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 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 interferon-beta-exposed patients with multiple sclerosis: results from the European Interferon-beta Pregnancy Registry

2020 ◽  
Vol 267 (6) ◽  
pp. 1715-1723 ◽  
Author(s):  
Kerstin Hellwig ◽  
◽  
Yvonne Geissbuehler ◽  
Meritxell Sabidó ◽  
Catrinel Popescu ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
General Population ◽  
Pregnancy Outcomes ◽  
Congenital Anomalies ◽  
Interferon Beta ◽  
European Economic Area ◽  
Spontaneous Abortions ◽  
Infant Outcomes ◽  
Ectopic Pregnancies ◽  
Pregnancy Registry

Abstract Background Family planning is an important consideration for women with multiple sclerosis (MS), who are often diagnosed during their reproductive years. Currently, limited data are available on pregnancy outcomes in patients exposed to interferon-beta (IFN-beta) before or during pregnancy. Here, we present the cumulative pregnancy exposure data and prevalence of pregnancy and infant outcomes in IFN-beta-exposed pregnant women with MS from the European IFN-beta Pregnancy Registry. Methods Using spontaneous and solicited reports, the registry collected data from 26 countries of the European Economic Area, consisting of information on women with MS identifying themselves to one of the Marketing Authorisation Holders (Bayer, Biogen, Merck KGaA, and Novartis) or healthcare professionals as pregnant and exposed to IFN-beta during pregnancy or within 1 month before conception. The outcomes collected by the registry included ectopic pregnancies, spontaneous abortions, elective terminations, live, and stillbirths with or without congenital anomalies. The prevalence of pregnancy outcomes was put in context with those reported in the general population. Results Between 2009 and 2017, the registry collected 948 pregnancy reports with a known pregnancy outcome. Overall, 82.0% (777/948) of pregnancies resulted in live birth without congenital anomaly. When comparing IFN-beta-exposed pregnancies with the general population, the prevalence of spontaneous abortions (10.7% vs. 10–21%) and congenital anomalies in live births (2.1% vs. 2.1–4.1%) were found to be within reported ranges. Conclusions The data gathered from these pregnancy cases suggest no evidence that IFN-beta exposure before conception and/or during pregnancy adversely increases the rate of congenital anomalies or spontaneous abortions.

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.

Is in utero early-exposure to interferon beta a risk factor for pregnancy outcomes in multiple sclerosis?

2008 ◽  
Vol 255 (8) ◽  
pp. 1250-1253 ◽  
Author(s):  
F. Patti ◽  
T. Cavallaro ◽  
S. Fermo ◽  
A. Nicoletti ◽  
V. Cimino ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Risk Factor ◽  
Pregnancy Outcomes ◽  
Interferon Beta ◽  
In Utero ◽  
Early Exposure

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.

Interferon-beta exposure during first trimester is safe in women with multiple sclerosis—A prospective cohort study from the German Multiple Sclerosis and Pregnancy Registry

2016 ◽  
Vol 22 (6) ◽  
pp. 801-809 ◽  
Author(s):  
Sandra Thiel ◽  
Annette Langer-Gould ◽  
Milena Rockhoff ◽  
Aiden Haghikia ◽  
Annette Queisser-Wahrendorf ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Birth Weight ◽  
Preterm Birth ◽  
Pregnancy Outcomes ◽  
Interferon Beta ◽  
First Trimester ◽  
Disease Modifying Therapies ◽  
Disease Modifying ◽  
Multiple Sclerosis Patients ◽  
Pregnancy Registry

Background: Available data suggest that pregnancy exposure to interferon-beta might result in lower mean birth weight and preterm birth. Objective: To determine the effect of interferon-beta exposure during pregnancy on pregnancy outcomes in multiple sclerosis patients. Methods: We compared the pregnancy outcomes of women exposed to interferon-beta with pregnancies unexposed to disease-modifying therapies. Women were enrolled into the German Multiple Sclerosis and Pregnancy Registry. A standardized questionnaire was administered during pregnancy and postpartum. Detailed information on course of multiple sclerosis and pregnancy, concomitant medications, delivery, and outcome of pregnancy was obtained. Results: We collected data on 251 pregnancies exposed to interferon-beta and 194 unexposed to disease-modifying therapies. In all, 246 (98.01%) women discontinued interferon-beta treatment during first trimester. No differences regarding mean birth weight (exposed: 3272.28 ± 563.61 g; unexposed: 3267.46 ± 609.81 g), mean birth length (exposed: 50.73 ± 3.30 cm; unexposed: 50.88 ± 3.45 cm), preterm birth ( p = 0.187), spontaneous abortion ( p = 0.304), and congenital anomalies ( p = 0.197) were observed between the two groups. Conclusions: Interferon-beta exposure during early pregnancy does not influence the mean birth weight, risk of preterm birth, or other adverse pregnancy outcomes. Our study provides further reassurance that interferon-beta treatment can be safely continued up until women become pregnant.

Pregnancy outcomes during treatment with interferon beta-1a in patients with multiple sclerosis

Neurology ◽  
2005 ◽  
Vol 65 (6) ◽  
pp. 802-806 ◽  
Author(s):  
M. Sandberg-Wollheim ◽  
D. Frank ◽  
T. M. Goodwin ◽  
B. Giesser ◽  
M. Lopez-Bresnahan ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Pregnancy Outcomes ◽  
Interferon Beta

scholarly journals The risk of malignancy is not increased in patients with multiple sclerosis treated with subcutaneous interferon beta-1a: analysis of data from clinical trial and post-marketing surveillance settings

2011 ◽  
Vol 17 (4) ◽  
pp. 431-440 ◽  
Author(s):  
Magnhild Sandberg-Wollheim ◽  
Gabrielle Kornmann ◽  
Dorina Bischof ◽  
Margaretha Stam Moraga ◽  
Brian Hennessy ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Safety Data ◽  
Data Set ◽  
Safety Database ◽  
Post Marketing Surveillance ◽  
Risk Of Malignancy ◽  
Post Marketing ◽  
Medical Dictionary

Background: Risks that are potentially associated with long-term therapies should be assessed. Objective: The present analyses were performed to determine the risk of malignancy in patients with multiple sclerosis (MS) receiving subcutaneous (sc) interferon (IFN) beta-1a, using pooled safety data from key clinical trials and data from the Merck Serono Global Drug Safety database. Methods: The standard Medical Dictionary for Regulatory Activities query “malignancies” was used to retrieve relevant cases from each data set. The incidence of malignancies per 1000 patient-years was calculated using the pooled safety data from clinical trials. The reporting rates of malignancy types were calculated for the post-marketing setting based on sales volume. Malignancies were grouped by organ localization and classified as medically confirmed or not medically confirmed according to the source of each report. The number of reported cases of each type was compared with the expected number in the general population. Results: Analysis of pooled safety data from 12 key clinical trials did not show an increased incidence of malignancy per 1000 patient-years with sc IFN beta-1a (4.0; 95% confidence interval (CI): 2.9–5.5) compared with placebo (6.4; 95% CI: 3.3–11.2). Analysis of the database shows that among the medically confirmed cases, reported to expected ratios ranged from 1 : 6 to 1 : 18 for solid tumours and from 1 : 2 to 1 : 9 for lymphohaematopoietic tumours. Conclusion: Safety data from both clinical trial and post-marketing settings suggest that treatment with sc IFN beta-1a does not increase the risk of malignancy in patients with MS.

scholarly journals SAT0117 TRIMESTER EXPOSURE AND PREGNANCY OUTCOMES IN WOMEN EXPOSED TO GOLIMUMAB – RESULTS FROM THE COMPANY PHARMACOVIGILANCE DATABASE

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 992.2-992
Author(s):  
M. Otero-Lobato ◽  
S. Esslinger ◽  
S. Gabriel ◽  
M. Clark ◽  
P. Sheridan ◽  
...  
Keyword(s):  
Pregnancy Outcome ◽  
Birth Outcomes ◽  
Pregnancy Outcomes ◽  
Congenital Anomalies ◽  
Spontaneous Abortions ◽  
Live Births ◽  
Elective Abortion ◽  
Induced Abortions ◽  
Pharmacovigilance Database ◽  
Inflammatory Bowel

Background:Rheumatologic disorders and inflammatory bowel disease can affect women of childbearing potential. Golimumab (GLM) is approved for several rheumatologic indications and ulcerative colitis (UC).Objectives:To characterize pregnancy outcomes in patients treated with GLM, data obtained from maternal exposure to GLM are presented.Methods:This dataset includes individual patient cases reported to the manufacturer through 06 April 2019. Cases included in the analysis were medically confirmed cases of maternal exposures to GLM during pregnancy or within 3 months prior to conception, and a reported pregnancy outcome. Both prospectively reported (ie, pregnancy outcome not known when first reported) and retrospectively reported cases (ie, pregnancy outcome known when first reported) were included. Cases originated from various sources, including spontaneous reporting, clinical studies, and registries.Results:Two hundred eight pregnancy cases (131 rheumatologic indications; 43 UC; and 34 other) with 211 reported birth outcomes were identified. Of these 208 pregnancy cases, 119 were prospective and 89 were retrospective. Average maternal age was 31.9 years. Of the 119 prospectively reported pregnancy cases, 89 (74.8%) resulted in live births, 19 (16.0%) resulted in spontaneous abortion (of these, 42.1% (8/19) received GLM in combination with methotrexate [MTX]), 10 (8.4%) resulted in induced/elective abortion, and 1 (0.8%) resulted in ectopic pregnancy. Overall, 9 congenital anomalies were reported (2 prospective and 7 retrospective cases).For 183 of the 208 pregnancy cases with reported outcomes, the trimester of exposure to GLM was known. Among the 110 prospectively reported cases, 82 (74.5%) were exposed during trimester 0 or 1. Of these, 19 had concomitant exposure to MTX, with the following birth outcomes: 8 live births, 8 spontaneous abortions, 3 elective/induced abortions. Eighteen of the prospectively reported cases (16.4%) were exposed to GLM through trimesters 1-3 and all resulted in live births (none with congenital anomalies; 1 infant with exposure to GLM and MTX was born preterm).Conclusion:The rates of congenital malformations and spontaneous abortions were consistent with published background rates for the general population. Persistent exposure throughout pregnancy was rare. Limitations of this analysis include the lack of a direct comparison group, the variable amount of data available in the reports, and the possible bias towards reporting more negative outcomes in retrospective cases.Disclosure of Interests:Marijo Otero-Lobato Shareholder of: Johnson & Johnson, Employee of: Johnson & Johnson, Suzan Esslinger Shareholder of: Johnson & Johnson, Consultant of: Johnson & Johnson, Novartis, Eli Lilly and Sandoz, Employee of: Johnson & Johnson, Susan Gabriel Shareholder of: Johnson & Johnson, Employee of: Johnson & Johnson, Merck, GSK, Michael Clark Shareholder of: Johnson & Johnson, Employee of: Johnson & Johnson, Pamela Sheridan Shareholder of: Johnson & Johnson, Roche Pharmaceuticals, Employee of: Johnson & Johnson, Roche, Novartis, Bayer, Anja Geldhof Shareholder of: Johnson & Johnson, Employee of: Johnson & Johnson

scholarly journals Pregnancy outcomes in patients treated with bosutinib

2020 ◽  
Vol 9 (2) ◽  
pp. IJH26 ◽  
Author(s):  
Jorge E Cortes ◽  
Carlo Gambacorti-Passerini ◽  
Michael Deininger ◽  
Elisabetta Abruzzese ◽  
Liza DeAnnuntis ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Pregnancy Outcomes ◽  
Contraceptive Use ◽  
Reproductive Toxicity ◽  
Maternal Exposure ◽  
Preclinical Studies ◽  
Paternal Exposure ◽  
Safety Database ◽  
Live Births ◽  
Potential Risks

Aim: Preclinical studies have shown reproductive toxicity with bosutinib, but little is known about its effects during conception or pregnancy in humans. Methods: Pregnancy cases in patients receiving bosutinib were identified from the Pfizer safety database. Results: Thirty-three pregnancy reports were identified. Sixteen cases of maternal exposure: six live births, four abortions and six with unknown outcomes. Seventeen instances of paternal exposure: nine live births, five abortions and three with unknown outcomes. Conclusion: Adverse effects of bosutinib exposure at conception or during pregnancy in humans cannot be excluded, particularly if therapy is not interrupted upon recognition of pregnancy. Contraceptive use is recommended for female patients receiving bosutinib, and patients should be made aware of the potential risks associated with bosutinib use during pregnancy.

Sign in / Sign up

Export Citation Format

Share Document