Are vaccinations the future of rheumatoid arthritis treatment?

This study investigated whether a new vaccination for rheumatoid arthritis could improve patients' symptoms.

Vaccinations are generally used to prepare peoples’ immune system to fight a bacteria or a virus they might one day come in contact with, like measles or the flu. It is now possible that a vaccination could be used to help a patients’ immune system fight against proteins produced by their own bodies when they have certain diseases.

Tumor necrosis factor alpha (TNFalpha) is a protein mainly produced by immune cells. In patients with rheumatoid arthritis the levels of TNFalpha are high in the fluid surrounding joints. It contributes to the inflammation and damage that occurs in the joints. As a result, new drugs that block TNFalpha (for example adalimumab [Humira]) are used to treat rheumatoid arthritis. These drugs have been very successful, but for some patients they have no effect. For those patients a vaccination that causes the immune system to fight TNFalpha could reduce the signs and symptoms of rheumatoid arthritis.

This study included 40 patients who had not responded to drugs that block TNFalpha. Patients were divided into 4 groups to test the safety and efficacy of a vaccine called TNF-Kinoid. 10 patients received a placebo (a substance with no effect on the body used as a comparison), 6 patients received 90 µg of TNF-Kinoid, 12 patients received 180 µg of TNF-Kinoid and 12 patients received 360 µg of TNF-Kinoid. Half the patients in each group received 2 injections (on days 0 and 28) and the other half received 3 injections (on days 0, 7 and 28).

The best response was seen in patients who were vaccinated 3 times with the highest dose of TNF-Kinoid. However, the response was not significant compared to the other groups. The best clinical improvement, or decrease in symptoms, was seen in patients who developed the proteins needed to fight TNFalpha after vaccination. After 12 months they had significantly less inflammation, less tender and swollen joints, and better health related quality of life.

Adverse event rates were similar between patients receiving the placebo and patients receiving the TNF-Kinoid vaccination. Serious adverse events occurred in 13.3% of patients treated with TNF-Kinoid compared to 30.0% of patients treated with the placebo. None of the adverse events reported were related to the treatment.

The authors suggest that the TNF-Kinoid vaccine is safe and might lead to clinical improvements. They highlight that future studies are needed to examine if higher or more frequent doses would be more successful.

This was a small pilot study. The TNF-Kinoid vaccine is not currently approved for use in patients and future trials are needed before it could get FDA approval. This study was funded by Neovacs, who are currently developing and testing the TNF-Kinoid vaccine.