Actemra: Preliminary Phase IV data

Preliminary data from the double-blind Phase IV ADACTA trial in 326 patients with severe active RA who either have an intolerance to methotrexate or in whom continued methotrexate is inappropriate showed that 8 mg/kg IV Actemra every 4 weeks met the primary endpoint of reducing disease activity as measured by the mean change in DAS28 score from baseline to week 24 vs. 40 mg subcutaneous Humira adalimumab every 2 weeks. Actemra also met the secondary endpoints of improving ACR20, ACR50 and ACR70 response vs. Humira. Additionally, a significantly greater proportion of patients receiving Actemra achieved low disease activity (DAS28 score of <=3.2 points) and clinical remission (DAS28 score of <2.6 points) at week 24 vs. Humira. Rates of adverse events were similar between treatment groups.

Actemra is approved in the U.S. to treat systemic juvenile idiopathic arthritis (sJIA), moderate to severe RA and for the inhibition and slowing of joint damage, improvement of physical function and achievement of major clinical response in RA patients. The drug is approved as RoActemra in the EU for RA and sJIA in patients ages >=2 years who have responded inadequately to NSAIDs, systemic corticosteroids or methotrexate. The product is also approved for RA in Australia, Brazil, India, Japan and Switzerland. Chugai, which is majority owned by Roche, co-developed the product and markets it in Japan. ...