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INFLIXIMAB MAINTENANCE THERAPY IN PEDIATRIC CROHN’S DISEASE: THE IMPACT OF DISCONTINUATION OF CONCOMITANT IMMUNOMODULATION
M Sherlock, EI Benchimol, T Walters, D Turner, M Zachos, AM Griffiths
The Hospital for Sick Children, Toronto, Ontario
BACKGROUND/AIMS: Clinical trial data indicates that regularly scheduled infliximab is associated with a low rate of infliximab antibody formation, and that concomitant immunomodulation dose not significantly enhance efficacy. In light of these data and the recent observation of hepatosplenic T-cell lymphoma (HSTCL) in young patients with Crohn’s Disease receiving dual therapy, infliximab monotherapy has become common. We reviewed one year outcome following immunomodulator (IM) discontinuation.
METHODS: In May 2006, all patients receiving infliximab plus IM therapy were systematically counseled regarding the occurrences of HSTCL and were informed that the causative role for azathioprine (Aza) or infliximab alone or in combination was unclear. Following discussion, patients and families decided upon subsequent therapy: monotherapy with infliximab or Aza alone, or continued dual therapy. Data concerning disease activity (PCDAI) , infliximab antibody formation, infusion reactions and loss of response were recorded at one year and compared to the preceding year
RESULTS: 28 patients, mean age 11.6 ± 2.5 years, 16 male, 12 female had received infliximab maintenance therapy for a median of 1.69 years in combination with Aza (n=20) or Methotrexate (MTX, n=7). 25 (89%) discontinued IM therapy; 1 remained on dual therapy with MTX; 2 discontinued infliximab. At one year follow up, 15/26 (58%) patients were in remission (PCDAI <= 10). The median infliximab dose while on IM therapy was 6.5mg/kg every 8 weeks. One year after discontinuing IM therapy the median dose was 6.9mg/kg every 7 weeks. Seven (26.9%) children developed infliximab antibodies which was associated with a loss of response in 6 patients. 5/26 patients had discontinued infliximab by 12 months of follow-up, 1 due to excellent clinical status and 4 because of loss of response. Drug reactions were uncommon.
CONCLUSION: Families wish to continue infliximab despite rare but potential serious side-effects. Clinical remission rates following 12 months of infliximab monotherapy are similar to published randomised controlled trial data of children receiving concomitant immunomodulation and infliximab.