Anifrolumab Pregnancy Study

Launched by ASTRAZENECA · Jun 25, 2025

Keywords

ClinConnect Summary

This study is looking at the safety of a medicine called Anifrolumab in women with Systemic Lupus Erythematosus (SLE) who become pregnant. SLE is a condition where the immune system attacks the body’s own tissues, and Anifrolumab is a treatment used to help manage it. This study will use existing health records to compare pregnancy outcomes in women with SLE who took Anifrolumab during or just before pregnancy to those who did not take the medicine, to better understand any risks or effects on mothers and babies.

Women who might take part are those who have been diagnosed with moderate to severe SLE before getting pregnant and have been regularly followed in a healthcare database for at least a year before pregnancy. Participants will be grouped into those who used Anifrolumab during pregnancy or within about four months before pregnancy, and those who did not use it but were treated with other standard lupus medicines. The study does not involve any new treatments or visits, as it only looks at existing medical records. This means participants won’t need to do anything extra, but their information will help doctors learn more about how safe Anifrolumab is during pregnancy.

Gender

FEMALE

Eligibility criteria

• Inclusion criteria for EXPOSED SOURCE POPULATION:
• • Women with a continuous enrolment in the database for ≥ 12 months prior to LMP2
• • Women diagnosed with SLE before pregnancy
• • Women exposed to anifrolumab (polytherapy, added to SLE SOC) during pregnancy and/or 16-week period prior to LMP2
• Exclusion criteria for EXPOSED SOURCE POPULATION:
• • - Pregnancies whose date of conception cannot be established
• Inclusion criteria for UNEXPOSED SOURCE POPULATION:
• • Women with a continuous enrolment in the database for ≥ 12 months prior to LMP2
• • Women diagnosed with SLE before pregnancy
• • Women treated with SLE SOC during pregnancy
• Exclusion criteria for UNEXPOSED SOURCE POPULATION:
• • Women treated with anifrolumab during pregnancy and/or 16-week period prior to LMP2
• • Pregnancies whose date of conception cannot be established
• Inclusion criteria for EXPOSED and UNEXPOSED STUDY POPULATION:
• • - Women with moderate/severe SLE
• Exclusion criteria for EXPOSED and UNEXPOSED STUDY POPULATION:
• • Women with a history of CM or chromosomal abnormalities (according to available records), before delivery
• • Women prescribed a confirmed teratogenic drug prior to LMP2 with a time period of 5-half-lives of relevant drug or during pregnancy