4 June 2015. A clinical trial of an immune system therapy shows one treatment reduces levels of harmful immune activity and joint inflammation in people with rheumatoid arthritis. The early-stage trial led by researchers at University of Queensland in Brisbane, Australia is reported yesterday in the journal Science Translational Medicine.
Rheumatoid arthritis is an autoimmune disease, where the immune system is tricked into attacking healthy cells, that leads to inflammation of joints (wrists, fingers, feet, and ankles) and surrounding tissue, affecting some 450,000 people in the Australia, according to the university. In the U.S., rheumatoid arthritis is estimated to affect 1.3 million people, making it the most prevalent autoimmune disease. While the rate of occurrence is declining, the disorder occurs in twice as many women as men.
Queensland rheumatology professor Ranjeny Thomas and colleagues aim to treat the disruptions in the immune system causing the joint pain and other symptoms, rather than relieving the symptoms like most current treatments. The therapy they call Rheumavax increases tolerance in people with rheumatoid arthritis for naturally-occurring chemicals in the body known as citrullinated peptides that can activate the immune system to counter the actions causing the pain and inflammation. Most people with rheumatoid arthritis have antibodies that block citrullinated peptides from working.
To encourage the immune system to tolerate citrullinated peptides, the research team — that includes members from Singapore, the Netherlands, and elsewhere in Australia — uses cells from the immune system called dendritic cells that regulate immune tolerance. The researchers first extract dendritic cells from the blood of people with rheumatoid arthritis, culture the cells with citrullinated peptides, then inject the cultured dendritic cells back into the patients.
The team tested Rheumavax in an exploratory clinical trial with individuals having rheumatoid arthritis, and who also have antibodies that block citrullinated peptides from working. Of the 34 participants, 18 received one treatment of Rheumavax in either high or low dosages, while 16 were left untreated for comparison. An earlier safety trial found the treatments caused mild side effects with a short duration. The researchers report the same mild and temporary reactions among patients receiving Rheumavax in the new trial.
After 1 month, participants receiving Rheumavax showed more therapeutic immune system action and fewer rheumatoid arthritis symptoms than people in the untreated group. Individuals treated with Rheumavax had sharply reduced levels of harmful autoimmune T-cells and more helpful regulatory T-cells than the untreated group, as well as reduced levels of proteins encouraging joint inflammation. People receiving Rheumavax also reported less severe joint inflammation and lower disease activity scores, using a standard clinical measure.
Thomas and colleagues from Queensland’s Diamantina Institute founded the company Dendright Pty in 2005 to commercialize their research on autoimmune disorders, where Thomas serves as the company’s chief technologist. Dendright is a subsidiary of Uniquest, Queensland’s technology transfer and commercialization office. In 2013 extended a collaboration with Janssen Biotech, a Johnson & Johnson company, to develop Rheumavax through early-stage clinical trials. Janssen Biotech is funding Dendright’s early-stage trials in return for an option to license the technology, which would make Dendright eligible for development and sales milestone payments, as well as royalties on sales.
Thomas says Rheumavax still needs to be formulated into a more feasible therapeutic vaccine, rather than the multi-stage process used in the clinical trial. “At this stage, the technique would not be ideal for widespread treatment or prevention of rheumatoid arthritis because it’s costly and time-consuming,” Thomas notes in a university statement. “However, the promising results of this trial lay the foundations for the development of a more cost-effective, clinically-practical vaccine technology that could deliver similar outcomes for patients.”
Thomas tells more about Rheumavax in the following video.
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Disclosure: The author owns shares in Johnson & Johnson.
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