Roche reports positive results from Phase III arthritis studies

Results of the Radiate study, which evaluated difficult-to-treat patients who failed to respond to prior anti-tumor necrosis factor (TNF)-alpha therapies, demonstrated that half of the patients treated with Actemra (8mg/kg) in combination with methotrexate achieved a 20% reduction (ACR20) in rheumatoid arthritis (RA) signs and symptoms, compared with 10% of patients treated with methotrexate alone.

Radiate, a three-arm, randomized, double-blind, placebo-controlled study, was designed to evaluate the safety and efficacy of Actemra plus methotrexate compared with placebo plus methotrexate in patients who failed to adequately respond to anti-TNF-alpha medications alone. Treatment with Actemra and methotrexate showed significant clinical benefits even in the subgroup analysis of difficult-to-treat patients who received up to three anti-TNF-alpha therapies that failed.

The Ambition study, which examined the effects of Actemra (8mg/kg) as monotherapy, showed that 70% of patients receiving Actemra achieved a 20% improvement in their signs and symptoms (ACR20), compared with 53% of patients receiving methotrexate alone. The study not only successfully met its primary endpoint of non-inferiority in patients with moderate to severe RA, but also demonstrated superiority over the standard effective dose regimen of methotrexate alone.

Ambition, a two-arm, randomized, double-blind, placebo-controlled study, was designed to evaluate the non-inferiority and subsequent superiority of Actemra monotherapy in patients with RA compared with methotrexate alone at 24 weeks.
In both studies, nearly one-third of all Actemra (8mg/kg) patients achieved disease remission and Actemra was generally well-tolerated compared with existing therapies.