Background: Multiple sclerosis (MS) is an inflammatory demyelinating chronic neurological disease that affects the central nervous system of young adults and their quality of life. Several studies have investigated the effects of pregnancy and breastfeeding on MS. However, the evidence regarding the influence of pregnancy and breastfeeding on MS is still accumulating. This review aimed to summarize the current evidence regarding the effects of pregnancy and breastfeeding on MS. Summary: A systematic electronic literature search of the PubMed and Embase databases was conducted to determine relevant published articles. The eligible studies were summarized and evaluated in tables. Key Messages: The majority of the studies indicated that pregnancy appears to lower the rate of MS relapses, particularly in the third trimester. The evidence regarding the effect of breastfeeding on MS remains inconsistent. Despite reports of negative obstetric outcomes in some pregnant women with MS, pregnancies in women with MS should not be categorized as high-risk pregnancies.

Multiple sclerosis (MS) is a chronic inflammatory demyelinating neurological disease that usually occurs between 20 and 40 years of age [1]. It is a complex disorder with different neurological system dysfunctions that vary in time and place, leading to disability [1]. MS is an immune-mediated disorder that causes an inflammatory reaction and demyelination of the central nervous system neurons. It is initiated by unknown extraneous factors in people with a genetic predisposition, and its underlying mechanisms are not fully understood. The different symptoms depend on the location of the demyelinating lesions [2].

In approximately 80% of the patients, MS may start with a relapsing-remitting pattern (RRMS); in 10–15%, it may be progressive (PPMS). In the natural history of untreated MS, 50% of untreated RRMS patients will gradually convert to secondary progressive MS (SPMS). Early identification of definite MS cases and treatment will reduce the relapses and delay disease progression and disability [3].

MS prevalence is increasing. It affects more women than men with a ratio as high as 3.2:1, particularly in the reproductive years, which makes pregnancy and labor in women with MS a particular concern [1, 4]. Previously, doctors advised patients with MS to avoid pregnancy because of concerns regarding adverse effects on the disease course [5]. Since the 1950s, pregnancy has been recommended as safe for patients with MS [6]. Investigators have explored the epidemiological, immunological, and therapeutic aspects of the relationship between pregnancy and MS [7‒11]. Several analyses, including systematic reviews and a national consensus, have been published, and the majority concluded that pregnancy has a protective effect on MS, and these pregnancies should not be considered as high risk [3, 12‒15]. However, the influence of breastfeeding on MS is still debated. This review aimed to examine and discuss the evidence regarding the effects of pregnancy and breastfeeding on MS.

PubMed and Embase databases were systematically searched for relevant studies published between January 2010 and September 2020 with no language restriction. Randomized clinical trials, nonrandomized clinical trials, prospective and retrospective cohorts, case-control studies, case reports, and case series were included. Animal studies were excluded. The study selection was in 3 stages: in the primary screening stage, an electronic search was conducted using the following terms: “(pregnant* OR gestational OR trimester OR “breastfeeding”) AND (multiple sclerosis) AND (incidence OR prevalence OR prognosis OR complication OR risk OR treatment OR prevent*).” Article titles and abstracts were then screened. The secondary screening stage involved the assessment of the full-text manuscripts. Finally, in the inclusion stage, studies that met our eligibility criteria were extracted. Tables 1 and 2 summarize these studies. The relevant original research studies published from the year 2001 onward were also included.

Table 1.

A summary of studies on the effect of pregnancy on MS

 A summary of studies on the effect of pregnancy on MS
 A summary of studies on the effect of pregnancy on MS
Table 2.

A summary of studies on the effect of breastfeeding on MS

 A summary of studies on the effect of breastfeeding on MS
 A summary of studies on the effect of breastfeeding on MS

Effects of Pregnancy on MS

Although the course of MS is highly unpredictable, disease activity in pregnancy is lower than in the prepregnancy period [16‒25]. A beneficial effect of pregnancy on disease progression has been found by some researchers, whereas others found that parity was not related to secondary disease progression [16, 26]. The Australian multicenter study of the environment and immune function Ausimmune also showed that parity confers an approximate 50% risk reduction for the first episode of clinical demyelination, with the lowest risk in multiparous women [27].

Relapse Rate

Confavreux and colleagues conducted the first prospective multicenter study addressing the relation of pregnancy with relapse rate. The Pregnancy in Multiple Sclerosis (PRIMS) study recruited 254 pregnant women from 12 European countries [7]. The annualized relapse rate (ARR) of MS decreased from 0.7 to 0.2 relapses per year during the third trimester of pregnancy compared with that in the prepregnancy year. However, postpartum, the ARR increased to 1.2 relapses per year. The clinical predictors have higher ARR in the year before pregnancy, an increased number of relapses during pregnancy, and a higher Expanded Disability Status Scale (EDSS) score at the beginning of pregnancy [28].

One of the largest international studies to evaluate pregnancy’s effect on the relapse rate of MS used data from the worldwide MSBase Registry [22]. In 893 pregnancies in 674 women with MS, it showed a drop in relapse rates to minimum 50% lower than that observed in the PRIMS study, with no change in EDSS. The ARR dropped from 0.3 in the preconception period to 0.1 in the third trimester and increased to 0.6 in the early postpartum period [22]. The strong predictive factor for postpartum relapse was preconception ARR. The study also showed that the preconception use of disease-modifying therapies (DMTs) was associated with a 45% reduction in postpartum relapse.

Portaccio et al. [29] correlated disease activity before and during pregnancy with postpartum relapses. Additionally, Bsteh et al. [30] investigated the possible predictors for relapse frequency in pregnancy and after delivery. Disease activity before and during pregnancy and the preconception use of highly active DMTs were essential predictors for relapses in pregnancy and the postpartum period [30]. Early resumption of DMTs reduced the rate of postpartum relapses [29, 30].

Dobson et al. [31] conducted the largest international single-arm meta-analysis of pregnancy-associated MS relapse rates over time. It included all the studies conducted since 1998 covering 7,034 pregnancies in 6,430 women. The ARR decreased from 0.57 in prepregnancy to 0.36, 0.29, and 0.16 during trimesters 1, 2, and 3, respectively, with a postpartum rebound of 0.85, which showed a lower relapse rate at all time points [31].

Pregnancy is a natural disease modifier in MS patients. There could be an upregulation of T helper 2 cells (anti-inflammatory effect) and interleukin-10 cytokines by the placenta during pregnancy, instead of Th 1 (proinflammatory effect). The increase in the postpartum period can also explained by the modest humoral immunity state and the drop in interleukin levels [32]. Saraste et al. [18] also reported a decrease in the percentage of circulating natural killer cells during the last trimester of pregnancy. This increases again soon after delivery, which correlates with MS disease activity during and after pregnancy [18]. Additionally, the high level of sex hormones provided immune modulation and neuroprotective effects during pregnancy [33].

Effect of Consecutive Pregnancies

A prospective assessment of the effect of consecutive pregnancies on the rate of relapse among 93 French women with MS showed that subsequent pregnancies had no negative effect on the relapse rate of MS [34]. The LeMS study also found no increase in the relapse rate among MS women with consecutive pregnancies [23].

Koch et al. [26] found that disability was not altered by parity and the number of pregnancies. A study by D’Amico et al. [35] of 86 women with MS found no relationship between the number of pregnancies and long-term disability. Another study found no association between the number of pregnancies and the time to reach disability but discovered that the rate of conversion from RRMS to SPMS was higher in monoparous than that in multiparous women [36].

Multiparity reduced the risk of progression in RRMS (but not PPMS) women compared with nulliparity in a cohort of 973 women from Belgium [37]. Masera et al. [38] reported a negative correlation between parity and disability score and observed an increase in the time to disability among parous women compared with nulliparous women [38].

Long-Term Progression and Conversion

In a study of 102 women with MS from Iran, the ARR 6 years after delivery was comparable with the ARR during pregnancy. There was no change in the average EDSS years after pregnancy [39]. Similarly, the findings of 2 large cohort studies by Karp et al. [40] indicated no relationship between pregnancy and long-term disability [40, 41]. A prospective study investigating 577 women who had carried one or more full-term pregnancies found no negative long-term effects of pregnancy [42].

Conversely, a protective effect has been observed. In a study of 55 pregnant women with MS, the mean EDSS in the postpartum period was 1.5, which was higher than that during pregnancy (EDSS: 0.7), suggesting that pregnancy has a protective effect on MS in terms of disability compared with the postpartum period [24]. In a cohort of 501 mothers with clinically isolated syndrome, pregnancy before or after clinically isolated syndrome had a preventive effect on clinically definite MS [43]. A Belgian study demonstrated a reduction in long-term disability in pregnant women [44]. Jokubaitis et al. [45] also demonstrated a protective effect of pregnancy in their large international retrospective cohort study (n = 2,466) with a lower long-term disability after 10 years.

One study reported some adverse effects of pregnancy on disease progression. Sixty pregnant women with radiologically isolated syndrome were compared with 53 nonpregnant patients with the same condition [46]. The conversion from the radiological into the clinical form of the disease occurred faster in pregnant women; however, the groups were not comparable, and the conclusion may not be generalizable.

Obstetric Outcomes and Motherhood Decisions

Comparison of obstetric outcomes between women with and without MS by Cuello et al. [47] showed no significant differences. Furthermore, the pregnancy-related morbidity was similar. However, more assisted deliveries occurred in MS patients [47], as described by Dahl et al. [48, 49]. Another study retrospectively compared 432 births in mothers with MS to 2,975 births in healthy women. There were no significant differences between groups in obstetric outcomes such as type of delivery, mean gestational age, or birth weight [50]. Negative outcomes, including an increase in the rate of cesarean sections and reduced length and birth weight of the newborn of MS women, have been documented [19, 48, 49, 51, 52].

Fecundity in French women with MS did not differ between before and after the diagnosis of MS, whereas the miscarriage rate was similar to the general population. However, the average number of children per woman with MS was lower than that of the general population [53]. The effect of MS on motherhood decisions was evaluated in Portuguese women with MS. The decisions were not affected by the type of MS or frequency of relapses; however, several mothers believed that pregnancy would lead to worse disease outcomes. Therefore, after an MS diagnosis, mothers intended to have fewer pregnancies than before [54]. This could be related to a fear of transmitting the disease to offspring, especially if another family member is affected by MS. Furthermore, the lifetime probability of developing MS is 2% for a child with 1 parent with MS and 6–12% when both parents have MS. Other factors might include sexual dysfunction because of the disease or the cytotoxic effect of the medications, especially in progressive MS [33].

DMTs and Pregnancy

DMTs’ initiation and drug choice is related to accessibility, safety, patient characteristics and comorbidity, and disease activity and severity. The pros and cons of continuing DMTs during pregnancy should be discussed with the patient to help her reach an informed choice [3].

The only licensed group B safe to use during pregnancy medication is glatiramer acetate (GA), as previously reported [55‒58]. In a prospective multicenter cohort study, 423 pregnant women, exposed to GA or not, were followed, and GA was not related to an elevated risk of spontaneous abortion, preterm delivery, or low birth weight [57]. However, some studies have suggested that there is an increase in the rate of assisted deliveries and birth defects [20, 58].

Most studies in the literature indicated the safety of continuing beta interferon (IFN-β) (Rebif®, Avonex®, Betaferon®, Extavia®, and Plegridy®) at least up until pregnancy [55, 59, 60]. Reports of IFN-β use during pregnancy showed no complications or harm to the fetus. However, the lower relapse rate during pregnancy means that IFN-β or GA during pregnancy may be unnecessary, although IFN-β takes several months to reach maximum effect after restarting [61, 62]. Some studies suggest that IFN-β increases the abortion rate; however, the rates were not significantly different from the general population comparators [63]. Conversely, early exposure in pregnancy has been linked to high assisted vaginal delivery rates, miscarriages, and birth defects [20, 58, 64].

A study of the exposure of women with MS in early pregnancy to natalizumab (Tysabri®, NTZ, 2004) showed no risk of adverse pregnancy outcomes [65]. The MS Study Group of the Italian Neurological Society collected data on pregnancies occurring in patients receiving NTZ. Portaccio and others published several analyses, showing that pregnancy in MS patients did not protect from disease reactivation after NTZ suspension of <10 weeks before conception. Moreover, NTZ withdrawal in early pregnancy, compared with preconception, significantly reduced the relapse rate and disability accumulation [66]. This may be because NTZ is used in patients with active disease; therefore, the natural disease modification of pregnancy cannot compensate enough [30, 67‒71].

Studies of NTZ exposure showed no negative prenatal or postnatal fetal health outcomes [72, 73]. The Italian group published several analyses, concluding that NTZ exposure in early pregnancy does not increase the risk of malformations; however, it increased the risk of spontaneous abortions in an Italian population [74]. Conversely, the risk of abortion associated with NTZ was within normal limits [69, 75]. Another controlled prospective study investigated fetal abnormalities associated with NTZ exposure in 101 German mothers with MS. No increase in major malformations and premature births was observed. However, miscarriage rates and low birth rates were significantly more prevalent than the controls among NTZ-exposed and disease-matched groups [76]. A systematic review and meta-analysis by Morris et al. [75] of women with MS treated with DMTs between January 2000 and August 2019 showed that the most common major congenital malformations reported were an atrial septal defect, polydactyly, and club foot; these are among the most prevalent in the general population. The reviewers concluded that IFN-β, GA, and NTZ do not increase the risk of spontaneous abortions, preterm birth, or major congenital malformations.

NTZ is actively transported across the placenta only during the second and third trimesters. Furthermore, there is a slightly increased risk of hematological changes and suboptimal somatometric features among newborns [62, 77‒81]. The Association of British Neurologists recommended that the last dose of NTZ be given at 34 gestational weeks and for treatment to resume early. To prevent MS relapses, NTZ should resume within 8–12 weeks of the last dose [62].

Fingolimod (Gilenya, 2011) is a sphingosine-1-phosphate analog that reduces the circulating lymphocyte count in the peripheral blood. The sphingosine-1-phosphate receptors play a role in the vascular formation, and the use of fingolimod is associated with vascular malformations and teratogenicity in animals [82]. The effect of fingolimod administered in early pregnancy has been associated with the developmental retardation and truncal ataxia in children [83]. The outcome of 66 pregnancies that occurred during the clinical development program of fingolimod in MS showed a higher rate of spontaneous abortions and, compared with the general population, the upper limit of abnormal fetal development [84]. Therefore, contraception is recommended with fingolimod in pregnancy. Fingolimod discontinuation is associated with MS rebound; therefore, replacement therapy is needed [85]. The UK consensus advice is that women with MS planning to become pregnant should stop fingolimod minimum 2 months before conception. In the event of an unplanned pregnancy, treatment should be stopped immediately, and the pregnancy should be closely monitored [62].

Teriflunomide (Aubagio®, 2012) is a dihydroorotate dehydrogenase inhibitor that inhibits the proliferation of autoreactive B and T cells. It is teratogenic and is classified in the FDA category X. It has a very long enterohepatic circulation, and women who wish to conceive should stop it and undergo a washout period with cholestyramine or activated powdered charcoal [62]. There were no significant adverse findings in 437 pregnancies confirmed exposed to teriflunomide. Of the 222 with a known outcome, there were 21.2% spontaneous abortions and a stillbirth rate of 0.5%, consistent with the general population. Four birth defects were reported [86].

Dimethyl fumarate (Tecfidera®, 2013) reduces the production and release of inflammatory molecules and has antioxidant properties. Although data on exposure in early pregnancy are limited, postmarketing data showed no increased risk of fetal abnormalities or spontaneous abortion [87]. Women with MS on dimethyl fumarate are advised to use contraception while on treatment, and if they become pregnant, they should only continue treatment if the potential benefit justifies the risk to the fetus [62].

Alemtuzumab (Lemtrada®, 2013) is a humanized monoclonal antibody against CD52, which causes a long-lasting depletion of lymphocytes. Contraception is recommended for 4 months posttreatment [88]. There is a 37% risk of developing autoimmune thyroid disease and less frequently others. The risk of other autoimmune diseases is increased for 4 years after treatment. In pregnancy, they can affect both the mother and fetus (e.g., neonatal thyrotoxicosis) [62].

Cladribine (Mavenclad®), an immunosuppressant drug which inhibits DNA synthesis and repair and is known as teratogen, has reproductive toxic effects and is embryolethal in animals and poses a serious potential risk to the fetus in humans. Women taking cladribine should continue contraception during and for minimum 6 months after treatment [62].

Ocrelizumab (Ocrevus®) and rituximab are anti-CD20 monoclonal humanized IgG antibodies. There are limited data regarding the use of ocrelizumab (Ocrevus) in pregnancy. It crosses the placenta and can potentially cause B-cell depletion in infants [62]. The manufacturers recommended contraception use during treatment and for 12 months after [62]. Transient peripheral B-cell depletion and lymphopenia have been reported in infants born to mothers exposed to rituximab during pregnancy. A study reported 90 live births, 22 premature births, 1 neonatal death after 6 weeks, 11 newborns with hematological changes, 4 newborn infections, and 2 congenital malformations [62].

Effect of Breastfeeding on MS

The effect of breastfeeding on MS remains debatable. Breastfeeding does not influence postpartum relapses [17, 89‒92]. Airas et al. [90] reported a null association and found that the rate of breastfeeding among MS women was inversely correlated with disease activity before pregnancy. A low breastfeeding rate among MS patients compared with healthy controls has been reported [47]. The most important predictor for postpartum relapses is the rate of relapses during pregnancy [92, 93].

Breastfeeding, however, lowered the rate of postpartum relapses in some studies [94‒96]. A multicenter randomized clinical trial that explored the effect of pregnancy on the rate of postpartum relapses concluded that women with MS who breastfed for >3 months had a lower rate of postpartum relapses than those who never breastfed [94]. Hellwig et al. [96] studied women with MS who breastfed their babies exclusively for minimum 2 months after delivery. They observed a low relapse rate within the first 6 months postpartum [96]. Similarly, exclusive breastfeeding and the suppression of menses were associated with a drop in the postpartum relapse rate in one cohort study [95].

A large case-control multinational study of 3,658 participants in Norway and Italy evaluated the effect of breastfeeding on future MS [97]. A significant association between no or reduced breastfeeding (for <3 months) and MS was detected only in Italy with a 1.3 odds ratio (95% confidence interval, 1.09–1.7). However, the association was only significant in males, for developing MS in the future [97]. This could be related to the antiapoptosis features of prolactin and the reduction in tumor necrosis factor-alpha [32].

The possible effect of breastfeeding and the type of delivery on the onset of MS in newborns have been addressed in a cohort study that recruited 2,205 patients with a mean age of 29.4 years. Individuals delivered by cesarean section developed MS 5.2 years earlier than those delivered vaginally. Moreover, breastfeeding for ≥6 months was associated with a delayed onset of MS compared with formula feeding. These associations were observed among the patients without a family history of MS [98].

MS Treatment and Breastfeeding

Some studies have evaluated the secretion of MS medications in breastmilk. The majority of DMTs are not recommended during breastfeeding [62]. A case report has described the transmission of methylprednisolone through breastfeeding to the baby. However, brief treatment with methylprednisolone poses little risk of exposure to the newborn. The delay of lactation for 2–4 h after intravenous drug administration is recommended [99].

The transfer of natalizumab into breast milk has been reported. The infant dose is 1.7% of the weight-adjusted mother’s dose [100]. The maximal infant relative dose at day 50 reached 5.3% with continued accumulation, which raises concerns regarding the fetal drug safety.

Pregnancy has an effect on reducing disease activity, especially in the third trimester. Whether pregnancy affects overall disability or MS disease progression is unclear. Similarly, the effect of breastfeeding on MS and the rate of postpartum relapses is undetermined.

Prepregnancy disease activity can predict a higher relapse rate during pregnancy and postpartum, and stabilization with DMTs is recommended. Family planning and pregnancy counseling must be considered when initiating and prescribing MS treatment. Current evidence reveals that pregnant women with MS are not at a high risk, and MS does not influence the mode of delivery or increase obstetric complications. Health education and reassurance for mothers regarding the protective benefits of pregnancy in MS should be adopted in multidisciplinary medical care involving primary health care specialists, neurologists, obstetricians, and gynecologists.

The study is exempt from ethics committee approval becuase it is based on review of previously published literature.

The authors have no conflicts of interest to declare.

The authors received no specific funding for this work.

The authors confirm the contribution to the manuscript as follows: Study conception and design: Dr. Mohsen Alhomoud, Dr. Abdul Sattar Khan, and Dr. Iftetah Alhomoud. Literature search: Dr. Mohsen Alhomoud and Dr. Iftetah Alhomoud. Data extraction and summarization: Dr. Mohsen Alhomoud. Discussion and interpretation of findings: Dr. Mohsen Alhomoud, Dr. Abdul Sattar Khan, and Dr. Iftetah Alhomoud. Manuscript preparation: Dr. Mohsen Alhomoud, Dr. Abdul Sattar Khan, and Dr. Iftetah Alhomoud. Manuscript editing: Dr. Mohsen Alhomoud, Dr. Abdul Sattar Khan, and Dr. Iftetah Alhomoud. Final approval of the manuscript: Dr. Mohsen Alhomoud, Dr. Abdul Sattar Khan, and Dr. Iftetah Alhomoud.

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