BACKGROUND: Giant-cell arteritis commonly relapses when glucocorticoids are 
tapered, and the prolonged use of glucocorticoids is associated with side 
effects. The effect of the interleukin-6 receptor alpha inhibitor tocilizumab on 
the rates of relapse during glucocorticoid tapering was studied in patients with 
giant-cell arteritis.
METHODS: In this 1-year trial, we randomly assigned 251 patients, in a 2:1:1:1 
ratio, to receive subcutaneous tocilizumab (at a dose of 162 mg) weekly or every 
other week, combined with a 26-week prednisone taper, or placebo combined with a 
prednisone taper over a period of either 26 weeks or 52 weeks. The primary 
outcome was the rate of sustained glucocorticoid-free remission at week 52 in 
each tocilizumab group as compared with the rate in the placebo group that 
underwent the 26-week prednisone taper. The key secondary outcome was the rate 
of remission in each tocilizumab group as compared with the placebo group that 
underwent the 52-week prednisone taper. Dosing of prednisone and safety were 
also assessed.
RESULTS: Sustained remission at week 52 occurred in 56% of the patients treated 
with tocilizumab weekly and in 53% of those treated with tocilizumab every other 
week, as compared with 14% of those in the placebo group that underwent the 
26-week prednisone taper and 18% of those in the placebo group that underwent 
the 52-week prednisone taper (P<0.001 for the comparisons of either active 
treatment with placebo). The cumulative median prednisone dose over the 52-week 
period was 1862 mg in each tocilizumab group, as compared with 3296 mg in the 
placebo group that underwent the 26-week taper (P<0.001 for both comparisons) 
and 3818 mg in the placebo group that underwent the 52-week taper (P<0.001 for 
both comparisons). Serious adverse events occurred in 15% of the patients in the 
group that received tocilizumab weekly, 14% of those in the group that received 
tocilizumab every other week, 22% of those in the placebo group that underwent 
the 26-week taper, and 25% of those in the placebo group that underwent the 
52-week taper. Anterior ischemic optic neuropathy developed in one patient in 
the group that received tocilizumab every other week.
CONCLUSIONS: Tocilizumab, received weekly or every other week, combined with a 
26-week prednisone taper was superior to either 26-week or 52-week prednisone 
tapering plus placebo with regard to sustained glucocorticoid-free remission in 
patients with giant-cell arteritis. Longer follow-up is necessary to determine 
the durability of remission and safety of tocilizumab. (Funded by F. Hoffmann-La 
Roche; ClinicalTrials.gov number, NCT01791153 .).