{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T08:31:50Z","timestamp":1790065910002,"version":"4.0.1"},"reference-count":45,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2018,7,22]],"date-time":"2018-07-22T00:00:00Z","timestamp":1532217600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"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":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis &amp; Rheumatology"],"published-print":{"date-parts":[[2018,9]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>Anti\u2013tumor necrosis factor (anti\u2010<jats:styled-content style=\"fixed-case\">TNF<\/jats:styled-content>) medications are effective in controlling chronic inflammatory diseases, but information about their use and safety in pregnancy is limited. Consequently, anti\u2010<jats:styled-content style=\"fixed-case\">TNF<\/jats:styled-content> agents are often discontinued early in gestation. Certolizumab pegol (<jats:styled-content style=\"fixed-case\">CZP<\/jats:styled-content>), a <jats:styled-content style=\"fixed-case\">PEG<\/jats:styled-content>ylated, Fc\u2010free anti\u2010<jats:styled-content style=\"fixed-case\">TNF<\/jats:styled-content> agent approved for the treatment of rheumatic diseases and\/or Crohn's disease, has minimal to no active placental transfer. This analysis was undertaken to evaluate pregnancy outcomes in women receiving <jats:styled-content style=\"fixed-case\">CZP<\/jats:styled-content>, especially those exposed during early pregnancy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Prospective and retrospective data on maternal <jats:styled-content style=\"fixed-case\">CZP<\/jats:styled-content> exposure were extracted from the <jats:styled-content style=\"fixed-case\">UCB<\/jats:styled-content> Pharma safety database through March 6, 2017. Analysis was limited to prospective reports to avoid potential bias associated with retrospective submissions. The numbers of live births, miscarriages, elective abortions, stillbirths, and major congenital malformations were ascertained.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 1,137 prospectively reported pregnancies with maternal exposure to <jats:styled-content style=\"fixed-case\">CZP<\/jats:styled-content>, 528 (including 10 twin pregnancies) had 538 known outcomes: 459 live births (85.3%), 47 miscarriages (8.7%), 27 elective abortions (5.0%), and 5 stillbirths (0.9%). There were 8 major congenital malformations (1.7%) among the 459 infants. First trimester exposure occurred in 367 (81.2%) of 452 pregnancies resulting in 459 live births. Exposure during all 3 trimesters occurred in 201 (44.5%) of 452 pregnancies.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This analysis represents the largest cohort of pregnant women exposed to an anti\u2010<jats:styled-content style=\"fixed-case\">TNF<\/jats:styled-content> agent for management of chronic inflammatory diseases. Analysis of pregnancy outcomes does not indicate a teratogenic effect of <jats:styled-content style=\"fixed-case\">CZP<\/jats:styled-content>, compared to the general population, nor an increased risk of fetal death. 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