An upcoming study will investigate the outcomes of exposing pregnant patients with neuromyelitis optica spectrum disorder (NMOSD) to inebilizumab-cdon.
Investigators will soon initiate the recruiting process for this research. This observational study will include approximately 60 participants with NMOSD who are currently pregnant and have received treatment with inebilizumab-cdon.
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The authors will observe and report the overall safety profile and any specific sequelae of inebilizumab-cdon in women exposed to this drug during pregnancy or within 6 months of conception.
The authors aim to report the number of newborns with major congenital malformations as one of the primary outcomes. In addition, the study will assess how many newborns are born preterm and/or with a low birth weight. The last primary outcome will be the number of stillbirths associated with pregnancy exposure to inebilizumab-cdon.
Moreover, the researchers will assess the number of newborns with minor congenital malformations, neurologic abnormalities, and/or immune system development abnormalities as the secondary outcomes. The investigators will further aim to identify if an infant does not meet developmental milestones, as well as report the number of spontaneous, induced, and elective abortions. The study will monitor the presence of all outcomes for a minimum of 10 years.
Female individuals of any age with a confirmed or suspected diagnosis of NMOSD who received inebilizumab-cdon 6 months prior to and/or during pregnancy, and provided informed consent, are welcome to participate.
Inebilizumab-cdon targets the cell surface antigen CD19, which is present on both pre-B cells and mature B lymphocytes. It is currently approved for treating NMOSD in patients who are anti-aquaporin-4 (AQP-4) antibody positive.
This novel research, titled “Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to Uplizna® During Pregnancy,” will begin in June 2023 and is expected to be completed by August 2032.
Reference
Observational safety study in women with neuromyelitis optica spectrum disorder (NMOSD) exposed to Uplizna® during pregnancy. ClinicalTrials.gov. June 18, 2023. Accessed June 29, 2023.
