Safe Use of Infliximab for the Treatment of

Experience in pregnant women ex-posed to TNF alpha antagonists is stilllimited. However, according to FDAclassification, infliximab, a chimericmonoclonal antibody antiTNF alpha, isconsidered a pregnancy categoryB drug(“no documented human toxicity”).We report the case of a womanwho inadvertently received infliximabfor the treatment of fistulizing CDwithin 3 months of conception.A 31-year-old woman with colonicCD was referred to our GastroenterologyUnit in July 2004 on account of an ano- vaginal fistuladraining mucopurulent ma-terial. CD had been diagnosed in May2002 according to standard endoscopic,radiologic, and histologic criteria. In July2002, for the development of an anovagi-nal fistula (2.5 cm from the anal verge),treatment with antibiotic (ciprofloxacin 1g/day and metronidazole 750 mg/day) andimmunosuppressive ( azathioprine2mg/kg per day) drugs was started withpartial closure of the fistula. In July 2004,for the reopening of the fistula and for amoderate relapse of intestinal symptoms( Crohn’s Disease Activity Index[CDAI]260), she received infliximabinfusions (5mg/kg) at weeks 0 and 2. Each infusionwas preceded by premedicationwith hy-drocortisone 100 mg iv.Three weeks after the second inflix-imab infusion, the patient was found to bepregnant in the 6th gestational week, andshe decided to allow the pregnancy eventhough she was informed about the ab-sence at that time, of well-known data onthe safety of infliximabin pregnancy aswell as on fetal outcomes. At the same