Interim Analysis of Pregnancy Outcomes After Exposure to Dimethyl Fumarate in a Prospective International Registry
Oral delayed-release dimethyl fumarate (DMF) is not recommended during pregnancy and should only be used if the potential benefit justifies the potential fetal risk. Although DMF was well tolerated in clinical trials with consistent safety results in postmarketing surveillance, data are limited in p...
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| Veröffentlicht in: | Neurology : neuroimmunology & neuroinflammation 2022-01, Vol.9 (1) |
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| creator | Hellwig, Kerstin Rog, David McGuigan, Christopher Houtchens, Maria K. Bruen, Denise R. Mokliatchouk, Oksana Branco, Filipe Peng, Xiaomei Everage, Nicholas J. |
| description | Oral delayed-release dimethyl fumarate (DMF) is not recommended during pregnancy and should only be used if the potential benefit justifies the potential fetal risk. Although DMF was well tolerated in clinical trials with consistent safety results in postmarketing surveillance, data are limited in pregnant women. The objective was to provide pregnancy outcomes and DMF exposure information from an interim analysis from a prospective, international registry (TecGistry; NCT01911767).
Women exposed to DMF from the first day of their last menstrual period before conception or during pregnancy were evaluated. Data were obtained at enrollment; 6-7 months' gestation; 4 weeks after estimated due date; and 4, 12, and 52 weeks after birth. Outcomes included live births, gestational size, pregnancy loss, birth defects, and infant or maternal death after delivery. Outcomes were analyzed cumulatively from October 30, 2013 (the start of TecGistry), to April 8, 2020.
Of 345 enrolled patients, median (range) age was 32 (20-43) years. The mean (SD) duration of gestational weeks of DMF exposure was 4.9 (3.8). Most infants were full-term at birth (n = 249/274; 91%) and of average gestational size (n = 190/232; 82%). Of 351 outcomes, 277 were live births; 17 (5%) spontaneous abortions (95% confidence interval [CI] 2.6%-7.1%), including 1 ( |
| doi_str_mv | 10.1212/NXI.0000000000001114 |
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Women exposed to DMF from the first day of their last menstrual period before conception or during pregnancy were evaluated. Data were obtained at enrollment; 6-7 months' gestation; 4 weeks after estimated due date; and 4, 12, and 52 weeks after birth. Outcomes included live births, gestational size, pregnancy loss, birth defects, and infant or maternal death after delivery. Outcomes were analyzed cumulatively from October 30, 2013 (the start of TecGistry), to April 8, 2020.
Of 345 enrolled patients, median (range) age was 32 (20-43) years. The mean (SD) duration of gestational weeks of DMF exposure was 4.9 (3.8). Most infants were full-term at birth (n = 249/274; 91%) and of average gestational size (n = 190/232; 82%). Of 351 outcomes, 277 were live births; 17 (5%) spontaneous abortions (95% confidence interval [CI] 2.6%-7.1%), including 1 (<1%) molar and 1 (<1%) ectopic pregnancy, were reported. There were 8 (2.9% [95% CI 1.3%-5.6%]) adjudicator-confirmed birth defects among the 277 live births.
Interim results from this large registry indicate that early DMF exposure was not significantly associated with adverse pregnancy outcomes. Outcomes are consistent with previous smaller reports and with the general population.
TecGistry; clinical trial registration number: NCT01911767.</description><identifier>ISSN: 2332-7812</identifier><identifier>EISSN: 2332-7812</identifier><identifier>DOI: 10.1212/NXI.0000000000001114</identifier><identifier>PMID: 34815321</identifier><language>eng</language><publisher>United States: Lippincott Williams & Wilkins</publisher><subject>Adult ; Dimethyl Fumarate - adverse effects ; Female ; Humans ; Immunosuppressive Agents - adverse effects ; Pregnancy ; Pregnancy Complications - chemically induced ; Pregnancy Outcome ; Prospective Studies ; Registries ; Young Adult</subject><ispartof>Neurology : neuroimmunology & neuroinflammation, 2022-01, Vol.9 (1)</ispartof><rights>Lippincott Williams & Wilkins</rights><rights>Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.</rights><rights>Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology. 2021 American Academy of Neurology</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4530-81f32c2a8873750bc92c8fd3d379b1be8f6001bae0895745d2bbbfeb79f9a6113</citedby><cites>FETCH-LOGICAL-c4530-81f32c2a8873750bc92c8fd3d379b1be8f6001bae0895745d2bbbfeb79f9a6113</cites><orcidid>0000-0002-4488-9628 ; 0000-0002-7262-4248 ; 0000-0003-4467-9011 ; 0000-0001-6077-0654</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8611504/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8611504/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,27903,27904,53769,53771</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34815321$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hellwig, Kerstin</creatorcontrib><creatorcontrib>Rog, David</creatorcontrib><creatorcontrib>McGuigan, Christopher</creatorcontrib><creatorcontrib>Houtchens, Maria K.</creatorcontrib><creatorcontrib>Bruen, Denise R.</creatorcontrib><creatorcontrib>Mokliatchouk, Oksana</creatorcontrib><creatorcontrib>Branco, Filipe</creatorcontrib><creatorcontrib>Peng, Xiaomei</creatorcontrib><creatorcontrib>Everage, Nicholas J.</creatorcontrib><title>Interim Analysis of Pregnancy Outcomes After Exposure to Dimethyl Fumarate in a Prospective International Registry</title><title>Neurology : neuroimmunology & neuroinflammation</title><addtitle>Neurol Neuroimmunol Neuroinflamm</addtitle><description>Oral delayed-release dimethyl fumarate (DMF) is not recommended during pregnancy and should only be used if the potential benefit justifies the potential fetal risk. Although DMF was well tolerated in clinical trials with consistent safety results in postmarketing surveillance, data are limited in pregnant women. The objective was to provide pregnancy outcomes and DMF exposure information from an interim analysis from a prospective, international registry (TecGistry; NCT01911767).
Women exposed to DMF from the first day of their last menstrual period before conception or during pregnancy were evaluated. Data were obtained at enrollment; 6-7 months' gestation; 4 weeks after estimated due date; and 4, 12, and 52 weeks after birth. Outcomes included live births, gestational size, pregnancy loss, birth defects, and infant or maternal death after delivery. Outcomes were analyzed cumulatively from October 30, 2013 (the start of TecGistry), to April 8, 2020.
Of 345 enrolled patients, median (range) age was 32 (20-43) years. The mean (SD) duration of gestational weeks of DMF exposure was 4.9 (3.8). Most infants were full-term at birth (n = 249/274; 91%) and of average gestational size (n = 190/232; 82%). Of 351 outcomes, 277 were live births; 17 (5%) spontaneous abortions (95% confidence interval [CI] 2.6%-7.1%), including 1 (<1%) molar and 1 (<1%) ectopic pregnancy, were reported. There were 8 (2.9% [95% CI 1.3%-5.6%]) adjudicator-confirmed birth defects among the 277 live births.
Interim results from this large registry indicate that early DMF exposure was not significantly associated with adverse pregnancy outcomes. Outcomes are consistent with previous smaller reports and with the general population.
TecGistry; clinical trial registration number: NCT01911767.</description><subject>Adult</subject><subject>Dimethyl Fumarate - adverse effects</subject><subject>Female</subject><subject>Humans</subject><subject>Immunosuppressive Agents - adverse effects</subject><subject>Pregnancy</subject><subject>Pregnancy Complications - chemically induced</subject><subject>Pregnancy Outcome</subject><subject>Prospective Studies</subject><subject>Registries</subject><subject>Young Adult</subject><issn>2332-7812</issn><issn>2332-7812</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkVFvFCEUhSdGY5vaf2AMj75M5cLMwryYbGqrmzTWGE18Iwx72UVnYAWm7fx7WVvrKgnhJtzzXQ6nql4CPQMG7M3Hb6szerAAoHlSHTPOWS0ksKcH9VF1mtL3fRNrW7EQz6sj3khoOYPjKq58xuhGsvR6mJNLJFjyKeLGa29mcj1lE0ZMZGlLG7m424U0RSQ5kHduxLydB3I5jTrqjMR5oos2pB2a7G6Q_GZ7nV0ocPIZNy7lOL-onlk9JDx9OE-qr5cXX84_1FfX71fny6vaNC2ntQTLmWFaSsFFS3vTMSPtmq-56HroUdpFsdRrpLJrRdOuWd_3FnvR2U4vAPhJ9faeu5v6EdcGfY56ULviVsdZBe3UvzfebdUm3ChZ1C1tCuD1AyCGnxOmrEaXDA6D9himpNiCQte1Hd3Pau5bTbGfItrHMUDVPjFVElP_J1Zkrw6f-Cj6k89f7m0Yyl-mH8N0i1FtUQ95qygIKRoKNaOMUSjUumxG-S_qWqMs</recordid><startdate>20220101</startdate><enddate>20220101</enddate><creator>Hellwig, Kerstin</creator><creator>Rog, David</creator><creator>McGuigan, Christopher</creator><creator>Houtchens, Maria K.</creator><creator>Bruen, Denise R.</creator><creator>Mokliatchouk, Oksana</creator><creator>Branco, Filipe</creator><creator>Peng, Xiaomei</creator><creator>Everage, Nicholas J.</creator><general>Lippincott Williams & Wilkins</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-4488-9628</orcidid><orcidid>https://orcid.org/0000-0002-7262-4248</orcidid><orcidid>https://orcid.org/0000-0003-4467-9011</orcidid><orcidid>https://orcid.org/0000-0001-6077-0654</orcidid></search><sort><creationdate>20220101</creationdate><title>Interim Analysis of Pregnancy Outcomes After Exposure to Dimethyl Fumarate in a Prospective International Registry</title><author>Hellwig, Kerstin ; Rog, David ; McGuigan, Christopher ; Houtchens, Maria K. ; Bruen, Denise R. ; Mokliatchouk, Oksana ; Branco, Filipe ; Peng, Xiaomei ; Everage, Nicholas J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4530-81f32c2a8873750bc92c8fd3d379b1be8f6001bae0895745d2bbbfeb79f9a6113</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Adult</topic><topic>Dimethyl Fumarate - adverse effects</topic><topic>Female</topic><topic>Humans</topic><topic>Immunosuppressive Agents - adverse effects</topic><topic>Pregnancy</topic><topic>Pregnancy Complications - chemically induced</topic><topic>Pregnancy Outcome</topic><topic>Prospective Studies</topic><topic>Registries</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hellwig, Kerstin</creatorcontrib><creatorcontrib>Rog, David</creatorcontrib><creatorcontrib>McGuigan, Christopher</creatorcontrib><creatorcontrib>Houtchens, Maria K.</creatorcontrib><creatorcontrib>Bruen, Denise R.</creatorcontrib><creatorcontrib>Mokliatchouk, Oksana</creatorcontrib><creatorcontrib>Branco, Filipe</creatorcontrib><creatorcontrib>Peng, Xiaomei</creatorcontrib><creatorcontrib>Everage, Nicholas J.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Neurology : neuroimmunology & neuroinflammation</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hellwig, Kerstin</au><au>Rog, David</au><au>McGuigan, Christopher</au><au>Houtchens, Maria K.</au><au>Bruen, Denise R.</au><au>Mokliatchouk, Oksana</au><au>Branco, Filipe</au><au>Peng, Xiaomei</au><au>Everage, Nicholas J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Interim Analysis of Pregnancy Outcomes After Exposure to Dimethyl Fumarate in a Prospective International Registry</atitle><jtitle>Neurology : neuroimmunology & neuroinflammation</jtitle><addtitle>Neurol Neuroimmunol Neuroinflamm</addtitle><date>2022-01-01</date><risdate>2022</risdate><volume>9</volume><issue>1</issue><issn>2332-7812</issn><eissn>2332-7812</eissn><abstract>Oral delayed-release dimethyl fumarate (DMF) is not recommended during pregnancy and should only be used if the potential benefit justifies the potential fetal risk. Although DMF was well tolerated in clinical trials with consistent safety results in postmarketing surveillance, data are limited in pregnant women. The objective was to provide pregnancy outcomes and DMF exposure information from an interim analysis from a prospective, international registry (TecGistry; NCT01911767).
Women exposed to DMF from the first day of their last menstrual period before conception or during pregnancy were evaluated. Data were obtained at enrollment; 6-7 months' gestation; 4 weeks after estimated due date; and 4, 12, and 52 weeks after birth. Outcomes included live births, gestational size, pregnancy loss, birth defects, and infant or maternal death after delivery. Outcomes were analyzed cumulatively from October 30, 2013 (the start of TecGistry), to April 8, 2020.
Of 345 enrolled patients, median (range) age was 32 (20-43) years. The mean (SD) duration of gestational weeks of DMF exposure was 4.9 (3.8). Most infants were full-term at birth (n = 249/274; 91%) and of average gestational size (n = 190/232; 82%). Of 351 outcomes, 277 were live births; 17 (5%) spontaneous abortions (95% confidence interval [CI] 2.6%-7.1%), including 1 (<1%) molar and 1 (<1%) ectopic pregnancy, were reported. There were 8 (2.9% [95% CI 1.3%-5.6%]) adjudicator-confirmed birth defects among the 277 live births.
Interim results from this large registry indicate that early DMF exposure was not significantly associated with adverse pregnancy outcomes. Outcomes are consistent with previous smaller reports and with the general population.
TecGistry; clinical trial registration number: NCT01911767.</abstract><cop>United States</cop><pub>Lippincott Williams & Wilkins</pub><pmid>34815321</pmid><doi>10.1212/NXI.0000000000001114</doi><orcidid>https://orcid.org/0000-0002-4488-9628</orcidid><orcidid>https://orcid.org/0000-0002-7262-4248</orcidid><orcidid>https://orcid.org/0000-0003-4467-9011</orcidid><orcidid>https://orcid.org/0000-0001-6077-0654</orcidid><oa>free_for_read</oa></addata></record> |
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| source | Wolters Kluwer Open Health; MEDLINE; DOAJ Directory of Open Access Journals; EZB-FREE-00999 freely available EZB journals; PubMed Central; Journals@Ovid Complete |
| subjects | Adult Dimethyl Fumarate - adverse effects Female Humans Immunosuppressive Agents - adverse effects Pregnancy Pregnancy Complications - chemically induced Pregnancy Outcome Prospective Studies Registries Young Adult |
| title | Interim Analysis of Pregnancy Outcomes After Exposure to Dimethyl Fumarate in a Prospective International Registry |
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