Transfer of ocrelizumab into breastmilk is negligible

The SOPRANINO study found that, in mothers receiving ocrelizumab while breastfeeding, the amount of ocrelizumab that transferred into breastmilk was negligible. Serum ocrelizumab levels were undetectable in infants whose mothers received ocrelizumab.

The open-label, multicentre, phase 4 SOPRANINO study (NCT04998851) aimed to help clinicians advise on post-partum initiation of ocrelizumab in women with MS who wish to breastfeed. It is the first prospective study to measure 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.

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; 6 were exclusively breastfed at baseline. Dr Bove stated that ocrelizumab levels in breastmilk were “negligible,” with a mean average daily infant dose (ADID) of 45.1 μg (while mothers received between 300 and 600 mg). Available blood samples of 9 infants showed 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 RM, 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, 18–20 September, Copenhagen, Denmark.

 

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Posted on 18 November 202425 November 2024