Trial of Tocilizumab in Giant-Cell Arteritis

Published on Jul 27, 2017in The New England Journal of Medicine70.67
· DOI :10.1056/NEJMoa1613849
John H. Stone70
Estimated H-index: 70
(Harvard University),
Katie Tuckwell8
Estimated H-index: 8
(Hoffmann-La Roche)
+ 13 AuthorsNeil Collinson9
Estimated H-index: 9
(Hoffmann-La Roche)
BackgroundGiant-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. MethodsIn 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 an...
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Abstract Objective To report entry criteria and clinical features of patients with newly diagnosed and relapsing giant cell arteritis (GCA) enrolled in a randomized trial of tocilizumab, an interleukin-6 receptor-alpha inhibitor. Methods Newly diagnosed GCA was defined as diagnosis ≤6 weeks before baseline. Relapsing GCA was defined as diagnosis >6 weeks before baseline with ≥2 consecutive weeks of prednisone ≥40 mg/day. All patients had active GCA within 6 weeks of baseline. All statistical res...
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