Prevalence of adverse pregnancy outcomes after exposure to interferon beta prior to or during pregnancy in women with MS: Stratification by maternal and newborn characteristics in a register-based cohort study in Finland and Sweden

Korjagina, Marta; Hakkarainen, Katja M.; Burkill, Sarah; Geissbühler, Yvonne; Sabidó, Meritxell; Everage, Nicholas J.; Suzart-Woischnik, Kiliana; Klement, Riho; Hillert, Jan; Verkkoniemi-Ahola, Auli; Bahmanyar, Shahram; Montgomery, Scott; Korhonen, Pasi K.

doi:10.1016/j.msard.2020.102694

Cited by 12 publications

(8 citation statements)

References 19 publications

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“…There were 15 European studies and eight of them were based on Scandinavian nationwide registers: Andersen et al studied the Danish population 18 , 24 , 39 , 40 Dahl et al and Strom et al studied the Norwegian population, 11 , 25 , 26 and Korjagina et al used data from Finland and Sweden in their register study. 27 Two of the three German studies were based on the same dataset, but with different timeslots and exposures, 28 , 29 and the two studies from Italy came from the same registry, but with different timeslots. 30 , 31 One study from the UK reported as a part of the Oxford Record Linkage Study on a cohort from 1970–1989.…”

Section: Resultsmentioning

confidence: 99%

“…Only a few additional papers have been published in this category since the study by Lopez-Leon et al 21 Three studies, published in the period January 2019 to February 2023, met our inclusion criteria. A Swedish cohort study focused on interferon-β-exposed children (n=718), 27 and one Danish cohort study focused on teriflunomide-exposed children (n=49) 39 and another on injectable first-line treatments, dimethyl fumarate and natalizumab-exposed children (n=711 liveborns). 18 None of the three studies found significant differences in the risk of adverse short-term birth outcome between DMT-exposed and unexposed children.…”

Section: Resultsmentioning

confidence: 99%

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Maternal Multiple Sclerosis and Health Outcomes Among the Children: A Systematic Review

Andersen¹,

Jølving²,

Stenager³

et al. 2023

CLEP

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Objective To summarize the available literature and provide an overview of in utero exposure to maternal multiple sclerosis (MS) and the influence on offspring health outcomes. Methods We conducted a systematic review by searching Embase, Medline and PubMed.gov databases, and we used covidence.org to conduct a thorough sorting of the articles into three groups; 1) women with MS and the influence on birth outcomes; 2) women with MS treated with disease-modifying therapy (DMT) during pregnancy and the influence on birth outcomes; and 3) women with MS and the influence on long-term health outcomes in the children. Results In total, 22 cohort studies were identified. Ten studies reported on MS without DMT and compared with a control group without MS, and nine studies on women with MS and DMT prior to or during pregnancy met the criteria. We found only four studies reporting on long-term child health outcomes. One study had results belonging to more than one group. Conclusion The studies pointed towards an increased risk of preterm birth and small for gestational age among women with MS. In terms of women with MS treated with DMT prior to or during pregnancy, no clear conclusions could be reached. The few studies on long-term child outcomes all had different outcomes within the areas of neurodevelopment and psychiatric impairment. In this systematic review, we have highlighted the research gaps on the impact of maternal MS on offspring health.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Maternal Multiple Sclerosis and Health Outcomes Among the Children: A Systematic Review

Andersen¹,

Jølving²,

Stenager³

et al. 2023

CLEP

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“…157 There is no increased risk of teratogenicity after exposure in the first trimester in more than 3000 pregnancies. 158–166 The most recent data are reassuring for miscarriage and lower birth weight. 158–167,168…”

Section: Resultsmentioning

confidence: 99%

Pregnancy and multiple sclerosis: 2022 recommendations from the French multiple sclerosis society

Vukusic

Ciron²,

Maillart

et al. 2022

Mult Scler

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Objective: The objective of this study was to develop evidence-based recommendations on pregnancy management for persons with multiple sclerosis (MS). Background: MS typically affects young women in their childbearing years. Increasing evidence is available to inform questions raised by MS patients and health professionals about pregnancy issues. Methods: The French Group for Recommendations in Multiple Sclerosis (France4MS) reviewed PubMed and university databases (January 1975 through June 2021). The RAND/UCLA appropriateness method was developed to synthesise the scientific literature and expert opinions on healthcare topics; it was used to reach a formal agreement. Fifty-six MS experts worked on the full-text review and initial wording of recommendations. A group of 62 multidisciplinary healthcare specialists validated the final proposal of summarised evidence. Results: A strong agreement was reached for all 104 proposed recommendations. They cover diverse topics, such as pregnancy planning, follow-up during pregnancy and postpartum, delivery routes, locoregional analgesia or anaesthesia, prevention of postpartum relapses, breastfeeding, vaccinations, reproductive assistance, management of relapses and disease-modifying treatments. Conclusion: The 2022 recommendations of the French MS society should be helpful to harmonise counselling and treatment practice for pregnancy in persons with MS, allowing for better and individualised choices.

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“…10 Overall, these results confirm previous evidence collected from large cohort studies on the safety of pregnant women and interferon exposure that interferon beta therapies do not increase the risk for spontaneous abortions, preterm birth, or major congenital malformations. 10,23,24 In addition, the inclusion of women who received their last interferon dose prior to conception indicated that late complications from interferon exposure are not expected regardless of timing.…”

Section: Discussionmentioning

confidence: 99%

Pregnancy outcomes in female multiple sclerosis patients exposed to intramuscular interferon beta-1a or peginterferon beta-1a reported in a German Patient Support Programme – results from the non-interventional post-authorization safety study PRIMA

Klehmet,

Begus-Nahrmann,

Taipale

et al. 2023

Ther Adv Neurol Disord

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Background: Based on data from two large cohort studies, a label update became applicable for the class of interferon beta therapies in 9/2019, allowing interferons during pregnancy and breastfeeding. Objective: To assess pregnancy outcomes of women with multiple sclerosis (MS) exposed to peginterferon beta-1a or intramuscular interferon beta-1a therapy (IFN). Design: Non-interventional post-authorization safety study. Methods: PRIMA was conducted from April to October 2021 in Germany. Retrospective pregnancy data were retrieved from adult female patients diagnosed with relapsing-remitting MS or clinically isolated syndrome, exposed to IFN before or during pregnancy and registered in the patient support programme (PSP) of the marketing authorization holder’s MS Service Centre. The primary endpoint was the outcome of pregnancy. Prospective postpartum data were collected from mothers reporting live births. Results: In total, 426 women reporting 542 pregnancies between December 2001 and July 2020 (14 pregnancies after the label update) were enrolled. Among patients with confirmed exposure during pregnancy ( N = 362), 306 pregnancies (84.5%) resulted in live births (77.6% without defects, 1.9% with defects and 4.4% preterm). Spontaneous abortion, elective termination and stillbirth were reported in 10.9%, 2.8% and 0.2% of the cases, respectively. Higher rates of spontaneous abortions were reported in women with continuous IFN use. A total of 162 women completed the questionnaire for 192 live births within the prospective study part. Mothers restarted IFN therapy or switched to another disease-modifying therapy postpartum in 51.0% and 14.1% of cases, respectively. 158/192 infants (82.3%) were breastfed [34/158 (21.5%)] during IFN therapy. Postpartum relapse activity was low (mothers of 87.3% of breastfed infants remained relapse-free during lactation). Conclusion: Overall, the prevalence of spontaneous abortions and congenital anomalies of females exposed to IFN exposure before or during pregnancy was within the range reported for the general population. Most mothers paused IFN during pregnancy and breastfeeding. Relapse activity during pregnancy and lactation was observed to be low. These real-world data from a PSP corroborate European and Scandinavian registry data. Trial registration: NCT04655222, EUPAS38347.

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Prevalence of adverse pregnancy outcomes after exposure to interferon beta prior to or during pregnancy in women with MS: Stratification by maternal and newborn characteristics in a register-based cohort study in Finland and Sweden

Cited by 12 publications

References 19 publications

Maternal Multiple Sclerosis and Health Outcomes Among the Children: A Systematic Review

Maternal Multiple Sclerosis and Health Outcomes Among the Children: A Systematic Review

Pregnancy and multiple sclerosis: 2022 recommendations from the French multiple sclerosis society

Pregnancy outcomes in female multiple sclerosis patients exposed to intramuscular interferon beta-1a or peginterferon beta-1a reported in a German Patient Support Programme – results from the non-interventional post-authorization safety study PRIMA

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