Long-term safety of in utero exposure to anti-TNF drugs for the treatment of inflammatory bowel diseases

María ChaparroServicio de Aparato DigestivoH. U. de La Princesa

IgG transplacental transfer

Chaparro M and Gisbert JP. Current Pharmaceutical Biotechnology 2011

PIANO: a 1000 Patient Prospective Registry of Pregnancy Outcomes in Women With IBD Exposed to Immunomodulators and Biologic Therapy

AIM To determine the complication rates are higher

among women with IBD and children exposed to AZA, MP, or anti-TNF agents during pregnancy compared to women with IBD who do not take these medications

RESULTS

• Infant height, weight and developmental milestones, adjusted for disease activity, were similar among infants in all groups at 4, 9 and 12 months of age

• Significant increase in infant infections from 9 to 12 months of age in the combo therapy group relative to the unexposed group (RR =1.5)

CONCLUSIONS

• Anti-TNF and immunosuppressants was not associated with an increase in congenital anomalies, abnormal newborn growth and development or other complications

• Increase in infections from 9 to 12 m among infants exposed to a combo during pregnancy merits further investigation

• As drug should no longer be detectable in infants at 9 to 12 m, this finding may suggest dysfunctional immune development

• Infants will continue to be followed until 4 years of age

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Objective

To estimate the relative risk of severe infections in children from IBD mothers who have been exposed in utero to anti-TNFα drugs

Secondary objectives

• To compare the prevalence of malformations in children exposed in utero to anti- TNFα drugs with those without exposition

• To evaluate the relative risk of developing neoplasia in anti-TNFα exposed children

• To know the relative risk of any complication in children exposed to anti-TNF drugs

Methods

Exposed cohort: Children from mothers treated with anti-TNFα drugs

Non-exposed cohort: Children from mothers treated neither with anti-TNFα drugs nor with thiopurines

Severe infection