{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T18:28:33Z","timestamp":1793212113079,"version":"4.5.0"},"reference-count":37,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2020,1,1]],"date-time":"2020-01-01T00:00:00Z","timestamp":1577836800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therap Adv Gastroenterol"],"published-print":{"date-parts":[[2020,1]]},"abstract":"<jats:sec><jats:title>Background and Aims:<\/jats:title><jats:p> Efficacy of adalimumab in Crohn\u2019s disease (CD) has not been shown in China. The aim of this study was to evaluate the efficacy and safety of adalimumab in Chinese patients with CD. <\/jats:p><\/jats:sec><jats:sec><jats:title>Methods:<\/jats:title><jats:p> This 26-week, multicenter, phase\u2009III study evaluated patients with moderately to severely active CD and elevated high-sensitivity C-reactive protein (\u2a7e3\u2009mg\/l) who were na\u00efve to anti\u2013tumor necrosis factor therapy. Patients were randomized to double-blind adalimumab 160\/80\u2009mg at weeks 0\/2 and 40\u2009mg at weeks 4\/6 or placebo at weeks 0\/2 followed by blinded adalimumab 160\/80\u2009mg at weeks 4\/6. At week 8, all patients received open-label 40\u2009mg adalimumab every other week through week 26. The primary endpoint was clinical remission [CD activity index (CDAI) &lt;150] at week 4. Clinical remission at week 26 was assessed in week-8 responders (decrease in CDAI \u2a7e70 points at week 8 from baseline) and compared with a clinically meaningful threshold of 30%. Adverse events (AEs) were recorded throughout the study. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results:<\/jats:title><jats:p> At baseline, 205 patients were enrolled, with mean [standard deviation (SD)] age of 32.9 (9.9) years and CD duration of 2.7 (3.0) years. At week 4, 38\/102 patients (37%) receiving adalimumab and 7\/103 (7%) receiving placebo ( p\u2009&lt;\u20090.001) achieved clinical remission. Among week-8 responders, 93\/144 (65%) achieved clinical remission at week 26 ( p\u2009&lt;\u20090.001). No unexpected AEs and no malignancies, active tuberculosis, or deaths were reported. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions:<\/jats:title><jats:p> Adalimumab induced and maintained remission in Chinese patients with CD. Safety results were consistent with the known safety profile of adalimumab. <\/jats:p><\/jats:sec><jats:sec><jats:title> identifier:<\/jats:title><jats:p> NCT02499783 <\/jats:p><\/jats:sec>","DOI":"10.1177\/1756284820938960","type":"journal-article","created":{"date-parts":[[2020,7,16]],"date-time":"2020-07-16T23:28:00Z","timestamp":1594942080000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":35,"title":["Efficacy and safety of adalimumab in Chinese patients with moderately to severely active Crohn\u2019s disease: results from a randomized trial"],"prefix":"10.1177","volume":"13","author":[{"given":"Baili","family":"Chen","sequence":"first","affiliation":[{"name":"The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiang","family":"Gao","sequence":"additional","affiliation":[{"name":"The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jie","family":"Zhong","sequence":"additional","affiliation":[{"name":"Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianlin","family":"Ren","sequence":"additional","affiliation":[{"name":"Zhongshan Hospital Xiamen University, Xiamen, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xuan","family":"Zhu","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital of Nanchang University, Nanchang, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0326-543X","authenticated-orcid":false,"given":"Zhanju","family":"Liu","sequence":"additional","affiliation":[{"name":"Shanghai Tenth People\u2019s Hospital, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaichun","family":"Wu","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital of Fourth Military Medical University, Xi\u2019an, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jasmina","family":"Kalabic","sequence":"additional","affiliation":[{"name":"AbbVie Deutschland GmbH & Co. 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