An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis

Pregnancy Outcomes Study of Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis

This study is to assess infant outcomes of women with AD who were exposed to ruxolitinib cream during pregnancy compared with a control cohort of women with AD who were exposed to a topical corticosteroid (TCS) during pregnancy.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Related; Atopic Dermatitis
• Intervention / Treatment: Drug: Ruxolitinib Cream; Drug: TCS

• Study Type: Observational
• Enrollment (Estimated): 5621

Contacts and Locations

• Study Contact: Name: Incyte Corporation Call Center (US); Phone Number: 1.855.463.3463; Email: medinfo@incyte.com

Study Locations

• United States
  • North Carolina
    • Morrisville, North Carolina, United States, 27560
      • Recruiting
      • Syneos Health (remote site)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Exposure cohort study of women within the US with atopic dermatitis (AD) who were exposed to ruxolitinib cream at any time during their pregnancy period.

Description

Inclusion Criteria:

• Women aged 14 years or older at pregnancy outcome.
• Pregnancy following FDA approval of ruxolitinib cream for AD on 21 SEP 2021.
• At least 1 pharmacy-dispensing claim for ruxolitinib cream (ruxolitinib-exposed cohort) or a TCS (TCS-exposed cohort).
• A diagnosis of AD prior to or on the day of the first pharmacy claim for ruxolitinib cream (ruxolitinib-exposed cohort) or a TCS (TCS-exposed cohort) from 6 months before the estimated date of conception.
• Continuous enrollment in the database from 6 months before the estimated date of conception through the end of pregnancy.
• For infant outcomes only, linkage of mother and infant data will be required (ie, pregnancies that cannot be linked to an infant will be excluded for infant outcomes but not for pregnancy outcomes). Infants will be followed for as long as they are continuously enrolled in the database up to 1 year after birth (ie, variable follow-up for each infant). A 1-year fixed period of continuous enrollment after birth will not be imposed so as not to introduce survival bias.

Exclusion Criteria:

• One or more pharmacy claims for oral ruxolitinib or other JAK inhibitors in the exposure window for a given outcome.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Infants of women with AD exposed to ruxolitinib cream during pregnancy	Drug: Ruxolitinib Cream; Ruxolitinib Cream; Other Names: Opzelura
Infants of women with AD exposed to a TCS prior to or during pregnancy	Drug: TCS; Topical corticosteroid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of major congenital malformation (MCM)s	Defined as any major structural or chromosomal defect in live-born infants, stillbirths or spontaneous losses equal to or greater than 20 weeks' gestation, or electively terminated pregnancies of any gestational age.	Up to 12 months after birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Pregnancy outcomes	Number of live births, still births, recognized spontaneous abortions and number of elective terminations as defined in the protocol.	Up to birth
Number of small-for-gestational age (SGA) births	Defined as a birthweight at or below the 10th percentile for a given gestational age.	At time of delivery

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Incyte Medical Monitor, Incyte Corporation

Publications and helpful links

Helpful Links

• An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2023
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): August 15, 2028

Study Registration Dates

• First Submitted: October 2, 2024
• First Submitted That Met QC Criteria: October 2, 2024
• First Posted (Actual): October 4, 2024

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: eczema; topical therapy; pruritus; Atopic Dermatitis; JAK inhibitor; ruxolitinib
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Skin Manifestations; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Dermatitis, Atopic; Eczema; Pruritus; ruxolitinib
• Other Study ID Numbers: INCB18424-MA-IAI-403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No