{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,20]],"date-time":"2026-02-20T04:41:35Z","timestamp":1771562495145,"version":"3.50.1"},"reference-count":34,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2019,11,28]],"date-time":"2019-11-28T00:00:00Z","timestamp":1574899200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis &amp; Rheumatology"],"published-print":{"date-parts":[[2019,12]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>Nationwide Danish guidelines regarding rheumatoid arthritis (<jats:styled-content style=\"fixed-case\">RA<\/jats:styled-content>) patients initiating biologic treatment (i.e., biologic disease\u2010modifying antirheumatic drugs [<jats:styled-content style=\"fixed-case\">DMARD<\/jats:styled-content>s]) are issued on an approximately annual basis. For biologics\u2010naive patients treated with concomitant methotrexate, mandatory medications included certolizumab pegol (<jats:styled-content style=\"fixed-case\">CZP<\/jats:styled-content>; year 2013\u20132014, recommended compliance 80%), abatacept (<jats:styled-content style=\"fixed-case\">ABA<\/jats:styled-content>; 2014\u20132015, 80%), and biosimilar infliximab (<jats:styled-content style=\"fixed-case\">CT<\/jats:styled-content>\u2010P13; 2015\u20132016, 50%). We hypothesized that these guidelines could be perceived as a surrogate randomization tool in which calendar period rather than patient\u2010specific factors defined the choice of the biologic <jats:styled-content style=\"fixed-case\">DMARD<\/jats:styled-content>. We undertook this study to assess compliance with guidelines (supporting the assumption of surrogate randomization) and to compare the effectiveness of <jats:styled-content style=\"fixed-case\">CZP<\/jats:styled-content>,<jats:styled-content style=\"fixed-case\"> ABA<\/jats:styled-content>, and <jats:styled-content style=\"fixed-case\">CT<\/jats:styled-content>\u2010P13 in patients treated according to guidelines.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This was an observational cohort study emulating a randomized trial (using intent\u2010to\u2010treat analyses). <jats:styled-content style=\"fixed-case\">RA<\/jats:styled-content> patients compliant with the treatment guidelines were identified in <jats:styled-content style=\"fixed-case\">DANBIO<\/jats:styled-content>, and information on prior comorbidities was obtained by linking to national registries. Outcome measures included remission rates according to the Disease Activity Score in 28 joints (<jats:styled-content style=\"fixed-case\">DAS<\/jats:styled-content>28) (at 6 and 12 months) and treatment retention at 1 year, compared across treatment regimens. Comorbidity\/confounder\u2010adjusted multivariable logistic and Cox regression analyses were used.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Seven hundred seventy\u2010six patients were included in the study (336 receiving <jats:styled-content style=\"fixed-case\">CZP<\/jats:styled-content>, 215 receiving <jats:styled-content style=\"fixed-case\">ABA<\/jats:styled-content>, 225 receiving <jats:styled-content style=\"fixed-case\">CT<\/jats:styled-content>\u2010P13). Compliance with treatment guidelines was high: 70%, 65%, and 59%, respectively. Six\u2010month <jats:styled-content style=\"fixed-case\">DAS<\/jats:styled-content>28 remission rates were 35%, 33%, and 42%, and 12\u2010month rates were 35%, 31%, and 35%, respectively. Compared to <jats:styled-content style=\"fixed-case\">CZP<\/jats:styled-content>, adjusted odds ratios for 6\u2010 and 12\u2010month <jats:styled-content style=\"fixed-case\">DAS<\/jats:styled-content>28 remission rates were 0.96 (95% confidence interval [95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>] 0.63\u20131.47) and 0.74 (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> 0.47\u20131.15) for <jats:styled-content style=\"fixed-case\">ABA<\/jats:styled-content> and 1.38 (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> 0.91\u20132.09) and 0.96 (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> 0.62\u20131.49) for <jats:styled-content style=\"fixed-case\">CT<\/jats:styled-content>\u2010P13, respectively. Adjusted hazard ratios for withdrawal (during days 0\u201390 and days 91\u2013365) were 0.70 (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> 0.39\u20131.27) and 1.16 (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> 0.84\u20131.60) for <jats:styled-content style=\"fixed-case\">ABA<\/jats:styled-content> and 0.58 (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> 0.33\u20131.10) and 0.83 (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> 0.59\u20131.17) for <jats:styled-content style=\"fixed-case\">CT<\/jats:styled-content>\u2010P13, respectively, compared to <jats:styled-content style=\"fixed-case\">CZP<\/jats:styled-content>.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The surrogate randomization procedure enabled head\u2010to\u2010head comparisons of <jats:styled-content style=\"fixed-case\">CZP<\/jats:styled-content>,<jats:styled-content style=\"fixed-case\"> ABA<\/jats:styled-content>, and <jats:styled-content style=\"fixed-case\">CT<\/jats:styled-content>\u2010P13. Although some differences in estimated effectiveness were observed across drugs, confidence intervals were wide and statistical significance was not reached.<\/jats:p><\/jats:sec>","DOI":"10.1002\/art.41031","type":"journal-article","created":{"date-parts":[[2019,7,3]],"date-time":"2019-07-03T08:39:45Z","timestamp":1562143185000},"page":"1997-2004","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Comparative Effectiveness of Certolizumab Pegol, Abatacept, and Biosimilar Infliximab in Patients With Rheumatoid Arthritis Treated in Routine Care: Observational Data From the Danish <scp>DANBIO<\/scp> Registry Emulating a Randomized Trial"],"prefix":"10.1002","volume":"71","author":[{"given":"Kathrine L.","family":"Gr\u00f8n","sequence":"first","affiliation":[{"name":"Rigshospitalet Glostrup, Glostrup, Denmark, and University of Copenhagen  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bente","family":"Glintborg","sequence":"additional","affiliation":[{"name":"Rigshospitalet Glostrup, Glostrup, Denmark, and University of Copenhagen  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mette","family":"N\u00f8rgaard","sequence":"additional","affiliation":[{"name":"Aarhus University Hospital  Aarhus Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frank","family":"Mehnert","sequence":"additional","affiliation":[{"name":"Aarhus University Hospital  Aarhus Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mikkel","family":"\u00d8stergaard","sequence":"additional","affiliation":[{"name":"Rigshospitalet Glostrup, Glostrup, Denmark, and University of Copenhagen  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lene","family":"Dreyer","sequence":"additional","affiliation":[{"name":"Rigshospitalet, Copenhagen, Denmark, and Aalborg University and Aalborg University Hospital  Aalborg Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Niels S.","family":"Krogh","sequence":"additional","affiliation":[{"name":"Zitelab  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jakob B.","family":"Bj\u00f8rner","sequence":"additional","affiliation":[{"name":"Optum Patient Insights, Johnston, Rhode Island, and University of Copenhagen  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Merete L.","family":"Hetland","sequence":"additional","affiliation":[{"name":"Rigshospitalet Glostrup, Glostrup, Denmark, and University of Copenhagen  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2019,11,28]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM200006223422507"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM200011303432202"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2011-201247"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-210713"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2007.080002"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2013-203843"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1532-5415.1999.tb01603.x"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1097\/EDE.0b013e3181875e61"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.2147\/CLEP.S99490"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/keq309"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1177\/1403494811401482"},{"key":"e_1_2_8_13_1","unstructured":"RADS.RADS: the Danish Council for the Use of Expensive Hospital medicines. URL:https\u200b:\/\/rads.dk\/media\/\u200b2830\/radsf\u200bolder-engel\u200bsk.pdf."},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1136\/jech-2011-200375"},{"key":"e_1_2_8_15_1","article-title":"A tool for assessing the feasibility of comparative effectiveness research","volume":"3","author":"Walker AM","year":"2013","journal-title":"J Comp Eff Res"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kwv254"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2016.04.014"},{"key":"e_1_2_8_18_1","unstructured":"Medicinr\u00e5det.Anbefalinger og vejledninger. URL:https\u200b:\/\/medic\u200binraa\u200bdet.dk\/anbef\u200baling\u200ber-og-vejle\u200bdninger."},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780230202"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/keh297"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780380107"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1186\/ar1740"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/0021-9681(87)90171-8"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.37711"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2015-207511"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(16)31651-8"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.1186\/ar3537"},{"key":"e_1_2_8_28_1","first-page":"CD012591","article-title":"Biologics or tofacitinib for people with rheumatoid arthritis unsuccessfully treated with biologics: a systematic review and network meta\u2010analysis","volume":"3","author":"Singh JA","year":"2017","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_8_29_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM200006223422506"},{"key":"e_1_2_8_30_1","doi-asserted-by":"publisher","DOI":"10.1002\/acr.22860"},{"key":"e_1_2_8_31_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11606-013-2755-z"},{"key":"e_1_2_8_32_1","doi-asserted-by":"publisher","DOI":"10.1097\/MLR.0b013e318070c08e"},{"issue":"2","key":"e_1_2_8_33_1","doi-asserted-by":"crossref","first-page":"451","DOI":"10.1136\/annrheumdis-2017-eular.4116","article-title":"Mandatory choice of first bDMARD in Denmark\u2014an opportunity to study real\u2010life effectiveness? Results from the DANBIO registry [abstract]","volume":"76","author":"Gr\u00f8n KL","year":"2017","journal-title":"Ann Rheum Dis"},{"key":"e_1_2_8_34_1","first-page":"725","article-title":"Efficacy and effectiveness of tumour necrosis factor inhibitors in the treatment of rheumatoid arthritis in randomized controlled trials and routine clinical practice","volume":"56","author":"Aaltonen KJ","year":"2017","journal-title":"Rheumatology (Oxford)"},{"key":"e_1_2_8_35_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2017-212395"}],"container-title":["Arthritis &amp; Rheumatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/art.41031","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/art.41031","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/acrjournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/art.41031","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T12:00:25Z","timestamp":1759924825000},"score":1,"resource":{"primary":{"URL":"https:\/\/acrjournals.onlinelibrary.wiley.com\/doi\/10.1002\/art.41031"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,11,28]]},"references-count":34,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2019,12]]}},"alternative-id":["10.1002\/art.41031"],"URL":"https:\/\/doi.org\/10.1002\/art.41031","archive":["Portico"],"relation":{},"ISSN":["2326-5191","2326-5205"],"issn-type":[{"value":"2326-5191","type":"print"},{"value":"2326-5205","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,11,28]]},"assertion":[{"value":"2019-03-27","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-06-27","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-11-28","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}