Objective. To study the efficacy of methotrexate (MTX) plus low dose c
orticosteroids for induction of remission in generalized Wegener's gra
nulomatosis (WG) and to possibly identify predictive factors for the o
utcome under this therapy. Methods. We conducted a prospective, open l
abel study, including 17 patients with not immediately life threatenin
g, generalized WG, Treatment consisted of intravenous MTX 0.3 mg/kg on
ce weekly plus daily oral low dose prednisone for initial diagnosis of
WC in 11 and for a generalized relapse of WG in 6 patients. Interdisc
iplinary, standardized assessments of disease activity and extent were
done 3-monthly. Results. Within a median treatment period of 24.5 mon
ths remission could be achieved in 10/17 patients (59%), their median
corticosteroid dose during that time was 1.75 mg/day, Seven patients w
ith a median concomitant prednisone dose of 7.5 mg/day did not respond
, among them 4 patients who were treated for a relapse of WG. Signs of
de novo glomerulonephritis occurred in 5 of the 7 nonresponders. Sign
ificant side effects, including opportunistic infections, did not occu
r. Conclusion. Weekly low dose MTX in combination with low dose cortic
osteroids leads to an acceptable remission rate of almost 60% without
significant side effects. Patients treated for a relapse of WG and pat
ients with a need for a higher concomitant prednisone dose seem to be
at risk for nonresponse, with a high likelihood of developing de novo
glomerulonephritis.