Pregnancy Outcomes in Patients with Crohnʼs Disease Treated with Infliximab: Results from the TREATTM Registry

Abstract

Purpose: The knowledge of pregnancy outcomes in patients with Crohn's disease (CD) receiving antitumor necrosis factor therapy remains limited. Methods: TREAT is an observational registry which evaluates clinical safety outcomes in CD patients treated with infliximab (IFX) and other standards of care in North America. Pregnancy outcomes between July, 1999 and February, 2012 are reported. Results: 6,273 patients were enrolled; 3440 received IFX. At enrollment, IFX-treated patients had a disease duration of 8.4 years, had more severe disease, were more often smokers, and were using more concomitant medication(s) when compared to patients on other CD treatments. A total of 348 pregnancies have been reported in TREAT. Of these, 273 were maternal pregnancies, and 105 occurred in mothers treated with IFX. IFX-treated mothers had higher disease activity during pregnancy: 17.3% had moderate-to-severe disease, 48.0% had mild-to-moderate disease, and 34.7% were in remission, compared to 3.4%, 37.5%, and 58% of the mothers on other CD treatments, respectively. Of the IFX-treated mothers, 33.7% were on AZA/6-MP, and 26.5% were on prednisone during pregnancy, compared to 36.4% and 11.4% of the mothers in the other-treatment-only group. Through an average of 6 years of patient follow-up, 81.6% (80/98) of pregnancies with known outcome in IFX-exposed mothers and 91.0% (81/89) in other-treatments-only exposed mothers resulted in live births (p=0.064). Spontaneous abortions were reported in 16.3% of IFX-treated and 9.0% of the other-treatment-only treated mothers (p=0.134). 92.5% of IFX-exposed and 87.7% of other-treatment-only live births resulted in healthy babies with no defect or other adverse event. One (1.3%) congenital malformation (an ectrodactyly in a familial context) was reported in the IFX-exposed infants, and 3 (3.7%) (a heart murmur associated with a suspicion of cystic fibrosis, a Down's syndrome, and a cortical vision delay) in the other-treatment-only infants. Five (4.8%) IFX-exposed infants were reported to have a prolonged hospital stay, compared to 12 (11.5%) in the other-treatment-only infants. Conclusion: Data from the TREAT registry show that the clinical condition of infants born to women with prenatal exposure to IFX is comparable to those exposed to other CD treatments. A trend for a lower rate of live birth was reported among IFX-exposed mothers, as compared to mothers not exposed to IFX. The confirmation of these results and the role of potential confounding factors, such as high disease activity before or during pregnancy, smoking, and concomitant medication use, will require further study. Disclosure - Lichtenstein GR, Feagan BG, Cohen RD, Salzberg BA, and Sandborn WJ-Grant/Research Support: Janssen Research and Development, LLC; Langholff W-Employee: Janssen Research and Development, LLC; Morgan J, Nissinen R, Reddy S, Taillard F-All employees Janssen Services, LLC. This research was supported by an industry grant from Janssen Research and Development, LLC.