{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T12:45:37Z","timestamp":1788871537520,"version":"build-2803163510"},"reference-count":47,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2015,5,28]],"date-time":"2015-05-28T00:00:00Z","timestamp":1432771200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Bundesministerium f\u00fcr Gesundheit (German Health Ministry"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2015,10]]},"abstract":"<jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>TNF\u2010\u03b1 inhibitors are considered relatively safe in pregnancy but experience is still limited. The aim of this study was to evaluate the risk of major birth defects, spontaneous abortion, preterm birth and reduced birth weight after first trimester exposure to TNF\u2010\u03b1 inhibitors.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Pregnancy outcomes of women on adalimumab, infliximab, etanercept, certolizumab pegol or golimumab were evaluated in a prospective observational cohort study and compared with outcomes of a non\u2010exposed random sample. The samples were drawn from pregnancies identified by institutes collaborating in the European Network of Teratology Information Services.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      In total, 495 exposed and 1532 comparison pregnancies were contributed from nine countries. The risk of major birth defects was increased in the exposed (5.0%) compared with the non\u2010exposed group (1.5%; adjusted odds ratio (OR\n                      <jats:sub>adj<\/jats:sub>\n                      ) 2.2, 95% CI 1.0, 4.8). The risk of preterm birth was increased (17.6%; OR\n                      <jats:sub>adj<\/jats:sub>\n                      1.69, 95% CI 1.1, 2.5), but not the risk of spontaneous abortion (16.2%; adjusted hazard ratio [HR\n                      <jats:sub>adj<\/jats:sub>\n                      ] 1.06, 95% CI 0.7, 1.7). Birth weights adjusted for gestational age and sex were significantly lower in the exposed group compared to the non\u2010exposed cohort (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.02). As a diseased comparison group was not possible to ascertain, the influence of disease and treatment on birth weight and preterm birth could not be differentiated.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>TNF\u2010\u03b1 inhibitors may carry a risk of adverse pregnancy outcome of moderate clinical relevance. Considering the impact of insufficiently controlled autoimmune disease on the mother and the unborn child, TNF\u2010\u03b1 inhibitors may nevertheless be a treatment option in women with severe disease refractory to established immunomodulatory drugs.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/bcp.12642","type":"journal-article","created":{"date-parts":[[2015,3,25]],"date-time":"2015-03-25T13:59:15Z","timestamp":1427291955000},"page":"727-739","source":"Crossref","is-referenced-by-count":130,"title":["Pregnancy outcome after TNF\u2010\u03b1 inhibitor therapy during the first trimester: a prospective multicentre cohort study"],"prefix":"10.1111","volume":"80","author":[{"given":"Corinna","family":"Weber\u2010Schoendorfer","sequence":"first","affiliation":[{"name":"Pharmakovigilanzzentrum Embryonaltoxikologie, Institut f\u00fcr Klinische Pharmakologie und Toxikologie Charit\u00e9 Universit\u00e4tsmedizin Berlin  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc","family":"Oppermann","sequence":"additional","affiliation":[{"name":"Pharmakovigilanzzentrum Embryonaltoxikologie, Institut f\u00fcr Klinische Pharmakologie und Toxikologie Charit\u00e9 Universit\u00e4tsmedizin Berlin  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evelin","family":"Wacker","sequence":"additional","affiliation":[{"name":"Pharmakovigilanzzentrum Embryonaltoxikologie, Institut f\u00fcr Klinische Pharmakologie und Toxikologie Charit\u00e9 Universit\u00e4tsmedizin Berlin  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathalie","family":"Bernard","sequence":"additional","affiliation":[{"name":"Centre R\u00e9gional de Pharmacovigilance Hospices Civils de Lyon  Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf of the network of French pharmacovigilance centres","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Delphine","family":"Beghin","sequence":"additional","affiliation":[{"name":"Centre de R\u00e9f\u00e9rence sur les Agents T\u00e9ratog\u00e8nes (CRAT) H\u00f4pitaux Universitaires Est Parisien (APHP)  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benedikte","family":"Cuppers\u2010Maarschalkerweerd","sequence":"additional","affiliation":[{"name":"Teratology Information Service MH \u2019s\u2010Hertogenbosch  Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan L.","family":"Richardson","sequence":"additional","affiliation":[{"name":"UK Teratology Information Service Newcastle upon Tyne Hospitals NHS Foundation Trust &amp; Newcastle University  Newcastle upon Tyne United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura E.","family":"Rothuizen","sequence":"additional","affiliation":[{"name":"Swiss Teratogen Information Service (STIS) and Division of Clinical Pharmacology University Hospital  Lausanne Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandra","family":"Pistelli","sequence":"additional","affiliation":[{"name":"Centro di Riferimento Regionale di Tossicologia Perinatale Azienda Ospedaliero Universitaria Careggi  Firenze Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heli","family":"Malm","sequence":"additional","affiliation":[{"name":"Teratology Information Service HUSLAB and Helsinki University Central Hospital  Helsinki Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Georgios","family":"Eleftheriou","sequence":"additional","affiliation":[{"name":"Poison Control Centre and Teratology Information Service Hospital Papa Giovanni XXIII  Bergamo Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Debra","family":"Kennedy","sequence":"additional","affiliation":[{"name":"Mothersafe Royal Hospital for Women  Randwick Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mine","family":"Kadioglu Duman","sequence":"additional","affiliation":[{"name":"Department of Pharmacology Karadeniz Technical University  Trabzon Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Reinhard","family":"Meister","sequence":"additional","affiliation":[{"name":"Department of Mathematics Beuth Hochschule f\u00fcr Technik Berlin (University of Applied Sciences)  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christof","family":"Schaefer","sequence":"additional","affiliation":[{"name":"Pharmakovigilanzzentrum Embryonaltoxikologie, Institut f\u00fcr Klinische Pharmakologie und Toxikologie Charit\u00e9 Universit\u00e4tsmedizin Berlin  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2015,5,28]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1186\/1741\u20107015\u201011\u2010174"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1136\/gut.39.5.690"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1097\/MIB.0000000000000092"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.crohns.2010.05.001"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/bdra.23033"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2013.171"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.080545"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2010.140822"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2012.430"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.reprotox.2013.11.004"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v19.i17.2591"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2014-eular.4415"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0016-5085(12)60561-7"},{"key":"e_1_2_9_15_1","first-page":"1014","article-title":"Tumor necrosis factor\u2010alpha inhibition and VATER association: a causal relationship","volume":"33","author":"Carter JD","year":"2006","journal-title":"J Rheumatol"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.081083"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.101316"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0897.2008.00669.x"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0897.2008.00585.x"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2008.71"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2012.11.011"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2011.04617.x"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/keq185"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0897.2007.00499.x"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(07)61602-X"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.reprotox.2008.05.064"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1097-0258(19981015)17:19<2265::AID-SIM918>3.0.CO;2-B"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.1037\/1082-989X.9.4.403"},{"key":"e_1_2_9_29_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.reprotox.2008.06.006"},{"key":"e_1_2_9_30_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0029-1241833"},{"key":"e_1_2_9_31_1","volume-title":"Statistical analysis with missing data","author":"Little RJA","year":"1987"},{"key":"e_1_2_9_32_1","doi-asserted-by":"publisher","DOI":"10.1002\/9780470316696"},{"key":"e_1_2_9_33_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2011.5"},{"key":"e_1_2_9_34_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.38368"},{"key":"e_1_2_9_35_1","doi-asserted-by":"publisher","DOI":"10.1186\/1750-1172-6-56"},{"key":"e_1_2_9_36_1","doi-asserted-by":"publisher","DOI":"10.1038\/ejhg.2012.14"},{"key":"e_1_2_9_37_1","doi-asserted-by":"publisher","DOI":"10.1023\/A:1021740108284"},{"key":"e_1_2_9_38_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2007.05.003"},{"key":"e_1_2_9_39_1","unstructured":"EUROCAT.Prevalence Tables. Available athttp:\/\/www.eurocat\u2010network.eu\/accessprevalencedata\/prevalencetables(last accessed 14\u20108\u20102014)."},{"key":"e_1_2_9_40_1","first-page":"1091","article-title":"Birth outcomes in women with inflammatory bowel disease: effects of disease activity and drug exposure","volume":"20","author":"Broms G","year":"2014","journal-title":"Inflamm Bowel Dis"},{"key":"e_1_2_9_41_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10995-006-0073-3"},{"key":"e_1_2_9_42_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.24914"},{"key":"e_1_2_9_43_1","first-page":"9","article-title":"High rate of preterm birth in pregnancies complicated by rheumatoid arthritis","volume":"31","author":"Langen ES","year":"2014","journal-title":"Am J Perinatol"},{"key":"e_1_2_9_44_1","doi-asserted-by":"publisher","DOI":"10.1002\/ajmg.c.30303"},{"key":"e_1_2_9_45_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2013.09.061"},{"key":"e_1_2_9_46_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.crohns.2010.07.004"},{"key":"e_1_2_9_47_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2008.104331"},{"key":"e_1_2_9_48_1","first-page":"353","volume-title":"Does the average drug exposure in pregnant women affect pregnancy outcome?","author":"Wacker E","year":"2015"}],"container-title":["British Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fbcp.12642","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fbcp.12642","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bcp.12642","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,13]],"date-time":"2023-09-13T14:08:53Z","timestamp":1694614133000},"score":1,"resource":{"primary":{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/10.1111\/bcp.12642"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,5,28]]},"references-count":47,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2015,10]]}},"alternative-id":["10.1111\/bcp.12642"],"URL":"https:\/\/doi.org\/10.1111\/bcp.12642","archive":["Portico"],"relation":{},"ISSN":["0306-5251","1365-2125"],"issn-type":[{"value":"0306-5251","type":"print"},{"value":"1365-2125","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,5,28]]}}}