By Pat Anson, PNN Editor

A biologic drug used to treat rheumatoid arthritis and other autoimmune conditions appears to be effective in preventing the disease from developing, according to the results of a mid-stage clinical trial.

Abatacept is a disease modifying antibody that was approved by the FDA in 2005 to treat moderate to severe rheumatoid arthritis (RA). Sold under the brand name Orencia, the drug interferes with the immune activity of T-cells, which helps reduce the inflammation and joint pain caused by RA. Abatacept is also used to treat psoriatic arthritis and juvenile idiopathic arthritis.

In the phase 2b clinical trial, 213 adult patients in the UK and the Netherlands at high risk of RA were randomly divided into two groups. One group was given weekly injections of abatacept for a year, while the other group received a placebo. Their progress was followed for another 12 months.

The study findings, recently published in The Lancet, show that only 6% of participants in the abatacept group were diagnosed with RA during the treatment period, compared to 29% in the placebo group. After 24 months, 25% of patients in the abatacept group progressed to RA, compared to 37% in the placebo group.

Patients on abatacept also reported lower pain scores, better physical function and quality of life, and had less inflammation in their joints.

“This is the largest rheumatoid arthritis prevention trial to date and the first to show that a therapy licensed for use in treating established rheumatoid arthritis is also effective in preventing the onset of disease in people at risk,” lead author Andrew Cope, PhD, head of King’s College London Center for Rheumatic Diseases, said in a news release.

“These initial results could be good news for people at risk of arthritis, as we show that the drug not only prevents disease onset during the treatment phase but can also ease symptoms such as pain and fatigue.”

One of the patients who participated in the trial was Philip Day, a 35-year-old software engineer and soccer player who had to give up the sport due to joint pain. He was considered at high risk of RA.

“The pain was unpredictable, it would show up in my knees one day, my elbows the next, and then my wrists or even my neck. At the time, my wife and I wanted to have children and I realized my future was pretty bleak if the disease progressed,” Day said.

“Enrolling in the trial was a no-brainer; it was a ray of hope at a dark time. Within a few months I had no more aches or pains and five years on I’d say I’ve been cured. Now, I can play football (soccer) with my three-year-old son and have a normal life.”

There are a few caveats about abatacept. A year’s worth of treatment in the U.S. costs about $37,500, depending on insurance. Most insurers consider abatacept a second or third-line therapy, and won’t pay for it unless other medications are tried first.

Like other biologic drugs that suppress the immune system, abatacept can have adverse side effects such as respiratory tract infections, pneumonia, flu, dizziness, nausea and diarrhea. Abatacept can also interfere with the effectiveness of vaccines.

Those are risks that many RA patients may be willing to accept, given the progressive nature of the disease, which cannot be cured and often results in disability.

“There are currently no drugs available that prevent this potentially crippling disease. Our next steps are to understand people at risk in more detail so that we can be absolutely sure that those at highest risk of developing rheumatoid arthritis receive the drug,” said Cope.

The abatacept study was funded by Bristol Myers Squibb, the maker of Orencia.