Recomendações nacionais baseadas em evidências científicas e opiniões dos especialistas sobre o uso do metotrexato nas doenças reumáticas, especialmente na artrite reumatoide: resultados da iniciativa 3E do Brasil

Abstract

Objectives: The use of methotrexate (MTX) has been the basis for rheumatoid arthritis (RA) therapy, but there is no uniformity on the guidelines for its clinical use. The objective of this study was to develop recommendations based on scientific evidence and opinions of experts on the use of MTX, which will allow the improvement of our clinical practice. Methods: 3E (Evidence, Expertise, Exchange) Initiative in Rheumatology is a multinational group of rheumatologists from 17 countries, including Brazil. After a selection of 10 questions about the use of MTX, held by the Delphi method, a systematic literature review (SLR) was done (Medline, Pubmed, Embase, Cochrane, Abstracts EULAR 2005 and ACR 2006 by six international bibliographic reviewers chosen by the mentors of the 3E study. Two other different national questions from Brazil were also included, and the SLR was done by a national bibliographic reviewer.** The results of SLR were presented by 7 members of our Brazilian 3E scientific committee* at a meeting of 48 rheumatologists, which discussed RSL details, voted, and produced the national recommendations presented here. These recommendations were subsequently used in the creation of multinational recommendations. Results and conclusions: 21 recommendations concerning the 10 international and the 2 national questions were formulated, with an agreement level of 77% among the participants (63-100%). Oral MTX should be started at a minimum dose of 10 mg/wk and a maximum dose of 25 mg/wk. Elevation of AST/ALT above 3x the upper limit, for at least 3 times consecutively, justifies the temporary suspension of MTX, which can be restored after normalization of serum liver enzyme levels; MTX is safe for long term use. The use of alcohol (100 g/wk) should be avoided. Combinations of MTX with disease modifying antirheumatic drugs are recommended, although there is risk of greater toxicity. Folic acid should be associated with MTX in dose higher than 5 mg/wk. Total blood cell count, creatinine, AST/ALT, serology for hepatitis B and C virus, and chest X-ray should be ordered before initiating MTX. Inquire about contraception methods, comorbidities, use of Pereira et al. 354Bras J Rheumatol 2009;49(4):346-61 illicit drugs, alcohol, and liver diseases and hepatotoxic drugs should be performed. The MTX can be maintained during elective surgeries; discontinuation of MTX for at least 3 months before planning of pregnancy is suggested, for both men and women Use of contraception method is justified with the use of MTX in reproductive age. MTX can be used to reduce the cumulative dose of corticosteroid in patients with giant cell arthritis, rheumatic polymyalgia (RPM), juvenile dermatomyositis, and in systemic lupus erythematosus (SLE) with cutaneous or joint involvement.