New Drug for Rheumatoid Arthritis May Provide Another Treatment Option

Rheumatoid arthritis (RA) is a painful autoimmune disease of the joints that causes pain and loss of function. A clinical trial of a new drug called olokizumab showed it was at least as effective as the currently available standard treatments for RA.

Mild RA can be treated with nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen or corticosteroids.

The current standard of care for moderate-to-severe RA is using one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate, adalimumab, or tofacitinib.

If it is approved, olokizumab could give RA patients another choice of treatment.

Olokizumab for RA

A recent study published in the New England Journal of Medicine showed that olokizumab worked better than a placebo for treating RA patients. It also worked as well as a standard RA treatment, adalimumab (the generic name for Humira).

The study was a phase III clinical trial—one of the final steps needed before the Food and Drug Administration (FDA) considers a drug for approval.

The researchers enrolled 464 RA patients who had not had a good response to methotrexate. The patients were put into different groups.

The patients were put into one of four treatment groups to get an under-the-skin (subcutaneous) injection during the trial:

• One group got olokizumab every two weeks
• One group got olokizumab every four weeks
• One group got adalimumab every four weeks
• One group got a placebo injection for the length of the trial

All patients continued to take methotrexate in addition to the treatment they were assigned for the duration of the study.

The main goal was to see if olokizumab reduced the number of swollen or tender joints a patient had by 20% or more as well as produced improvements by 20% or more after 12 weeks of treatment. This endpoint is known as the American College of Rheumatology 20 (ACR20) response.

When they looked at how the patients were doing at week 12, the researchers found that:

• About 67% of the patients that received adalimumab had an ACR20 response
• About 70% of the patients that received olokizumab every two weeks had an ACR20 response
• About 71% of the patients that received olokizumab every four weeks had an ACR20 response
• About 44% of patients in the placebo group had an ACR20 response

On Par With Current Treatment

The researchers concluded that olokizumab was “superior” to the placebo and “non-inferior” to adalimumab.

Brett Smith, DO, a rheumatologist with Tennessee Direct Rheumatology and East Tennessee Children’s Hospital, told Verywell that these results were not surprising and that olokizumab is “within the vicinity of prior studies”—meaning that it meets the expectations for phase III trials.

While those words might be meaningful for researchers and providers, what about patients?

Smith—who was not involved in the study—said that “non-inferior” is a statistical term. Researchers choose endpoints like “superiority” and “non-inferiority” as measures that get set before a study starts.

When you’re looking at just the numbers from the olokizumab trial, Smith said that “the response is better—but statistically, the response is considered the same.”

According to Smith, that means we can’t accurately say that olokizumab is superior or better than adalimumab, but that the findings did show that olokizumab is certainly better than placebo.

Donald Miller, PharmD, a professor in the department of pharmacy practice at North Dakota State University School of Medicine, told Verywell that the study’s findings would be expected because olokizumab “works in a similar way to tocilizumab and sarilumab [two similar drugs already on the market].”

Miller said that while providers “can say olokizumab is another alternative to Humira,” it “is unlikely to offer an advantage.”

It could also come with some downsides. About 70% of patients who received olokizumab in the trial experienced mild-to-moderate adverse events—mostly infections. However, that’s not uncommon with DMARDs.

Giving RA Patients More Treatment Options

Some drugs used to treat RA work by targeting the interleukin-6 receptor, a protein that plays a role in the immune response in the body. Others inhibit specific chemicals, like tumor necrosis factor.

Olokizumab is a monoclonal antibody that binds directly with interleukin-6 and blocks its action.

A patient with RA might try one type of treatment only to find it doesn’t help. Others start out on one therapy and it works for a while, then stops working. In these circumstances, having another option could make a big difference in helping them manage the disease.

“Additional options are usually a benefit for patients with rheumatoid arthritis,” Smith said. “Changing the target in RA—even within classes of biologics—can be effective enough to improve disease activity and quality of life in many patients. A patient and physician could consider switching to olokizumab if there was an inadequate response to a product like adalimumab, as changing mechanism of action of a drug can be very effective in patients with RA.”

While the research is promising and could mean there’s a potential for another treatment choice in the future, at this point, olokizumab still is not approved by the Food and Drug Administration (FDA).

Miller said that generally, the FDA “wants to see at least two independent studies so that we have data on more patients for a longer time.”

Therefore, Miller doubts that olokizumab will be approved based on this study alone.

The researchers would agree, as they acknowledged that more—and longer-lasting—studies are needed to determine if olokizumab is an effective and safe RA treatment.