scholarly journals 886. Pregnancy Outcomes Following Raltegravir Exposure

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S20-S21
Author(s):  
Hala Shamsuddin ◽  
Casey Raudenbush ◽  
Brittany Sciba ◽  
Erica N Gooch ◽  
Wayne Greaves ◽  
...  
Keyword(s):  
Spontaneous Abortion ◽  
Neural Tube ◽  
Neural Tube Defects ◽  
Pregnancy Outcomes ◽  
Congenital Anomalies ◽  
Reproductive Potential ◽  
First Trimester ◽  
Hiv Treatment ◽  
Safety Database ◽  
Live Births

Abstract Background Safety data are needed regarding HIV treatment in women of reproductive potential and during pregnancy. This review is to evaluate pregnancy outcomes following prospective exposures (exposure report prior to knowledge of pregnancy outcome) to raltegravir during pregnancy. Methods Exposures to raltegravir during pregnancy reported cumulatively through March 26, 2019 to the internal safety database at Merck & Co., Inc. were reviewed. This database includes all reports of pregnancy from clinical trials sponsored by the company, spontaneous post-marketing reports, and noninterventional data sources. Prospective pregnancy reports were evaluated to determine rates of spontaneous abortion, stillbirth, and congenital anomalies, including neural tube defects. Data from two ongoing cohorts of pregnant women with HIV-1 infection, not included in the internal safety database, were also reviewed. Results A total of 2,508 prospective pregnancy reports with reported outcomes were identified among women exposed to raltegravir: 919 from the internal safety database (Table 1) and 1,589 from the UK/Ireland and French pregnancy cohorts. Among the 2,508 prospective pregnancy exposures, 945 were in the first trimester, of which 757 were within the periconception period (within 28 days of conception). Of the 471 documented first trimester exposures identified in the internal safety database, the rates of spontaneous abortion (6.9%), stillbirth (1%), and congenital anomalies (1.5% per live births) were similar to the rates observed in the background populations of the United States Among outcomes following any exposure, the rate of congenital anomalies was 3.4% per live births. There were no reports of neural tube defects identified within the internal safety database or among the cohort data. Conclusion Prospectively collected pregnancy outcome data do not suggest an association between raltegravir exposure and spontaneous abortion, stillbirth, or congenital anomalies, including neural tube defects. These data support the current HIV treatment recommendations for the use of raltegravir 400 mg twice daily in women of reproductive potential and during pregnancy. Disclosures All Authors: No reported Disclosures.

scholarly journals Pregnancy Outcomes in Subjects Exposed to Certolizumab Pegol

2015 ◽  
Vol 42 (12) ◽  
pp. 2270-2278 ◽  
Author(s):  
Megan E.B. Clowse ◽  
Douglas C. Wolf ◽  
Frauke Förger ◽  
John J. Cush ◽  
Amanda Golembesky ◽  
...  
Keyword(s):  
Pregnancy Outcomes ◽  
Additional Data ◽  
Certolizumab Pegol ◽  
Harmful Effect ◽  
First Trimester ◽  
Safety Database ◽  
Live Births ◽  
Induced Abortions ◽  
Concomitant Medications ◽  
Almost All

Objective.To provide information on pregnancy outcomes in women receiving certolizumab pegol (CZP).Methods.The UCB Pharma safety database was searched for pregnancies through to September 1, 2014. Reports for maternal and paternal CZP exposure were included and outcomes examined, and data on CZP exposure, pregnancy, comorbidities, and infant events were extracted by 2 independent reviewers. Concomitant medications and disease activity were reviewed for clinical trial patients.Results.Of 625 reported pregnancies, 372 (59.5%) had known outcomes. Paternal exposure pregnancies (n = 33) reported 27 live births, 4 miscarriages, 1 induced abortion, and 1 stillbirth. Maternal exposure pregnancies (n = 339) reported 254 live births, 52 miscarriages, 32 induced abortions, and 1 stillbirth. Almost all reported pregnancies had exposure to CZP in the first trimester, when organogenesis takes place, and a third of them continued the drug into the second and/or third trimesters. The most frequent indications for maternal CZP use were Crohn disease (192/339) and rheumatic diseases (118/339). Twelve cases of congenital malformation and a single neonatal death were reported.Conclusion.Analysis of pregnancy outcomes after exposure to CZP supports previous reports, suggesting a lack of harmful effect of maternal CZP exposure on pregnancy outcomes. However, additional data from a larger number of outcomes after exposure and studies including an unexposed comparison group are required to fully evaluate CZP safety and tolerability in pregnancy.

scholarly journals Pregnancy Outcomes in Patients Treated with Bosutinib

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 1729-1729 ◽  
Author(s):  
Jorge E. Cortes ◽  
Carlo Gambacorti-Passerini ◽  
Michael W. Deininger ◽  
Elisabetta Abruzzese ◽  
Liza DeAnnuntis ◽  
...  
Keyword(s):  
Spontaneous Abortion ◽  
Pregnancy Outcomes ◽  
Research Funding ◽  
First Trimester ◽  
Maternal Exposure ◽  
Safety Database ◽  
Spontaneous Reports ◽  
Dilation And Curettage ◽  
Vaginal Deliveries ◽  
Induced Abortions

Abstract Introduction: Studies in animals have shown reproductive toxicity with bosutinib exposure, with teratogenic events in maternal exposure, but little is known about its effect during conception or pregnancy in humans. Methods: Here we describe pregnancy outcomes in bosutinib-treated patients from the Pfizer safety database, which includes cases from both clinical trials and spontaneous reports. Pregnancy cases reported up to February 28, 2018 were identified by searching the database using the Standardized MedDRA Query Pregnancy and Neonatal Topics in patients receiving bosutinib. Results: The database search identified 33 relevant pregnancy reports, including 17 cases of exposure via the father and 16 cases of maternal exposure. Among the 16 cases of maternal exposure, 5 vaginal deliveries of healthy babies, 2 patient-requested induced abortions, 1 spontaneous abortion, and 1 partial molar pregnancy requiring a dilation and curettage were reported. In 1 case, the patient was reported to have delivered a baby, but the details of the status of the baby was not provided. Outcomes in 6 cases are unknown. Of the healthy deliveries, 4 pregnancies went to full term (≥39 weeks) and 1 was of unknown duration; bosutinib was discontinued during the first trimester of pregnancy in all 5 cases. The reported spontaneous abortion was due to a suspected ectopic pregnancy in a 34-year-old patient who began taking bosutinib 500 mg once daily while pregnant and was thought to be unrelated to bosutinib exposure. Of the 17 cases of exposure via father, 8 vaginal deliveries of healthy babies, 1 Caesarean section delivery of a healthy baby, 4 induced abortions, and 1 spontaneous abortion were reported. The remaining 3 cases had unknown outcomes. Of the 4 induced abortions, 1 was elective due to an unintended pregnancy, and 2 were due to unknown reasons. In the last case, it was reported that the fetus was not growing properly and that the pregnancy would subsequently be terminated; no confirmation of congenital abnormality or further information is available. The reported spontaneous abortion was thought to be unrelated to bosutinib; fetal biopsy revealed basal deciduitis with necrosis loci and bleeding. Conclusions: Overall, a review of the available experience with bosutinib in pregnancy did not identify any safety signals. However, adverse effects of bosutinib exposure at conception or during pregnancy in humans cannot be ruled out, particularly if therapy is not interrupted upon recognition of pregnancy. Bosutinib is not recommended for use during pregnancy, and patients on bosutinib treatment should use effective contraception. Disclosures Cortes: Astellas Pharma: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; Daiichi Sankyo: Consultancy, Research Funding; Pfizer: Consultancy, Research Funding; Arog: Research Funding. Gambacorti-Passerini:BMS: Consultancy; Pfizer: Consultancy, Honoraria, Research Funding. Deininger:Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees; Blueprint: Consultancy. Abruzzese:Novartis: Consultancy; Ariad: Consultancy; BMS: Consultancy; Pfizer: Consultancy. DeAnnuntis:Pfizer Inc: Employment, Equity Ownership. Brümmendorf:Janssen: Consultancy; Merck: Consultancy; Novartis: Consultancy, Research Funding; Pfizer: Consultancy, Research Funding; Takeda: Consultancy.

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 Pregnancy outcomes in multiple sclerosis following subcutaneous interferon beta-1a therapy

2011 ◽  
Vol 17 (4) ◽  
pp. 423-430 ◽  
Author(s):  
Magnhild Sandberg-Wollheim ◽  
Enrica Alteri ◽  
Margaretha Stam Moraga ◽  
Gabrielle Kornmann
Keyword(s):  
Multiple Sclerosis ◽  
Pregnancy Outcomes ◽  
Congenital Anomalies ◽  
Interferon Beta ◽  
Safety Data ◽  
Individual Case ◽  
In Utero ◽  
Available N ◽  
Safety Database ◽  
Live Births

Background: Women with multiple sclerosis (MS) are advised to discontinue interferon-beta therapy before trying to conceive. Unplanned pregnancies occur and risks related to exposure remain unclear. Methods: To determine pregnancy outcomes following interferon-beta therapy, we examined pregnancies from a global drug safety database containing individual case safety reports received in the post-marketing setting and safety data from clinical trials of subcutaneous interferon beta-1a in MS. Results: One thousand and twenty-two cases of exposure to subcutaneous interferon beta-1a during pregnancy were retrieved; 679 had a documented outcome. In cases for which exposure duration was available ( n = 231), mean time of foetal exposure to subcutaneous interferon beta-1a before treatment discontinuation was 28 days; most pregnancies (199/231; 86.1%) were exposed for ≤45 days. To avoid bias, only outcomes for prospective data ( n = 425) in pregnancies exposed to interferon beta-1a in utero were analysed further. Of these, 324 (76.2%) resulted in normal live births and four (0.9%) in live births with congenital anomalies (3 [0.7%] were ‘major’). Four (0.9%) pregnancies resulted in stillbirths (1 [0.2%] with foetal defects). There were 5 (1.2%) ectopic pregnancies, 49 (11.5%) spontaneous abortions and 39 (9.2%) elective terminations. Most pregnancies exposed to subcutaneous interferon beta-1a in utero were associated with normal live births. The rates of spontaneous abortion and major congenital anomalies in live births were in line with those observed in the general population. Conclusions: These data should be taken into account when considering options for women with MS who become pregnant or who are planning pregnancy while on treatment with subcutaneous interferon beta-1a.

scholarly journals POS0022 PHARMACOVIGILANCE PREGNANCY DATA IN A LARGE POPULATION OF PATIENTS WITH CHRONIC INFLAMMATORY DISEASE EXPOSED TO CERTOLIZUMAB PEGOL: PREGNANCY OUTCOMES AND CONFOUNDERS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 213.2-213
Author(s):  
M. Clowse ◽  
R. Fischer-Betz ◽  
C. Nelson-Piercy ◽  
A. Scheuerle ◽  
T. Kumke ◽  
...  
Keyword(s):  
Birth Weight ◽  
Preterm Birth ◽  
Low Birth Weight ◽  
Pregnancy Outcomes ◽  
Congenital Malformations ◽  
Certolizumab Pegol ◽  
First Trimester ◽  
Research Support ◽  
Safety Database ◽  
Live Births

Background:Chronic inflammatory diseases (CID) in women of reproductive age are increasingly being treated with tumour necrosis factor inhibitors (TNFi), in line with recent guidelines.1 However, data on TNFi-exposed pregnancy outcomes are still limited. Certolizumab pegol (CZP), a PEGylated, Fc-free TNFi, has no/minimal placental transfer from mother to infant during the third trimester.2Objectives:To assess pregnancy outcomes from the UCB Pharmacovigilance safety database from over 1,300 prospectively reported pregnancies with maternal CZP exposure.Methods:Details of CZP-exposed pregnancies from the UCB Pharmacovigilance safety database were reviewed up to November 1, 2020. Analysis was limited to prospectively reported cases with known pregnancy outcomes to avoid potential reporting bias. Confounders (specific CID, non-biologic medications and maternal infection) were evaluated using a multivariate stepwise regression model; results from the confounders analysis are reported as odds ratios (OR) with 95% confidence intervals (CI). Patients with missing information about presence or absence of confounders were excluded from the model.Results:1,392 prospective pregnancies (1,425 fetuses) with maternal CZP exposure and known outcomes were reported (Figure 1). Mean (SD) maternal age was 31.9 (5.1) years. Of these, 1,021/1,392 (73.3%) pregnancies had at least first-trimester CZP exposure and 547/1,392 (39.3%) were exposed during all trimesters. Overall, there were 1,259/1,425 (88.4%) live births, 150/1,425 (10.5%) abortions (miscarriages and terminations), 11/1,425 (0.8%) stillbirths, and 5/1,425 (0.4%) ectopic pregnancies. Congenital malformations were reported in 35/1,425 fetuses (2.5%) and in 30/1,259 live-born infants (2.4%); 26 (2.1%) congenital malformations were major according to the Metropolitan Atlanta Congenital Defects Program criteria. There was no pattern of specific congenital malformations. Preterm births occurred in 124/1,259 (9.8%) live births, and 101/1,259 (8.0%) of infants had low birth weight (<2.5 kg). In the confounders analysis, reported corticosteroid use was independently associated with increased odds of preterm birth (OR [95% CI]: 2.1 [1.3–3.4]; p<0.005) and low birth weight (OR [95% CI]: 1.7 [1.0–2.9]; p<0.05), but decreased odds of abortion (OR [95% CI]: 0.5 [0.3–0.9]; p<0.05). Reported NSAID use was associated with increased odds of abortion (OR [95% CI]: 2.2 [1.2–4.0]; p<0.05), as was methotrexate/leflunomide use (OR [95% CI]: 3.2 [1.7–6.2]; p<0.0005). Maternal infections were associated with increased odds of preterm birth (OR [95% CI]: 1.9 (1.1–3.5; p<0.05). Finally, there was an association between a diagnosis of Crohn’s disease and odds of abortion (OR [95% CI]: 2.5 [1.5–4.1]; p=0.0005), and between rheumatoid arthritis and low birth weight (OR [95% CI]: 1.9 [1.1–3.3]; p<0.05).Conclusion:This prospective analysis, including more than 1,000 pregnancies with CZP exposure in at least the first trimester, represents one of the largest cohorts of pregnancies with known outcomes in patients with CID. Our data confirm the impact of specific CID, concomitant drugs or comorbidities on pregnancy outcomes. In particular, additional use of corticosteroids was highlighted as a risk factor for preterm birth and low birth weight in our cohort of CZP-treated patients. No increase in adverse pregnancy outcomes or specific congenital malformations was observed in CZP-exposed pregnancies, compared to the general population,3,4 which offers further reassurance for women of childbearing age considering CZP treatment.References:[1]Sammaritano LR. Arthritis Rheum 2020;72:529–56;[2]Mariette X. Ann Rheum Dis 2018;77:228–33;[3]Ventura SJ. Natl Vital Stat Rep 2012;60:1–21;[4]Lee H. BMC Pregnancy Childbirth 2020;20:33.Acknowledgements:This study was funded by UCB Pharma. Editorial services were provided by Costello Medical.Disclosure of Interests:Megan Clowse Consultant of: UCB Pharma, Grant/research support from: Janssen, Pfizer, Rebecca Fischer-Betz Consultant of: AbbVie, BMS, Celgene, Chugai, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi, UCB Pharma, Catherine Nelson-Piercy Consultant of: Alliance Pharma, UCB Pharma, Angela Scheuerle Consultant of: Antiretroviral Pregnancy Registry, Harmony Biosciences, IQVIA, ICON, NovoNordisk, PPD, Roche, Sanofi-Genzyme, Syneos, UCB Pharma, ViiV, Thomas Kumke Shareholder of: UCB Pharma, Employee of: UCB Pharma, Bernard Lauwerys Employee of: UCB Pharma, Rachna Kasliwal Employee of: UCB Pharma, Frauke Förger Speakers bureau: Mepha, Roche, UCB Pharma, Grant/research support from: UCB Pharma.

Detection of spina bifida in the first trimester of gestation in association with triploidy

2017 ◽  
Author(s):  
K.K. Otaryan , C.G. Gagaev
Keyword(s):  
Spina Bifida ◽  
Early Detection ◽  
Neural Tube ◽  
Neural Tube Defects ◽  
First Trimester ◽  
Termination Of Pregnancy ◽  
Diagnostic Tools ◽  
Prenatal Detection ◽  
Post Abortion

The case of prenatal detection of spina bifida at 12+3 weeks of gestation is described. Termination of pregnancy was performed at 13+3 weeks. Post-abortion karyotyping revealed triploidy (69XXX). Diagnostic tools for early detection of neural tube defects in the 1st trimester of gestation and subsequent appropriate management of pregnancy are discussed.

scholarly journals Kisspeptin and Hematologic Parameters as Predictive Biomarkers for First-Trimester Abortions

2021 ◽  
Author(s):  
Ümit Görkem ◽  
Özgür Kan ◽  
Mehmet Ömer Bostancı ◽  
Deniz Taşkıran ◽  
Hasan Ali İnal
Keyword(s):  
Pregnant Women ◽  
Spontaneous Abortion ◽  
Pregnancy Outcomes ◽  
Significant Relationship ◽  
Blood Count ◽  
Complete Blood Count ◽  
First Trimester ◽  
Study Groups ◽  
Control Group ◽  
Gestational Stage

Objective: Spontaneous abortion is the most common complication of early pregnancy, affecting up to 20% of recognized pregnancies. Kisspeptin is predominantly released by placental syncytiotrophoblasts, and regulates their placental invasion into the uterine matrices. We aimed to establish an association of serum kisspeptin levels with pregnancy outcomes during the early gestational stage of the first trimester. Method: In this prospective study, 90 pregnant women in their 7 to 8 6/7 gestational weeks were classified into three groups: (i) The control group, consisting of healthy pregnant women (n=30), (ii) the threatened abortion group (n=30), and (iii) the spontaneous abortion group (n=30). The maternal serum samples were analyzed for complete blood count parameters and kisspeptin levels. Results: There was no statistical difference regarding body mass index (BMI) and gestational age (p=0.370). Regarding detailed obstetric notations, including gravida, parity, abortion, and living children, socioeconomic levels, and employment rates, all study groups were comparable (p>0.05, for all). No significant association was found regarding the biochemical parameters of complete blood count, including neutrophil, lymphocyte, and platelet concentrations, as well as neutrophil-to-lymphocyte ratios (NLR) and platelet-to-lymphocyte ratios (PLR) (p>0.05, for all). The median serum kisspeptin levels of the study groups did not differ between the groups (p=0.153). Correlation analysis revealed no significant relationship between serum kisspeptin levels and other study parameters in any study groups (p>0.05, for all) Conclusions: We found no statistically significant relationship between serum kisspeptin concentrations and pregnancy outcomes in the early gestational stage of the first trimester, and serum kisspeptin concentrations did not seem to be a reliable marker to distinguish abortion status from viable pregnancy

scholarly journals Sulfonamide Use During the First Trimester of Pregnancy and Risk of Selected Congenital Anomalies Among Live Births

2016 ◽  
Vol 3 (3) ◽  
pp. 202-203
Author(s):  
Craig Hansen ◽  
Susan E Adrade ◽  
Heather Freiman ◽  
Sascha Dublin ◽  
Katie Haffenreffer ◽  
...  
Keyword(s):  
Congenital Anomalies ◽  
First Trimester ◽  
Live Births ◽  
First Trimester Of Pregnancy

scholarly journals Community acceptability of dolutegravir-based HIV treatment in women: a qualitative study in South Africa and Uganda

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Yussif Alhassan ◽  
Adelline Twimukye ◽  
Thoko Malaba ◽  
Catherine Orrell ◽  
Landon Myer ◽  
...  
Keyword(s):  
South Africa ◽  
Focus Group ◽  
Neural Tube ◽  
Neural Tube Defects ◽  
Urban Poor ◽  
Hiv Treatment ◽  
Childbearing Age ◽  
Community Awareness ◽  
Depth Interviews ◽  
In Pregnancy

Abstract Background Despite concerns about dolutegravir use in pregnancy, most low- and middle-income countries are accelerating the introduction of dolutegravir-based regimens into national antiretroviral treatment programmes. Questions remain about the acceptability of dolutegravir use in women due to the potential risks in pregnancy. This study from South Africa and Uganda explored community values, preferences and attitudes towards the use of dolutegravir-based regimens in women. Methods This study employed a qualitative design involving in-depth interviews and focus group discussion conducted between August 2018 to March 2019. The study was conducted in the months following an announcement of a potential risk for neural tube defects with dolutegravir use among women during conception and the first trimester. Participants included HIV positive pregnant and lactating women and their partners. They were selected purposively from urban poor communities in South Africa and Uganda. Data was analysed thematically in NVivo. Results Forty-four in-depth interviews and 15 focus group discussions were conducted. Most participants had positive views of dolutegravir-based regimens and perceived it to be more desirable compared with efavirenz-containing regimens. There was widespread concern about use of dolutegravir during pregnancy and among women of childbearing age due to publicity around the possible association with neural tube defects. Acceptability was gendered, with nearly all male participants preferring their female spouses of childbearing potential not to use dolutegravir, while most women not planning pregnancy wanted access to contraception alongside dolutegravir. Community awareness and knowledge of dolutegravir was low and characterised by negative information. Women were concerned about HIV-related stigma and wanted the privacy features of dolutegravir to be strengthened with modification of the pill appearance and disguised packaging. Conclusions Dolutegravir-based regimens were found to be generally acceptable for use in women except during pregnancy. Interest in a dolutegravir-based regimen was linked with its perceived potential to enhance health, privacy and reduce stigma while concerns about neural tube defects were the main potential barrier to dolutegravir uptake in women. In order to optimise the community acceptability and uptake of acceptability-based regimen among women it is critical to strengthen community awareness and understanding of dolutegravir treatment, improve contraception services alongside the introduction of dolutegravir, and engage with male partners.

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