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Drug concentration in plasma may be a factor affecting the observed variability in therapeutic response. In this study, we aimed to identify the plasma concentrations of the anti\u2010TNF certolizumab pegol (CZP), associated with improvement in disease activity in patients with RA. Data were pooled from three randomized, controlled clinical trials with a combined total of 1,935 patients analyzed. Clinical outcomes of low disease activity (LDA) and remission were defined as Disease Activity Score in 28 joints with C\u2010reactive protein (DAS28(CRP)) \u2264 2.7 and &lt; 2.3, respectively. Quartile analysis results indicated that there may be an exposure\u2012response relationship between CZP concentration and LDA\/remission outcomes at weeks 12 and 24; the association was strongest for LDA (<jats:italic>P<\/jats:italic>\u00a0&lt;\u00a00.05). Receiver operating characteristic (ROC) analysis showed that CZP concentrations \u2265 28.0\u00a0\u03bcg\/ml at week 12, and \u2265 17.6\u00a0\u03bcg\/ml at week 24, were associated with a greater likelihood of achieving LDA\/remission outcomes. Although confirmatory studies are warranted to define the optimal CZP therapeutic range at weeks 12 and 24, these data indicate that CZP concentrations may be associated with improvement of disease activity.<\/jats:p>","DOI":"10.1111\/cts.12760","type":"journal-article","created":{"date-parts":[[2020,2,26]],"date-time":"2020-02-26T10:51:00Z","timestamp":1582714260000},"page":"743-751","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Exposure\u2013Response Relationship of Certolizumab Pegol and Achievement of Low Disease Activity and Remission in Patients With Rheumatoid Arthritis"],"prefix":"10.1111","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8830-4273","authenticated-orcid":false,"given":"St\u00e9phane","family":"Paul","sequence":"first","affiliation":[{"name":"Department of Immunology CIC1408 GIMAP EA3064 Universit\u00e9 Jean Monnet Saint \u00c9tienne France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hubert","family":"Marotte","sequence":"additional","affiliation":[{"name":"Department of Rheumatology SAINBOISE AINBIOSE INSERM 1059 University of Lyon Saint\u2010\u00c9tienne France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arthur","family":"Kavanaugh","sequence":"additional","affiliation":[{"name":"Division of Rheumatology, Allergy &amp; Immunology University of California San Diego School of Medicine La Jolla California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Philippe","family":"Goupille","sequence":"additional","affiliation":[{"name":"Department of Rheumatology University Hospital of Tours EA 7501 Tours France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tore K.","family":"Kvien","sequence":"additional","affiliation":[{"name":"Department of Rheumatology Diakonhjemmet Hospital Oslo Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marc","family":"de Longueville","sequence":"additional","affiliation":[{"name":"UCB Pharma Brussels Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Denis","family":"Mulleman","sequence":"additional","affiliation":[{"name":"Department of Rheumatology University Hospital of Tours EA 7501 Tours France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William J.","family":"Sandborn","sequence":"additional","affiliation":[{"name":"Department of Medicine University of California San Diego La Jolla California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Niels","family":"Vande Casteele","sequence":"additional","affiliation":[{"name":"Department of Medicine University of California San Diego La Jolla California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,4]]},"reference":[{"key":"e_1_2_10_1_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa020888"},{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/RHU.0000000000000229"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2006.065615"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2006.057745"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2012-202220"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2012.06.032"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2011-200184"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2009.07.062"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0009-9236(02)17635-1"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1873-9946(13)60538-3"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2013-204172"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.10302"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1873-9954(10)70058-6"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2004.030452"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-1253(19)30012-3"},{"key":"e_1_2_10_16_1","unstructured":"EMA.CIMZIA\u00ae (Certolizumab pegol) Annex 1: summary of product characteristics. 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