Pregnancy and infant outcomes in women receiving ocrelizumab

Updated pregnancy outcomes in MS patients receiving ocrelizumab showed an increase in the number of reported pregnancies over the previous year. The cumulative data did not suggest an increased risk of preterm birth, major congenital abnormalities, or other adverse outcomes with in utero exposure to ocrelizumab.

Updated pregnancy outcomes in MS patients receiving ocrelizumab were presented by Prof. Celia Oreja-Guevara (University Hospital San Carlos, Spain) [1]. Included were 2,020 cumulative MS pregnancies of women exposed to ocrelizumab before or during pregnancy from November 2008 up to 31 March 2022, which is an increase of 65% compared with the previous data cut-off in 2021. Additionally included were the outcomes of 61 infants of up to 1 year of age exposed to ocrelizumab in utero and/or during breastfeeding. Prof. Oreja-Guevara focused on the 1,498 prospectively reported cases.

From the 596 women (39.8%) with known pregnancy outcomes, 286 were exposed to ocrelizumab (of 147, exposure was unknown) (see Table). Most pregnancies (79.0%) resulted in live births; proportions were similar in the exposed and non-exposed groups. Prof. Oreja-Guevara expressly noted that results in the exposed and non-exposed groups, e.g. the percentage of preterm births, did not differ significantly. The percentage of elective termination of pregnancy was higher in the exposed (11.5%) versus the non-exposed group (3.7%). However, the overall cumulative proportion of elective abortions decreased: it was 15.7% in 2021. The percentage of spontaneous abortions was lower in the exposed group (8%) than in the non-exposed group (10.4%), which is still lower than the overall rate in Spain, which is around 15%.

Table: Pregnancy outcomes by ocrelizumab exposure [1]

 

Combining prospective and retrospective cases, of 809 children born alive, 10 (0.9%) had major congenital abnormalities, of which 8 were in the exposed group. Two of these had Down syndrome. There were 0 cases of major congenital abnormalities in the non-exposed group, but as Prof. Oreja-Guevara noted, in this group underreporting is always a problem in this type of study. Follow-up data of 1 year was present of only 61 newborns; these will be presented in more detail at the ECTRIMS meeting of 2023.

In conclusion, Prof. Oreja-Guevara noted 2 important tendencies: “We see more and more pregnancies, but there is not an increased risk of adverse pregnancy of infant outcomes with ocrelizumab in utero exposure compared with previous reports and epidemiological data. Most importantly: The proportion of patients undergoing elective abortion decreased over the previous year, probably because both patients and physicians are less afraid of adverse outcomes.”

1. Oreja-Guevara C. Pregnancy and infant outcomes in women receiving ocrelizumab for the treatment of multiple sclerosis. Abstract O038, ECTRIMS 2022, Amsterdam, 26–28 October, the Netherlands.

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Posted on 20 December 2022