There are 12 non-controlled and only two controlled studies using methotrex
ate (MTX) in a total of 207 SLE patients in the literature. The majority of
these studies evaluated mainly cutaneous and/or articular involvement and
attained good results. Two studies evaluated a small number of patients wit
h lupus nephritis, achieving discordant results. Two other studies in pedia
tric onset systemic lupus erythematosus (SLE) also presented conflicting re
sults, it being relevant that the one with poor response had the majority o
f patients with nephritis. One of the controlled trials was retrospective a
nd concluded that MTX was effective in the treatment of antimalarial-resist
ant lupus arthritis and that toxicity leading to discontinuation of MTX was
infrequent. The other controlled study was a double-blind, randomized, pla
cebo-controlled clinical trial that evaluated SLE patients with mild activi
ty. The authors concluded that MTX was effective in controlling cutaneous a
nd articular activity and permitted prednisone dose reduction. The side eff
ects were frequent but only 10% of patients needed to discontinue the medic
ation.
The accumulative evidence suggests that MTX in a low weekly dose may be eff
ective in SLE patients with articular and/or cutaneous involvement with no
response to antimalarials and low-dose prednisone and in patients in whom w
e can not reduce prednisone dose due to articular or cutaneous activity. Ca
ution is required concerning the side effects.