{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,19]],"date-time":"2026-06-19T00:09:14Z","timestamp":1781827754017,"version":"3.54.5"},"reference-count":50,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2022,11,30]],"date-time":"2022-11-30T00:00:00Z","timestamp":1669766400000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100002998","name":"College ter Beoordeling van Geneesmiddelen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100002998","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Lupus"],"published-print":{"date-parts":[[2023,2]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>The first biologic authorized for systemic lupus erythematosus (SLE) up to this date, belimumab, is currently not recommended for use during pregnancy due to lack of data. Provided that the health of the child begins with the health of the mother, pregnant patients face the dilemma of cessation or continuation of belimumab. If belimumab is stopped, there will be a risk of SLE flare and its consequences for the mother and the foetus. Continuation is also not optimal because of the lack of knowledge on safety for use during pregnancy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>To compare the reported foetal outcomes in SLE patients who stopped scheduled belimumab within the first trimester (group A) and those who continued scheduled belimumab during the first trimester or thereafter (group B).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Material and method<\/jats:title>\n                    <jats:p>All belimumab-exposed pregnancy-related reports were extracted from the EudraVigilance (EV) database until March 11th, 2021. After case review, repeated cases, uninformative reports, non-medical elective abortions and foetal chromosomal abnormalities were excluded. Included pregnancies were divided into two groups (group A and B, as described above). Foetal outcomes were divided into live birth or foetal death (due to miscarriage or stillbirth) and were compared between both groups. Furthermore, neonatal outcomes, such as reporting rates of preterm birth, low birth weight and major congenital malformations were compared.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>No statistical difference in foetal death was observed between group A and B (reported numbers (%) = 32 (46.4) and 11 (52.4), respectively). Odds ratio (OR, [95% Confidence Intervals (CIs)]) of foetal death in group B compared to group A was 1.27 [0.48, 3.32]. Reporting rates of preterm birth and low birth weight were higher \u2013 though not statistically different \u2013 in group A.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The positive results of our study are supportive for the continuation of belimumab during pregnancy. Since the analysis is based on spontaneous reports\/retrospective data, additional studies are needed to confirm the results.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/09612033221143286","type":"journal-article","created":{"date-parts":[[2022,11,30]],"date-time":"2022-11-30T04:31:23Z","timestamp":1669782683000},"page":"189-197","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":18,"title":["Dilemma of belimumab therapy (dis)continuation during pregnancy: Results of a retrospective study in eudravigilance"],"prefix":"10.1177","volume":"32","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7130-2749","authenticated-orcid":false,"given":"Nafise","family":"Ghalandari","sequence":"first","affiliation":[{"name":"Department of Rheumatology, Erasmus University Medical Center, Rotterdam, The Netherlands"},{"name":"Medicines Evaluation Board (MEB), Utrecht, The Netherlands"},{"name":"Academic Center of Inflammunity, Erasmus University Medical Center, Rotterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hubertina JMJ","family":"Crijns","sequence":"additional","affiliation":[{"name":"Medicines Evaluation Board (MEB), Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Radboud JEM","family":"Dolhain","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Erasmus University Medical Center, Rotterdam, The Netherlands"},{"name":"Academic Center of Inflammunity, Erasmus University Medical Center, Rotterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johanna MW","family":"Hazes","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Erasmus University Medical Center, Rotterdam, The Netherlands"},{"name":"Academic Center of Inflammunity, Erasmus University Medical Center, Rotterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eugene P","family":"van Puijenbroek","sequence":"additional","affiliation":[{"name":"Netherlands Pharmacovigilance Centre Lareb, \u2018s Hertogenbosch, The Netherlands"},{"name":"Unit of Pharmacotherapy, -Epidemiology & -Economics, Faculty of Science and Engineering, University of Groningen, Groningen, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2022,11,30]]},"reference":[{"key":"bibr1-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1097\/BOR.0000000000000480"},{"key":"bibr2-09612033221143286","doi-asserted-by":"publisher","DOI":"10.5114\/reum.2017.66685"},{"key":"bibr3-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1177\/09612033211004716"},{"key":"bibr4-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/keu394"},{"key":"bibr5-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1007\/s40272-018-0312-2"},{"key":"bibr6-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2249.2005.02795.x"},{"key":"bibr7-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2001180"},{"key":"bibr8-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2001180"},{"key":"bibr9-09612033221143286","volume-title":"Summary of product characteristics (SmPC) Belimumab (benlysta) European medicines agency 2021","author":"Agency EM","year":"2021"},{"key":"bibr10-09612033221143286","volume-title":"Results of the open-label, non-randomized 52-week study to evaluate treatment holidays and rebound phenomenon after treatment with belimumab in patients with SLE. Arthritis & Rheumatology","author":"Bae S-C","year":"2019"},{"key":"bibr11-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1002\/9781119413431.ch10"},{"key":"bibr12-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-018-0647-1"},{"key":"bibr13-09612033221143286","volume-title":"Guideline on Good Pharmacovigilance Practices (GVP)-Module VI-Management and Reporting of Adverse Reactions to Medicinal Products (Rev 1)","author":"Agency EEM","year":"2014"},{"key":"bibr14-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.19504"},{"key":"bibr15-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1002\/9781118820186.ch10"},{"key":"bibr16-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2021.01.015"},{"key":"bibr17-09612033221143286","volume-title":"Screening for Adverse Reactions in EudraVigilance","author":"European Medicines A","year":"2016"},{"key":"bibr18-09612033221143286","doi-asserted-by":"publisher","DOI":"10.2165\/11534410-000000000-00000"},{"key":"bibr19-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kwy237"},{"key":"bibr20-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-017-0569-3"},{"key":"bibr21-09612033221143286","first-page":"3","volume":"30","author":"Bacino CA","year":"2021","journal-title":"UpToDate Obtenido el"},{"key":"bibr22-09612033221143286","unstructured":"EUROCAT Guide 1.4 and Reference Documents (version 07.10.2021). 2021. https:\/\/eu-rd-platformjrceceuropaeu\/eurocat\/data-collection\/guidelines-for-data-registration_en"},{"key":"bibr23-09612033221143286","volume-title":"Firestein & Kelley\u2019s Textbook of Rheumatology-E-Book","author":"Firestein GS","year":"2020"},{"key":"bibr24-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaut.2017.02.009"},{"key":"bibr25-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1002\/art.20864"},{"key":"bibr26-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1007\/s00404-003-0574-x"},{"key":"bibr27-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1016\/j.rdc.2007.01.002"},{"key":"bibr28-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-209770"},{"key":"bibr29-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2015-208840"},{"key":"bibr30-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2019-215089"},{"key":"bibr31-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1016\/j.semarthrit.2014.05.006"},{"key":"bibr32-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1016\/j.semarthrit.2016.03.005"},{"key":"bibr33-09612033221143286","volume":"17","author":"Gandino IJ","year":"2020","journal-title":"Reumatol Clin"},{"key":"bibr34-09612033221143286","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.170327"},{"key":"bibr35-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1016\/j.semarthrit.2021.06.005"},{"key":"bibr36-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1016\/j.reprotox.2009.07.002"},{"key":"bibr37-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.104"},{"key":"bibr38-09612033221143286","volume-title":"EPAR Initial Scientific Discussion Belimumab (benlysta)","author":"Ema) EMA","year":"2011"},{"key":"bibr39-09612033221143286","unstructured":"Ema) EMA. Guideline on good pharmacovigilance practices (GVP); Module, VI, Rev 2, 2017. https:\/\/wwwemaeuropaeu\/en\/documents\/regulatory-procedural-guideline\/guideline-good-pharmacovigilance-practices-gvp-module-vi-collection-management-submission-reports_enpdf"},{"key":"bibr40-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2015.09.066"},{"key":"bibr41-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1186\/ar3945"},{"key":"bibr42-09612033221143286","unstructured":"Ema) EMA. Methotrexate Article-31 Referral - Jylamvo : EPAR - Product Information. Amsterdam, Netherlands. European Medicines Agency 2019, p. 11, https:\/\/www.ema.europa.eu\/documents\/referral\/methotrexate-article-31-referral-jylamvo-epar-product-information_.pdf"},{"key":"bibr43-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1186\/ar4014"},{"key":"bibr44-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1177\/0961203320947814"},{"key":"bibr45-09612033221143286","author":"Oon S","year":"2019","journal-title":"Annals of the Rheumatic Dis"},{"key":"bibr46-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1007\/s00296-017-3682-9"},{"key":"bibr47-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1007\/s40620-020-00706-3"},{"key":"bibr48-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.879"},{"key":"bibr49-09612033221143286","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.13098"},{"key":"bibr50-09612033221143286","volume-title":"Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling","author":"European Medicines A","year":"2008"}],"container-title":["Lupus"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/09612033221143286","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/09612033221143286","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/09612033221143286","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T23:26:29Z","timestamp":1777677989000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/09612033221143286"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,11,30]]},"references-count":50,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2023,2]]}},"alternative-id":["10.1177\/09612033221143286"],"URL":"https:\/\/doi.org\/10.1177\/09612033221143286","relation":{},"ISSN":["0961-2033","1477-0962"],"issn-type":[{"value":"0961-2033","type":"print"},{"value":"1477-0962","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,11,30]]}}}