A comparison of the efficacy and safety of leflunomide and MTX for the treatment of RA

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Rheumatology (Oxford). 2000 Jun;39(6):655-65.

A comparison of the efficacy and safety of leflunomide and methotrexate

for the treatment of rheumatoid arthritis.

Emery P, Breedveld FC, Lemmel EM, Kaltwasser JP, Dawes PT, Gomor B, Van

Den Bosch F, Nordstrom D, Bjorneboe O, Dahl R, Horslev-sen K,

De La Serna A, Molloy M, Tikly M, Oed C, Rosenburg R,

Loew-Friedrich I.

Department of Rheumatology and Rehabilitation, University of Leeds

School of Medicine, Leeds, UK.

OBJECTIVE: To compare the clinical efficacy and safety of leflunomide

and methotrexate for the treatment of rheumatoid arthritis (RA).

METHODS: In this multicentre, double-blind trial, 999 subjects with

active RA were randomized to leflunomide (n = 501; loading dose 100

mg/day for 3 days, maintenance dose 20 mg/day) or methotrexate (n = 498;

10-15 mg/week) for 52 weeks. After 1 yr the subjects could choose to

stay for a second year of double-blind treatment. The primary end-points

were tender and swollen joint counts and overall physician and patient

assessments. Analyses were of the intent-to-treat group. RESULTS: After

1 yr, the mean changes in the leflunomide and methotrexate groups,

respectively, were -8.3 and -9.7 for tender joint count; -6.8 and -9.0

for swollen joint count; -0.9 and -1.2 for physician global

assessment; -0.9 and -1.2 for patient global assessment; -14.4 and -28.2

for erythrocyte sedimentation rate. Improvements seen with methotrexate

were significantly greater than those with leflunomide. No further

improvement occurred after the second year of treatment and the

distinction between the two treatments in terms of tender joint count

and patient global assessment was lost. During the first year of

treatment, a small and equivalent degree of radiographically assessed

disease progression was seen with both drugs. After 2 yr, disease

progression was significantly less with methotrexate. The most common

treatment-related adverse events in both groups were diarrhoea, nausea,

alopecia, rash, headache, and elevated plasma liver enzyme levels. Over

2 yr, 21 subjects receiving methotrexate were withdrawn due to elevated

plasma liver enzymes vs eight subjects taking leflunomide. Two

drug-related deaths from pulmonary causes were recorded with

methotrexate vs no drug-related deaths among the subjects receiving

leflunomide.

CONCLUSIONS: Both leflunomide and methotrexate are efficacious for

prolonged treatment of RA. At the doses used, some clinical benefit of

methotrexate over leflunomide was observed in the first year of

treatment. This benefit must be weighed against the potential toxicity

of this drug when used without folate supplementation.

Publication Types:

a.. Clinical Trial

b.. Multicenter Study

c.. Randomized Controlled Trial

PMID: 10888712

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