Researchers expect to file for FDA approval within the year following the successful phase 3 trial.
Olokizumab, a new treatment for rheumatoid arthritis, may be as effective as current “gold standard” treatments, according to results from a phase 3 clinical trial published in the New England Journal of Medicine.1,2
The current gold standard treatment for rheumatoid arthritis combines a monoclonal antibody and TNF (tumor necrosis factor) inhibitor called adalimumab with a folic acid antagonist called methotrexate. It is most effective for patients who do not respond to methotrexate alone.1
"This new therapy will significantly expand the range of treatment options, since this agent has a different mode of action than all other drugs," said study lead Josef Smolen, MD, in a press release.1
Rheumatoid arthritis is a chronic autoimmune disease affecting individuals aged 40 to 70 and more than 65% of patients are women.3 The disease inflames the joints, which can impact the bones and cause permanent disability if left untreated.3 Although many patients benefit from current therapies like methotrexate and adalimumab—among other treatment options—they are not effective for approximately 25% of patients.
Olokizumab, the new drug under consideration, is a humanized monoclonal antibody like adalimumab. It is similar to TNF drugs because it acts like a messenger molecule.2 Olokizumab, however, directly inhibits immune signaling from interleukin-6 cytokine molecules, which cause inflammation and joint damage because they activate the body’s inflammatory responses.1
Researchers determined the efficacy of olokizumab with methotrexate in 1600 patients who were unresponsive to first-line methotrexate.2 The researchers compared the olokizumab treatment with a placebo and standard combination adalimumab with methotrexate. After being divided into 4 groups, participants either received olokizumab every 2 weeks, olokizumab every 4 weeks, adalimumab every 2 weeks, or the placebo.2
After 24 weeks, researchers found that treatment with olokizumab was more effective than the placebo and at least as effective as adalimumab treatment.2 Although researchers determined olokizumab was marginally more effective than adalimumab, it was not significant enough to boast superiority.2
"The new drug helps many patients with rheumatoid arthritis who failed methotrexate to achieve so-called low disease activity, which is the primary therapeutic goal in this population. Complete disappearance of symptoms of active disease, so-called remission, occurs in 1 out of 8 patients," Smolen said in the press release.1
It is expected that olokizumab will reach market approval in the US and Europe within the next year.1
"This will give us another excellent treatment opportunity for our patients," said Daniel Aletaha, Head of the Division of Rheumatology, MD, MS, in a press release. "We soon will have another option for those patients who do not respond to a first or subsequent therapies."1