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Injection of methotrexate not superior to oral therapy in juvenile arthritis treatment

Oral approach may spare pediatric patients pain of injections

A retrospective analysis of methotrexate (MTX) safety data found that injection of this disease-modifying anti-rheumatic drug (DMARD) was not superior to oral therapy in long-term treatment of patients with juvenile idiopathic arthritis (JIA). Findings published in Arthritis Care & Research, a peer-reviewed journal of the American College of Rheumatology (ACR), suggest that with similar efficacy and tolerability the more comfortable oral approach may be more suitable to treat pediatric arthritis patients.

There are a number of chronic arthritis conditions, collectively referred to as JIA, that affect children and teens. Medical evidence reports JIA incidence ranges from 10 to 100 per 100,000 children under 16 years of age, making it the most common chronic pediatric inflammatory disease. In the U.S. the ACR estimates that 294,000 children are diagnosed with JIA, which can lead to severe disability.

Previous studies have confirmed the safety and efficacy of MTX, which is one of most common first line DMARD treatments for arthritis. While side effects such as nausea and vomiting may limit MTX use in children, the type of delivery method may also pose a significant burden to the patients," explains Dr. Ariane Klein from Asklepios Klinik in Sankt Augustin, Germany. "Our study compares the efficacy of oral MTX to injection of the drug and to assess side effects in children with JIA."

Using data collected by the German Methotrexate Registry since 2005, researchers identified JIA patients who were treated with MTX for at least 6 months and who did not receive additional biologic therapies. Participants who changed their MTX approach during the observation period were excluded. The study groups consisted of 259 (63%) patients who received oral MTX and 152 (32%) patients receiving MTX injections. In both groups, patients had a median age of ten years, two-thirds were female, and all received a comparable dose of MTX.

A clinical response (efficacy) based on the PedACR 30 score after six months of MTX therapy was found in 72% receiving oral therapy and 73% of patients using injections. At least one adverse event was reported in 22% of patients in the oral cohort compared to 27% in the injection therapy group. Researchers found that significantly more patients receiving MTX injections discontinued treatment due to adverse events compared to those on oral treatment at 11% versus 5%, respectively.

Dr. Klein concludes, "Our analysis found that efficacy and tolerability of MTX was similar in both delivery methods. The often unpopular MTX injection did not appear to be superior to oral administration and may likely be spared without clinical consequences." The authors advised further controlled studies to determine the best application route of MTX treatment in patients with juvenile arthritis."

Throughout the month of May, the American College of Rheumatology, ACR Research and Education Foundation, Arthritis Foundation, Mayo Clinic, and Nemours are partnering to celebrate Arthritis Action Month (formerly Arthritis Awareness Month) in the U.S.

This study is published in Arthritis Care & Research. Media wishing to receive a PDF of this article may contact

Full citation: "Efficacy and Safety of Oral and Parenteral Methotrexate Therapy in Children with Juvenile Idiopathic Arthritis." Ariane Klein, Ingrid Kaul, Ivan Foeldvari, Gerd Ganser, Urban Andreas and Gerd Horneff. Arthritis Care and Research; Published Online: May 30, 2012 (DOI: 10.1002/acr.21697).

Author Contact: To arrange an interview with Dr. Klein, please contact Stefanie Klotz, with Asklepios Klinik at

About the Journal:

Arthritis Care & Research is an official journal of the American College of Rheumatology (ACR), and the Association of Rheumatology Health Professionals (ARHP), a division of the College. Arthritis Care & Research is a peer-reviewed research publication that publishes both original research and review articles that promote excellence in the clinical practice of rheumatology. Relevant to the care of individuals with arthritis and related disorders, major topics are evidence-based practice studies, clinical problems, practice guidelines, health care economics, health care policy, educational, social, and public health issues, and future trends in rheumatology practice. The journal is published by Wiley-Blackwell on behalf of the American College of Rheumatology (ACR). For more information, please visit

About Wiley-Blackwell:

Wiley-Blackwell is the international scientific, technical, medical, and scholarly publishing business of John Wiley & Sons, with strengths in every major academic and professional field and partnerships with many of the world's leading societies. Wiley-Blackwell publishes nearly 1,500 peer-reviewed journals and 1,500+ new books annually in print and online, as well as databases, major reference works and laboratory protocols. For more information, please visit or our new online platform, Wiley Online Library (, one of the world's most extensive multidisciplinary collections of online resources, covering life, health, social and physical sciences, and humanities.

Dawn Peters | EurekAlert!
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