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

Table 6.

Therapeutic Trials of Other Cytotoxic and Immunomodulatory Agents for Giant Cell Arteritis

Agent Study Design N Population Intervention Primary
Endpoint		 Outcome
Infliximab Hoffman
et al.48 		RCT 44 GCA as per ACR
criteria, in steroid-
induced remission
for ≥ 1 week		 Oral corticosteroid
(prednisone or
prednisolone) with
scheduled taper, plus:

  1. Infliximab, 5 mg/kg

  2. Placebo

 Number of
patients relapse
free by week 22;
adverse effects		 No significant
benefit or harm with
infliximab; trial was
stopped early
Azathioprine De Silva
and
Hazleman52 		RCT 31 Either GCA or
PMR by Jones/
Hazleman criteria,
in steroid-induced
remission for
≥ 3 months		 Oral prednisolone
taper, with:

  1. Azathioprine, 150 mg/d

  2. Placebo

 Prednisolone
dosage at
52 weeks		 Benefit with
azathioprine vs
placebo in steroid
dose at 52 weeks
(1.9 mg vs 4.2 mg;
P < .05); high
dropout rate in
azathioprine group
Cyclosporine
A		 Schaufelberger
et al.54 		RCT,
open-
label		 60 Biopsy-proven
GCA meeting
ACR criteria		 Prednisone with
scheduled taper, with:

  1. Cyclosporine A, 2 mg/kg/d (tapered according to response and adverse effects)

  2. Placebo

 Change in
steroid dose
over 12 months		 No efficacy data
provided by
authors; high rate
of premature
termination and
adverse effects in
cyclosporine A group

ACR, American College of Rheumatology; GCA; giant cell arteritis; PMR, polymyalgia rheumatica; RCT, randomized controlled trial.