REVIEW - Long term safety of MTX monotherapy in RA patients

[Guest guest]

Ann Rheum Dis. Published Online First: 5 December 2008.

doi:10.1136/ard.2008.093690

--------------------------------------------------------------------------------

Extended Report

Long term safety of Methotrexate monotherapy in rheumatoid arthritis

patients: A systematic literature research

Carine Salliot 1* and Désirée van der Heijde 2

1 Rheumatology B Department, Cochin Hospital, France

2 Rheumatology Department, Leiden University Medical Center, Netherlands

Abstract

Objective: To perform a systematic literature review regarding the

long term safety of methotrexate (MTX) monotherapy in rheumatoid

arthritis (RA).

Methods: The search was performed in MEDLINE, COCHRANE and EMBASE. The

population studied was adults with RA who received MTX monotherapy for

more than 2 years.

Results: 88 published studies were included. Over 12 years of

treatment, the termination rate of MTX for toxicity is less than for

Sulfasalazine, Gold, D-penicillamine and higher than for HCQ (level of

evidence 2a-2b). Long term use of MTX treatment does not appear as a

risk factor for serious infections including herpes zoster (2b-4) and

could provide a survival benefit by reduction of cardiovascular

mortality (2b). The prevalence of elevated liver enzymes (more than

twice upper limit of normal) is close to 13% of the patients and 3.7%

of them stopped MTX permanently for liver toxicity (2b). Data on the

risk for liver fibrosis/cirrhosis are conflicting: a meta-analysis

shows an incidence of fibrosis of 2.7% after 4 years of MTX (2a).

However, 2 other studies on sequential liver biopsies do not show

evidence for developing severe damage (2b). Insufficient data are

available to fully assess the risk of lymphoma and malignancies,

although there is no strong evidence of increased risk (2b-4).

Conclusion: This systematic literature search on MTX monotherapy with

relatively low dose use during at least 2 years shows a favourable

long-term safety.

--------------------------------------------------------------------------------

http://ard.bmj.com/cgi/content/abstract/ard.2008.093690v1?papetoc

Not an MD