Pregnancy and lactation
Pregnancy outcomes1
- As of March 2021, 1,223 pregnancies had been reported in women with MS treated with OCR, an increase of approximately 100% relative to the previous data cut (n=608; March 2020)1,2
- Updated data do not suggest an increased risk of adverse pregnancy outcomes with ocrelizumab use, with or without in utero exposure, and remain in line with previous reports and expected epidemiological ranges3,4
MINORE study5,6
- MINORE (NCT04998812) will evaluate placental transfer of OCR and the corresponding pharmacodynamic effects in the infants of women with CIS or MS whose last dose of OCR was administered at any time ≤6 months before the LMP until the end of the first trimester
SOPRANINO study7,8
- SOPRANINO (NCT04998851) will evaluate the pharmacokinetics of OCR in the breast milk of lactating women with CIS or MS as well as the corresponding exposure and pharmacodynamic effects in the infant
Summary of pregnancy outcomes by exposure category*,1
Across exposure categories, data were in line with expected epidemiological ranges3,4
Five stillbirths (0.8%) were reported, of which three presented with comorbidities as potential confounders. All were retrospectively reported cases and no increase in rate was observed since the 2020 data cut2
Seven major congenital anomalies (1.6%) were reported, of which four were potentially confounded by risk factors
MINORE5,6
Enrolment of ~44 women between GWk 22–26, whose last OCR dose occurred at any time from 6 months before the LMP until the end of the first trimester
Primary endpoint: Proportion of infants with B-cell levels below LLN at Week 6 of life
- Key secondary endpoints: Serum OCR levels in umbilical cord blood, infant humoral immune responses to vaccinations
- More information is available at ClinicalTrials.gov
SOPRANINO7,8
Enrolment of at least 20 women who delivered a term infant and
made the decision to breastfeed whilst receiving OCR
(inclusion from 2–24 weeks post-partum)Co-primary endpoints: Proportion of infants with B-cell levels below the LLN, measured 30 days after the mother’s first postpartum OCR infusion; Estimated ADID over 60 days after the mother’s first postpartum OCR infusion
More information is available at ClinicalTrials.gov
Do you have patients with MS receiving OCR who are pregnant? Please remember to report the pregnancy accordingly:
If you are in the United States, your patients may be able to take part in a global registry of women with MS who are pregnant and either have or have not received ocrelizumab during or within 6 months before their pregnancy. Click here for information
Outside the United States: Please report any occurrence of pregnancy in women receiving OCR here
Summary of pregnancy outcomes by exposure category
*An embryo/foetus was considered to have exposure to OCR in utero if the last infusion occurred within 3 months of conception, during pregnancy or in utero with timing unknown;
†Proportions of live births, ectopic pregnancies, therapeutic/elective abortions, spontaneous abortions and stillbirths were calculated using known outcomes of the respective exposure category as the denominator;
‡Total exposed in utero includes seven in utero exposure cases for which exact timing of exposure could not be determined;
§Proportions of live birth gestational age and anomalies were calculated using live births in the respective exposure category as the denominator.
Abbreviations
ADID, average daily oral infant dose; CIS, clinically isolated syndrome; GWk, gestation week; LLN, lower limit of normal; LMP, last menstrual period;
MCA, major congenital anomalies; OCR, ocrelizumab.
References
- Dobson R. et al. Presented at ECTRIMS 2021 (Presentation P641);
- Bove R, et al. Presented at ECTRIMS 2020 (Presentation P1132);
- Lopez-Leon S, et al. J Neurol 2020;267:2721–31;
- Centers for Disease Control and Prevention (CDC). MMWR Morb Mortal Wkly Rep 2008;57:1–5;
- ClinicalTrials.gov identifier: NCT04998812;
- Hellwig K, et al. Presented at ECTRIMS 2021 (Poster P655);
- ClinicalTrials.gov identifier: NCT04998851;
- Bove R, et al. Presented at ECTRIMS 2021 (Poster P686).
M-XX-00007062 (Date of preparation: October 2021)