Genentech announced that the FDA has approved Actemra (tocilizumab injection) for the inhibition and slowing of structural joint damage, improvement of physical function, and achievement of major clinical response in adult patients with moderately to severely active rheumatoid arthritis (RA), when given in combination with methotrexate (MTX). This approval was based on data from the Phase 3, randomized, double-blind, placebo-controlled LITHE trial which demonstrated that patients receiving Actemra 4mg/kg or 8mg/kg in combination with MTX had significantly less damage to their joints at one year, compared to patients who received MTX plus placebo.

The study also showed that patients who received Actemra 4mg/kg or 8mg/kg plus MTX showed significant improvement in physical function, compared with patients who received MTX plus placebo at week 52 (63% and 60%, respectively, compared to 53%). More patients treated with Actemra also achieved major clinical response (7% and 4%, respectively), defined as achieving an American College of Rheumatology Criteria (ACR) 70 response for a continuous 24-week period, compared to MTX plus placebo (1%).

Actemra is already indicated to treat moderately to severe active RA in adult patients after an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. It can be used as monotherapy or in combination with MTX or other disease modifying anti-rheumatic drugs (DMARDS).

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