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 References
Rheumatoid arthritis (RA) is an autoimmune inflammatory disease. In RA, the immune system mistakenly attacks healthy cells in your body, which causes joint swelling, pain, and stiffness. RA can also affect other areas, including your lungs, heart, and eyes. About 1.5 million people in the United States have RA. While there’s currently no cure for the disease, researchers have identified many treatments in recent years that can help lessen symptoms and minimize joint damage.
Read on to learn more about new and experimental therapies for RA management. Grace Cary / Getty Images Experimental therapies are new treatments that show promise but aren’t yet proven for treating certain medical conditions, such as RA. Researchers test these therapies in clinical trials to see how well they work. If the medicines are shown to be safe and effective in clinical trials, the Food and Drug Administration (FDA) may approve them for use in the general public. The latest treatments for RA may help patients find more relief, so they can get back to doing what they enjoy most. JAK inhibitors are some of the newest treatments to gain FDA approval for RA. These medications come in pill form and help stop a person’s immune system from producing certain enzymes that can stimulate inflammation. JAK inhibitors may be used alone or with other RA medicines for a compound effect.
The FDA has approved the following JAK inhibitors for RA:
Researchers are expecting more of these types of drugs to be approved in the future. Researchers are studying an experimental medicine called fenebrutinib, which blocks the action of Bruton’s tyrosine kinase (BTK), an enzyme that promotes inflammation in the body. In a phase 2 clinical trial, fenebrutinib was effective at reducing RA activity in patients with an inadequate response to other treatments. Fenebrutinib showed similar results when compared to the popular RA drug Humira (adalimumab). While more research is needed, scientists are excited about the potential of BTK inhibitors for helping people with RA. Researchers are studying the potential of vagus nerve stimulation, a treatment that uses electrical impulses to stimulate the vagus nerve, which runs from the brain stem to the stomach. This nerve is involved in regulating inflammation in the body. In a small pilot study, investigators implanted vagus nerve neurostimulators or placebos in 14 people with RA. Results showed that four out of six of the patients who received the vagus nerve stimulation once a day for 12 weeks reported symptom improvement.
Vagus nerve stimulation has also been used to treat other conditions, such as epilepsy and depression. In recent years, several clinical trials have been conducted to test supplements as possible treatments for RA. Some compounds that have shown promise for RA include: You should always talk to your healthcare provider before using a supplement, as many can interact with other medications you take. Several other treatments are on the horizon for RA. For example, researchers in Australia are conducting the first human trial of DEN-181, a vaccine for people with RA. Scientists are also experimenting with ways to train stem cells to become “smart cells” by fighting inflammation, turning on and off, and delivering biologic drugs. Treatments for RA have evolved dramatically over the last three decades. Some of the first therapies focused only on providing symptom relief. Then, treatment options progressed to impact disease activity and slow joint damage. If you have RA, staying informed about the latest treatment options can be helpful. You might want to share information you learn with your healthcare provider and ask if you're a candidate for new therapies. Some helpful resources to check out include:
RA therapies can be costly. In fact, biologic medicines are some of the most expensive drugs on the market, costing, on average, $10,000 to $30,000 a year. The most expensive can run more than $500,000. If you can’t afford your recommended medications, talk to your healthcare provider or pharmacist about ways to cut your costs. Many organizations, such as Good Days, provide financial assistance to people with chronic illnesses. Drug companies may also offer discounts to patients in need. It also might help to check out websites like GoodRx and RxSaver for coupons and where to find the lowest prices in your area. As with most treatments, RA drugs can cause unwanted symptoms. Possible side effects of JAK inhibitors include:
In September 2021, the FDA announced that JAK inhibitors are required to carry warnings about an increased risk of heart-related events, cancer, blood clots, and death. Making lifestyle changes or trying complementary and alternative medicine (CAM) therapies may help reduce symptoms in people with RA. Some approaches that may be useful include:
Rheumatoid arthritis is an inflammatory autoimmune disease affecting the joints. Though effective treatment options are available, scientists are always looking for new and better ways to treat RA. JAK inhibitors, BTK inhibitors, vagus nerve stimulation, stem cells, and vaccines are some novel treatments being explored. As researchers and healthcare providers learn more about what causes RA, therapeutic options are likely to improve even more in the coming years. If you live with RA, you likely experience pain that impacts your daily life. Fortunately, experimental treatments are showing promise. Some are already available, and others may be an option soon. Arming yourself with information about your disease and available therapies can help you manage your condition. Frequently Asked Questions
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