Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users

An anomaly or abnormality of body structure that is present at birth, is of prenatal origin (i.e., birth defect), poses no significant health problem in the neonatal period, and tends to have limited social or cosmetic consequences for the affected individual. Relevant exposure window includes any trimester of pregnancy.

Any increase in disease activity or severity in the pregnancy period compared to the baseline period (6 months prior to pregnancy) as assessed by the disease flare or disease activity algorithms or as reported by an HCP. Relevant exposure window includes any trimester of pregnancy.

A disorder of pregnancy defined as rupture of membranes before the onset of labor. Relevant exposure window includes any trimester of pregnancy.

A disorder of pregnancy defined as a systolic blood pressure 140 mmHg or more or a diastolic blood pressure of 90 mmHg or more, or both, on 2 occasions at least 4 hours apart after 20 weeks gestation, in a woman with a previously normal blood pressure. Relevant exposure window includes any trimester of pregnancy.

Preeclampsia is a disorder of pregnancy associated with new-onset hypertension, which occurs most often after 20 weeks of gestation and frequently near term, and proteinuria. Or, in the absence of proteinuria, it is defined as new-onset hypertension with the new onset of any of the following:

• Thrombocytopenia: platelet count less <100 ,000/mL
• Renal insufficiency: serum creatinine concentrations >1.1mg/dL or a doubling of the serum creatinine concentration in the absence of other renal disease
• Impaired liver function: elevated blood concentrations of liver transaminases to twice normal concentration
• Pulmonary edema
• New-onset headache unresponsive to medication and not accounted for by alternative diagnoses or visual symptoms.

Eclampsia is new-onset tonic-clonic, focal, or multifocal seizures in the absence of other causative conditions such as epilepsy, cerebral arterial ischemia and infarction, intracranial hemorrhage, or drug use.

An inpatient hospital admission unrelated to delivery occurring during pregnancy. Relevant exposure window includes any trimester of pregnancy.

An involuntary fetal loss or the expulsion of the products of conception occurring at <20 gestational weeks.

An intervention that is intended to terminate a suspected or known ongoing intrauterine pregnancy and that does not result in a live birth. Relevant exposure window includes any trimester of pregnancy.

A cesarean delivery that is performed due an immediate threat to the health or safety of the fetus and/or the mother. Relevant exposure window includes any trimester of pregnancy.

A live birth occurring at <37 gestational weeks.

Birthweight <10th percentile for sex and gestational age using standard growth charts for full and preterm live-born infants. Relevant exposure window includes any trimester of pregnancy.

Weight, length, or head circumference in <10th percentile for sex and chronological age using standard growth charts. Relevant exposure window includes any trimester of pregnancy.

Failure to achieve the developmental milestones for chronological age, as defined by the CDC. Relevant exposure window includes any trimester of pregnancy.

An inpatient hospital admission occurring in the first year of life. Relevant exposure window includes any trimester of pregnancy.

An infection that occurs within an infant's first year of life and is either opportunistic (i.e., occurs more often or is more severe in people with weakened immune systems than in people with healthy immune systems) or serious (i.e., results in significant disability, incapacity, or death; is life-threatening; requires inpatient or prolonged hospitalization; or is considered medically important). Relevant exposure window includes any trimester of pregnancy.