Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users

Launched by ASTRAZENECA · Sep 10, 2024

Keywords

ClinConnect Summary

The PRIMULA Lac trial is a research study looking at how the medication anifrolumab affects mothers with systemic lupus erythematosus (SLE), their infants, and breastfeeding. This study aims to gather important information about whether anifrolumab, which is used to treat SLE, is present in breast milk and blood samples from both mothers and their babies. The goal is to ensure that using this medication while breastfeeding is safe for both the mother and the child.

To participate in this study, mothers must be at least 18 years old, have a diagnosis of moderate to severe lupus, and be currently receiving anifrolumab treatment. They should also be actively breastfeeding or pumping milk for their baby, who should be at least 32 weeks old and in good health. Participants will need to regularly pump or breastfeed during the study period and will have some milk samples collected on a specific day after receiving their medication. It’s important for mothers to know that they should not be using any other similar medications or have certain medical conditions that could affect the study results. This trial is currently recruiting participants and aims to provide valuable insights into the safety of anifrolumab for breastfeeding mothers and their babies.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• Maternal:
• • 1. 18 years or older
• • 2. Signed informed consent to participate
• • 3. Diagnosis of moderate/severe SLE
• • 4. Ongoing treatment with anifrolumab
• • 5. 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
• • 6. 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)
• • 7. 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.
• • 8. Plans to continue feeding infant breast milk at least throughout the duration of the study and is not weaning
• • 9. 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
• • 10. Agrees to use only lanolin nipple cream during the sampling period
• Infant:
• • 1. Gestational age at delivery ≥32 weeks
• • 2. Birthweight \> 10th percentile
• • 3. Weight \> 10th percentile at the time of enrollment
• Exclusion Criteria:
• Maternal:
• • 1. Received any investigational compound or approved biologic or biosimilar within 30 days or 5 half-lives (whichever is longer) prior to enrollment in the study
• • 2. Diagnosis of lupus nephritis in the last 12 months5
• • 3. History of breast implants, breast augmentation, or breast reduction surgery that significantly impacts breastfeeding or collection of milk from 1 or both breasts
• • 4. History of malignancy in the last 10 years
• • 5. History of mastectomy
• • 6. Evidence of mastitis or any other significant active infection at Day 1 (pre-dose)
• Infant:
• • 1. Any abnormality noted or clinically significant medical condition, including cardiac, pulmonary, and liver disease, glucose instability, or active infection at the time of screening that, in the opinion of the investigator, may make implementation of the protocol or interpretation of the trial difficult or would put the infant participant at risk by participating in the study