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We report pregnancy outcomes from prospectively reported pregnancies in Japanese women treated with certolizumab pegol (CZP).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Data from July 2001 to November 2020 on CZP\u2010exposed pregnancies from the CZP Pharmacovigilance safety database were reviewed. Pregnancy outcomes analyzed included live birth, ectopic pregnancy, abortion (miscarriage or medically indicated\/elective), and stillbirth. Congenital anomalies (major and minor), preterm delivery, and low birth weight were also examined.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among 149 prospective pregnancies with maternal CZP exposure and known outcomes identified in Japanese women, 111\/149 (74.5%) involved at least first\u2010trimester exposure and 53\/149 (35.6%) were exposed in all trimesters; 135\/149 (90.6%) live births, 12\/149 (8.1%) abortions (11 miscarriages, one elective termination), 2\/149 (1.3%) stillbirths, no ectopic pregnancies reported. One (0.7%) infant, whose mother had first\u2010trimester exposure, manifested a minor congenital anomaly (accessory auricle). There were no major congenital anomalies. Among live births, 3\/135 (2.2%) were preterm and 10\/135 (7.4%) had low birth weight.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The safety profile of CZP in pregnant Japanese women was consistent with published global data.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/1756-185x.70048","type":"journal-article","created":{"date-parts":[[2025,1,15]],"date-time":"2025-01-15T05:31:37Z","timestamp":1736919097000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Pharmacovigilance Pregnancy Data in a Population of Japanese Patients With Chronic Inflammatory Disease Exposed to Certolizumab Pegol"],"prefix":"10.1111","volume":"28","author":[{"given":"Mikako","family":"Goto","sequence":"first","affiliation":[{"name":"Japan Drug Information Institute in Pregnancy National Center for Child Health and Development  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shigeru","family":"Saito","sequence":"additional","affiliation":[{"name":"University of Toyama  Toyama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Angela E.","family":"Scheuerle","sequence":"additional","affiliation":[{"name":"UT Southwestern Medical Center  Dallas Texas USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shinya","family":"Yasuda","sequence":"additional","affiliation":[{"name":"UCB  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Niamh","family":"Houston","sequence":"additional","affiliation":[{"name":"UCB  Slough UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Kumke","sequence":"additional","affiliation":[{"name":"UCB  Monheim am Rhein Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bernard","family":"Lauwerys","sequence":"additional","affiliation":[{"name":"UCB  Brussels Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Atsuko","family":"Murashima","sequence":"additional","affiliation":[{"name":"Japan Drug Information Institute in Pregnancy National Center for Child Health and Development  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,1,15]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/acr.22516"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.semarthrit.2021.04.003"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen\u20102013\u2010004081"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.3390\/medicina58060780"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.semarthrit.2022.151993"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.2340\/00015555\u20102923"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/key053"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/1471\u20100528.15836"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.semarthrit.2019.09.010"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1186\/ar1957"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/acr.24130"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/keac551"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis\u20102015\u2010208840"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/kez405"},{"key":"e_1_2_10_16_1","volume-title":"StatPearls","author":"Benjamin O.","year":"2023"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1177\/1753495X211028779"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms19051349"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis\u20102019\u2010215882"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2012.11.011"},{"key":"e_1_2_10_21_1","unstructured":"\u201cInfliximab (Remicade Flixabi Inflectra Remsima and Zessly): Use of Live Vaccines in Infants Exposed in Utero or During Breastfeeding \u201dEuropean Medicines Agency (EMA) 2022 https:\/\/www.ema.europa.eu\/en\/documents\/dhpc\/direct\u2010healthcare\u2010professional\u2010communication\u2010dhpc\u2010infliximab\u2010remicade\u2010flixabi\u2010inflectra\u2010remsima_en.pdf."},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.crohns.2010.05.001"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/keac141"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis\u20102017\u2010212196"},{"key":"e_1_2_10_25_1","unstructured":"\u201cCimzia\u00ae 200mg Syringe for S.C. 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