A new study on the safety of inebilizumab in women with neuromyelitis optica spectrum disorder (NMOSD) during pregnancy is now open. The observational study will monitor women who were exposed to the treatment during pregnancy or within 6 months before becoming pregnant.
The trial sponsored by Horizon Therapeutics is not yet open for recruitment but aims to recruit 60 female participants with NMOSD of all ages. It requires voluntary reporting of pregnancies.
Investigators will collect pregnancy- and pregnancy outcome-related data as well as potential confounding factors for at least 10 years. No study drug will be administered.
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The primary outcome measures will be the number of newborns with major congenital malformations, preterm birth, and low birth weight and the number of stillbirths.
Secondary outcome measures will be the number of newborns with minor congenital malformations, the number of infants with developmental milestone abnormalities and neurologic and immune system development abnormalities, the number of spontaneous abortions, and the number of induced or elective abortions.
The trial is estimated to be completed in August 2032.
Inebilizumab, marketed under the brand name Uplizna®, is a monoclonal antibody directed against CD19 that is indicated for the treatment of adults with anti-aquaporin-4 (AQP4) antibody-positive NMOSD.
The exact mechanism of action of inebilizumab is not known, but it is thought to involve binding to CD19-positive B cells, which play an important role in the immunopathogenesis of NMOSD, producing AQP4 autoantibodies that target the AQP4 protein expressed on astrocytes in the central nervous system.
Read more about inebilizumab for NMOSD
Inebilizumab was first approved by the US Food and Drug Administration (FDA) in June 2020. It is not known whether the drug can harm a fetus, and women are advised to use contraception during treatment with inebilizumab and for 6 months after the last inebilizumab infusion.
Reference
Observational safety study in women with neuromyelitis optica spectrum disorder (NMOSD) exposed to Uplizna® during pregnancy. ClinicalTrials.gov. Updated June 18, 2023. Accessed June 21, 2023.
