Study type

Study type

Non-interventional study
Non-interventional study

Non-interventional study design

Other
Study drug and medical condition

Name of medicine

Otezla

Study drug International non-proprietary name (INN) or common name

APREMILAST

Anatomical Therapeutic Chemical (ATC) code

(L04AA32) apremilast
Population studied

Age groups

Preterm newborn infants (0 – 27 days)
Term newborn infants (0 – 27 days)
Infants and toddlers (28 days – 23 months)

Special population of interest

Pregnant women

Estimated number of subjects

350
Study design details

Main study objective

Among women exposed to Otezla during pregnancy, the main objective of the study is to estimate the proportion of pregnancy and maternal complications, adverse events in the developing fetuses and neonates, and among their infants, adverse events during the first year of life.

Outcomes

Number of cases reporting pregnancy and maternal complications, live full-term births, spontaneous abortion, elective abortion, stillbirth, and premature delivery.
Infant Outcomes: Number of cases reporting adverse events including complications, medical problems or congenital anomalies at birth and adverse events at 6 months and 12 months of age.

Data analysis plan

All analyses will be descriptive. Analysis will include the exposed cases overall, and, where possible, group cases by whether outcomes were known when the exposure was reported (retrospectively) or whether the exposure was reported prior to occurrence of outcomes (prospectively). Pregnancy and infant outcomes will be summarized overall and separately for cases identified retrospectively and prospectively. These data constitute a case series, thus line listings of pregnancy and maternal complications, pregnancy outcomes, infant outcomes and adverse events will be summarized along with tabulations of the numbers and proportions of outcomes based on timing of exposure (first, second, or third trimester), and indication for use of the medication.