Transfer of monoclonal antibodies into breastmilk in neurologic and non-neurologic diseases

Abstract

ObjectiveTo review currently available data on the transfer of monoclonal antibodies (mAbs) in the breastmilk of women receiving treatment for neurologic and non-neurologic diseases.MethodsWe systematically searched the medical literature for studies referring to 19 selected mAb therapies frequently used in neurologic conditions and “breastmilk,” “breast milk,” “breastfeeding,” or “lactation.” From an initial list of 288 unique references, 29 distinct full-text studies met the eligibility criteria. One additional study was added after the literature search based on expert knowledge of an additional article. These 30 studies were reviewed. These assessed the presence of our selected mAbs in human breastmilk in samples collected from a total of 155 individual women.ResultsDrug concentrations were typically low in breastmilk and tended to peak within 48 hours, although maximum levels could occur up to 14 days from infusion. Most studies did not evaluate the breastmilk to maternal serum drug concentration ratio, but in those evaluating this, the highest ratio was 1:20 for infliximab. Relative infant dose, a metric comparing the infant with maternal drug dose (<10% is generally considered safe), was evaluated for certolizumab (<1%), rituximab (<1%), and natalizumab (maximum of 5.3%; cumulative effects of monthly dosing are anticipated). Importantly, a total of 368 infants were followed for ≥6 months after exposure to breastmilk of mothers treated with mAbs; none experienced reported developmental delay or serious infections.ConclusionsThe current data are reassuring for low mAb drug transfer to breastmilk, but further studies are needed, including of longer-term effects on infant immunity and childhood development.

Anti-CD20 therapies and pregnancy in neuroimmunologic disorders

“…Recent publications deliver reassurance for the use of mAbs during breastfeeding in neuroimmunologic diseases. 35 The amount of RTX in the breast milk was shown to be minimal. Data on OCR transfer are not available yet but can be anticipated to be very low.…”

Susac syndrome and pregnancy: a review of published cases and considerations for patient management

“…During lactation, current data for administration of NAT are limited, but reassuring. 63,67,69 In conclusion, the mechanism of action of NAT and clinical experience suggest that this agent may be of interest in SuS patients. Acetyl salicylic acid.…”

“Time to recharge”

“…In addition to these studies, the July issue of Neurology: Neuroimmunology & Neuroinflammation contains a review on the current knowledge of the transfer of monoclonal antibodies into breastmilk that complements nicely the study of Ciplea et al and 2 clinical/scientific notes describing COVID-19 infection concurrent with Guillain-Barré syndrome and MS. [5][6][7] I hope that these and all the other interesting articles in this issue will catch your attention.…”