PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users): The AstraZeneca Pregnancy Study for Anifrolumab
PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users) is a prospective, observational cohort study designed to evaluate the association between anifrolumab exposure during pregnancy and subsequent adverse maternal, fetal, and infant outcomes. This study will fulfil an FDA post-marketing requirement.
⁃ Exposed cohort
• Currently or recently (within 1 year of pregnancy outcome) pregnant
• Diagnosis of moderate/severe SLE
• Consent to participate
• Authorization for their HCP(s) to provide data to the registry
• Exposure to at least 1 dose of anifrolumab at any time during pregnancy
⁃ Unexposed cohort
• Currently or recently pregnant
• Diagnosis of moderate/severe SLE
• Consent to participate
• Authorization for their HCP(s) to provide data to the registry
• Exposure to other products for the treatment of moderate/severe SLE