(Arthritis & Rheumatism) -- Ankylosing Spondylitis (AS) is a serious form of arthritis, marked by inflammation of the joints of the spine. Although this disease affects both sexes, the majority of AS patients are young men.

When in their twenties and thirties, patients with AS begin to develop chronic low back pain and general stiffness. The disease can fuse the spine and lead to serious problems of the hip and other joints. This may occur gradually but may also happen rather rapidly. Because it strikes at such a young age, and because its early symptoms are often overlooked, AS can be difficult to treat. Currently, therapy for AS usually consists of nonsteroidal anti-inflammatory drugs (NSAIDs) and physiotherapy. This therapy, however, has shown limited ability to relieve the pain of AS, or reduce its negative impact on quality of life.

A recent study offers new hope for treating AS, with a novel drug that has proven highly effective in easing the symptoms rheumatoid Arthritis (RA), another serious form of inflammatory arthritis. In a six-month clinical trial, a team of researchers affiliated with the German Rheumatology Research Center in Berlin tested the effectiveness of etanercept--a fully human protein that inhibits tumor necrosis factor (TNF), a major culprit for joint inflammation--on patients with AS. Published in the June 2003 issue of Arthritis & Rheumatism, the results of this study showed a dramatic reduction of disease activity through a course of treatment combining etanercept with NSAIDs.

In addition to its success in the treatment of RA, studies have documented etanercept as an effective therapy for Juvenile Rheumatoid Arthritis (JRA). In this new study, etanercept was shown as clearly effective in treating the progression of the painful and debilitating inflammation characteristic of AS.

The study included 30 male patients in their thirties with active AS. Prior to and throughout the study, the patients were treated with NSAIDs, but all other therapies--disease- modifying anti-rheumatic drugs (DMARDs) and steroids--were discontinued. The subjects were randomly divided into two groups. For the first phase of the study, a total of six weeks, 14 of the AS patients were treated with etanercept (25 milligrams twice weekly) and 16 of the AS patients were given a placebo. For the next and final phase of the study, another six-week period, all 30 of the AS patients were treated with etanercept.

Treatment with etanercept resulted in at least a 50 percent regression of disease activity in 57 percent of the AS patients at week six, compared with a mere 6 percent of the placebo-treated patients. After the placebo-treated patients switched to etanercept, 56 percent improved, significantly. While being treated with etanercept, the AS patients overwhelming reported improvements in mobility, which were confirmed by a battery of tests, as well as relief from pain and stiffness. No severe adverse events, including major infections, were observed during the clinical trial. After the cessation of the etanercept therapy, almost all patients experienced a relapse of pronounced AS symptoms within a few weeks.

"The findings of this trial not only confirm the clear-cut efficacy of etanercept in the treatment of patients with active AS who are receiving conventional NSAID therapy," observes research team spokesperson Dr. J. Brandt, "but also show that no additional therapy with DMARDs and steroids is needed to obtain the results." Noting the compelling fact of relapse after withdrawing etanercept treatment, Dr. Brandt suggests: "It seems probable that etanercept must be administered continually in most AS patients to achieve permanent inhibition of the inflammatory process."