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Long-term outcome of maintenance infliximab therapy in children with Crohn's disease

Hyams, Jeffrey S. MD1,*; Lerer, Trudy MS1; Griffiths, Anne MD2; Pfefferkorn, Marian MD3; Kugathasan, Subra MD4; Evans, Jonathan MD5; Otley, Anthony MD6; Carvalho, Ryan MD7; Mack, David MD8; Bousvaros, Athos MD9; Rosh, Joel MD10; Mamula, Petar MD11; Kay, Marsha MD12; Crandall, Wallace MD13; Oliva-Hemker, Maria MD14; Keljo, David MD, PhD15; LeLeiko, Neal MD, PhD16; Markowitz, James MD17

doi: 10.1002/ibd.20845
Original Article: Original Clinical Articles

Background: Infliximab therapy has short-term benefits in children with moderate-to-severe Crohn's disease (CD). We assessed the long-term outcome of infliximab maintenance therapy in children with CD.

Methods: We performed a multicenter cohort study of 729 pediatric patients with CD enrolled in the Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry. Children younger than 16 years and newly diagnosed with CD were eligible for this study. Disease and medication information were collected prospectively from the treating physician at diagnosis, 30 days, and quarterly thereafter. No interventions were specified, per protocol.

Results: In all, 202 of 729 patients received infliximab: 62%, 23%, and 15% within 1, 1–2, and >2 years of diagnosis, respectively. The mean age at infliximab initiation was 12.7 years. A total of 158 infliximab-treated patients received maintenance therapy, 29 episodic (8 converted to maintenance), and 15 had incomplete follow-up. Among 128 patients administered maintenance infliximab and followed for ≥1 year, concomitant medications at infliximab initiation included corticosteroids (52%) and immunomodulators (90%). By 1, 2, and 3 years, <10% of patients continuing on maintenance infliximab were receiving corticosteroids (P < 0.001). Following maintenance therapy initiation, 26%, 44%, and 33% of patients continuing on maintenance infliximab over 0–1, 1–2, and 2–3 years, respectively, had clinically inactive disease not requiring corticosteroids or surgery. The likelihood of continuing maintenance infliximab at 1, 2, and 3 years was 93%, 78%, and 67%, respectively.

Conclusions: Infliximab maintenance therapy was a durable and effective treatment that was associated with prolonged corticosteroid withdrawal over a 3-year period in children with CD.

1 Connecticut Children's Medical Center, Hartford, Connecticut

2 Hospital for Sick Children, Toronto, Ontario

3 Riley Hospital for Children, Indianapolis, Indiana

4 Medical College of Wisconsin, Milwaukee, Wisconsin

5 Nemours Children's Clinic, Jacksonville, Florida

6 IWK Health Centre, Halifax, Nova Scotia

7 Children's Medical Center, Dayton, Ohio

8 Children's Hospital of Eastern Ontario, Ottawa, Ontario

9 Children's Hospital, Boston, Massachusetts

10 Morristown Memorial Hospital, Morristown, New Jersey

11 Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

12 Cleveland Clinic, Cleveland, Ohio

13 Nationwide Children's Hospital, Columbus, Ohio

14 Johns Hopkins Hospital, Baltimore, Maryland

15 Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania

16 Hasbro Children's Hospital, Providence, Rhode Island

17 North Shore-Long Island Jewish Health System, New Hyde Park, New York

*Division of Digestive Diseases, Hepatology, and Nutrition, Connecticut Children's Medical Center, 282 Washington St., Hartford, CT 06106


Received 3 October 2008; Accepted 6 November 2008

Published online 23 December 2008 in Wiley Inter-Science (

Grant sponsor: Centocor, Inc. (Malvern, PA); Grant sponsor: Astra Zeneca (Wilmington, DE); Grant sponsor: Reach Out for Youth With Ileitis and Colitis (Melville, NY); Grant sponsor: Collaborating institutions.

Author disclosures: The authors declare the following conflicts of interest: Jeffrey Hyams, MD: Centocor (consultant, research support, speaker's bureau), Astra Zeneca (research support), Abbott (consultant, research support), Elan (consultant); Trudy Lerer, MS: Astra Zeneca (research support); Anne Griffiths, MD: Centocor (consultant, research support, speaker's bureau), Schering-Plough (consultant, research support, speaker's bureau), Abbott (consultant, research support, speaker's bureau), UCB (consultant); Marian Pfefferkorn, MD: Centocor (research support), Abbott (research support); Subra Kugathasan, MD: Centocor (consultant, research support); Anthony Otley, MD: Centocor (research support), Schering-Plough (consultant), Abbott (consultant, research support); David Mack, MD: Schering-Plough (research support, speaker's bureau), Astra Zeneca (speaker's bureau), Abbott (speaker's bureau); Athos Bousvaros, MD: Abbott (speaker's bureau); Joel Rosh, MD: Centocor (consultant), Schering-Plough (consultant), Astra Zeneca (research support), Abbott (research support, speaker's bureau), Shire (speaker's bureau); Wallace Crandall, MD: Centocor (consultant, research support); Maria Oliva-Hemker, MD: Centocor (unrestricted grant), Abbott (research support); Neal LeLeiko, MD: Centocor (research support), Abbott (speaker's bureau); James Markowitz, MD: Centocor (consultant, research support, speaker's bureau), Astra Zeneca (research support), Abbott (consultant, research support).

© Crohn's & Colitis Foundation of America, Inc.
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