Anifrolumab Pregnancy Registry

What is a registry and why is it important?

A pregnancy registry is a study that collects health information from women who take prescription medications when they are pregnant. Information is also collected on their newborn baby. This information is compared with women who have not taken medications during pregnancy.

You may report side effects related to AstraZeneca products.

Who is eligible to participate?

Patients may be eligible if they are:

  • A resident of the United States
  • Currently pregnant or have been pregnant in the past year and:
    • Have been diagnosed with Systemic Lupus Erythematosus and have taken SAPHNELO® (anifrolumab) during pregnancy or just prior to pregnancy
      OR
    • Have been diagnosed with Systemic Lupus Erythematosus and have taken other medications than SAPHNELO® (anifrolumab) for the treatment of Systemic Lupus Erythematosus during pregnancy or just before pregnancy

How do I enroll a patient?

If you have patients who you think may be eligible, you can help them enroll by having them:

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Complete the the Potential Participant Consent Request Form here, and a Registry team member will contact them

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Call the Registry team toll-free at 1-888-337-0045 (hours of operation: 8:30 am – 5:00 pm EST Monday – Friday).

What is SAPHNELO® (anifrolumab)?

SAPHNELO® (anifrolumab) is a prescription medication made by AstraZeneca that is used for the treatment of moderate to severe forms of Systemic Lupus Erythematosus in adults.

Systemic Lupus Erythematosus (SLE) affects women of reproductive age at a higher rate than men and pregnant women with SLE are at higher risk of experiencing adverse pregnancy outcomes (Dao 2022; Society for Maternal-Fetal Medicine 2022).

Eligible patients and their healthcare provider will provide information to the registry about their pregnancies and the health of their infants up to 1 year of age. This information can be provided by completing paper forms, via the website portal or via a short phone interview with one of the registry team members. Only information normally documented in patients´ medical records will be collected.

There will be:

  • No extra doctor’s visit or additional testing
  • No changes to patients’ medication or care

Eligible patients and their doctor will receive compensation for providing data to the Registry.

The pregnant women’s healthcare provider(s) will be asked to provide data at enrollment, approximately the end of the second trimester, and pregnancy outcome. For live-born infants, healthcare provider(s) will be asked to provide data at approximately 4 and 12 months after delivery.

The following data will be collected:

  • Maternal obstetric history
  • Maternal and paternal family history of congenital malformation
  • SLE disease and flare history
  • Baseline and ongoing pregnancy information, including pregnancy dating and prenatal test information
  • Maternal exposures during pregnancy
  • SLE - related medical conditions during pregnancy
  • Non-SLE related medical conditions during pregnancy
  • Pregnancy related medical conditions and complications
  • Pregnancy outcome information, including fetus/infant characteristics and presence of congenital malformation
  • Infant growth and developmental information

Healthcare provider(s) will be compensated when they submit data to the Registry.

Eligible patients will be asked to provide information to the Registry at enrollment and periodically throughout pregnancy:

  • At enrollment, pregnant women will be asked to provide basic demographic information (e.g., race, ethnicity, education) height and weight, and information about their history of SLE disease and SLE flares
  • At follow-up visits throughout pregnancy, pregnant women and their healthcare provider(s) will be asked to provide information about SLE-related medical conditions, non-SLE medical conditions during pregnancy, and pregnancy related conditions and complications
  • After giving birth, women and their healthcare provider(s) will be asked to provide information about their babies’ health and development up to one year of age

References

Dao KH, Bermas BL. Systemic Lupus Erythematosus Management in Pregnancy. Int J Womens Health. 2022; 14:199-211

Society for Maternal-Fetal Medicine (SMFM), Silver R, Craigo S, Porter F, Osmundson S, Norton ME. Society for Maternal-Fetal Medicine (SMFM) Consult Series #64 : Systemic Lupus Erythematosus in pregnancy [published online ahead of print, 2022 Sep 6]. Am J Obstet Gynecol. 2022;S0002-9378(22)00722-0

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