Pediatrics

Efficacy and safety of oral and parenteral methotrexate therapy in children with juvenile idiopathic arthritis: An observational study with patients from the German Methotrexate Registry†

  1. A. Klein1,*,
  2. I. Kaul2,
  3. I. Foeldvari3,
  4. G. Ganser4,
  5. A. Urban5,
  6. G. Horneff1

Article first published online: 27 AUG 2012

DOI: 10.1002/acr.21697

Issue

Arthritis Care & Research

Arthritis Care & Research

Volume 64, Issue 9, pages 1349–1356, September 2012

Additional Information

How to Cite

Klein, A., Kaul, I., Foeldvari, I., Ganser, G., Urban, A. and Horneff, G. (2012), Efficacy and safety of oral and parenteral methotrexate therapy in children with juvenile idiopathic arthritis: An observational study with patients from the German Methotrexate Registry. Arthritis Care Res, 64: 1349–1356. doi: 10.1002/acr.21697

Author Information

  1. 1

    Asklepios Klinik Sankt Augustin, Sankt Augustin, Nordrheinwestfalen, Germany

  2. 2

    Institute of Medical Statistics, University of Cologne, Cologne, Nordrheinwestfalen, Germany

  3. 3

    Hamburger Zentrum für Kinder- und Jugendrheumatologie, Hamburg, Germany

  4. 4

    St. Josef-Stift, Sendenhorst, Germany

  5. 5

    Klinikum Sankt Marien, Amberg, Germany

*Asklepios Klinik Sankt Augustin, Arnold-Janssen-Strasse 29, D-53757 Sankt Augustin, Germany

  1. †

    The German Methotrexate Registry is sponsored by Wyeth Biopharma, which was acquired by Pfizer in October 2009.

Publication History

  1. Issue published online: 27 AUG 2012
  2. Article first published online: 27 AUG 2012
  3. Accepted manuscript online: 30 MAY 2012 10:03AM EST
  4. Manuscript Accepted: 28 MAR 2012
  5. Manuscript Received: 22 NOV 2010

Funded by

  • Wyeth
  • Abbott
  • Novartis
  • Roche
  • Essex

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Abstract

Objective

The German Methotrexate Registry has been collecting data concerning the efficacy and safety of methotrexate (MTX) treatment since 2005. The aim of this retrospective analysis is to compare oral and parenteral MTX treatment regarding efficacy and safety.

Methods

Inclusion criteria were diagnosis of juvenile idiopathic arthritis, MTX treatment for at least 6 months, a consistent route of administration of MTX, and no previous or concomitant treatment with biologic agents. Efficacy was measured by the American College of Rheumatology (ACR) pediatric (Pedi) criteria. Primary outcome was efficacy defined as the number of patients reaching ACR Pedi 30 improvement criteria after 6 months of treatment. Secondary outcome criteria were the ACR Pedi 50 and Pedi 70 criteria at 6 and 12 months, respectively. Analyses were performed with the intent-to-treat population.

Results

Of the 411 eligible patients, 259 (63%) received oral MTX and 152 (37%) received subcutaneous MTX. In both patient groups, a comparable weekly dose of MTX (0.4 mg/kg versus 0.42 mg/kg) was used, and a comparable number of patients received concomitant steroids. The primary outcome in both treatment groups was that a comparably high number of patients showed a clinical response according to the ACR Pedi 30 score after 6 months of treatment (73% versus 72%; P = 0.87). Twenty-two percent of patients with oral therapy and 27% with subcutaneous therapy had at least 1 documented adverse event. Discontinuation of treatment was observed in both groups with equal frequency, while significantly more patients with subcutaneous application discontinued MTX because of adverse events (11% versus 5%; P = 0.02).

Conclusion

In this retrospective analysis, parenteral MTX was not superior to oral administration regarding efficacy and tolerability.

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