Remicade (Infliximab) Highly Effective in Ankylosing Spondylitis

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Remicade (Infliximab) Highly Effective in Ankylosing Spondylitis

BERLIN, GERMANY -- April 4, 2002 -- For the first time, there is a therapy that

can significantly reduce disease activity for the majority of patients with

ankylosing spondylitis (AS), a chronic inflammatory rheumatic disease that often

leads to stiffening and subsequent fusion of the spine.

The study, to be published in the April 6 issue of The Lancet, found more than

80 percent of patients treated with Remicade (infliximab) experienced clinical

improvement and more than 50 percent had their disease activity reduced by more

than half.

" Treatment with infliximab, a biological medication from the new group of tumor

necrosis factor alpha (TNF-alpha) blockers, can be regarded as a breakthrough

for patients suffering from ankylosing spondylitis, " emphasizes rheumatologist

Dr. Jurgen Braun, lead physician at the Rheumatological Center in Herne and

professor at the Free University of Berlin. The study was conducted together

with his colleagues Dr. Jochen Sieper and Dr. Jan Brandt from the Medical Clinic

I, University of lin, Berlin.

Ankylosing spondylitis affects predominantly young patients, men somewhat more

often than women. With no available therapies to impede the progression of the

disease, patients have been limited to alleviating pain with non-steroidal

anti-inflammatory drugs, exercising to counteract stiffening, and treating the

signs and symptoms of the non-spinal arthritis that frequently accompanies AS

with drugs such as sulfasalazine.

In contrast to other rheumatic diseases, such as rheumatoid arthritis, the

spinal inflammation at the center of ankylosing spondylitis has not been

effectively managed. To date, cortisone preparations and immunomodulating

substances have had very little or no effect. Thus, a patient's ability to

function can become significantly impaired and their quality of life reduced. As

a result, the socio-economic costs are high -- in part because it is a common

disease.

The data published in The Lancet document the excellent effectiveness of

infliximab for patients with active ankylosing spondylitis. TNF-alpha has been

found in the inflamed joints of patients with AS and appears to play a

significant role in the chronic inflammation associated with the disease.

Although the study was coordinated in Berlin, patients participated at eight

clinics(1) within the Kompetenznetz Rheuma [Competency Network Rheumatology], a

system of rheumatological institutions across Germany. The study is already

considered a milestone in the treatment of AS because it is the first

placebo-controlled study with a TNF-alpha blocker in this disease, and the

initiative for the study came from the investigators themselves.

A total of 70 patients with active AS were registered for the study and

randomised equally to receive either placebo or an infusion of infliximab 5

mg/kg at weeks zero, two and six. The observation period was 12 weeks. Proven

instruments for measuring disease activity, functional limitations, mobility,

and the quality of life of patients with ankylosing spondylitis were used to

evaluate the success of the therapy.

Treatment with infliximab led to rapid and often dramatic clinical improvement.

After 12 weeks, 53 percent of patients treated with infliximab experienced at

least a 50 percent reduction in disease activity compared to only 9 percent of

those treated with placebo. Everyday functionality and quality of life improved

significantly for those treated with infliximab but not among those taking

placebo.

The use of non-steroidal anti-inflammatory drugs was reduced by more than half

in 56 percent of infliximab patients versus 19 percent of those treated with

placebo. In addition, inflammation parameters in the blood (C-reactive proteins)

dropped significantly under infliximab treatment but not under placebo.

" Although studies are difficult to compare, infliximab appears to be at least as

effective if not more so for patients with ankylosing spondylitis than for

patients with rheumatoid arthritis for whom the drug has already been approved, "

reasons Dr. Sieper, head of rheumatology at the Medical Clinic I, University of

lin.

Treatment with infliximab was well tolerated by most patients. However, relevant

side effects appeared in three cases: one patient developed tuberculosis, one

patient an allergic granulomatosis of the lung and another showed a temporary

reduction of leucocytes. All side effects were treated successfully, however,

tuberculosis is obviously a serious complication. Thus, Dr. Braun recommends

tuberculosis screening prior to such a treatment and a prophylactic tuberculosis

treatment if necessary.

Anti-TNF therapy should only initially be used in centers with special

rheumatological experience. Long-term data are not yet available, however,

experts expect that the effective suppression of the inflammation with

ankylosing spondylitis will also be able to prevent the stiffing of the spine.

Between 0.2 and 0.9 percent of the population suffer from ankylosing

spondylitis. Every year, six new cases per 100,000 individuals can be expected.

Men are slightly more affected than women with symptoms typically first

appearing between the ages of 20 and 40, sometimes even in childhood.

The main symptom of AS is a deep-seated back pain that appears especially at

night. In addition to the joints of the spine, inflammation can also attack

other joints and tendons as well as the iris, heart valve, aorta, lungs or

kidneys. Pain, general symptoms of the disease, and the eventual stiffening of

the spine significantly impair the quality of life of the patients; in rare

cases, complications may even be fatal.

Reference:

(1) Berlin-UKBF, Berlin-Charite, Berlin-Buch, Berlin-Schlosspark-Klinik,

Hannover, Munchen, Dusseldorf, Deutsches Rheuma-Forschungszentrum Berlin

SOURCE: Kompetenznetz Rheuma

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