Systemic Lupus Erythematosus
Conditions
Keywords
pregnancy, anifrolumab, SLE
Brief summary
This is a non-interventional multi-database post-authorisation study to assess pregnancy-related safety data from women with SLE exposed to Anifrolumab.
Detailed description
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.
Interventions
None listed
Sponsors
AstraZeneca
IQVIA Pty Ltd
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 130 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative risk of MCM | From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births | Estimate the relative risk of MCM in live and non-live offspring from the women who had moderate/severe SLE and were exposed to anifrolumab during the first trimester of pregnancy or exposed to SOC and unexposed to anifrolumab during the first trimester of pregnancy |
| Risk of select pregnancy loss outcomes | At delivery/birth | Describe and estimate the risk of select pregnancy loss outcomes (composite of spontaneous abortion and stillbirth) in all pregnancies from women who had moderate/severe SLE and were exposed or unexposed to anifrolumab during pregnancy |
| Relative risk of select pregnancy loss outcomes | At delivery/birth | Estimate the relative risk of select pregnancy loss outcomes (composite of spontaneous abortion and stillbirth) in pregnancies from women who had moderate/severe SLE and were exposed or unexposed to anifrolumab during pregnancy |
| Risk of major congenital malformations (MCM) | From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births | Describe and estimate the risk of MCM in live and non-live offspring from the women who had moderate/severe SLE and were exposed to anifrolumab during the first trimester of pregnancy or exposed to SOC and unexposed to anifrolumab during the first trimester of pregnancy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk of adverse birth outcomes | At delivery/birth | Describe and estimate the risk of adverse birth outcomes (preterm birth, small for gestational age (SGA)) in live offspring from women who had moderate/severe SLE and were exposed or unexposed to anifrolumab during pregnancy |
| Relative risk of adverse birth outcomes | At delivery/birth | Estimate the relative risk of adverse birth outcomes (preterm birth, small for gestational age (SGA)) in live offspring from women who had moderate/severe SLE and were exposed or unexposed to anifrolumab during pregnancy |
| Risk of minor congenital malformations (mCM) | From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births | Describe and estimate the risk of mCM in live and non-live offspring from women with moderate/severe SLE who were exposed or unexposed to anifrolumab during pregnancy |
| Demographic and clinical characteristics | From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births | Describe the demographic and clinical characteristics of the live and non-live offspring and their mothers who had moderate/severe SLE and were exposed or unexposed to anifrolumab during the first trimester of pregnancy or anytime during pregnancy |
| Relative risk of mCM | From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births | Estimate the relative risk of mCM in live and non-live offspring from women who had moderate/severe SLE and were exposed or unexposed to anifrolumab during pregnancy |
| Risk of adverse pregnancy outcomes | At delivery/birth | Describe and estimate the risk of adverse pregnancy outcomes (ectopic pregnancy, spontaneous abortion, elective termination of pregnancy, stillbirth, infections requiring hospitalisation during pregnancy, emergency caesarean section) in all pregnancies from women who had moderate/severe SLE and were exposed or unexposed to anifrolumab during pregnancy |
| Relative risk of adverse pregnancy outcomes | At delivery/birth | Estimate the relative risk of adverse pregnancy outcomes (ectopic pregnancy, spontaneous abortion, elective termination of pregnancy, stillbirth, infections requiring hospitalisation during pregnancy, emergency caesarean section) in pregnancies from women who had moderate/severe SLE and were exposed or unexposed to anifrolumab during pregnancy |
Countries
United States
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed