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Giant Cell Arteritis Untouched by Methotrexate

05/20/2002

By Anne MacLennan

Adjuvant methotrexate treatment does not appear to reduce disease activity

in patients with newly diagnosed giant cell arteritis, a multicentre

international trial has found.

Findings from a study conducted with 98 patients at 16 centres of the

International Network for the Study of Systemic Vasculitides do not support

the adjunctive use of methotrexate (MTX) to control disease activity or to

decrease the cumulative dose and toxicity of cumulative corticosteroid (CS)

in these patients, researchers report.

S. Hoffman from the Cleveland Clinic Foundation, Cleveland, Ohio,

United States, and colleagues from various international institutions

enrolled patients with unequivocal giant cell arteritis (GCA) for their

randomised, double blind study. Their objective was to determine if MTX

reduces GCA relapses and CS requirements and diminishes disease- and

treatment-related morbidity.

The patients, who were enrolled over four years, were initially treated with

prednisone 1 mg/kg/day, up to a maximum of 60 mg every day, plus either

placebo or 0.15 mg/kg/week MTX, increased to 0.25 mg/kg/week for a maximum

weekly dosage of 15 mg. Median dosage of MTX was 15 mg/week.

Two doctors, one responsible for global medical care and the other for

assessing GCA status, evaluated patients at every trial visit. Both doctors

were blinded to specific treatment allocations.

At study outset, there were no significant differences in patients in terms

of age, frequency of positive temporal artery biopsy findings (placebo 87

percent, MTX 79 percent) or comorbidities.

After 12 months, incidence of treatment failure was comparable between

groups, with 57.5 percent in the MTX group failing treatment versus 77.3

percent in the placebo group. regression analysis indicated MTX was not

linked with a reduced risk of treatment failure. Nor were any significant

differences found between groups in terms of abnormal elevations of the

erythrocyte sedimentation rate following initial remissions, serious

morbidity due to GCA, cumulative CS dose or treatment toxicity.

In the MTX group, there were fewer cases of GCA relapse heralded by symptoms

of isolated polymyalgia rheumatica (one case versus five in the placebo

group).

The results " do not support the adjunctive use of MTX to control disease

activity or to decrease the cumulative dose and toxicity of CS in patients

with GCA " , the researchers conclude.

Arthritis & Rheumatism Volume 46, Issue 5, 2002. Pages: 1309-1318