NOV 15, 2016
Phase 3 results for tocilizumab (Actemra), a novel interleukin-6 (IL-6) receptor antagonist, shows it outperforms steroid-only treatment for treatment of giant cell arteritis.
Genentech says the multinational, double-blind, placebo-controlled trial met its primary and key secondary endpoints by showing treated subjects were significantly more likely to achieve sustained disease remission and reduced steroid exposure compared with patients on a steroid-only regimen.
If approved, tocilizumab will be the first GCA therapy approved in more than 50 years.
Patients were randomized to receive 162 mg of subcutaneous tocilizumab once or twice weekly for 52 weeks in combination with a 6-month daily oral prednisone taper or a 6- or 12-month prednisone-only regimen.
At 1 year, 56% (P<0.0001) of once-weekly patients and 53.1% of twice-weekly (P=0.0002) patients reached sustained remission, compared with only 17.6% and 14% of 12 and 6-month steroid-only patients, respectively. No new safety signals were observed.
Results will be submitted to the FDA and other regulatory authorities around the world by the end of 2016. A 104-week, open label extension study on the drug’s long-term safety and treatment duration is ongoing.
Tocilizumab is already approved in the U.S. and other countries for treatment of rheumatoid arthritis and both polyarticular and systemic juvenile idiopathic arthritis. IL-6 inhibitors have been shown especially beneficial in individuals who do not respond to TNF inhibitors.