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
Study drug and medical condition

Medical condition to be studied

Dermatitis atopic
Population studied

Age groups

Adolescents (12 to < 18 years)
Adults (18 to < 46 years)

Special population of interest

Pregnant women

Estimated number of subjects

400
Study design details

Main study objective

The CIBINQO™ Pregnancy Registry will add to the current body of knowledge regarding the safety of CIBINQO exposure during pregnancy. This prospective, registry-based, observational cohort study will be conducted to provide information on maternal, fetal, and infant outcomes following exposure to CIBINQO during pregnancy in the post-approval setting.

Outcomes

To estimate the crude proportion of maternal, fetal, and infant outcomes of women with moderate-to-severe atopic dermatitis who are exposed to CIBINQO during pregnancy and women with moderate-to-severe atopic dermatitis who are unexposed to CIBINQO during pregnancy. To compare the proportion of maternal, fetal, and infant outcomes between women with moderate-to-severe atopic dermatitis who are exposed to CIBINQO during pregnancy and women with moderate-to-severe atopic dermatitis who are unexposed to CIBINQO during pregnancy, if sample size permits.

Data analysis plan

Demographic and baseline characteristics will be summarized with descriptive statistics for each cohort. For each continuous variable, the number of observations, median, mean, standard deviation, minimum, and maximum for each cohort will be reported. For each categorical variable, the frequency and percentage in each category by cohort will be reported. For each exposure group, the proportion of participants with the outcomes of interest will be calculated. If sample size permits, the proportion of outcomes will be compared between treatment groups.