The Safety Assessment of Vedolizumab During Pregnancy in IBD Patient

Study Overview
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Brief Summary
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The safety assessment of Vedolizumab during pregnancy in IBD patients. The primary objective of this study is: To quantify incidence of major structural birth defects and other birth outcomes in infants born to women with UC/CD with exposure to Entyvio compared to women with exposure to other biological agents or conventional IBD therapy during pregnancy To assess the health and developmental status of infants up to 1yr of age.

Detailed Description
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The IBD MOM clinic currently follows women with IBD from the preconception stage through postpartum period. In addition, we have now started following the offspring for 1 year with an option of extending the follow up until 4 years after birth with participation of the family health center. Data is collected longitudinally on use of non-immunomodulator medications, AZA/6MP, biologic therapy infliximab, adalimumab, certolizumab, and natalizumab. Corticosteroids,5-ASA and Methotrexate), disease activity during gestation, complications of pregnancy and delivery, and infant birth outcomes during the first year of the child's life because from population-based data, including the Kaiser sample1 and studies from Europe2-4 women with IBD clearly have an increased risk of adverse pregnancy outcomes such as preterm birth and/or low birth weight infants, even with inactive disease.10. Study duration: September 2015- September 2022 This is a non-interventional observational prospective cohort study to be conducted in an actual clinical practice setting. This is an exposure-based cohort study in which there will be 3 reference groups. Women on conventional therapy only, women on Vedolizumab and women on other biologics. The source database contains information collected from our IBD MOM clinic in Shaare Zedek Medical Center in Jerusalem, Israel.

Official Title
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The Safety Assessment of Vedolizumab During Pregnancy in IBD Patient

Conditions
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Pregnancy Complications

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for the UC/CD Prospective Cohort: The subject is a currently pregnant woman with UC or CD The subject has exposure to Entyvio or other biologic agents or conventional therapy (non-biological therapy) at any dose, and at any time from first day of LMP, The subject enrolls no later than 19 completed weeks after LMP. All pregnancies in Entyvio users will be included in the study. Those recruited prior to Week 20 will be entered into the prospective registry, and those recruited after week 20 (included retrospective reports after delivery) will be entered into the separate Case Series. The subject agrees to the conditions and requirements of the study including the interview schedule, release of medical records, and the physical examination of live born infants. Exclusion Criteria for the UC/CD Prospective Cohort: The subject is >19 completed weeks gestation prior to enrollment, The subject has first contact with OTIS after prenatal diagnosis of any major structural defect, The subject has enrolled in this registry with a previous pregnancy, The subject has had an exposure to the known or suspected human teratogens: Chlorambucil Cyclophosphamide Mycophenylate mofetil Any Entyvio exposed mother who does not meet the entry criteria will be entered into an Entyvio case series, which will be used to provide support data to cohort study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vedolizumab Cohort<br>Group 1a Mothers exposed to Vedolizumab at any time during pregnancy (and up to 3 months prior to last menstrual period [LMP], if this information is available). Group 1b Infants born to Group 1a patients. | |
| Anti-TNF Agents Cohort<br>Group 2a Patients with IBD who were exposed to anti-TNFs at any time during pregnancy (and up to 3 months prior to LMP, if this information is available). Group 2b Infants born to Group 2a patients. | |
| Conventional therapy only Cohort<br>Patients with IBD who were exposed to conventional therapy only any time during pregnancy (and up to 3 months prior to LMP, if this information is available). • Group 3b Infants born to Group 3a patients. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major body measurements defects of the infant | A major Body measurements defect is defined as a defect that has either cosmetic or functional significance to the child (eg, a cleft lip), as defined by the Centers for Disease Control and Prevention (CDC; [4]). These defects in aggregate typically occur in <4% of the general population. Over 100 specific structural defects are considered to be major. Measurements of head circumference, length, weight, palpebral fissure length, inner canthal distance, ear length, and philtrum length will be taken. These will be compared to mean values for infants of the same age and sex (where sex-specific normative data are available). Less than or greater than 2 standard deviations from the mean will be used to define such terms as microcephaly, hypertelorism, etc. | 1 year from birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minor body measurements defects of the infant | A minor structural defect is defined as a defect that has neither cosmetic nor functional significance to the child (eg, complete 2,3 syndactyly of the toes) and is identified using a study-related checklist incorporated into the study dysmorphology examination of live born infants. Measurements of head circumference, length, weight, palpebral fissure length, inner canthal distance, ear length, and philtrum length will be taken. These will be compared to mean values for infants of the same age and sex (where sex-specific normative data are available). Less than or greater than 2 standard deviations from the mean will be used to define such terms as microcephaly, hypertelorism, etc. | 1 year from birth |