{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,8,31]],"date-time":"2025-08-31T10:09:23Z","timestamp":1756634963806,"version":"3.37.3"},"reference-count":13,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2020,1,3]],"date-time":"2020-01-03T00:00:00Z","timestamp":1578009600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2020,1,3]],"date-time":"2020-01-03T00:00:00Z","timestamp":1578009600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","award":["Not applicable"],"award-info":[{"award-number":["Not applicable"]}],"id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Health Qual Life Outcomes"],"published-print":{"date-parts":[[2020,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>We assessed the external validity of composite indices Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Assessment in SpondyloArthritis international Society (ASAS) 40 response (ASAS40) by evaluating the correlations between the changes in some patient reported outcomes (PROs) for patients with non-radiographic axial spondyloarthritis (nr-axSpA) and the changes in the scores of the composite indices.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This was a post-hoc analysis of data from the EMBARK study in patients with nr-axSpA treated with etanercept. PROs were grouped according to ASDAS status (inactive [&lt;\u20091.3], low [\u2265 1.3 to &lt;\u20092.1], high [\u2265 2.1 to \u22643.5], and very high [&gt;\u20093.5]), patient achievement of &gt;\u200950% improvement in BASDAI (BASDAI50 responders), and\u2009&gt;\u200940% improvement in ASAS (ASAS40 responders) at 104\u2009weeks. Analyses were conducted on observed cases available at Week 104. Changes in PROs from Baseline to Week 104 were assessed using analysis of covariance with adjustment for baseline with linear contrast.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Higher ASDAS disease activity at 104\u2009weeks was associated with lower long-term improvement from baseline in PROs (e.g., total back pain [visual analog scale, cm (95% confidence interval): \u2212\u20094.58 (\u2212\u20094.95, \u2212\u20094.21), \u2212\u20093.86 (\u2212\u20094.28, \u2212\u20093.43), \u2212\u20092.15 (\u2212\u20092.68, \u2212\u20091.61), and 1.30 (\u2212\u20090.51, 3.12) for inactive, low, high, and very high ASDAS disease activity, respectively; Multidimensional Fatigue Inventory (MFI) general fatigue: \u2212\u20094.77 (\u2212\u20095.70, \u2212\u20093.84), \u2212\u20092.96 (\u2212\u20094.04, \u2212\u20091.87), \u2212\u20091.00 (\u2212\u20092.32, 0.31), and 2.14 (\u2212\u20092.10, 6.38); all <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001)]. BASDAI50 non-responders had less improvement in PROs from Baseline to Week 104 vs. responders (e.g., total back pain: \u2212\u20091.61 (\u2212\u20092.05, \u2212\u20091.18) vs. \u20134.43 (\u2212\u20094.69, \u2212\u20094.18); MFI general fatigue: \u2212\u20090.01 (\u2212\u20091.12, 1.09) vs. \u20134.30 (\u2212\u20094.98, \u2212\u20093.62); all <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001). ASAS40 non-responders also had less improvement in PROs from Baseline to Week 104 vs. responders (e.g., total back pain: \u2212\u20091.91 (\u2212\u20092.30, \u2212\u20091.52) vs. \u20134.75 (\u2212\u20095.05, \u2212\u20094.46); MFI general fatigue: \u2212\u20090.63 (\u2212\u20091.56, 0.30) vs. \u20134.64 (\u2212\u20095.37, \u2212\u20093.91); all <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>Composite indices are valid for monitoring treatment response and adequately reflect treatment-related changes experienced by patients with nr-axSpA.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>ClinicalTrials.gov identifier: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01258738\">NCT01258738<\/jats:ext-link>. Registered 9 December 2010.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12955-019-1260-4","type":"journal-article","created":{"date-parts":[[2020,1,3]],"date-time":"2020-01-03T17:02:43Z","timestamp":1578070963000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Relationship between disease activity status or clinical response and patient-reported outcomes in patients with non-radiographic axial spondyloarthritis: 104-week results from the randomized controlled EMBARK study"],"prefix":"10.1186","volume":"18","author":[{"given":"Maxime","family":"Dougados","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"D\u00e9sir\u00e9e","family":"van der Heijde","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wen-Chan","family":"Tsai","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Diego","family":"Saaibi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lisa","family":"Marshall","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Heather","family":"Jones","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ron","family":"Pedersen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bonnie","family":"Vlahos","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Miriam","family":"Tarallo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2020,1,3]]},"reference":[{"key":"1260_CR1","first-page":"4","volume":"78","author":"A Boonen","year":"2006","unstructured":"Boonen A, van der Linden SM. 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Rheumatology (Oxford). 2016;55:80\u20138.","journal-title":"Rheumatology (Oxford)"}],"container-title":["Health and Quality of Life Outcomes"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s12955-019-1260-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1186\/s12955-019-1260-4\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s12955-019-1260-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,1,2]],"date-time":"2021-01-02T00:16:15Z","timestamp":1609546575000},"score":1,"resource":{"primary":{"URL":"https:\/\/hqlo.biomedcentral.com\/articles\/10.1186\/s12955-019-1260-4"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,1,3]]},"references-count":13,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2020,12]]}},"alternative-id":["1260"],"URL":"https:\/\/doi.org\/10.1186\/s12955-019-1260-4","relation":{},"ISSN":["1477-7525"],"issn-type":[{"type":"electronic","value":"1477-7525"}],"subject":[],"published":{"date-parts":[[2020,1,3]]},"assertion":[{"value":"27 July 2019","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"13 December 2019","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"3 January 2020","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"The EMBARK study was conducted in accordance with International Conference on Harmonisation Guidelines for Good Clinical Practice and the Declaration of Helsinki. Institutional review board approval and informed consent from all participants were obtained prior to study initiation.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"MD has received consulting fees from AbbVie, Celgene, Eli Lilly, Merck, Novartis, Pfizer, Roche, Sanofi-Aventis, and UCB. DvdH has received consulting fees from AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi, Eli-Lilly, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, and UCB, and is the director of Imaging Rheumatology BV. W-CT has received consulting fees from AbbVie, Pfizer, and Roche. DS has no conflicts to declare. RP, LM, and HJ were employees of Pfizer at the time of the study and have company stock options\/bond holdings. BV and MT are employees of Pfizer and have company stock options\/bond holdings.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"4"}}