Scientists from MedUni Vienna found that a new drug for treating rheumatoid arthritis has proved to be at least as effective as the current “gold standard” treatment for this autoimmune disease.
This opens up new treatment options for affected patients.
Currently, a combination of the drugs adalimumab (which inhibits the mediator of inflammation TNF (tumor necrosis factor) and methotrexate (a folic acid antagonist) is one of the most effective options (“gold standard”) for patients who fail to respond adequately to initial treatment with methotrexate.
Despite this and other effective drug regimens, up to 25% of patients do not respond well to any of the currently available therapeutic options.
The new drug olokizumab is a humanized monoclonal antibody that directly targets the interleukin-6 cytokine.
This is a messenger molecule that, like TNF, activates inflammatory responses in the body and is involved in the progression of joint damage in rheumatoid arthritis.
Olokizumab is the first direct inhibitor (blocker) of interleukin-6 which will soon be filed for approval for commercial use for this indication.
In this study with more than 1,600 volunteers, the efficacy of the new drug in combination with methotrexate was tested against placebo and adalimumab plus methotrexate.
The team found this new therapy proved to be more efficacious than a placebo and at least as effective as the current gold standard.
The new drug helps many patients with rheumatoid arthritis who failed methotrexate to achieve so-called low disease activity, which is the primary goal in this population.
The team also found complete disappearance of symptoms of active disease, so-called remission, occurs in 1 out of 8 patients.
This new therapy will strongly expand the range of treatment options since this agent has a different mode of action than all other drugs.
The new drug is about to be filed for approval in the EU and the U.S. within the coming year. The researchers expect it to be in clinical use soon thereafter.
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The research was published in the New England Journal of Medicine and conducted by Josef Smolen et al.
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