Journal of Gynecology Obstetrics and Human Reproduction
Case ReportNeonatal pancytopenia in a child, born after maternal exposure to natalizumab throughout pregnancyPancytopénie néonatale chez une enfant née après une exposition maternelle au natalizumab durant toute la grossesse
Introduction
Natalizumab (NTZ) is a monoclonal antibody indicated for the treatment of second line in patients with recurrent relapsing-remitting multiple sclerosis (RRMS).
According to the recommendations of good practice, its use is theoretically prohibited during the pregnancy, the product being classified as C by the Food Drug Administration [1]. However, prolonged exposure during pregnancy, particularly as a result of persistent disease, are possible [2], [3], [4], [5], [6].
Section snippets
Observation
The case of a 27-year-old Caucasian woman is reported, with exposure to NTZ throughout pregnancy. The patient was followed for a 7-year RRMS with an active form of the disease, marked by medullary relapses. After the birth of her second child, she presented a vestibular relapse with an aggravation of the MRI parameters. She accepted a treatment with NTZ, which began on April 29, 2014. Despite medical recommendations for effective contraception, the patient began a third pregnancy, after 3
Discussion
Despite recommendations of good practice, exposures throughout pregnancy of the third trimester, due to an intense activity of the disease are possible and begin to be reported [2], [3], [4], [5], [6]. These decisions may be specific to patients: they can decide not to inform their neurologist of their pregnancy status as [4]; these decisions may follow a reflection between the neurologist and his patient during a “benefit–risk” reflection [5], [6]. As much as there are safety arguments for
Conclusion
During prolonged exposure to NTZ throughout the pregnancy or during its prescription during the 3rd trimester, it is necessary to remain attentive to a possible haematological risk for the newborn. This requires good coordination between the neurologist and the gynaecological or paediatric team. This observation also advocates the need to strengthen the registry of pregnancies exposed to NTZ with monitoring of the biological blood data of these newborns. One question that can be asked is the
Disclosure of interest
The authors declare that they have no competing interest.
References (10)
- et al.
Natalizumab throughout pregnancy: risk of low platelet count in the newborn at delivery
Rev Neurol
(2016) - et al.
Evaluation of pregnancy outcomes from the TYSABRI® (natalizumab) pregnancy exposure registry. AAN annual meeting (abstract)
Neurology
(2013) - et al.
Natalizumab use during the third trimester of pregnancy
JAMA Neurol
(2014) - et al.
How safe is natalizumab during pregnancy?
MSJ
(2015) - et al.
Delivery of healthy babies after natalizumab use for multiple sclerosis: a report for two cases
Acta Neurol Scand
(2011)
Cited by (12)
Severe thrombocytopenia during Natalizumab therapy: A case report
2020, Journal of the Neurological SciencesNatalizumab exposure during pregnancy in multiple sclerosis: a systematic review
2019, Journal of the Neurological SciencesCitation Excerpt :An additional 2 studies were identified through citation searching. Finally, 17 studies were included [6–22]. Mean gestational ages at the time of enrollment were 12.5 weeks in Ebrahimi et al. and 11.8 weeks in Friend et al.; mean gestational age was not clear in Portaccio et al.
The use and impact of monoclonal antibody biologics during pregnancy
2021, CMAJCitation Excerpt :A variety of infections, mostly uncomplicated and self-limited, have also been reported in small case series of infants exposed to monoclonal antibody biologics, although infections requiring hospitalizations are rare.76-78 Severe cytopenias (e.g., neutropenia, lymphopenia and anemia) at birth have been reported in infants exposed to natalizumab,48,79 rituximab80 and, on rare occasions, infliximab.81 In some cases, screening of exposed infants with a complete blood count may be considered.
The Risks and Benefits of Monoclonal Antibody Therapy during Pregnancy and Postpartum: Maternal, Obstetric, and Neonatal Considerations
2023, Obstetrical and Gynecological SurveyExpected impact of immunomodulatory agents during pregnancy: A newborn's perspective
2023, Pediatric Allergy and ImmunologyNatalizumab treatment during pregnancy in multiple sclerosis—clinical and bioethical aspects of an ongoing debate
2022, Wiener Medizinische Wochenschrift