A combination of tocilizumab plus prednisone-tapered therapy was superior to placebo plus steroid taper for achieving glucocorticoid-free remission in giant-cell arteritis (GCA), the phase 3 Giant-Cell Arteritis Actemra (GiACTA) trial shows.
John H. Stone, MD, from Harvard Medical School, Boston, Massachusetts, and colleagues published the results of their study in the July 27 issue of the New England Journal of Medicine.
“This trial of tocilizumab for the treatment of [GCA] showed that the two regimens of tocilizumab weekly and of tocilizumab every other week, in combination with a prednisone taper over a period of 26 weeks, were superior to placebo plus a prednisone taper of 26 weeks and to placebo plus a prednisone taper of 52 weeks with regard to sustained remission,” the authors write.
Case series and a phase 2 trial have suggested that the interleukin 6 (IL-6) inhibitor tocilizumab allows for tapering of the glucocorticoid doses that control GCA while still maintaining disease remission, the researchers write.
They therefore conducted the 1-year trial to determine whether subcutaneous tocilizumab resulted in higher rates of sustained glucocorticoid-free remission of GCA compared with placebo.
The researchers randomly assigned 251 patients with GCA in a 2:1:1:1 ratio to receive tocilizumab (162 mg) weekly with a 26-week prednisone taper, tocilizumab (162 mg) every other week with a 26-week prednisone taper, placebo with a 26-week prednisone taper, or placebo with a 52-week prednisone taper.
At week 52, 56% of patients receiving weekly tocilizumab had achieved sustained remission, as had 53% of those receiving tocilizumab every other week. In contrast, only 14% of patients receiving placebo plus a 26-week prednisone taper, and only 18% of those receiving placebo plus a 52-week taper, had achieved sustained remission (P < .0001 for all comparisons of tocilizumab with placebo).