ObjectivesTo evaluate the efficacy and toxicity of infliximab in children with severe Crohn disease (CD), the authors prospectively monitored 21 children aged 15 ± 2 years with severe CD who they treated with infliximab (5 mg/kg) on days 0, 15, and 45. One patient received only one injection. Eighteen patients were corticosteroid dependent, and 6 were receiving parenteral nutrition. Three patients were corticoid resistant (1 mg/kg/d >15 days). Sixteen had perianal disease.ResultsThe Harvey-Bradshaw index (HB) decreased from 8 ± 3 on day 0 to 1 ± 2 on day 45 (P= 0.001). The inflammation factors decreased (P= 0.001), and albumin increased (P= 0.002). Nineteen children were in complete remission (HB < 4) on day 45, and 2 had improved (HB = −6 points). Tumor necrosis factor-&agr; (TNF&agr;) in the stools (n = 16) decreased (P= 0.04). All perianal fistulas (n = 12) were closed by day 90. Fourteen of 21 patients had stopped taking steroids at 3 months, and all had stopped parenteral nutrition. Growth velocity was significantly greater after infliximab administration (Z score, +0.5) than before (−0.45;P= 0.004). Nineteen of 21 patients had relapsed (90%) at 1 year despite continued immunosuppressors. Seven had surgery because of an uncontrolled relapse (5), stenosis (1), or fistula (1). Six patients developed antinuclear antibodies (1/40–1/640e), and two had anti-DNA antibodies. Epstein-Barr virus (EBV) polymerase chain reaction (PCR) values increased (>100-fold) in eight patients. One child developed an anaphylactic reaction to the medication, and one had a catheter-related sepsis.ConclusionInfliximab produces spectacular results for children with severe CD and is well tolerated. However, its effect is transitory for many (90%), with frequent relapses despite continued immunosuppressors. Long-term management with infliximab should be tested despite its worrying side effects.