Efficacy and safety of leflunomide alone and in combination with methotrexate in the treatment of refractory rheumatoid arthritis.

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dc.contributor.authorAntony, Ten_US
dc.contributor.authorJose, V Men_US
dc.contributor.authorPaul, B Jen_US
dc.contributor.authorThomas, Ten_US
dc.date.accessioned2006-08-26en_US
dc.date.accessioned2009-05-29T05:07:03Z
dc.date.available2006-08-26en_US
dc.date.available2009-05-29T05:07:03Z
dc.date.issued2006-08-26en_US
dc.description.abstractBACKGROUND: Rheumatoid arthritis patients who develop refractoriness are left with no alternatives other than leflunomide and costly biological response modifiers. Leflunomide, though effective, was associated with adverse events and has not been extensively studied in the Indian population. AIMS: Determination of safety and efficacy of leflunomide alone and if not useful, in combination with methotrexate in patients refractory to conventional disease-modifying agents. SETTING AND DESIGN: Open labeled clinical trial with leflunomide [100 mg, OD x 3 days followed by 20 mg, OD x 6 months], if no improvement at three months, combined with methotrexate [5-7.5 mg, OD x 3 months] at a tertiary care hospital. MATERIALS AND METHODS: The primary endpoint in the improvement in EULAR criteria and secondary endpoints were patient and physician global evaluation, incidence of remission and biochemical and clinical adverse events. STATISTICAL ANALYSIS: Chi square test or Fisher's exact test and parametric and non-parametric repeat measure ANOVA were used for analysis. RESULTS: Among 84 patients who were included in the study, leflunomide showed improvement and remission in 52 [62%] and 6 [7%] in six months, by intention to treat analysis. Adverse events were observed in 15, discontinuation in 5 and 24 dropped out. With combination in 11 patients, there was improvement and remission in nine [91%] and one [9%] after three months. Adverse events were observed in six and one discontinued. CONCLUSIONS: If regular monitoring of hepatic function and hematological parameters are performed, leflunomide is an effective and safe drug in the Indian population in resistant rheumatoid arthritis patients, especially if used alone.en_US
dc.description.affiliationDepartment of Pharmacology, Government Medical College, Calicut, Kerala, India.en_US
dc.identifier.citationAntony T, Jose VM, Paul BJ, Thomas T. Efficacy and safety of leflunomide alone and in combination with methotrexate in the treatment of refractory rheumatoid arthritis. Indian Journal of Medical Sciences. 2006 Aug; 60(8): 318-26en_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/67273
dc.language.isoengen_US
dc.source.urihttps://www.indianjmedsci.orgen_US
dc.subject.meshAgeden_US
dc.subject.meshAnalysis of Varianceen_US
dc.subject.meshAntirheumatic Agents --adverse effectsen_US
dc.subject.meshArthritis, Rheumatoid --drug therapyen_US
dc.subject.meshChi-Square Distributionen_US
dc.subject.meshDrug Therapy, Combinationen_US
dc.subject.meshFemaleen_US
dc.subject.meshHumansen_US
dc.subject.meshImmunosuppressive Agents --adverse effectsen_US
dc.subject.meshIsoxazoles --adverse effectsen_US
dc.subject.meshMaleen_US
dc.subject.meshMethotrexate --adverse effectsen_US
dc.subject.meshMiddle Ageden_US
dc.subject.meshTreatment Outcomeen_US
dc.titleEfficacy and safety of leflunomide alone and in combination with methotrexate in the treatment of refractory rheumatoid arthritis.en_US
dc.typeClinical Trialen_US
dc.typeJournal Articleen_US
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