This study will utilize a prospective, observational, exposure cohort design to examine pregnancy and infant outcomes in women and infants who are exposed to tildrakizumab during pregnancy to treat an approved indication.
The pregnancy registry cohort study will be conducted by the Organization of Teratology Information Specialists (OTIS), which is a network of university and health department based information centers serving pregnant women and healthcare providers throughout North America. These services provide a basis for collaborative research such as this Registry.
These Services located throughout the United States (US) and Canada will serve as a source of referrals not only for tildrakizumab-exposed pregnancies but also for similarly ascertained disease-matched comparison pregnant women who have not used tildrakizumab in pregnancy.
The target follow-up period will be until end of pregnancy and 1 year of age for live born infants.
Pregnant women
Exposure to tildrakizumab for the treatment of an approved indication, for any number of days, at any dose, and at any time from the first day of the last menstrual period up to and including the end of pregnancy
Agree to the conditions and requirements of the study including the interview schedule, and release of medical records
Pregnant women
Women who have first contact with the project after prenatal diagnosis of any major structural defect
Women who have enrolled in the tildrakizumab cohort study with a previous pregnancy (women may only enroll once in the Tildrakizumab Pregnancy Study)
Women who have used tildrakizumab for an indication other than a currently approved indication
Retrospective enrollment after the outcome of pregnancy is known
Pregnant women diagnosed with tildrakizumab-approved indication with and without tildrakizumab
Cohort
Prospective
Pregnant women exposed to tildrakizumab
DrugSubjects exposure to tildrakizumab for the treatment of an approved indication, for any number of days, at any dose, and at any time from the first day of the last menstrual period (LMP) up to and including the end of pregnancy
Pregnant women not exposed to tildrakizumab
DrugSubjects diagnosed with a tildrakizumab-approved indication; frequency matched to the exposed group by disease indication, with the indication validated by medical records when possible, and Subjects with no exposure to tildrakizumab at any time in the current pregnancy; may or may not have taken another medication for their disease in the current pregnancy
Major structural defects in children
defined and classified using the US Centers for Disease Control and Prevention (CDC) coding manual that is used for the Metropolitan Atlanta Congenital Defects Program (MACDP) classification of major structural defects
Spontaneous abortion/miscarriage
defined as non-deliberate fetal death that occurs prior to 20.0 weeks post-last menstrual period
Stillbirth
defined as non-deliberate fetal death anytime in gestation at or after 20.0 weeks post-last menstrual period
Elective termination/abortion
defined as deliberate discontinuation of pregnancy through medication or surgical procedures
neonatal/infant death
defined as any death in a live born infant during the first 6 months of age
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