing) endpoints were frequently more discriminant than single (i.e., clinical) endpoints. <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"ClinicalTrials.gov\" xlink:type=\"simple\">ClinicalTrials.gov<\/jats:ext-link> (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT01298531\">NCT01298531<\/jats:ext-link>).<\/jats:p><\/jats:sec>","DOI":"10.3899\/jrheum.150378","type":"journal-article","created":{"date-parts":[[2015,11,16]],"date-time":"2015-11-16T01:07:47Z","timestamp":1447636067000},"page":"2361-2368","source":"Crossref","is-referenced-by-count":3,"title":["Discriminant Capacity of Clinical Efficacy and Nonsteroidal Antiinflammatory Drug-sparing Endpoints, Alone or in Combination, in Axial Spondyloarthritis"],"prefix":"10.3899","volume":"42","author":[{"given":"Maxime","family":"Dougados","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emily","family":"Wood","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laure","family":"Gossec","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arnaud","family":"Dubanchet","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Isabelle","family":"Logeart","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"D\u00e9sir\u00e9e","family":"van der Heijde","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2262","published-online":{"date-parts":[[2015,11,15]]},"reference":[{"issue":"Suppl 28","key":"2018112909350717000_42.12.2361.1","first-page":"S65","article-title":"NSAIDs in ankylosing spondylitis","volume":"20","author":"Miceli-Richard","year":"2002","journal-title":"Clin Exp Rheumatol"},{"key":"2018112909350717000_42.12.2361.2","doi-asserted-by":"publisher","DOI":"10.1002\/1529-0131(200101)44:1<180::AID-ANR24>3.0.CO;2-K"},{"key":"2018112909350717000_42.12.2361.3","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/kep393"},{"key":"2018112909350717000_42.12.2361.4","doi-asserted-by":"publisher","DOI":"10.1002\/art.21054"},{"key":"2018112909350717000_42.12.2361.5","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2012-201370"},{"key":"2018112909350717000_42.12.2361.6","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2011-201252"},{"key":"2018112909350717000_42.12.2361.7","doi-asserted-by":"publisher","DOI":"10.1186\/1471-230X-9-41"},{"key":"2018112909350717000_42.12.2361.8","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2006.055012"},{"key":"2018112909350717000_42.12.2361.9","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kwj331"},{"key":"2018112909350717000_42.12.2361.10","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2006.068650"},{"key":"2018112909350717000_42.12.2361.11","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjcard.2009.01.014"},{"key":"2018112909350717000_42.12.2361.12","first-page":"205","article-title":"A metaanalysis of chondroitin sulfate in the treatment of osteoarthritis","volume":"27","author":"Leeb","year":"2000","journal-title":"J Rheumatol"},{"key":"2018112909350717000_42.12.2361.13","doi-asserted-by":"publisher","DOI":"10.1185\/03007995.2013.855184"},{"key":"2018112909350717000_42.12.2361.14","doi-asserted-by":"publisher","DOI":"10.2515\/therapie:2006063"},{"key":"2018112909350717000_42.12.2361.15","doi-asserted-by":"publisher","DOI":"10.1002\/art.22371"},{"key":"2018112909350717000_42.12.2361.16","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-141-7-200410050-00005"},{"key":"2018112909350717000_42.12.2361.17","first-page":"807","article-title":"Glucocorticoid sparing effect of tumour necrosis factor alpha inhibitors in rheumatoid arthritis in real life practice","volume":"27","author":"Seror","year":"2009","journal-title":"Clin Exp Rheumatol"},{"key":"2018112909350717000_42.12.2361.18","first-page":"2334","article-title":"Effectiveness, predictive response factors, and safety of anti-tumor necrosis factor (TNF) therapies in anti-TNF-naive rheumatoid arthritis","volume":"34","author":"Fern\u00e1ndez-Nebro","year":"2007","journal-title":"J Rheumatol"},{"key":"2018112909350717000_42.12.2361.19","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2005.044404"},{"key":"2018112909350717000_42.12.2361.20","first-page":"1238","article-title":"Long-term safety and efficacy of etanercept in patients with rheumatoid arthritis","volume":"28","author":"Moreland","year":"2001","journal-title":"J Rheumatol"},{"key":"2018112909350717000_42.12.2361.21","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2011.151563"},{"key":"2018112909350717000_42.12.2361.22","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/keq242"},{"key":"2018112909350717000_42.12.2361.23","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2008.091025"},{"key":"2018112909350717000_42.12.2361.24","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.293.6552.911"},{"key":"2018112909350717000_42.12.2361.25","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2010.133488"},{"key":"2018112909350717000_42.12.2361.26","doi-asserted-by":"publisher","DOI":"10.1186\/s13075-014-0481-5"},{"key":"2018112909350717000_42.12.2361.27","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2008.099226"},{"key":"2018112909350717000_42.12.2361.28","first-page":"2286","article-title":"A new approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing Spondylitis Disease Activity Index","volume":"21","author":"Garrett","year":"1994","journal-title":"J Rheumatol"},{"key":"2018112909350717000_42.12.2361.29","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2003.016717"},{"key":"2018112909350717000_42.12.2361.30","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2008.100826"},{"key":"2018112909350717000_42.12.2361.31","doi-asserted-by":"crossref","first-page":"1543","DOI":"10.1002\/art.30223","article-title":"Clinical efficacy and safety of etanercept versus sulfasalazine in patients with ankylosing spondylitis: a randomized, double-blind trial","volume":"63","author":"Braun","year":"2011","journal-title":"Arthritis Rheum"},{"key":"2018112909350717000_42.12.2361.32","doi-asserted-by":"publisher","DOI":"10.1002\/art.38721"},{"key":"2018112909350717000_42.12.2361.33","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2013-204231"},{"key":"2018112909350717000_42.12.2361.34","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2012-201766"},{"key":"2018112909350717000_42.12.2361.35","doi-asserted-by":"publisher","DOI":"10.1002\/art.21913"},{"key":"2018112909350717000_42.12.2361.36","doi-asserted-by":"publisher","DOI":"10.1002\/art.23167"}],"container-title":["The Journal of Rheumatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.3899\/jrheum.150378","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2018,11,29]],"date-time":"2018-11-29T19:04:10Z","timestamp":1543518250000},"score":1,"resource":{"primary":{"URL":"http:\/\/www.jrheum.org\/lookup\/doi\/10.3899\/jrheum.150378"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,11,15]]},"references-count":36,"journal-issue":{"issue":"12","published-online":{"date-parts":[[2015,12,1]]},"published-print":{"date-parts":[[2015,12]]}},"alternative-id":["10.3899\/jrheum.150378"],"URL":"https:\/\/doi.org\/10.3899\/jrheum.150378","relation":{},"ISSN":["0315-162X","1499-2752"],"issn-type":[{"value":"0315-162X","type":"print"},{"value":"1499-2752","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,11,15]]}}}