Transfer of ocrelizumab into breastmilk is negligible

In mothers receiving ocrelizumab while breastfeeding, ocrelizumab transfer into breastmilk was negligible. In infants breastfed by these mothers, serum ocrelizumab levels were undetectable. These were the main results of the SOPRANINO study, intended to help clinicians advise on post-partum initiation of ocrelizumab in women with MS who wish to breastfeed.

SOPRANINO (NCT04998851) is the first prospective study measuring the pharmacodynamic effects of ocrelizumab in breastfed infants. The primary analysis was presented by Dr Riley Bove (University of California San Francisco, CA, USA) [1]. She stressed that the clinical decision to start ocrelizumab during breastfeeding preceded study enrollment. Investigated infants were 2–24 weeks of age at the time of their mother’s first post-partum ocrelizumab infusion. A blood sample of the infant was collected 30 days after infusion. The study’s co-primary outcomes were: ocrelizumab concentrations in breastmilk (average daily infant dose: ADID) over 60 days after the mother's first post-partum infusion and the proportion of infants with B-cell levels below the lower limit of normal (LLN) at 30 days post-infusion.

SOPRANINO enrolled 13 women with relapsing-remitting MS with a median age of 35 years, and their 13 infants, with a median age of 2.0 months at maternal infusion. Dr Bove stated that ocrelizumab levels in breastmilk were “negligible,” at a mean ADID of 45.1 μg. Blood samples of 9 infants were available for analysis, showing that ocrelizumab was undetectable (below the lower limit of quantification [LLQ] of 156 ng/ml. Dr Bove added that all infants had B-cell levels within age-specific normal ranges.

Adverse events (AEs) in the infants were consistent with common childhood diseases in the first year of life. Of 13 infants, 11 (85%) had ≥1 AE, mostly of grade 1–2; 1 infant had a grade 3 AE (bronchiolitis, resolved within 12 days). There were no serious AEs.

1. Bove R, et al. B-cell levels and breastmilk transfer in infants of lactating women with multiple sclerosis treated with ocrelizumab: Primary results of the prospective multicenter, open-label phase IV study SOPRANINO. Abstract O039, ECTRIMS 2024, 17–20 October 2024, Copenhagen, Denmark.

Medical writing support was provided by Michiel Tent

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Posted on 24 September 202424 September 2024