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. Author manuscript; available in PMC: 2011 Jan 4.
Published in final edited form as: Rev Neurol Dis. 2008 Summer;5(3):140–152.

Table 5.

Therapeutic Trials of Methotrexate for Giant Cell Arteritis

Study Design N Population Intervention Primary Endpoint Outcome
Spiera
et al.41 		RCT 21 Diagnosis of GCA
based on clinical,
biopsy, and
angiographic criteria		 Oral prednisone,
1 mg/kg/d with a
taper to 30 mg/d,
and then:

  1. MTX, 7.5 mg/week

  2. Placebo

 Cumulative steroid
dose at 1 year;
duration of steroid
taper; functional status;
adverse effects		 No benefit with
MTX vs placebo
Jover
et al.43 		RCT 42 Biopsy-proven GCA Oral prednisone,
60 mg/d with a
taper, and:

  1. MTX, 10 mg/week

  2. Placebo

 Number of relapses;
cumulative steroid
dose at 2 years		 Benefit with MTX vs
placebo in number
of relapses (45% vs
84.2%; P = .02) and
cumulative steroid
dose (4187 mg vs
5489.6 mg; P = 0.009)
Hoffman
et al.42 		RCT 98 Diagnosis of GCA
based on clinical,
biopsy, or angiographic
criteria		 Oral prednisone,
1 mg/kg/d with a taper
to eod dosing, and:

  1. MTX, 0.15 mg/kg/week, increased to 0.25 mg/kg/week

  2. Placebo

 Relapse and treatment
failure rate; cumulative
steroid dose at 1 year		 No benefit with
MTX vs placebo
Mahr
et al.44 		Individual
patient
meta-analysis		 161 Individual patients
with GCA, from
the above 3 trials		 Oral prednisone and:

  1. MTX, 7.5-10 mg/week

  2. Placebo

 Time to first and
second relapses of
GCA; cumulative
steroid dose at
48 weeks		 Benefit with MTX vs
placebo in risk of
first and second
relapse (HR = 0.65;
P = .04; and HR = 0.49;
P = .02, respectively),
and cumulative steroid
dose at 48 weeks (842 mg
difference; P < .001)

Eod, every other day; GCA, giant cell arteritis; HR, hazard ratio; MTX, methotrexate; RCT, randomized controlled trial.