I NTRODUCTION
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system that predominantly affects women of reproductive age.[ 1 , 2 , 3 ] One of the major challenges in managing women with MS is planning for pregnancy and lactation. Pregnancy is generally associated with a reduction in inflammatory disease activity, particularly during the third trimester; whereas the risk of relapse transiently increases in the postpartum period.[ 4 ] Highly effective disease-modifying therapies (DMTs), including rituximab and ocrelizumab play an important role in controlling active MS. Both agents are anti-CD20 monoclonal antibodies that reduce disease activity through B-cell depletion. However, because immunoglobulin G (IgG) antibodies can cross the placenta, particularly during the second and third trimesters, concerns remain regarding potential fetal and neonatal effects following exposure during pregnancy. Safety considerations also extend to breastfeeding, although transfer of monoclonal antibodies into breast milk is generally expected to be low.[ 5 ] The prescribing information for ocrelizumab recommends avoiding pregnancy for a defined period after treatment, commonly reported as 6 to 12 months depending on the regulatory label and setting.[ 6 ] Nevertheless, unplanned or unavoidable pregnancies may occur during treatment, and continuation or resumption of therapy after delivery to prevent postpartum relapse is also an important clinical consideration.[ 4 ] Therefore, evidence on maternal disease course, pregnancy outcomes, breastfeeding safety, and potential neonatal complications after exposure to rituximab or ocrelizumab, is essential for informed clinical decision-making.[ 1 ] This article presents a structured narrative review of studies published between 2000 and 2026 on the clinical outcomes and safety of rituximab and ocrelizumab during pregnancy and breastfeeding in women with MS.
M ETHODOLOGY
This review was conducted as a structured narrative review informed by PRISMA reporting principles. A comprehensive literature search was performed in PubMed, Scopus, Web of Science, and Google Scholar. The search covered studies published from January 2000 to December 2025, reflecting the latest available evidence up to early 2026.
A combination of relevant English and Persian keywords was used; the principal terms included: MS, Pregnancy, breastfeeding, rituximab, ocrelizumab, pregnancy outcome, disease-modifying therapy in pregnancy, and their Persian equivalents. Inclusion criteria comprised any study reporting information on pregnancy outcomes (such as live birth rate, miscarriage, and obstetric complications), MS disease status (such as relapse rates during pregnancy and postpartum), or drug-related adverse effects in women with MS treated with rituximab or ocrelizumab during pregnancy or lactation. Study types included clinical trials, cohort studies, case–control studies, case reports, and systematic reviews. No restrictions were applied regarding language or geographic location.
Titles and abstracts were screenedfollowed by full-text assessment of potentially eligible studies. Relevant data, including study population, timing of drug exposure, pregnancy and lactation outcomes, neonatal outcomes, and reported maternal or infant complications, were extracted and summarized in tables. Duplicate records and studies not meeting the inclusion criteria were excluded. In addition, reference lists of relevant reviews and clinical guidelines were manually searched to identify further eligible studies. The findings are presented narratively according to the following themes: maternal disease course during pregnancy and postpartum, pregnancy outcomes, neonatal outcomes, complications during pregnancy and safety considerations during breastfeeding.
Impact of pregnancy and anti-CD20 therapies on the course of multiple sclerosis
Pregnancy is classically associated with a relative reduction in MS disease activity, particularly during the third trimester. Immunological changes during pregnancy, including an increase in regulatory immune cell activity, are thought tocontribute to reduced relapse rates.[ 7 ] However, in the absence of effective treatment, relapse risk may increase during the first three to six months postpartum and may return to pre-pregnancy levels or, in some patients, exceed them.[ 8 ]
Large retrospective studies have confirmed this increase in postpartum disease activity. For example, in a cohort study of women with MS in the United States, approximately 30% of patients experienced a relapse within three months after delivery, whereas relapse rates during pregnancy were substantially lower, at around 10%. These findings highlight the clinical importance of active disease management around pregnancy, particularly during the postpartum period.[ 4 ]
Anti-CD20 therapies such as rituximab and ocrelizumab are among the most effective options for controlling active MS and may help maintain disease stability around pregnancy. Smith et al . (2020), in a retrospective study of 74 pregnancies in 55 patients treated with rituximab before conception, reported that only two patients, approximately 5%, experienced a relapse during pregnancy or within six months postpartum.[ 9 ] In this study, rituximab exposure occurred mainly before conception, and the study did not evaluate planned or routine continuation of rituximab throughout pregnancy. Therefore, the low relapse rate should be interpreted primarily as reflecting the sustained effect of pre-pregnancy treatment and long-term B-cell depletion, rather than as evidence supporting regular rituximab administration during pregnancy.
Similarly, a global registry-based study from MSBase by Yeh et al . (2024), showed that women who had received ocrelizumab before pregnancy experienced no relapses during pregnancy, and only 4.1% relapsed within six months postpartum.[ 4 ] This rate was markedly lower than the postpartum relapse rate observed in patients treated with lower-efficacy therapies, such as interferon-beta or glatiramer acetate among whom approximately 17.6% experienced postpartum relapse (4 As in the rituximab cohort, patients in the ocrelizumab group were mainly treated before pregnancy, and the study did not assess the regular or planned continuation of anti-CD20 therapy throughout pregnancy. Thus, the absence of relapses during pregnancy and the reduced relapse rate after delivery should primarily be attributed to the sustained biological effect of pre-pregnancy anti-CD20 therapy and B-cell depletion, rather than to continuous drug use during pregnancy. In the same MSBase study, a small subgroup of women treated with rituximab also experienced no relapses during pregnancy, while the postpartum relapse rate was approximately 12.5%.[ 4 ] Overall, these findings suggest that anti-CD20 treatment before pregnancy and, when clinically appropriate, timely continuation or resumption after delivery, may substantially reduce disease reactivation during pregnancy and postpartum.[ 4 ] In other words, the disease course of MS in women receiving rituximab and ocrelizumab during pregnancy is generally more stable, with fewer relapses. Nevertheless, it should be noted that administration of these drugs during pregnancy remains outside formally approved indications, and decision-making should be individualized based on disease severity and patient preference.[ 5 ] In other words, the available evidence suggests that women who received rituximab or ocrelizumab before conception or close to the time of pregnancy may experience a more stable disease course with fewer relapses during pregnancy and after delivery. However, this finding should not be interpreted as evidence supporting the routine continuation of rituximab or ocrelizumab throughout pregnancy. The disease stability observed in the aforementioned studies is likely mainly related to pre-pregnancy exposure to anti-CD20 therapies and the long-lasting biological effect of B-cell depletion. However, the use of these medications during pregnancy remains outside officially approved indications, and decision making should be individualized based on disease severity, the timing of the last infusion, the maternal relapse risk, fetal safety considerations, and patient preference.
Pregnancy outcomes following exposure to rituximab
Current evidence largely indicates that rituximab exposure around pregnancy is not necessarily associated Current evidence suggest that rituximab exposure around conception or during early pregnancy is not clearly associated with an increased obstetric complications or fetal harm. Several case series and small cohort studies have reported pregnancy outcomes in women with MS exposed to RTX.
The study by Smith et al . (2020), discussed above relation to disease control, also evaluated pregnancy safety outxomes. In this study, 38 live births were reported, and no cases of stillbirth, intrauterine infection, chorioamnionitis, or major congenital anomalies were observed among the newborns. One neonatal death occurred in one of a pair of preterm twins born at 25 weeks’ gestation and was attributed to complications of extreme prematurity. The overall first-trimester spontaneous miscarriage rate was approximately 31% (23 of 74 pregnancies), corresponding to 15 women or27% of patients, experiencing at least one miscarriage. Although this rate appears relatively high, more than half of these women had a history of infertility or related risk factors, and analyses did not indicate a significant increase compared with the expected rate in the general population. Neither cumulative dose nor timing of the last rituximab infusion was directly associated with miscarriage risk. Furthermore, five women with a history of miscarriage subsequently had successful pregnancies with live births despite rituximab exposure, and two additional women were in the third trimester of healthy pregnancies at the time of publication.[ 9 ]
Case reports and case series have also contributed to the evidence base on pregnancy outcomes with RTX exposure. For example, Ahadi et al . (2021), in a case-series study of 21 pregnancies in Iran, reported a live birth rate of approximately 48% and a first-trimester spontaneous miscarriage rate of about 9.5%. No major congenital anomalies were reported in this series, and all live-born infants were healthy.[ 10 ] In a more recent systematic review and meta-analysis combining multiple RTX studies in MS, the cumulative term live birth rate was estimated at approximately 62%–64%, and preterm birth occurred in only about 4% of cases, suggesting no unusual increase in preterm delivery among these patients.[ 11 ]
In recent systematic review and meta-analysis that combined several studies on rituximab in patients with MS, the pooled rate of term live birth was estimated to be approximately 62-64%, and preterm delivery occurred in only about 4% of cases. For comparison, preterm birth occurs in approximately 10% of live births worldwide in the general population, with reported rates ranging from about 4% to 16% across different countries. Therefore, the available data do not suggest a higher-than-expected rate of preterm birth among pregnancies exposed to rituximab.[ 12 ]
Overall, current evidence suggests that RTX exposure around conception or in early pregnancy is not associated with a marked increase in obstetric complications or congenital anomalies.[ 9 ] Nevertheless, in accordance with precautionary principles, pregnancy is generally planned after an interval from the last rituximab infusion, commonly 3 to 6 months, to reduce direct fetal exposure, particularly later in pregnancy when placental transfer of IgG increases.[ 5 ]
Pregnancy outcomes following exposure to ocrelizumab
Ocrelizumab has been available since 2017 as an effective first-and second-line therapy for active MS. Although early clinical trials of ocrelizumab excluded pregnancy and therefore provided limited information on pregnancy safety, valuable real-world data have gradually accumulated.[ 1 ] Vukusic et al ., in collaboration with the manufacturer, established a global pharmacovigilance database that has tracked several thousand pregnancies in women receiving ocrelizumab.[ 1 ] The most comprehensive analysis of these data was published by Vukusic and colleagues using the Roche global pharmacovigilance database, which included 3244 pregnancies in women with MS who had been exposed to ocrelizumab.[ 1 ] Among prospectively reported pregnancies, 855 involved in utero exposure, defined as the last infusion occurring within 3 months prior to conception or during pregnancy. In pregnancies with known outcomes, the live birth rate was similar between exposed and non-exposed pregnancies, at 84.2% and 88.3%, respectively. Likewise, the rate of spontaneous abortion among exposed pregnancies was 7.4%, comparable to the non-exposed group (9.1%) and within the expected range for the general population. The rate of spontaneous abortion was also comparable between groups, at 7.4% in exposed pregnancies and 9.1% in non-exposed pregnancies. These rates falls within the expected background range for clinically recognized pregnancies, in which early pregnancy loss is generally reported in approximately 10–20% of cases. Overall, the available data do not indicate an increased risk of spontaneous abortion associated with ocrelizumab exposure.[ 13 ]
A notable difference between the two groups was a higher rate of elective termination among women exposed to ocrelizumab (7.4% vs. 1.7%), likely reflecting medical or personal decisions to terminate pregnancy due to concerns about drug exposure. Reassuringly, major MCA in newborns was infrequent and nearly identical in both groups (about 2% in exposed vs. 1.9% in non-exposed). A notable difference between groups was the higher frequency of elective termination among women with in utero exposure to ocrelizumab compared with non-exposed pregnancies (7.4% vs. 1.7%), likely reflecting medical or personal decisions to terminate pregnancy due to concerns about fetal drug exposure rather than a direct drug-related adverse effect. Reassuringly, major congenital anomalies (MCA) in newborns were infrequent and occurred at similar rates in exposed and non-exposed live births, at approximately 2.1% and 1.9%, respectively. These rates are consistent with population-based estimates of congenital malformations and do not suggest an increased teratogenic risk associated with ocrelizumab. In the in utero exposure group, one stillbirth (fetal death after 22 weeks) and one neonatal death were prospectively reported; these events appeared to be related to specific obstetric or maternal complications, including extremely preterm birth due to chorioamnionitis or severe maternal COVID-19 infection, rather than a clear direct effect of ocrelizumab.[ 1 ]
Additional real-world studies support these findings. Gitman et al . (2022) analyzed data from the Canadian ocrelizumab patient support program and identified 65 pregnancies with known outcomes. The live birth rate was 72.3% spontaneous abortion occurred in 20.0%, and elective termination in 3.1% of pregnancies. One infant was born with a congenital anomaly, polydactyly, or which additional contributing factors were considered possible;; the remaining newborns were reported to be healthy and without major complications.[ 14 ] In a smaller retrospective German case series, three women treated with ocrelizumab were reported, including one who received treatment during the second trimester, and two who initiated therapy postpartum. No serious obstetric or neonatal complications were obsereved. The infant exposed during pregnancy had a transient reduction in B-cell counts, which normalized within a few weeks.[ 15 ]
Taken together, current evidence suggests that accidental exposure to ocrelizumab in early pregnancy or unintended continuation during unplanned pregnancies, is not generally associated with major adverse outcomes.[ 1 ] Nevertheless, current guidelines continue to contraception during treatment and for a defined interval after the last infusion. Recommendations vary by region, with a 6-month interval commonly advised and a longer 12-month interval included in European labeling.[ 1 ] In patients with highly active disease, however, the benefits of maintaining treatment may outweigh potential theoretical fetal risks. Such decisions should be individualized and made through shared decision-making involving the patient, neurologist, and obstetric team.[ 5 ]
Adverse effects and safety considerations during pregnancy and the postpartum period
Maternal and fetal safety during exposure to anti-CD20 therapies remains an important clinical concern for both clinicians and patients. Overall, available evidence has been reassuring, and no consistent signal of increased severe pregnancy complications following exposure to rituximab or ocrelizumab.[ 9 ] As noted earlier, the rates of spontaneous miscarriage, preterm delivery, preeclampsia, and other obstetric complications in women treated with these agents have generally been comparable to those reported in untreated MS cohorts or the general population.[ 1 ] In data collected from 3244 pregnancies exposed to ocrelizumab, only 2.9% of women experienced an obstetric complication (such as gestational hypertension or gestational diabetes), which falls within the expected range for typical pregnancies.[ 1 ] The most common reported complications among these mothers were gestational hypertension (1.6%), gestational diabetes (1.1%), and preeclampsia (1.1%). Overall, only three maternal deaths were reported in this large dataset, none of which were directly related to the drug (two due to COVID-19 pneumonia and one due to severe bacterial infection).[ 1 ] From the perspective of fetal and neonatal safety, the most notable concern relates to the potential impact on the neonatal immune system. Because rituximab and ocrelizumab are immunoglobulin G1 antibodies, they can cross the placenta beginning in the late second trimester and reach the fetus.[ 5 ] This transfer may lead to a transient reduction in neonatal B lymphocytes. In the Roche-sponsored study, B-cell levels were abnormal (below the reference range) in only 6 of 62 evaluated infants, all of whom had been exposed to ocrelizumab during either the first or third trimester of pregnancy.[ 1 ] These infants exhibited low B-cell counts at birth or during the 1 st weeks of life, but follow-up demonstrated that in all cases B lymphocyte counts returned to the normal range within weeks to months after birth.[ 15 ] As a precautionary measure, clinical guidelines recommend delaying administration of live vaccines (such as Bacille Calmette–Guérin (BCG) or rotavirus vaccines) in infants whose mothers were exposed to these drugs in late pregnancy until full recovery of immune function is confirmed.[ 5 ] This recommendation is particularly important for infants whose mothers received rituximab or ocrelizumab during the third trimester. Overall, no significant increase in severe neonatal infections or delays in growth and development has been reported to date.[ 16 ]
Although some studies have noted that a proportion of infants with in utero exposure experienced common early-life infections (such as upper respiratory infections, bronchiolitis, or otitis media), these occurred within expected population ranges and all resolved without serious sequelae.[ 17 ] For example, among 43 infants followed in one study, the most frequent infections included respiratory syncytial virus infection, COVID-19, and otitis media, with no life-threatening infections reported.[ 1 ]
Breastfeeding and treatment with rituximab and ocrelizumab
A key postpartum concern for women with MS is whether breastfeeding can be continued safely while high-efficacy treatment is resumed. Older injectable therapies, such as interferon-beta and glatiramer acetate, are generally considered safe during lactation, but until recently, data for newer agents such as anti-CD20 monoclonal antibodies were limited. From a pharmacological perspective, rituximab and ocrelizumab are large immunoglobulin G1 monoclonal antibodies, and transfer into breast milk is expected to be low. In addition, oral absorption by the infant is likely to be limited because these proteins are expected to undergo degradation in the gastrointestinal tract.[ 5 ]
Emerging clinical data support this biological expectation. In a prospective study by Anderson et al ., which measured drug concentrations in breast milk, the mean concentration of ocrelizumab was only about 0.08 µg/mL, and the maximum concentration during the 1 st week after infusion reached merely 0.3 µg/mL.[ 18 ]
The estimated relative infant dose was below 1%, substantially lower than commonly accepted threshold of clinical concern. In the same study, ocrelizumab levels were undetectable in the peripheral blood of nine tested infants (below the detection limit of 0.156 µg/mL).[ 18 ] All infants breastfed by mothers receiving anti-CD20 therapy demonstrated normal levels of B lymphocytes and IgG, and no signs of immune suppression were observed. Regarding physical growth and neurodevelopment, the study by Anderson et al . also found that at 8–12 months of age, growth and developmental indices in infants of treated breastfeeding mothers did not differ from those in infants whose mothers did not breastfeed. Approximately 77% of these infants experienced common mild infections during the 1 st year of life (mostly upper respiratory or ear infections), all of which resolved without complications, and no serious infections were reported.[ 18 ] Based on this evidence, many recent clinical guidelines recommend that breastfeeding during treatment with ocrelizumab or rituximab is permissible and even desirable.[ 5 ] For example, the 2022 guideline of the Association of British Neurologists states that continuing anti-CD20 therapy during lactation is safe and women with MS who require postpartum treatment should not be denied these medications solely because they are breastfeeding.[ 5 ] It is nevertheless recommended, when feasible, that the first postpartum treatment dose be administered 1–2 weeks after delivery to allow for initial neonatal adaptation, after which the mother may receive the drug and continue breastfeeding (this precaution is largely theoretical, as available evidence indicates that even administration in the early postpartum days has been safe).[ 18 ] Ultimately, decisions regarding continuation of breastfeeding alongside treatment resumption should consider maternal preference and the potential risk of MS relapse if therapy is withheld. Many women, reassured by the minimal transfer of the drug into breast milk, choose to continue breastfeeding, which can be supported through coordinated care with the treatment team.
Clinical recommendations and summary
Based on the available evidence, several practical strategies may be considered for women with MS who are planning pregnancy, are pregnant or are breastfeeding:
Preconception planning: In women with highly active MS requiring high-efficacy therapies, the use of rituximab or ocrelizumab before pregnancy may be an appropriate option for disease control.[ 19 ] A treatment-to-conception interval of approximately 3–6 months is commonly recommended to allow circulating drug levels to decline while maintaining a period of disease control.[ 20 ] However, in patients with highly active disease in whom treatment interruption may carry substantial maternal risk, a shorter interval may be considered after individualized counseling, as current data do not suggest a major increase in serious fetal adverse outcomes after periconceptional or early pregnancy exposure.[ 5 ]
Management during pregnancy
If an unintended pregnancy occurs shortly after anti-CD20 treatment, available evidence does not support an increased risk of miscarriage, congenital malformations, or other major complications.[ 9 ] Therefore, elective termination of pregnancy is not recommended solely on the basis of rituximab or ocrelizumab exposure. If pregnancy occurs soon after an infusion, continuation of pregnancy with careful monitoring is acceptable. Routine administration of rituximab or ocrelizumab during pregnancy is not recommended except in highly selected cases (e.g., severely active, potentially disabling disease), in which decisions are usually made after the first trimester and in consultation with an obstetric team.[ 5 ] In women who received their last dose in late pregnancy, neonatal lymphocyte subsets, particularly B-cell counts, should be assessed after birth, and live vaccines should be deferred until lymphocyte counts normalize.[ 5 ]
Resumption of therapy after delivery
Given the high risk of MS relapse during the first 3–6 months postpartum, it is recommended that effective therapies be restarted immediately after delivery (usually within the first 2–4 weeks after birth).[ 4 ] Rituximab or ocrelizumab are appropriate options at this stage, as evidence shows that they suppress the return of disease activity while remaining safe for the infant.[ 17 ] Early initiation of these therapies in women with highly active disease can prevent severe and even disabling postpartum relapses.[ 4 ]
Breastfeeding
Women should be encouraged to continue breastfeeding if they wish, even while receiving rituximab or ocrelizumab.[ 7 ] The care team should provide reassurance that drug transfer into breast milk is minimal and that no adverse effects on infant growth or immune function have been reported to date.[ 18 ] At the same time, monitoring the infant’s health (in terms of growth, infections, and vaccine responses) during the 1 st year is recommended so that any issues can be promptly identified, although no problems beyond the normal range have thus far been observed.[ 17 ]
C ONCLUSION
Based on the available evidence, anti-CD20 therapies such as rituximab and ocrelizumab can be used in women with MS around the time of pregnancy with relative confidence, provided that the benefits of disease control are weighed against potential fetal risks. These agents maintain disease stability during pregnancy and markedly reduce postpartum relapses. Current evidence indicates that fetal exposure to these drugs does not increase congenital anomalies or neonatal complications, and most pregnancies result in the birth of a healthy infant. Continuation of therapy during lactation may also be necessary to control maternal disease, and according to existing data, this approach appears safe and does not interfere with infant health. Nevertheless, it remains essential that all therapeutic decisions during pregnancy be individualized and made in partnership with the mother. The accumulation of additional data from MS pregnancy registries and the conduct of prospective studies will further clarify the long-term effects of these treatments on both mother and child. With the increased use of anti-CD20 agents in young individuals, accurate, evidence-based counseling regarding pregnancy and breastfeeding will play a key role in reducing patient anxiety and facilitating appropriate therapeutic decision-making.
A UTHORS ’ C ONTRIBUTION
FA contributed to the conceptualization of the study, literature search and drafting of the manuscript. MM contributed to the study design, critical revision of the manuscript for important intellectual content, and supervision. Both authors approved the final version of the manuscript.
Data availability
No new data were generated or analyzed in this review. All data supporting the findings of this study are available within the article and its cited references.
Conflicts of interest
There are no conflicts of interest.
Funding Statement
Nil.
R EFERENCES
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13. American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins-Gynecology. ACOG practice bulletin No. 200: Early pregnancy loss. Obstet Gynecol. 2018;132:e197–207. doi: 10.1097/AOG.0000000000002899.
14. Gitman V, Stavropoulos A, Saenz V, Pasquarelli N, Zecevic D, Devonshire V. Pregnancy outcomes of women with multiple sclerosis treated with ocrelizumab in Canada: A descriptive analysis of real-world data. Mult Scler Relat Disord. 2022;62:103792. doi: 10.1016/j.msard.2022.103792.
15. Ciplea AI, Langer-Gould A, de Vries A, Schaap T, Thiel S, Ringelstein M, et al. Monoclonal antibody treatment during pregnancy and/or lactation in women with MS or neuromyelitis optica spectrum disorder. Neurol Neuroimmunol Neuroinflamm. 2020;7:e723. doi: 10.1212/NXI.0000000000000723.
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Associated Data
Data Availability Statement
No new data were generated or analyzed in this review. All data supporting the findings of this study are available within the article and its cited references.