Dataset Information

Pregnancy outcomes after exposure to interferon beta: a register-based cohort study among women with MS in Finland and Sweden.

ABSTRACT:

Background

Our aim was to estimate and compare the prevalence of adverse pregnancy outcomes among pregnant women with multiple sclerosis (MS) exposed to interferon beta (IFNB) and among women with MS unexposed to any MS disease-modifying drug (MSDMD).

Methods

This cohort study used Finnish (1996-2014) and Swedish (2005-2014) national register data. Women with MS having IFNB dispensed 6 months before or during pregnancy as the only medication were considered as IFNB exposed (only IFNB-exposed), whereas women with MS unexposed to any MSDMD were considered unexposed (MSDMD-unexposed). Prevalence was described and compared using log-binomial or logistic regression and adjusted for potential confounders including maternal age and comorbidity.

Results

Among 2831 pregnancies, 2.2% of the only IFNB-exposed and 4.0% of the MSDMD-unexposed women had serious adverse pregnancy outcomes [elective termination of pregnancy due to foetal anomaly (TOPFA), major congenital anomaly (MCA) in live, or stillbirth]. After adjustments, the prevalence of serious adverse pregnancy outcomes was lower among the only IFNB-exposed compared with the MSDMD-unexposed [relative risk 0.55, 95% confidence interval (CI) 0.31-0.96]. The prevalence of individual outcomes, including MCA, spontaneous abortions, and stillbirths was not increased with IFNB exposure. Women with MS exposed to IFNB appeared more likely to terminate their pregnancy for reasons other than foetal anomaly, compared with MSDMD-unexposed pregnant MS patients (odds ratio 1.71, 95% CI 1.06-2.78).

Conclusion

In this large cohort study, no increase in the prevalence of adverse pregnancy outcomes was observed in women with MS exposed to IFNB compared with MS patients unexposed to any MSDMDs. This study together with other evidence led to a change in the labels of the IFNB products in September 2019 in the European Union, and IFNB use today may be considered during pregnancy, if clinically needed.

SUBMITTER: Hakkarainen KM

PROVIDER: S-EPMC7549181 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Publications

Pregnancy outcomes after exposure to interferon beta: a register-based cohort study among women with MS in Finland and Sweden.

Hakkarainen Katja Marja KM Juuti Rosa R Burkill Sarah S Geissbühler Yvonne Y Sabidó Meritxell M Popescu Catrinel C Suzart-Woischnik Kiliana K Hillert Jan J Artama Miia M Verkkoniemi-Ahola Auli A Myhr Kjell-Morten KM Mehtälä Juha J Bahmanyar Shahram S Montgomery Scott S Korhonen Pasi P

Therapeutic advances in neurological disorders 20201007

<h4>Background</h4>Our aim was to estimate and compare the prevalence of adverse pregnancy outcomes among pregnant women with multiple sclerosis (MS) exposed to interferon beta (IFNB) and among women with MS unexposed to any MS disease-modifying drug (MSDMD).<h4>Methods</h4>This cohort study used Finnish (1996-2014) and Swedish (2005-2014) national register data. Women with MS having IFNB dispensed 6 months before or during pregnancy as the only medication were considered as IFNB exposed (only I ...[more]

PMID: 33101459

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Project description:Background and objectivesThere is a lack of well-controlled US studies of intramuscular (IM) interferon beta (IFNβ)-1a use in pregnant women with multiple sclerosis; however, in the European Medicines Agency region, IFNβ formulations may be considered during pregnancy if clinically needed based on data from European Union cohort registries. The AVONEX Pregnancy Exposure Registry was established to prospectively study the effects of IM IFNβ-1a on the risk of birth defects and spontaneous pregnancy loss in a US population.MethodsPregnant women with multiple sclerosis exposed to IM IFNβ-1a within ~ 1 week of conception or during the first trimester were included. Participants were followed until there was a pregnancy outcome, live-born infants were followed until age 8-12 weeks. Data were collected on IM IFNβ-1a exposure, demographics, patient characteristics, medical history, and pregnancy outcomes, including live births (with or without birth defect), spontaneous abortions/miscarriages and fetal death/stillbirth, elective abortions (with and without birth defect), and ectopic pregnancies. A population-based birth defect surveillance program, the Metropolitan Atlanta Congenital Defects Program (MACDP), served as the primary external control group for evaluating the risk of birth defects.ResultsThree-hundred and two patients with a median (range) age of 31.0 (16-48) years and a median (range) gestational age at the time of enrollment of 10.1 (4-39) weeks were evaluable. Most patients (n = 278/302; 92%) reported IM IFNβ-1a exposure in the week before conception and most (n = 293/302; 97%) discontinued treatment before the end of the first trimester. Of 306 pregnancy outcomes, there were 272 live births, 28 spontaneous abortions of 266 pregnancies enrolled before 22 weeks' gestation (rate 10.5%; 95% confidence interval 7.2-15.0), five elective abortions, and one stillbirth. There were 17 adjudicator-confirmed major birth defects of 272 live births (rate 6.3%; 95% confidence interval 3.8-10.0); the pattern of birth defects observed was not suggestive of a relationship to prenatal IM IFNβ-1a exposure.ConclusionsThis large US registry study suggests IM IFNβ-1a exposure during early pregnancy was not clinically associated with adverse pregnancy outcomes in women with multiple sclerosis. These findings help inform clinicians and patients in weighing the risks and benefits of IM IFNβ-1a use during pregnancy.Clinical trial registrationClinicalTrials.gov: NCT00168714, 15 September, 2005.

Project description:ObjectiveTo assess associations of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and pregnancy outcomes considering testing policy and test-positivity-to-delivery interval.DesignNationwide cohort study.SettingSweden.PopulationFrom the Pregnancy-Register we identified 88 593 singleton births, 11 March 2020-31 January 2021, linked to data on SARS-CoV-2-positivity from the Public Health Agency, and information on neonatal care admission from the Neonatal Quality Register. Adjusted odds ratios (aORs) were estimated stratified by testing-policy and test-positivity-to-delivery interval.Main outcome measuresFive-minute Apgar score, neonatal care admission, stillbirth and preterm birth.ResultsDuring pregnancy, SARS-CoV-2 test-positivity was 5.4% (794/14 665) under universal testing and 1.9% (1402/73 928) under non-universal testing. There were generally lower risks associated with SARS-CoV-2 under universal than non-universal testing. In women testing positive >10 days from delivery, generally no significant differences in risk were observed under either testing policy. Neonatal care admission was more common (15.3% versus 8.0%; aOR 2.24, 95% CI 1.62-3.11) in women testing positive ≤10 days before delivery under universal testing. There was no significant association with 5-minute Apgar score below 7 (1.0% versus 1.7%; aOR 0.64, 95% CI 0.24-1.72) or stillbirth (0.3% versus 0.4%; aOR 0.72, 95% CI 0.10-5.20). Compared with term births (2.1%), test-positivity was higher in medically indicated preterm birth (5.7%; aOR 2.70, 95% CI 1.60-4.58) but not significantly increased in spontaneous preterm birth (2.3%; aOR 1.12, 95% CI 0.62-2.02).ConclusionsTesting policy and timing of test-positivity impact associations between SARS-CoV-2-positivity and pregnancy outcomes. Under non-universal testing, women with complications near delivery are more likely to be tested than women without complications, thereby inflating any association with adverse pregnancy outcomes compared with findings under universal testing.Tweetable abstractTesting policy and time from SARS-CoV-2 infection to delivery influence the association with pregnancy outcomes.

Project description:BackgroundRecently, the relationship between air pollution and reproductive outcomes has become a research focus. However, there is a lack of research on the relationship between air pollution and polycystic ovary syndrome (PCOS).MethodsThis is a retrospective cohort study included a total of 1,652 women with PCOS and 12,543 women without PCOS conducted from 1 January 2015 to 31 December 2019. The average daily concentration data of six air pollutants (PM2.5, PM10, O3, NO2, SO2, and CO) during different exposure windows were obtained. Generalized estimating equation models were used to evaluate the association of air pollution with pregnancy outcomes.ResultsAir pollutants were not found to have a significant association with pregnancy rates among patients with PCOS. However, each IQR increase in PM10 exposure during period 3 (embryo transfer to serum HCG test) was associated with the reduced clinical pregnancy rate (adjusted OR = 0.92, 95% CI: 0.84-0.99) for patients without PCOS. Patients without PCOS showed lower clinical pregnancy rates with increased exposure to NO2 during periods 2 (oocyte retrieval to embryo transfer) and 5 (start of gonadotropin medication to embryo transfer), with aORs and 95% CIs of 0.94 (0.88, 0.99) and 0.94 (0.88, 0.98), respectively. Each IQR increase in SO2 among patients without PCOS during periods 1 (start of gonadotropin medication to oocyte retrieval), 2, 5, and 6 (start of gonadotropin medication to serum HCG test) was related to a decrease in clinical pregnancy rate. For the live birth rate, no significant relationship was found between air pollutants, including PM2.5, PM10, SO2, NO2, CO, and O3, and the live birth rate for women with PCOS. However, women without PCOS presented a lower probability of live birth with exposure to SO2 during periods 1, 2, 5, and 6.ConclusionThis retrospective study of reproductive-aged women observed no significant relationships between ambient pollutants and pregnancy outcomes among women with PCOS but found negative associations among women without PCOS.

Dataset Information

Pregnancy outcomes after exposure to interferon beta: a register-based cohort study among women with MS in Finland and Sweden.

Background

Methods

Results

Conclusion

Publications

Pregnancy outcomes after exposure to interferon beta: a register-based cohort study among women with MS in Finland and Sweden.

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