A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants

Study Overview
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Brief Summary
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The purpose of this retrospective observational cohort study is to assess pregnancy and infant outcomes in three groups: the first is women with ulcerative colitis (UC) who were exposed to ozanimod during pregnancy; the second is women with UC exposed to conventional therapy during pregnancy; the third is women with UC exposed to advanced therapy during pregnancy. This study will use data from a large US healthcare claims database.

Official Title
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Ozanimod Pregnancy Safety Study in Pregnant Women With Ulcerative Colitis and Their Offspring

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: Ozanimod
* Drug: Conventional therapy
* Drug: Advanced therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 49 years on date of conception Date of conception between June 1, 2021 and September 1, 2030 Continuous medical and pharmacy coverage for a minimum of 6 months prior to date of last menstrual period through the end of the pregnancy episode Diagnosis of UC during the 12 months prior to conception through the end of the first trimester Exclusion Criteria: • Pregnancies exposed to any known teratogens and the exposure falls within the period of 5 half-lives prior to the estimated date of conception through the end of the first trimester (assessed via the presence of national drug codes or medical procedure codes)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ozanimod exposed<br> | Drug: Ozanimod<br>* Women with UC exposed to ozanimod during pregnancy<br>|
| Conventional therapy exposed<br> | Drug: Conventional therapy<br>* Women with UC exposed to conventional therapy (aminosalicylates, azathioprine, or mercaptopurine) during pregnancy<br>|
| Advanced therapy exposed<br> | Drug: Advanced therapy<br>* Women with UC exposed to advanced therapy (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib, cyclosporine, or tacrolimus) during pregnancy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of major congenital malformations among infants | To estimate and compare the prevalence of major congenital malformations among infants born to pregnant women with UC who were exposed to ozanimod during first trimester relative to the prevalence among (i) infants born to women with UC exposed to conventional UC treatments and (ii) infants born to women with UC exposed to advanced UC treatment during first trimester of pregnancy. | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of spontaneous abortions |  | Up to 10 years | 
| Number of stillbirths |  | Up to 10 years | 
| Number of participants with pre-eclampsia |  | Up to 10 years | 
| Number of participants with eclampsia |  | Up to 10 years | 
| Number of preterm births |  | Up to 10 years | 
| Number of infants small for gestational age |  | Up to 10 years | 
| Number of serious or opportunistic infections in liveborn infants up to 1 year of age |  | Up to 10 years | 
| Number of infant postnatal growth deficiencies |  | Up to 10 years | 
| Number of infant developmental deficiencies |  | Up to 10 years | 
| Number of neonatal hospitalizations |  | Up to 10 years | 
| Number of infant deaths |  | Up to 10 years | 
| Number of neonatal deaths |  | Up to 10 years | 
| Number of perinatal deaths |  | Up to 10 years |