Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

This is a phase 4, observational, retrospective cohort study using electronic health administrative claims databases in the US
Study drug and medical condition

Name of medicine

TREMFYA

Medical condition to be studied

Psoriasis
Population studied

Age groups

Adults (18 to < 46 years)

Estimated number of subjects

100
Study design details

Main study objective

To estimate and compare the prevalence of MCM between infants born to women with PsO who were exposed to guselkumab and infants born to women with PsO who were exposed to other biologics during pregnancy, To estimate and compare the risk of a composite adverse pregnancy outcome between women with PsO exposed to guselkumab and women with PsO exposed to other biologics during pregnancy

Outcomes

Major congenital malformation AND composite adverse outcome of major congenital malformation, spontaneous abortion, stillbirth, small for gestational age, preterm birth, neonatal death combined, Spontaneous abortion, stillbirth, preterm birth, small for gestational age, neonatal death, and infant infections

Data analysis plan

Descriptive analysis will include maternal characteristics and pregnancy outcomes according to PsO treatment during pregnancy, including guselkumab, other biologics, non-biologics, photo-therapies, or topical alone. The prevalence of the adverse pregnancy outcomes will be estimated as the number of pregnancies ending with these outcomes divided by the number of completed pregnancies at-risk during the study period. A 1:5 matched sample will be constructed based on propensity score (PS) for pregnancy exposure to guselkumab versus other biologics to balance the distribution of potential confounders. The primary analysis will use logistic regression model to estimate the risk ratio of the adverse pregnancy outcomes associated with maternal exposure to guselkumab during the pre-specified at-risk time windows. For the infant outcome of hospitalized infections up to 1 year of age, a Cox regression model will be conducted.