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Retrospective Cohort Study of Methotrexate Use in the Treatment of Pediatric Crohn's Disease

Sunseri, Whitney MD1; Hyams, Jeffrey S. MD2; Lerer, Trudy MS2; Mack, David R. MD3; Griffiths, Anne M. MD4; Otley, Anthony R. MD5; Rosh, Joel R. MD6; Carvalho, Ryan MD7; Grossman, Andrew B. MD8; Cabrera, Jose MD9; Pfefferkorn, Marian D. MD10; Rick, James MD11; Leleiko, Neal S. MD12; Hitch, Meredith C. MD13; Oliva-Hemker, Maria MD14; Saeed, Shehzad A. MD15; Kappelman, Michael MD16; Markowitz, James MD17; Keljo, David J. MD, PhD1; For the Pediatric Inflammatory Bowel Disease Collaborative Research Group

doi: 10.1097/MIB.0000000000000102
Original Clinical Articles

Background: Methotrexate (MTX) use as an alternative to thiopurines in the treatment of Crohn's disease (CD) in children is increasing. This study was undertaken to assess safety and efficacy of MTX in children with CD.

Methods: Patients treated with MTX with a minimum of 1-year follow-up were identified in the Pediatric IBD Collaborative Research Group Registry, a prospective inception cohort study started in 2002. The clinical efficacy and safety of MTX were analyzed retrospectively.

Results: Two hundred ninety patients treated with MTX were identified. One hundred seventy-two patients received at least 3 months of MTX without thiopurine or biologicals and had ≥1 year of follow-up. Eighty-one of 172 patients (47%) received MTX as first immunomodulator (IMM), of which 22 (27%) achieved ≥12 months of sustained clinical remission without surgery, thiopurine, biologicals, or corticosteroids. Those receiving MTX as second IMM achieved similar remission rate (35%, P = not significant). Fourteen percent received MTX as first IMM in 2002 and 60% in 2010 (P = 0.005). Disease location did not affect outcomes. MTX doses were equivalent in both groups. Fifteen percent of patients developed an alanine aminotransferase >60 international units/liter and 12% developed a white blood cell <4000 cells per microliter while on MTX. Only 4% of these discontinued MTX completely. A small group of 6 centers, which contributed only about one-third of patients with CD in the registry, contributed nearly two-thirds of the patients receiving MTX (P < 0.001).

Conclusions: MTX use as first choice IMM is increasing in pediatric CD. MTX provided sustained clinical remission in nearly one-third of patients with minimal toxicity. There is large center-to-center variability in its use.

Article first published online 30 June 2014.

1Department of Pediatrics, Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania;

2Department of Pediatrics, Connecticut Children's Medical Center, Hartford, Connecticut;

3Department of Pediatrics, Children's Hospital of Eastern Ontario, Ottawa, ON, Canada;

4Division of Gastroenterology, Hepatology and Nutrition, Hospital for Sick Children, Toronto, ON, Canada;

5Department of Pediatrics, I.W.K. Health Center, Halifax, NS, Canada;

6Pediatric Gastroenterology, Goryeb Children's Hospital, Morristown, New Jersey;

7Department of Pediatrics, Nationwide Children's Hospital, Columbus, Ohio;

8Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania;

9Department of Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin;

10Section of Gastroenterology/Hepatology/Nutrition, Riley Hospital for Children, Indianapolis, Indiana;

11Department of Gastroenterology, Dayton Children's, Dayton, Ohio;

12Division of Pediatric Gastroenterology, Nutrition and Liver Diseases, Hasbro Children's Hospital, Providence, Rhode Island;

13Department of Pediatrics, Russell Children's Hospital, Birmingham, Alabama;

14Division of Pediatric Gastroenterology and Nutrition, Johns Hopkins University School of Medicine, Baltimore, Maryland;

15Division of Gastroenterology, Hepatology and Nutrition, Cincinnati Children's Medical Center, Cincinnati, Ohio;

16Department of Pediatrics, University of North Carolina, Chapel Hill, North Carolina; and

17Department of Pediatrics, Cohen Children's Medical Center, New Hyde Park, New York.

Reprints: David J. Keljo, MD, PhD, Inflammatory Bowel Disease Center Children's Hospital of Pittsburgh, 4401 Penn Avenue, Pittsburgh, PA 15224 (e-mail: keljodj@upmc.edu).

Supported in part for the present study came from a grant provided by Janssen Ortho-Biotech. The Pediatric Inflammatory Bowel Disease Collaborative Research Group is currently supported by the participating institutions.

J.S. Hyams is a consultant for Janssen, Abbvie, TNI Biotech and Soligenix and received payment for lectures including service on speakers bureaus for Janssen Ortho Biotech. A. M. Griffiths is a consultant to Abbvie, Janssen, Pfizer, Johnson and Johnson, and Nestle; and received payment for lectures including service on speakers bureaus from Merck, Abbvie, and Ferring and payment for development of educational presentations from Ferring. D. Mack is a board member of Abbvie and Janssen and received payment for development of educational presentations from Abbvie. A. Otley is a Pediatric Advisory Board member of AbbVie and Janssen. R. Carvalho is a consultant to Nestle Nutrition. S. A. Saeed received payment for lectures including service on speakers bureaus from Department of Pediatrics Grand Rounds, Charleston, WV and Department of Pediatrics Grand Rounds, Akron Children's Hospital. J. Rosh is a consultant to Abbvie, Aptalis, Given, Prometheus and Soligenix and received payment for lectures including service on speakers bureaus from Abbot Nutrition and Prometheus. The other authors have no conflicts of interest to disclose.

Received April 10, 2014

Accepted May 2, 2014

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