By Bill Berkrot
NEW YORK, Oct 17 (Reuters) - Roche's rheumatoid arthritis drug, Actemra, significantly halted theprogression of joint damage in patients with rheumatoid arthritis for two years when combined with the common treatment methotrexate, according to data from a late-stage clinical trial.
Actemra, a biotechnology medicine that is administered by infusion once every four weeks, is already available in Europe, but is still awaiting a U.S. approval decision.
In the two-year study involving nearly 1,200 subjects with rheumatoid arthritis, significantly more patients who received either the 4 milligrams per kilogram of body weight dose of Actemra, or 8 mg/kg dose plus methotrexate had no progression of joint damage than those who received methotrexate alone, the company said.
At two years, 75 percent in the 4 mg/kg group and 83 percent of the 8 mg/kg Actemra group had no joint damage progression, compared with 66 percent of patients on methotrexate alone, according to data to be presented next week at the American College of Rheumatology meeting in Philadelphia.
The study also showed that patients who received either dose of Actemra plus methotrexate showed significant improvement in physical function, compared with those who received methotrexate plus placebo, Roche said.
In addition, 65 percent of patients who received Actemra at 8 mg/kg plus methotrexate for two years had a DAS28 remission score of 2.6 or less compared with 48 percent of people treated for just one year, the company said. A DAS28 remission rate of 2.6 or less, means the disease was no longer active or reduced to near remission.
'This study showed that Actemra both improved physical function and delayed progression of joint damage in people with moderate to severe RA and importantly, that benefit was sustained for two years,' Hal Barron, chief medical officer at Genentech, which is now wholly owned by Roche Holding AG, said in a statement.
Actemra works by inhibiting the action of interleukin-6, a protein involved in inflammation that also affects a variety of tissues and organ systems in the body.
In January, it was approved in Europe to treat adults with moderate to severe active rheumatoid arthritis who failed to respond to, or were unable to tolerate, treatment with other RA medicines.
The U.S. Food and Drug Administration had requested additional data on the potential billion-dollar a year treatment late last year and accepted Roche's resubmission of an approval application in late July. The FDA is expected to make its decision in January.
(Reporting by Bill Berkrot; editing by Andre Grenon) Keywords: RHEUMATOLOGY/ROCHE (bill.berkrot@thomsonreuters.com +1 646 223-6030; Reuters Messaging: bill.berkrot.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
NEW YORK, Oct 17 (Reuters) - Roche's rheumatoid arthritis drug, Actemra, significantly halted theprogression of joint damage in patients with rheumatoid arthritis for two years when combined with the common treatment methotrexate, according to data from a late-stage clinical trial.
Actemra, a biotechnology medicine that is administered by infusion once every four weeks, is already available in Europe, but is still awaiting a U.S. approval decision.
In the two-year study involving nearly 1,200 subjects with rheumatoid arthritis, significantly more patients who received either the 4 milligrams per kilogram of body weight dose of Actemra, or 8 mg/kg dose plus methotrexate had no progression of joint damage than those who received methotrexate alone, the company said.
At two years, 75 percent in the 4 mg/kg group and 83 percent of the 8 mg/kg Actemra group had no joint damage progression, compared with 66 percent of patients on methotrexate alone, according to data to be presented next week at the American College of Rheumatology meeting in Philadelphia.
The study also showed that patients who received either dose of Actemra plus methotrexate showed significant improvement in physical function, compared with those who received methotrexate plus placebo, Roche said.
In addition, 65 percent of patients who received Actemra at 8 mg/kg plus methotrexate for two years had a DAS28 remission score of 2.6 or less compared with 48 percent of people treated for just one year, the company said. A DAS28 remission rate of 2.6 or less, means the disease was no longer active or reduced to near remission.
'This study showed that Actemra both improved physical function and delayed progression of joint damage in people with moderate to severe RA and importantly, that benefit was sustained for two years,' Hal Barron, chief medical officer at Genentech, which is now wholly owned by Roche Holding AG, said in a statement.
Actemra works by inhibiting the action of interleukin-6, a protein involved in inflammation that also affects a variety of tissues and organ systems in the body.
In January, it was approved in Europe to treat adults with moderate to severe active rheumatoid arthritis who failed to respond to, or were unable to tolerate, treatment with other RA medicines.
The U.S. Food and Drug Administration had requested additional data on the potential billion-dollar a year treatment late last year and accepted Roche's resubmission of an approval application in late July. The FDA is expected to make its decision in January.
(Reporting by Bill Berkrot; editing by Andre Grenon) Keywords: RHEUMATOLOGY/ROCHE (bill.berkrot@thomsonreuters.com +1 646 223-6030; Reuters Messaging: bill.berkrot.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.