In a phase 3 trial, tocilizumab showed positive phase 3 trial results for patients with giant cell arteritis.
“The publication of these phase 3 results in The New England Journal of Medicine validates the significance of our considerable basic and clinical autoimmune disease research in medical practice,” Sandra Horning, MD, chief medical officer and head of Global Product Development, said in a press release from Genentech. “The data from the GiACTA supported the FDA approval of the first new treatment option for patients with [giant cell arteritis] GCA in more than 50 years, and we are committed to continuing to explore new treatment options for autoimmune diseases with significant unmet medical need.”
John H. Stone, MD, MPH, and colleagues assessed 251 patients who were randomized to receive 162-mg subcutaneous tocilizumab weekly or every other week in combination with a prednisone taper or placebo in combination with prednisone taper for 26 weeks or 52 weeks. The primary outcome was sustained glucocorticoid-free remission after 52 weeks for both tocilizumab groups in comparison with the 26-week prednisone-taper placebo group.
Investigators found sustained remission occurred in 56% of patients who were treated with weekly tocilizumab compared with 53% of patients who were treated with tocilizumab every other week. This was found in 14% of the 26-week placebo group and in 18% of the 52-week placebo group. The cumulative median dose of prednisone was 1,862 mg for the 52-week tocilizumab groups compared with 3,296 mg for the 26-week placebo group and 3,818 mg in the 52-week placebo group. There were serious adverse events in 15% of patients who received weekly tocilizumab, in 14% of patients who received tocilizumab every other week, in 22% of the 26-week placebo group and in 25% of the 52-week placebo group. – by Will Offit
Disclosures: Stone reports grant support and personal fees from Roche, Genentech and Xencor outside the submitted work. Please see the full study for a list of all other authors’ relevant financial disclosures.