Key Clinical Summary

• An analysis of more than 5000 reported pregnancies found no increased risk of adverse pregnancy or infant outcomes among women with multiple sclerosis (MS) exposed to ocrelizumab.
• Most pregnancies resulted in live births, with similar rates of spontaneous abortion, stillbirth, and preterm delivery between exposed and nonexposed groups.
• The findings support ongoing clinician-patient discussions regarding family planning and disease control in women receiving high-efficacy MS therapy.

New long-term pregnancy safety data presented in an analysis of more than 5000 pregnancies suggest that ocrelizumab exposure before or during pregnancy was not associated with increased adverse maternal or infant outcomes in women with MS.

Study Findings 

Investigators analyzed pregnancy outcomes from the Roche global safety database through March 27, 2025, including both clinical trial and postmarketing reports involving women with MS treated with ocrelizumab.

The dataset included 5098 reported pregnancies overall, with 1309 prospective pregnancies having known exposure status and known outcomes. Among these, 763 pregnancies involved potential in utero exposure to ocrelizumab, defined as treatment administered within 3 months before the last menstrual period or during pregnancy. The remaining 546 pregnancies were categorized as nonexposed.

Most pregnancies resulted in live births in both groups. Live birth rates were 86.9% in the exposed cohort and 89.9% in the nonexposed cohort.

Rates of preterm live births were similar between groups, occurring in 9.2% of exposed pregnancies and 6.9% of nonexposed pregnancies.

Fetal loss outcomes were also comparable. Spontaneous abortion rates were 6.7% in exposed pregnancies vs 8.1% in nonexposed pregnancies, while stillbirth occurred in 0.4% of exposed pregnancies and none of the nonexposed pregnancies.

Elective and therapeutic pregnancy terminations were more common among exposed patients, occurring in 5.4% of exposed pregnancies compared with 1.5% in nonexposed pregnancies. However, investigators noted that reasons for termination were similar between groups and most occurred early in gestation.

The authors reported that pregnancy outcomes were generally consistent with epidemiologic rates observed in both MS populations and the broader general population.

Clinical Implications

For clinicians managing women of childbearing age with MS, the findings address a growing clinical challenge. Ocrelizumab is a high-efficacy disease-modifying therapy commonly used to reduce relapse risk and disability progression, but prescribing information currently recommends contraception during treatment and for several months afterward.

As more women with MS pursue pregnancy while receiving highly effective therapies, real-world safety data are becoming increasingly important for treatment planning and counseling.

The investigators emphasized that balancing maternal disease control with fetal safety remains critical. Disease activity during pregnancy or postpartum can lead to long-term neurologic consequences, making discontinuation decisions complex.

For managed care stakeholders and clinicians, these findings may help support evidence-based shared decision-making and individualized family planning discussions.

Conclusion

This large pregnancy outcomes analysis suggests that ocrelizumab exposure before or during pregnancy was not associated with increased adverse maternal or infant outcomes in women with MS. The data provides important real-world evidence to guide treatment and family planning discussions in clinical practice.

References

Krysko KM, Dobson R, Vukusic S. A decade of pregnancy outcomes in women with multiple sclerosis receiving ocrelizumab: analysis of over 5000 pregnancies. Presented at: Consortium of Multiple Sclerosis Centers Annual Meeting; May 27-29, 2026; Charlotte, NC.