Background: Inflammatory bowel disease (IBD) is often diagnosed in women of childbearing age, which may influence therapeutic decisions in those patients. Despite several studies have suggested the safety of tumour necrosis alpha antagonists (anti-TNFα) during pregnancy, there are still concerns regarding their long-term effect, and the optimal timing for their discontinuation is not yet fully established. The aim of this study was to evaluate IBD and pregnancy-related outcomes in patients who were treated with anti-TNFα drugs, as well as their children's safety.
Methods: We conducted a retrospective review of women with IBD who received anti-TNFα therapy during pregnancy between 2004 and 2016. Clinical characteristics, disease and drugs history, pregnancy and neonatal complications and data regarding children's growth, development and medical history were collected.
Results: We analysed 22 pregnancies in 17 women: 15 with Crohn's disease (CD), 2 with ulcerative colitis (UC), mean age of 30±5 years, range 19–38 years. During gestation, 13 patients used infliximab and 9 used adalimumab; 41% of them (n=9) had concomitant treatment with azathioprine/6-mercaptopurine. Ninety-one percent of women (20/22) had inactive disease before pregnancy. Last anti-TNFα administration was performed between the 20th and the 35th week of pregnancy (median of 28 weeks gestation). The relapse rate during pregnancy and puerperal period was 14% (n=3): an UC patient and a CD patient had a flare in the 3rd and in the 1st trimester, respectively, both medically treated; a woman with CD, who had moderately active disease at conception, relapsed in the 2nd and required surgery in the 3rd trimester. Of the 22 cases, 21 were full pregnancies (one of which a twin pregnancy) and 1 is still in course. Apart from a case of twin-twin transfusion syndrome (successfully treated with good outcome) and a low-birth weight infant (in the patient who relapsed and underwent surgery), there were no other complications, including stillbirth, preterm birth or congenital anomalies. All children (n=22, from 21 full pregnancies; mean age of 62±40 months, range 1–134 months) had normal growth and the rate and severity of infections was not different from those observed in the pediatric non-IBD population.
Conclusions: In our study, the vast majority of women had inactive disease at conception and biological therapy was effective in maintaining their clinical remission. Moreover, anti-TNFα treatment was not associated with an increased risk of pregnancy/neonatal events, infectious complications or childhood development disorders. Our data reinforces that controlling the disease, either before and during gestation, may be more important to pregnancy and IBD outcomes than the administered therapy.