GiACTA (tocilizumab weekly)
Trial question
What is the role of tocilizumab in patients with active giant cell arteritis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
77.0% female
23.0% male
N = 150
150 patients (116 female, 34 male).
Inclusion criteria: patients with active giant cell arteritis and an elevated ESR.
Interventions
N=100 tocilizumab (SC dose of 162 mg weekly, combined with a 26-week prednisone taper).
N=50 placebo (placebo, combined with a 26-week prednisone taper).
Primary outcome
Sustained corticosteroid-free remission at week 52
56%
14%
56.0 %
42.0 %
28.0 %
14.0 %
0.0 %
Tocilizumab
Placebo
Significant
increase ▲
NNT = 2
Significant increase in sustained corticosteroid-free remission at week 52 (56% vs. 14%; AD 42%, 99% CI 18 to 66).
Safety outcomes
No significant difference in adverse events.
Significant difference in serious adverse events (15% vs. 22%).
Conclusion
In patients with active giant cell arteritis and an elevated ESR, tocilizumab was superior to placebo with respect to sustained corticosteroid-free remission at week 52.
Reference
Stone JH, Tuckwell K, Dimonaco S et al. Trial of Tocilizumab in Giant-Cell Arteritis. N Engl J Med. 2017 Jul 27;377(4):317-328.
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