{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,12]],"date-time":"2025-07-12T22:56:29Z","timestamp":1752360989505,"version":"3.37.3"},"reference-count":31,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2015,6,17]],"date-time":"2015-06-17T00:00:00Z","timestamp":1434499200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100015661","name":"UCB Pharma","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100015661","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2015,8]]},"abstract":"Summary<\/jats:title>Background<\/jats:title>Certolizumab pegol (CZP<\/jats:styled-content>) is Food and Drug Administration (FDA<\/jats:styled-content>)\u2010approved to treat Crohn's disease (CD<\/jats:styled-content>). However, the efficacy and safety of CZP<\/jats:styled-content> outside clinical trials are not well established.<\/jats:p><\/jats:sec>Aim<\/jats:title>To report the efficacy, safety and predictors of response to CZP<\/jats:styled-content> in CD<\/jats:styled-content> patients treated during a 6\u2010year period since FDA<\/jats:styled-content>\u2010approval at a tertiary care centre.<\/jats:p><\/jats:sec>Methods<\/jats:title>All CD<\/jats:styled-content> patients who received CZP<\/jats:styled-content> at our institution between 2008 and 2013 were evaluated through retrospective medical record\u2010based review of steroid\u2010free complete response (SCR<\/jats:styled-content>), loss of response and safety.<\/jats:p><\/jats:sec>Results<\/jats:title>A total of 358 patients were included. One hundred twelve patients (31.3%) and 189 (52.8%) received CZP<\/jats:styled-content> as their second and third biological agent, respectively. The probability of SCR<\/jats:styled-content> at 26\u00a0week was 19.9% (95% CI<\/jats:styled-content>, 15.9\u201324.5). The probability of survival free of loss of response at 2\u00a0year was 45.7% (95% CI<\/jats:styled-content>, 32.5\u201359.5). A predictor of SCR<\/jats:styled-content> was age at CD<\/jats:styled-content> diagnosis of >40\u00a0years old (hazard ratio, HR<\/jats:styled-content> relative to those <17, 4.69; 95% CI<\/jats:styled-content>, 1.75\u201312.61). Negative predictors included present perianal fistula (HR<\/jats:styled-content>, 0.39; 95% CI<\/jats:styled-content>, 0.16\u20130.98) and prior primary nonresponse to adalimumab (ADA; HR<\/jats:styled-content> relative to secondary loss of response, 0.18; 95% CI<\/jats:styled-content>, 0.04\u20130.76). Twenty\u2010three patients (6.4%) experienced serious adverse events and 19 patients (5.3%) discontinued CZP<\/jats:styled-content> due to adverse events.<\/jats:p><\/jats:sec>Conclusions<\/jats:title>Certolizumab pegol was both effective and well tolerated for the treatment of Crohn's disease in this large tertiary care centre enriched with biologics\u2010exposed patients. It may be more effective in patients without early\u2010aged Crohn's disease diagnosis, prior primary nonresponse to adalimumab and present perianal fistula.<\/jats:p><\/jats:sec>","DOI":"10.1111\/apt.13288","type":"journal-article","created":{"date-parts":[[2015,6,17]],"date-time":"2015-06-17T07:15:22Z","timestamp":1434525322000},"page":"428-440","source":"Crossref","is-referenced-by-count":17,"title":["Efficacy and safety of certolizumab pegol for Crohn's disease in clinical practice"],"prefix":"10.1111","volume":"42","author":[{"given":"W.","family":"Moon","sequence":"first","affiliation":[{"name":"Division of Gastroenterology and Hepatology Mayo Clinic Rochester MN USA"},{"name":"Department of Internal Medicine Kosin University College of Medicine Busan Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"L.","family":"Pestana","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Mayo Clinic Rochester MN USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"B.","family":"Becker","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Mayo Clinic Rochester MN USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"suffix":"Jr","given":"E. V.","family":"Loftus","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Mayo Clinic Rochester MN USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"K. A.","family":"Hanson","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Mayo Clinic Rochester MN USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"D. H.","family":"Bruining","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Mayo Clinic Rochester MN USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"W. J.","family":"Tremaine","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Mayo Clinic Rochester MN USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S. V.","family":"Kane","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Mayo Clinic Rochester MN USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2015,6,17]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra0804647"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMct1209614"},{"key":"e_1_2_7_4_1","doi-asserted-by":"crossref","first-page":"1819","DOI":"10.1053\/j.gastro.2008.04.034","article-title":"FDA approves Cimzia to treat Crohn's disease","volume":"134","author":"Lang L","year":"2008","journal-title":"Gastroenterology"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa062897"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa067594"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2010.01.014"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.12930"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2010.04.021"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2010.04360.x"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2010.04568.x"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2009.03929.x"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/ibd.21127"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/ibd.21521"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1097\/MIB.0000000000000146"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2010.392"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2003.10.047"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/ibd.21272"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2005.06.064"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2004.02285.x"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.13083"},{"key":"e_1_2_7_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0016-5085(08)60620-4"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.1136\/gut.2008.155812"},{"key":"e_1_2_7_24_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2009.07.062"},{"key":"e_1_2_7_25_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2010.78"},{"key":"e_1_2_7_26_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2012.05214.x"},{"key":"e_1_2_7_27_1","doi-asserted-by":"publisher","DOI":"10.1080\/00365520802699278"},{"key":"e_1_2_7_28_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-146-12-200706190-00159"},{"key":"e_1_2_7_29_1","doi-asserted-by":"publisher","DOI":"10.1002\/jps.20178"},{"key":"e_1_2_7_30_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2008.092833"},{"key":"e_1_2_7_31_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.374"},{"key":"e_1_2_7_32_1","doi-asserted-by":"publisher","DOI":"10.1093\/ndt\/gfh1092"}],"container-title":["Alimentary Pharmacology & Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fapt.13288","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/apt.13288","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,23]],"date-time":"2023-09-23T21:39:20Z","timestamp":1695505160000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/apt.13288"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,6,17]]},"references-count":31,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2015,8]]}},"alternative-id":["10.1111\/apt.13288"],"URL":"https:\/\/doi.org\/10.1111\/apt.13288","archive":["Portico"],"relation":{},"ISSN":["0269-2813","1365-2036"],"issn-type":[{"type":"print","value":"0269-2813"},{"type":"electronic","value":"1365-2036"}],"subject":[],"published":{"date-parts":[[2015,6,17]]}}}