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OSWALDO CASTANEDA and M. GOPAL NAIR ABSTRACT. Objective. To investigate the clinical efficacy, safety, tolerability, and toxicity profile of a metabolically stable antifolate, CH-1504, compared to methotrexate (MTX) in the treatment of rheumatoid arthritis (RA). Methods. A 24-week open-label trial of MTX and CH-1504 was performed in 20 patients with RA. Results. Improvements in clinical and laboratory indicators were observed in both study groups. Improvement in the CH-1504 group was greater than in the MTX group. Both treatments were generally well tolerated; however, the liver function test abnormalities and gastrointestinal related adverse events expected with this class of medication were not seen with CH-1504. Conclusion. CH-1504 appears to be clinically efficacious and may possess a superior safety and tolerance profile compared to MTX. (J Rheumatol 2006;33:862-4) Key Indexing Terms: EFFICACY
From the Universidad Peruana Cayetano Heredia, Lima, Peru; and College of Medicine, University of South Alabama, Mobile, Alabama, USA. Supported in part by grant CA-27101 from the National Institutes of Health. O. Castaneda, MD, PhD, Professor and Chair, Departments of Immunology and Rheumatology, Universidad Peruana Cayetano Heredia; M.G. Nair, PhD, Professor, College of Medicine, University of South Alabama. Address reprint requests to Dr. M.G. Nair, College of Medicine, University of South Alabama, Mobile, AB 36688. E-mail: m_gopal_nair@comcast.net Accepted for publication December 29, 2005.
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