New rheumatoid arthritis drug passes Phase 3 trial, looks to approval
Research published in The New England Journal of Medicine has reported positive Phase 3 trial results for a new monoclonal antibody treatment targeting rheumatoid arthritis. The novel therapy is hoped to offer a new option for patients struggling with current treatment options and should be available within the next 12 months.
One of the most common current treatments for severe rheumatoid arthritis is a monoclonal antibody called adalimumab. This treatment inhibits an immune signaling molecule called tumor necrosis factor (TNF), which has been found to reduce inflammation associated with the condition.
But TNF inhibitors don’t work for all patients. Around 25 percent of rheumatoid arthritis patients don’t respond to any currently available treatment. So there is a need for more options.
Olokizumab is a new kind of monoclonal antibody. Instead of targeting inflammatory TNF molecules, this antibody aims to inhibit a different immune molecule, called interleukin-6 (IL-6).
IL-6, like TNF, plays a significant role in immune signaling, and inhibiting this molecule can reduce the inflammation associated with autoimmune diseases such as rheumatoid arthritis.
There is a monoclonal antibody treatment currently on the market called tocilizumab, which targets IL-6. However, tocilizumab works by binding to IL-6 receptors, and blocking the immune signal that way, whereas olokizumab directly engages with IL-6 molecules.
This newly published study reports the results of a Phase 3 human trial testing olokizumab. The trial recruited 1,648 volunteers with rheumatoid arthritis who were unresponsive to methotrexate, an immunosuppressive drug often used as a first-line treatment for the disease. The cohort was split into four groups: olokizumab every two weeks, olokizumab every four weeks, adalimumab every two weeks, or placebo.
Across all measures, after 24 weeks, both dose levels of olokizumab were significantly effective compared to placebo. Although olokizumab was found to be marginally more effective than adalimumab, the researchers suggest the increase was not statistically significant enough to consider it superior. But, the fact it was at least as equally effective as adalimumab means it should be a promising new option for patients not responding to that currently available treatment.
"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,” said lead on the trial, Josef Smolen from University Hospital Vienna. “Complete disappearance of symptoms of active disease, so called remission, occurs in one out of eight patients. This new therapy will significantly expand the range of treatment options, since this agent has a different mode of action than all other drugs.”
The researchers expect the company developing olokizumab will use this new data to file for market approval with drug regulatory bodies in the US and Europe over the next six to 12 months.
The new research was published in The New England Journal of Medicine.
Source: Medical University of Vienna