| Title | Infliximab Therapy in Children With Concurrent Perianal Crohn Disease: Observations From REACH. | | Author(s) | Crandall W, Hyams J, Kugathasan S, Griffiths A, Zrubek J, Olson A, Liu G, Heuschkel R, Markowitz J, Cohen S, Winter H, Veereman-Wauters G, Ferry G, Baldassano RN | | Institution | *Nationwide Children's Hospital, Columbus, OH, USA daggerConnecticut Children's Center, Hartford, USA double daggerMedical College of Wisconsin, Milwaukee, USA section signHospital for Sick Children, University of Toronto, Toronto, Ontario, Canada ||Centocor Inc, Malvern, PA, USA paragraph signRW Johnson Pharmaceutical Research and Development, La Jolla, CA, USA #Addenbrooke's Hospital, Cambridge, UK **North Shore-Long Island Jewish Health System, New Hyde Park, NY, USA daggerdaggerChildren's Center for Digestive Health Care, Atlanta, GA, USA double daggerdouble daggerMassGeneral Hospital for Children, Boston, MA, USA section sign section signQueen Paola Children's Hospital, Antwerp, Belgium ||||Texas Children's Hospital, Houston, USA paragraph sign paragraph signChildren's Hospital of Philadelphia, Philadelphia, PA, USA ##RW Johnson Pharmaceutical Research and Development, Titusville, NJ, USA. | | Source | J Pediatr Gastroenterol Nutr 2009 Jun 23. | | 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. | | Language | ENG | | Pub Type(s) | JOURNAL ARTICLE
| | PubMed ID | 19561542 |
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