New drug expands treatment options for

In its latest phase III clinical trial, a new drug for the treatment of rheumatoid arthritis has been shown to be at least as effective as the current “gold standard” treatment for this autoimmune disease. This opens new treatment options for affected patients. The results of the international multicenter study conducted by MedUni Vienna were recently published in the prestigious New England Journal of Medicine.

Currently, a combination of the drugs adalimumab (which inhibits the inflammation mediator TNF (tumor necrosis factor)) and methotrexate (a folic acid antagonist) is one of the most effective options (“gold standard” ) for patients who do not respond adequately to initial treatment with methotrexate. Despite this and other effective treatment regimens, up to 25% of patients do not respond well to any of the treatment options currently available. The new drug olokizumab is a humanized monoclonal antibody that directly targets the cytokine interleukin-6. It is a messenger molecule which, like TNF, activates inflammatory responses in the body and is implicated in the progression of joint damage in rheumatoid arthritis. Olokizumab is the first direct inhibitor (blocker) of interleukin-6 that will soon be filed for commercial use authorization in this indication.

In this phase III clinical trial with more than 1,600 volunteers, the effectiveness of the new drug in combination with methotrexate was tested against a placebo and adalimumab plus methotrexate. This new therapy has proven to be more effective than placebo and at least as effective as the current gold standard. “The new drug helps many rheumatoid arthritis patients who have failed methotrexate to achieve what is called low disease activity, which is the main therapeutic goal in this population. The complete disappearance of disease symptoms active, called remission, occurs in 1 out of 8 patients,” says study leader Josef Smolen, Division of Rheumatology, Department of Medicine III, MedUni Vienna and University Hospital Vienna. “This new therapy will greatly expand the range of treatment options, as this agent has a different mode of action than all other drugs.”

“This will give us another excellent treatment opportunity for our patients,” says Daniel Aletaha, head of the rheumatology division. “We will soon have another option for patients who do not respond to first treatment or subsequent treatments.”

The new drug is set to be filed for approval in the EU and US in the coming year. Researchers expect it to be in clinical use soon after.

About Rheumatoid Arthritis
Rheumatoid arthritis is a chronic autoimmune disease that mainly affects women (about two-thirds of those affected) and is usually diagnosed between the ages of 40 and 70. About 1% of the world’s population suffers from rheumatoid arthritis. The disease causes inflammation of the joints, leading to swelling, overheating and functional disorders. If left untreated, it leads to progressive destruction of joints and nearby bone, causing misalignment, malformation, and permanent and progressive disability. About 80,000 people in Austria suffer from this disease.


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About Antoine L. Cassell

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