The aim of this study is to describe congenital malformations, adverse pregnancy and birth outcomes in pregnancies/offspring from women with moderate/severe SLE exposed to anifrolumab during pregnancy and to compare with outcomes in women with moderate/severe SLE who are exposed to other standard of care but not anifrolumab. Adverse outcomes related to infant growth up to one year of age will also be investigated.
Age
18–130
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
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
\- Women with moderate/severe SLE
You may not be if
\- Pregnancies whose date of conception cannot be established
Women treated with anifrolumab during pregnancy and/or 16-week period prior to LMP2
Pregnancies whose date of conception cannot be established
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
