053 Pregnancy outcomes with delayed-release dimethyl fumarate: interim results from an international registry

2018 ◽  
Vol 89 (6) ◽  
pp. A22.1-A22
Author(s):  
Nicholas J Everage ◽  
Shifang Liu ◽  
Jang Yun ◽  
Claudia Prada ◽  
Jerome Hanna
Keyword(s):  
Birth Defects ◽  
Pregnancy Outcomes ◽  
Ductus Arteriosus ◽  
Dimethyl Fumarate ◽  
Essential Information ◽  
Live Births ◽  
Delayed Release ◽  
International Registry ◽  
Post Marketing ◽  
Reported Data

IntroductionClinical trials and post marketing reports show no safety signals with delayed-release dimethyl fumarate (DMF) exposure during pregnancy; however, these data are limited and the product label recommends use during pregnancy only if the potential benefit justifies the potential risk to the foetus. We assessed pregnancy outcomes in an ongoing international registry (NCT01911767) of women with MS exposed to DMF since the first day of their last menstrual period prior to conception or at any time during pregnancy.MethodsDMF-exposed women were prospectively evaluated for live births and pregnancy loss. Ectopic and molar pregnancies, birth defects, congenital anomalies or infant death occurring at ≤52 weeks of age, and maternal death at ≤12 weeks post-delivery, were reported. Data were collected at baseline (enrolment), 6–7 months of gestation, 4 weeks after the estimated delivery date, and 4, 12, and 52 weeks after birth. Potential birth defects were adjudicated by an external expert.ResultsAs of 30, Sept 2016 104 patients were enrolled in the registry; mean (SD) age was 315 years. DMF exposure occurred in the first (95%), second (1%), and third (0%) trimester in the 94 patients with a known exposure date. To date, 58 pregnancy outcomes have been reported, including 52 patients with 54 live births and 4 (7%) spontaneous abortions (<22 weeks). Of the 54 (93%) live births, 47 (87%) were full term (delivered ≥37 weeks) and four (7%) premature. Two (4%) infants had adjudicator-confirmed birth defects; one with pyloric stenosis, and one with transposition of the great vessels/patent ductus arteriosus. No maternal, neonatal, perinatal, or infant deaths were reported.ConclusionThe results from this ongoing registry did not identify a safety signal for DMF exposure on pregnancy outcomes, are consistent with previous reports, and provide essential information concerning exposure to DMF during pregnancy.

scholarly journals Interim Analysis of Pregnancy Outcomes After Exposure to Dimethyl Fumarate in a Prospective International Registry

2021 ◽  
Vol 9 (1) ◽  
pp. e1114
Author(s):  
Kerstin Hellwig ◽  
David Rog ◽  
Christopher McGuigan ◽  
Maria K. Houtchens ◽  
Denise R. Bruen ◽  
...  
Keyword(s):  
Birth Defects ◽  
Pregnancy Outcomes ◽  
Interim Analysis ◽  
Dimethyl Fumarate ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
Live Births ◽  
Link Type ◽  
International Registry ◽  
Adverse Pregnancy

Background and ObjectivesOral 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).MethodsWomen 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.ResultsOf 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.DiscussionInterim 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.Trial Registration InformationTecGistry; clinical trial registration number: NCT01911767.

Pregnancy Outcomes From an International Registry of Patients Treated With Delayed-release Dimethyl Fumarate

2019 ◽  
Vol 175 ◽  
pp. S94 ◽  
Author(s):  
Nicholas J. Everage ◽  
Cynthia C. Jones ◽  
Kerstin Hellwig ◽  
David Rog ◽  
Shifang Liu ◽  
...  
Keyword(s):  
Pregnancy Outcomes ◽  
Dimethyl Fumarate ◽  
Delayed Release ◽  
International Registry

scholarly journals Pregnancy outcomes from the global pharmacovigilance database on interferon beta-1b exposure

2020 ◽  
Vol 13 ◽  
pp. 175628642091031 ◽  
Author(s):  
Kerstin Hellwig ◽  
Fernando Duarte Caron ◽  
Eva-Maria Wicklein ◽  
Aasia Bhatti ◽  
Alessandra Adamo
Keyword(s):  
Cohort Study ◽  
Health Status ◽  
Spontaneous Abortion ◽  
Birth Defects ◽  
Pregnancy Outcomes ◽  
Congenital Anomalies ◽  
Interferon Beta ◽  
Live Births ◽  
Congenital Birth Defects ◽  
Pharmacovigilance Database

Background: The goal of the present cohort study was to review outcomes of patients exposed to interferon beta-1b during pregnancy. Methods: Pregnancy cases with exposure to interferon beta-1b reported to Bayer’s pharmacovigilance (PV) database from worldwide sources from January 1995 through February 2018 were retrieved for evaluation. Only cases where pregnancy outcomes were unknown at the time of reporting (i.e. prospective cases) were included in the analysis of this retrospective cohort study. Results: As of February 2018, 2581 prospective pregnancies exposed to interferon beta-1b were retrieved from the database; 1348 pregnancies had documented outcomes. The majority of outcomes [1106 cases (82.0%)] were live births. Health status was known for 981 live births (no known health status for 125). Most of the prospective pregnancies with known outcomes corresponded to live births with no congenital anomalies [896 cases (91.3%)]. Spontaneous abortion occurred in 160 cases (11.9%). Congenital birth defects were observed in 14/981 live births with known health status [1.4%, 95% confidence interval (CI) 0.78–2.38]. No consistent pattern in the type of birth defect was identified. Rates of both spontaneous abortion and birth defects were not higher than the general population. Conclusions: These PV data, the largest sample of interferon beta-1b-exposed patients reported to date, suggest no increase in risk of spontaneous abortion or congenital anomalies in women exposed during pregnancy.

scholarly journals Delayed-Release Dimethyl Fumarate and Pregnancy: Preclinical Studies and Pregnancy Outcomes from Clinical Trials and Postmarketing Experience

2015 ◽  
Vol 4 (2) ◽  
pp. 93-104 ◽  
Author(s):  
Ralf Gold ◽  
J. Theodore Phillips ◽  
Eva Havrdova ◽  
Amit Bar-Or ◽  
Ludwig Kappos ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Pregnancy Outcomes ◽  
Dimethyl Fumarate ◽  
Preclinical Studies ◽  
Delayed Release

scholarly journals Ulipristal acetate and pregnancy outcome—an observational study

2020 ◽  
Vol 35 (4) ◽  
pp. 751-758
Author(s):  
Jenny Katharina Wagner ◽  
Katarina Dathe ◽  
Christof Schaefer ◽  
Maria Hoeltzenbein
Keyword(s):  
Observational Study ◽  
Pregnancy Outcome ◽  
Birth Defects ◽  
Pregnancy Outcomes ◽  
Conflicts Of Interest ◽  
Termination Of Pregnancy ◽  
Ulipristal Acetate ◽  
Live Births ◽  
Increased Risk ◽  
In Pregnancy

Abstract STUDY QUESTION Is the failure of the selective progesterone receptor modulator ulipristal acetate (UPA) as emergency contraception (EC; 30 mg, single) or inadvertent exposure for myoma treatment (5 mg/d) in pregnancy associated with a higher risk of birth defects, spontaneous abortion (SAB) or elective termination of pregnancy (ETOP)? SUMMARY ANSWER We did not find an increased risk for birth defects, SABs or ETOPs after UPA exposure during implantation and early embryogenesis. WHAT IS KNOWN ALREADY Pregnancy outcome data after exposure to UPA are very limited. In cases of EC failure or unplanned pregnancy during myoma treatment, women need well-grounded risk assessment to minimize anxiety and prevent unjustified termination of pregnancy. STUDY DESIGN, SIZE, DURATION Observational study of prospectively ascertained pregnancies from the German Embryotox institute with UPA exposure (EC, n = 95; myoma, n = 7). Four retrospectively reported pregnancy outcomes were evaluated separately. PARTICIPANTS/MATERIALS, SETTING, METHODS A total of 226 requests on ulipristal were directed to the German Embryotox institute during the study period 2010–2018. Outcomes of pregnancies exposed—(i) precycle, (ii) preconceptional or (iii) first trimester—were ascertained using standardized questionnaires. Descriptive statistics were applied. MAIN RESULTS AND THE ROLE OF CHANCE Failed EC with UPA resulted in 95 prospectively ascertained pregnancies, of which 56 had completed follow-up: 37 live births, 7 SABs and 12 ETOPs. There was no major birth defect. Just 34% of women had taken UPA during the fertile window. Seven prospectively enrolled pregnancies were treated for myoma and had known pregnancy outcomes: five healthy live births and two SABs. Among the four retrospectively reported pregnancies after EC, there was one child diagnosed with Beckwith-Wiedemann syndrome (BWS). LIMITATIONS, REASONS FOR CAUTION Our limited sample size does not allow concluding safety of UPA use in pregnancy. WIDER IMPLICATIONS OF THE FINDINGS We provide a preliminary basis for reassuring women who wish to carry their pregnancy to term after EC or myoma treatment with UPA. However, because of the report of a BWS after UPA exposure, a possible epigenetic effect could not be excluded and requires further evaluation. STUDY FUNDING/COMPETING INTEREST(S) This work was performed with financial support from the German Federal Institute for Drugs and Medical Devices (BfArM). All authors declare that they have no conflicts of interest. TRIAL REGISTRATION NUMBER Registered with the German Clinical Trial Register (DRKS00015155).

scholarly journals Reproductive History and Burden of Adverse Pregnancy Outcomes in Women in Southern India (P11-006-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Amy Fothergill ◽  
Yan Ping Qi ◽  
Krista Crider ◽  
Christina Johnson ◽  
Wesley Bonam ◽  
...  
Keyword(s):  
Birth Defects ◽  
Pregnancy Outcomes ◽  
Cleft Lip ◽  
Reproductive History ◽  
Reproductive Age ◽  
Southern India ◽  
Women Of Reproductive Age ◽  
Community Based Research ◽  
Live Births ◽  
Talipes Equinovarus

Abstract Objectives To characterize the reproductive history and pregnancy outcomes in women of reproductive age as part of an ongoing periconceptional surveillance program in Southern India. Methods Participants were women of reproductive age (15-40 y) who were not pregnant or lactating and resided in households within the 50 km2 catchment area of our community-based research site in Southern India (n = 813). After obtaining informed consent/assent, reproductive and obstetric histories were captured by a trained OB/GYN nurse via an electronic interviewer-administered questionnaire with the study participants. Results In this population, most participants reported being married (76.1%) and having some formal education (83.7%), with a median age of 30 (interquartile range [IQR] 24, 36) years. The average age of menarche reported was 13.0 (IQR 12.0, 14.0) years, and the median age at first pregnancy was 19.0 (IQR 17.0, 21.0) years. A total of 76.6% of women reported at least one previous pregnancy; 7.9% were primiparous and 65.7% were multiparous, with a median of 2.0 (IQR 2.0, 2.0) children currently living per woman. Approximately 80% of women reported taking any iron (80.4%) or folic acid (77.9%) supplements at any point during pregnancy. To date, women reported a total of 1,614 previous pregnancies with 1,318 live births (n = 1,308 singleton live births, n = 5 sets of twins), 169 spontaneous abortions, 94 induced abortions, and 42 stillbirths. Fifteen pregnancies were reported to have been affected by birth defects (n = 1 cleft lip, n = 2 cleft palate with cleft lip, n = 2 talipes equinovarus/clubfoot, n = 3 spina bifida, n = 3 encephalocele, n = 1 anencephaly, and n = 3 other birth defects). A total of 48 women reported a biological relative with a birth defect diagnosed at birth. Conclusions A substantial burden of birth defects was reported in this population (7 neural tube defects in 1,614 pregnancies). Findings from this survey will inform the establishment of an ongoing birth defects surveillance system and a randomized efficacy trial for prevention of anemia and birth defects in Southern India. Funding Sources Centers for Disease Control and Prevention. AF was supported by the National Institutes of Health #5 T32 HD087137

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