The annual meeting of the American Academy of Neurology (AAN) is the largest neurological congress worldwide and covers all sub-areas of neurology. The AAN is not necessarily the most important meeting for the discussion of news and controversies in the field of MS. Nevertheless, it is of course worth taking a look at which topics were discussed at this year’s meeting, which took place from April 5th to 9th in San Diego.
This year, the focus was primarily on the new (McDonald) diagnostic criteria, which unfortunately have not yet been published, and especially the studies on the BTKi inhibitor Tolebrutinib (GEMINI I + II, HERCULES). However, they are not that new and were already the subject of DocBlog articles. Finally, the results of the MINORE and SOPRANINO studies were presented during the large plenary session “Contemporary Clinical Issues”. MINORE is a study that deals with the transplacental transmission of the antibody Ocrelizumab. SOPRANINO is a study that investigates the transfer of Ocrelizumab into breast milk. The results of both studies are interesting, they have been known for a long time, and I had already discussed them in a DocBlog article at the beginning of 2025. The reason I want to revisit these studies now is because their results have led to changes in the Ocrelizumab package leaflet by the European Medicines Agency (EMA), which is of great importance for women wishing to have children.
Studies on highly potent MS therapies and desire to have children
Therefore, a brief overview of the studies: In MINORE, 35 women with MS (average age 34 years) were included, who had been treated with Ocrelizumab for an average of 14 months and received their last infusion either 3.2 (0.3 – 4.5) months before or 1.9 (0.1 – 3.2) months after their last period and were thus potentially exposed to Ocrelizumab during their pregnancy. However, Ocrelizumab could not be detected in the umbilical cord blood of the newborns and in the serum of the 6-week-old infants. The number of B cells in the infants was also within the normal range. And the observed “side effects” of the mothers and infants were the typical complaints that are to be expected during pregnancy, childbirth and in the postpartum phase in mothers and children.
In SOPRANINO, 13 women with MS (average age 35 years) were included, 8 of whom had previously received Ocrelizumab and started Ocrelizumab on average after 2 (0.5 – 5 months) after giving birth. A total of 6 women breastfed exclusively during this time, 7 supplemented breastfeeding. In these women, the concentration of Ocrelizumab in the mother’s milk was negligible, Ocrelizumab could not be detected in the child’s serum.
As already mentioned, these data were able to convince the European Medicines Agency to change the package leaflet for Ocrelizumab. It previously stated that contraception should be used for 12 months when using Ocrelizumab. A recommendation that is ultimately nonsensical for a therapy given every 6 months and has led to great uncertainty among women wanting to have children and their doctors. On the basis of MINORE, the EMA has now reduced the recommendation for contraception to 4 months, which is still quite conservative, but ultimately signals to women with MS and their treating neurologists that having children and Ocrelizumab are compatible.
Furthermore, the package insert was also changed based on the data from the SOPRANINO study and the use of Ocrelizumab during breastfeeding was approved. Thus, Ocrelizumab is now the first and only highly effective therapy available that is approved for use during breastfeeding. These changes are to be welcomed as they make it possible to reconcile effective disease control with the health of the (unborn) child.
This post was translated from German to English with the help of AI.
