Retrospective cohort study of Methotrexate use in the treatment of pediatric Crohn's disease

Whitney Sunseri, Jeffrey S. Hyams, Trudy Lerer, David R. Mack, Anne M. Griffiths, Anthony R. Otley, Joel Rosh, Ryan Carvalho, Andrew B. Grossman, Jose Cabrera, Marian D. Pfefferkorn, James Rick, Neal S. Leleiko, Meredith C. Hitch, Maria Oliva-Hemker, Shehzad A. Saeed, Michael Kappelman, James Markowitz, David J. Keljo

Research output: Contribution to journalArticle

22 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1341-1345
Number of pages5
JournalInflammatory Bowel Diseases
Volume20
Issue number8
DOIs
StatePublished - Jan 1 2014
Externally publishedYes

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Methotrexate
Cohort Studies
Retrospective Studies
Immunologic Factors
Therapeutics
Crohn Disease
Pediatric Crohn's disease
Registries
Safety
Alanine Transaminase
Adrenal Cortex Hormones
Leukocytes

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Gastroenterology

Cite this

Sunseri, W., Hyams, J. S., Lerer, T., Mack, D. R., Griffiths, A. M., Otley, A. R., ... Keljo, D. J. (2014). Retrospective cohort study of Methotrexate use in the treatment of pediatric Crohn's disease. Inflammatory Bowel Diseases, 20(8), 1341-1345. https://doi.org/10.1097/MIB.0000000000000102
Sunseri, Whitney ; Hyams, Jeffrey S. ; Lerer, Trudy ; Mack, David R. ; Griffiths, Anne M. ; Otley, Anthony R. ; Rosh, Joel ; Carvalho, Ryan ; Grossman, Andrew B. ; Cabrera, Jose ; Pfefferkorn, Marian D. ; Rick, James ; Leleiko, Neal S. ; Hitch, Meredith C. ; Oliva-Hemker, Maria ; Saeed, Shehzad A. ; Kappelman, Michael ; Markowitz, James ; Keljo, David J. / Retrospective cohort study of Methotrexate use in the treatment of pediatric Crohn's disease. In: Inflammatory Bowel Diseases. 2014 ; Vol. 20, No. 8. pp. 1341-1345.
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abstract = "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.",
author = "Whitney Sunseri and Hyams, {Jeffrey S.} and Trudy Lerer and Mack, {David R.} and Griffiths, {Anne M.} and Otley, {Anthony R.} and Joel Rosh and Ryan Carvalho and Grossman, {Andrew B.} and Jose Cabrera and Pfefferkorn, {Marian D.} and James Rick and Leleiko, {Neal S.} and Hitch, {Meredith C.} and Maria Oliva-Hemker and Saeed, {Shehzad A.} and Michael Kappelman and James Markowitz and Keljo, {David J.}",
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Sunseri, W, Hyams, JS, Lerer, T, Mack, DR, Griffiths, AM, Otley, AR, Rosh, J, Carvalho, R, Grossman, AB, Cabrera, J, Pfefferkorn, MD, Rick, J, Leleiko, NS, Hitch, MC, Oliva-Hemker, M, Saeed, SA, Kappelman, M, Markowitz, J & Keljo, DJ 2014, 'Retrospective cohort study of Methotrexate use in the treatment of pediatric Crohn's disease', Inflammatory Bowel Diseases, vol. 20, no. 8, pp. 1341-1345. https://doi.org/10.1097/MIB.0000000000000102

Retrospective cohort study of Methotrexate use in the treatment of pediatric Crohn's disease. / Sunseri, Whitney; Hyams, Jeffrey S.; Lerer, Trudy; Mack, David R.; Griffiths, Anne M.; Otley, Anthony R.; Rosh, Joel; Carvalho, Ryan; Grossman, Andrew B.; Cabrera, Jose; Pfefferkorn, Marian D.; Rick, James; Leleiko, Neal S.; Hitch, Meredith C.; Oliva-Hemker, Maria; Saeed, Shehzad A.; Kappelman, Michael; Markowitz, James; Keljo, David J.

In: Inflammatory Bowel Diseases, Vol. 20, No. 8, 01.01.2014, p. 1341-1345.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Retrospective cohort study of Methotrexate use in the treatment of pediatric Crohn's disease

AU - Sunseri, Whitney

AU - Hyams, Jeffrey S.

AU - Lerer, Trudy

AU - Mack, David R.

AU - Griffiths, Anne M.

AU - Otley, Anthony R.

AU - Rosh, Joel

AU - Carvalho, Ryan

AU - Grossman, Andrew B.

AU - Cabrera, Jose

AU - Pfefferkorn, Marian D.

AU - Rick, James

AU - Leleiko, Neal S.

AU - Hitch, Meredith C.

AU - Oliva-Hemker, Maria

AU - Saeed, Shehzad A.

AU - Kappelman, Michael

AU - Markowitz, James

AU - Keljo, David J.

PY - 2014/1/1

Y1 - 2014/1/1

N2 - 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.

AB - 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.

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DO - 10.1097/MIB.0000000000000102

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