Study: Olokinzumab As Effective as “Gold Standard” Treatment for Rheumatoid Arthritis

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

References

1. New drug expands treatment opportunities for rheumatoid arthritis. Medical University of Vienna; August 25, 2022. Accessed August 26, 2022. https://www.eurekalert.org/news-releases/962836
2. Haridy, R. New rheumatoid arthritis drug passes Phase 3 trial, looks to approval. New Atlas; August 25, 2022. Accessed August 26, 2022. https://newatlas.com/health-wellbeing/olokizumab-rheumatoid-arthritis-phase3-monoclonal-antibody/
3. Cornall, J. New drug boosts options for rheumatoid arthritis treatment. Labiotech; August 25, 2022. Accessed August 26, 2022. https://www.labiotech.eu/trends-news/rheumatoid-arthritis-treatment/