PRIMULA Lac (Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users): The AstraZeneca Lactation Study for Anifrolumab
Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users (PRIMULA Lac) is a Post Marketing Requirements (PMR) study designed to fulfill the FDA post-marketing requirements. The study will collect data about the presence of anifrolumab in human breast milk and serum (maternal and infant) among lactating individuals who receive anifrolumab therapeutically.
‣ Maternal:
• 18 years or older
• Signed informed consent to participate
• Diagnosis of moderate/severe SLE
• Ongoing treatment with anifrolumab
• Has reached or will reach steady state (\
‣ 85 days postpartum, at least 3 consecutive previous doses during the post-partum period) with anifrolumab by the time of study Day 1 (pre-dose milk collection)1
• Established lactation in the index post-partum period (breastfeeding or pumping for at least 4 weeks at time of Day 1 visit to ensure mature milk production)
• Willing to breastfeed or pump regularly during the study period to maintain milk supply and exclusively pump breast milk for the 24-hour period of breast milk collection on Day 1 post IV dose.
• Plans to continue feeding infant breast milk at least throughout the duration of the study and is not weaning
• Must be exclusively breast milk-feeding their infant (or if not exclusively breast milk-feeding, not providing more than 1 supplemental bottle of formula per day) at the time of enrollment and throughout the study period
⁃ Agrees to use only lanolin nipple cream during the sampling period
‣ Infant:
• Gestational age at delivery ≥32 weeks
• Birthweight \> 10th percentile
• Weight \> 10th percentile at the time of enrollment