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

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 tap 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 (I 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. JPGN 49-183-190, 2009.