Live vaccine counseling is critical for newborns of IBD patients on immunosuppressive therapy

Abstract

Introduction: The introduction of immunosuppressive therapy for the treatmentof inflammatory bowel disease (IBD) has led to improved disease control.As new data continues to support the safety of immunosuppressive therapy duringpregnancy, more women with IBD will become pregnant while maintainedon thiopurines and TNF-a inhibitors. However, immunosuppressants can cross theplacenta and serum drug levels have been found in newborns for up to sixmonths. A recently reported live vaccine related fatality in a newborn of an IBDmother on immunosuppressants emphasizes the danger of administering livevaccines, including rotavirus, in these newborns. This retrospective study evaluatedgastroenterologists' counseling of pregnant IBD women on immunosuppressantsabout newborn vaccination. Methods: Medical records for all female IBD patients on immunosuppressive therapywhile pregnant or breast-feeding at an urban university medical center werereviewed. There were no exclusion criteria. Patient age, race, medication regimen, diagnosis, and treatment course were recorded. Electronic medical records werereviewed for documented discussions regarding consequences of immunosuppressivetherapy during pregnancy and counseling about newborn vaccinations. A databasemaintaining patient confidentiality was created using Microsoft Excel. Statisticalanalysis was performed using Fisher Exact test with significance set at P < 0.05. Results: Records of 7 IBD patients on immunosuppressive therapy during pregnancywere evaluated. The mean age was 32.3 years (range 22 - 36 years). There was 1 AfricanAmerican, 4 Caucasian, and 2 patients of unknown race. Six were diagnosed withCrohn's disease and 1 with ulcerative colitis. Five patients were on 6-MP, 1 infliximab, and 1 adalimumab. Four patients (57.14%) had documented discussions with their physicianregarding adverse pregnancy outcomes related to immunosuppressive agents.There was no statistically significant difference in the rate of such discussion based ondiagnosis (p=1.0), drug regimen (p=0.58), or race (p=1.0). There were no documenteddiscussions about the risk of administering live vaccines to newborns. Conclusion: The crossover immunosuppressive effects of pregnant IBD patientscreates a potential risk of live vaccine administration in their newborns, a matterwhere the risk-benefits should be appropriately weighed. This study revealed thatthere was inconsistent counseling of pregnant women by gastroenterologistsabout immunosuppressant risks during pregnancy. Additionally, there were nodocumented discussions about the potential risks of live vaccinations in newborns.The clear risk and recently reported newborn fatality following administrationof a live vaccine makes it imperative that specific discussions occur aboutnewborn immunizations. While this study is limited by small sample size, singleinstitution, and retrospective design, it demonstrates the need for improved communicationregarding maternal immunosuppressive therapy and possible vaccinationconcerns for the newborn infants of IBD mothers.