Clinical efficacy and adverse effects of weekly single dose leflunomide in refractory rheumatoid arthritis |
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Affiliation: | 1. Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.;2. Liver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran.;3. Basic and Molecular Epidemiology of Gastrointestinal Disorders Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.;4. Department of Medical Microbiology, Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.;5. Department of Biology, Science and Research Branch, Islamic Azad University, Tehran, Iran.;6. Department of Microbiology, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.;1. Monash Centre of Cardiovascular Research and Education in Therapeutics, Department of Epidemiology and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, VIC 3004, Australia;2. Department of Cardiology B, Oslo University Hospital Ullevål, Norway;3. Faculty of Medicine, University of Oslo, Norway;1. Department of Pharmacology, Institute of Biomedical Science, University of São Paulo, Avenida Professor Lineu Prestes, 1524, São Paulo 05508-900, Brazil;2. Department of Biochemistry, Federal University of Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil;3. Neurobiology Department, Max Planck Institute for Biophysical Chemistry, Göttingen, Germany |
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Abstract: | AimTo study the clinical efficacy and adverse events of weekly single dose of leflunomide in patients with refractory rheumatoid arthritis in comparison with conventional daily regimen.MethodsPatients with refractory rheumatoid arthritis were taken up for the study; 91 patients were enlisted of whom 3 became non-compliant and were excluded. A concurrent parallel study was designed with the patients divided into two groups and efficacy and adverse events recorded at third and sixth months.ResultsA total of 88 patients were included in the study and were divided into two groups. At the end of 6 months, in the daily group 37 (82.2%) out of 45 patients had disease activity score (DAS) less than 3.2 indicating a low disease activity and 8 patients (17.8%) had moderate disease activity. None had high disease activity. In the weekly group, 36 (83.7%) out of 43 patients had low disease activity and 7 (16.3%) had moderate disease. None had high disease activity. Four (8.9%) patients developed adverse reactions in the daily group. One patient (2.2%) had alopecia and the other (2.2%) had diarrhoea and were withdrawn from the study. Two (4.4%) patients had elevated liver enzymes and the drug was stopped at 6 months. None in the weekly group reported any adverse events.ConclusionsWeekly regimen was found to be better in terms of compliance and had a lower adverse effect profile. The result was statistically significant. Clinical efficacy of weekly therapy was found to be similar to that of conventional therapy in terms of DAS. |
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