Skip Navigation LinksHome > August 2009 - Volume 49 - Issue 2 > Infliximab Therapy in Children With Concurrent Perianal Croh...
Journal of Pediatric Gastroenterology & Nutrition:
doi: 10.1097/MPG.0b013e3181a70f21
Original Articles: Gastroenterology

Infliximab Therapy in Children With Concurrent Perianal Crohn Disease: Observations From REACH

Crandall, Wallace*; Hyams, Jeffrey; Kugathasan, Subra; Griffiths, Anne§; Zrubek, Julie||; Olson, Allan; Liu, Grace##; Heuschkel, Robert#; Markowitz, James**; Cohen, Stanley††; Winter, Harland‡‡; Veereman-Wauters, Gigi§§; Ferry, George||||; Baldassano, Robert N¶¶

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Abstract

Objective: Post hoc analyses evaluated the effect of infliximab upon concurrent perianal Crohn disease (CD) in a subpopulation of 31 patients from REACH, a randomized trial of 112 children with moderately to severely active luminal CD.

Materials and Methods: The Pediatric Crohn Disease Activity Index perirectal subscore was used to assess perianal symptom activity and therapeutic response. Patients with no symptoms or asymptomatic tags received a score of 0; those with “1–2 indolent fistula, scant drainage, no tenderness” received a score of 5; and those with “active fistula, drainage, tenderness or abscess” received a score of 10. Initial perirectal subscores of 10 or 5 decreasing to 0 were considered complete response. Subscores of 10 decreasing to 5 were considered partial response. All patients were followed for efficacy and safety through week 54.

Results: Twenty-two patients with baseline perianal disease were randomized at week 10 following a 3-dose infliximab induction regimen. At week 2, 40.9% (9/22) of patients with signs and symptoms of perianal disease at baseline attained response (4 partial and 5 complete). At week 54, 72.7% (16/22) of patients with signs and symptoms of perianal disease attained response (1 partial and 15 complete). Nine patients developed perianal signs and symptoms during treatment; 7 had complete response and 2 had no response at week 54. The incidence of adverse events for patients with perianal symptoms at baseline and for those in the overall REACH population was similar (95.7% vs 94.6%).

Conclusions: Infliximab rapidly reduced concurrent perianal disease signs and symptoms in this REACH cohort.

© 2009 Lippincott Williams & Wilkins, Inc.

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