GiACTA Study Shows Benefit of Adding Tocilizumab to Steroid Taper in Giant Cell Arteritis Save

The GiACTA study has published its top line results demonstrating the efficacy of adding tocilizumab (TCZ) to steroid-tapered therapy in patients with giant cell arteritis (GCA). 

GiACTA is a 52-week, Phase III, global, randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of tocilizumab in patients with GCA. The trial include 251 patients from 14 countries. 

Patients were randomized to receive either TCZ 162 mg subcutaneously weekly or every 2 weeks or placebo for 52 weeks, with tapering oral daily doses of prednisone. At week 52, those in remission will stop study treatment and enter long-term follow-up, and patients with disease activity or flares will receive open-label TCZ 162 mg subcutaneously weekly for up to 104 weeks (MD discretion). The primary endpoint was percentage achieving sustained remission at Week 52 (TCZ + 26 weeks prednisone taper versus placebo + 26 weeks prednisone taper).

The study met its primary and key secondary endpoints, showing TCZ, initially combined with a six-month steroid regimen, more effectively sustained remission through one year compared to a six or 12-month steroid-only regimen in people with newly diagnosed and relapsing GCA. No new safety signals were observed at the time of this analysis. Adverse events were similar to those seen in previous TCZ developmental clinical studies.