Press release

Orthokine treatment is effective for knee arthritis, even after two years

Long-term clinical study confirms effectiveness of autologous therapy

Düsseldorf, August 4th  2008: The results of a two-year representative study of osteoarthritis of the knee, published today in the internationally renowned journal “Osteoarthritis and Cartilage”, confirm the safety and effectiveness of Orthokine therapy, in which anti inflammatory proteins obtained from the patient’s own blood are injected into the arthritic joint.

Researchers at Heinrich Heine University in Düsseldorf conducted a long-term study to determine the most effective treatment for osteoarthritis of the knee joint. They compared the effects of injections of Orthokine, hyaluronic acid and placebo in 310 arthritis patients over a two-year period. Hyaluronic acid, a joint lubricant, is widely used to treat arthritis. Saline was used as the placebo. “The two-year results confirm our previous studies: Orthokine therapy provides long-term relief from pain and joint dysfunction in many patients and does so more effectively than comparable treatments”, said Prof. Peter Wehling, chairman of the board of Orthogen AG, on Friday in Düsseldorf.

Two years after the series of injections, patients treated with Orthokine scored substantially better than those treated with hyaluronic acid or placebo on measures of pain and joint function. “Long-term treatment effects take on particular importance for patients suffering from arthritis, since this is a chronic condition. Improvement in the symptoms of osteoarthritis means an improvement in patients’ quality of life“, notes study physician Carsten Moser, MD. The results are also of wider interest as arthritis affects at least 200 million people worldwide. Arthritis treatments whose effectiveness is highly controversial and that, according to the World Health Organization (WHO), in some cases can result in serious side effects.

Two-year results
Two years after the initial treatment, 188 of the 310 patients were still reporting improvements with respect to pain and joint function, while 122 had sought other treatments in the meantime such as surgery, injections, medication or acupuncture. The number of patients requiring further treatment was smallest in the Orthokine group. Two years after treatment, improvement was still measurable in all three groups. A clear difference was seen, however, in scores on the WOMAC test, a questionnaire measuring joint function and quality of life. From a initial score of around 124, the Orthokine group scored 58 on the WOMAC after two years, with marked improvements in joint function and mobility, while the comparison groups scored substantially higher at 88 and 84 while the hyaluronic acid and placebo groups scored substantially higher at 88 and 84 respectively. “Orthokine treatment is a safe, long-lasting alternative to conventional methods”, said Moser. On the visual analog scale (VAS) that measures pain from 0 (no pain) to 100 (most intense pain imaginable), the average pain intensity prior to treatment was 70. Two years after treatment, the VAS score of the Orthokine group was 30 (mild pain). Pain intensity in the other two groups was 39 in the hyaluronic acid group and 37 in the placebo group.

The GOAT study (German Osteoarthritis Trial), a randomized, prospective, placebo-controlled trial, initially included 376 men and women with an average age 58. Two years later, 310 participants agreed to take part in a follow-up examination. The main inclusion criterion of the osteoarthritis study was chronic knee pain due to osteoarthritis of the knee. Participants were randomly allocated to one of three treatment groups that received injections of Orthokine, hyaluronic acid or salt solution (placebo). Treatment consisted of six sessions over three weeks. After six weeks, three months, six months (double blinded) and 24 months (single blinded), the patients underwent a full examination. The examination included the administration of internationally recognized pain measurement instruments such as the visual analog scale (VAS) and the WOMAC questionnaire.

Autologous arthritis treatment based on protective proteins
Orthokine therapy was developed by Düsseldorf orthopaedic surgeon Dr. Peter Wehling and molecular biologist Dr. Julio Reinecke. It is based on an understanding of the biological mechanisms that lead to of osteoarthritis and pain. In osteoarthritis, the body produces interleukin-1 (IL-1), a protein that contributes to the breakdown of cartilage. To slow down or stop this process, the biological adversary of IL-1, the interleukin-1 receptor antagonist (IL-1Ra), is used. IL-1Ra neutralizes the effect of IL 1, and has anti-inflammatory, analgesic and cartilage-protective effects. In the Orthokine method, various anti-flammatory proteins and growth factors such as IL-1Ra are obtained from the patient’s own blood and injected back into the affected joint.

Publication
“Osteoarthritis and Cartilage” is a respected scientific journal (impact factor 4.017) that publishes only original, peer-reviewed research into new methods for the treatment of diseases of the locomotor system.
For further information please visit: http://oarsi.org/


For more information please contact:
Orthogen AG
Public relations
Daniele Voss/Prof. Dr. Peter Wehling
Graf-Adolf-Str. 41
40210 Düsseldorf
Tel.: 0211/ 387 00 76
Mobile: 0177/ 588 344 2
Fax: 0211/387 00 10
E-mail: Daniele.Voss@orthogen.com