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¶¶

Journal of Pediatric Gastroenterology & Nutrition: August 2009 - Volume 49 - Issue 2 - p 183–190
doi: 10.1097/MPG.0b013e3181a70f21
Original Articles: Gastroenterology

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.

*Nationwide Children's Hospital, Columbus, OH, USA

Connecticut Children's Center, Hartford, USA

Medical College of Wisconsin, Milwaukee, USA

§Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada

||Centocor Inc, Malvern, PA, USA

RW 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

††Children's Center for Digestive Health Care, Atlanta, GA

‡‡MassGeneral Hospital for Children, Boston, MA, USA

§§Queen Paola Children's Hospital, Antwerp, Belgium

||||Texas Children's Hospital, Houston, USA

¶¶Children's Hospital of Philadelphia, Philadelphia, PA, USA

##RW Johnson Pharmaceutical Research and Development, Titusville, NJ, USA

Received 16 September, 2008

Accepted 23 March, 2009

Address correspondence and reprint requests to Dr Wallace Crandall, Nationwide Children's Hospital, The Ohio State University School of Medicine, 700 Children's Drive, Columbus, OH 43205 (e-mail: Wallace.Crandall@NationwideChildrens.org).

Centocor Inc (Malvern, PA) provided support for this study.

Wallace Crandall received research funding in conjunction with the conduct of this study, served as a consultant to Centocor, and received an honorarium from Centocor. Jeffrey Hyams received research funding in conjunction with the conduct of this study and other studies sponsored by Centocor; and served as a consultant to Centocor. Subra Kugathasan received research funding in conjunction with the conduct of this study, served as a consultant to Centocor, and received an honorarium from Centocor. Anne Griffiths received research funding in conjunction with the conduct of this study. Julie Zrubek is an employee of Centocor Inc. Allan Olson and Grace Liu, currently employed at Robert Wood Johnson Pharmaceutical Research and Development, are former employees of Centocor Inc. Robert Heuschkel received research funding in conjunction with the conduct of this study and also received a grant from Schering-Plough. James Markowitz received research funding in conjunction with this and other studies, served as a consultant to Centocor; and received an honorarium from Centocor. Stanley Cohen received research funding in conjunction with the conduct of this study, received other research grants, and chaired conferences sponsored by Centocor. Harland Winter received research funding in conjunction with the conduct of this study and served as a consultant to Centocor. Gigi Veereman-Wauters received research funding in conjunction with the conduct of this study. George Ferry received research funding in conjunction with the conduct of this study and served as a consultant to Centocor. Robert Baldassano received research funding in conjunction with the conduct of this study.

© 2009 Lippincott Williams & Wilkins, Inc.