RESEARCH - Efficacy and safety of Arava alone and in combination with MTX in the treatment of refractory RA

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Indian J Med Sci. 2006 Aug;60(8):318-26.

Efficacy and safety of leflunomide alone and in combination with

methotrexate in the treatment of refractory rheumatoid arthritis.

Department of Pharmacology, Government Medical College, Calicut, Kerala,

India.

BACKGROUND: 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.

PMID: 16864918

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Retrieve & dopt=Abstra\

ctPlus & list_uids=16864918

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