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Osteoarthritis: Two-Year Results Show The Benefits Of The Orthokine Therapy



13 Sept 2007

As edited by Joint-Pain-Forum.com


Within the scope of the German Osteoarthritis Trial (GOAT) the effects of different innovative medications in osteoarthritis (OA) therapy were studied. All 376 participants in the trial suffered from painful OA of the knee joint and were treated with Orthokine, hyaluronic acid, or placebo injections. Orthokine therapy uses autologous, anti-inflammatory proteins, which are isolated from the patient's blood and injected into the joint. Six months after the treatment, the outcome differed depending on the therapy: The condition of Orthokine-treated patients was found to be much better than that of patients treated with hyaluronic acid or placebo. The trial was conducted by the Heinrich Heine University in collaboration with the Center for Molecular Orthopaedics (Duesseldorf, Germany) and was recently published in the scientific journal "Biodrugs". In the meantime, results obtained over two years give further support to the therapy utilising autologous proteins.

Osteoarthritis, the age-related degeneration of joints, is becoming an increasing problem for the health-care system and society in general. Because the mobility of affected people gradually decreases, aching knee and hip joints cause long-term complications, such as cardiovascular diseases. In Germany alone, in the last year, 90,000 artificial knee and 170,000 artificial hip joints were implanted in cases of terminal-stage osteoarthritis, and the trend is upward. "With our society getting ever older, the demand for non operative treatment options is steadily increasing", explained Professor Rüdiger Krauspe, M.D., Director of the Department of Orthopaedics at the Heinrich Heine University (Düsseldorf/ Germany) on Wednesday in Düsseldorf.

In past years, scientists have set high hopes on so-called biologicals - therapies using biological substances. These should directly address the cause of the disease and as a result, be particularly effective. Following a long period of developing new approaches against OA - among others the Orthokine therapy - biologicals are in the clinical trial phase. During this phase, the GOAT study was a milestone in the clinical research of the use of biologicals in orthopaedics.

Study design

376 patients, who on average were 58 years old, were enrolled in the randomized, prospective, placebo-controlled GOAT study. Chronic knee pain due to OA was the most important inclusion criterion. Participants were randomly assigned to one of three different medications (Orthokine, hyaluronic acid, or placebo). During Orthokine therapy, autologous, anti-inflammatory proteins are isolated from the patient's blood and injected into the joint. Hyaluronic acid is a major component of the synovial fluid in the joint, where it acts as a "lubricant" during joint movements. Physiological saline solution was injected as placebo. Each therapy consisted of a total of six treatment appointments. Check-up of patients was carried out after six weeks, and three and six months using internationally recognised pain parameters, such as the visual analogue scale (VAS) and the WOMAC questionnaire. In the WOMAC test, patients are questioned about their pain, joint stiffness, and joint function and their answers are rated on a scale of 0 = no knee problems to 240 = strongest possible restriction in daily activities due to knee problems.







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Article adapted by www.Joint-Pain-Forum.com from original press release.
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Results

On the VAS (0 = no pain to 100 = most intense pain imaginable) the average pain intensity prior to therapy was rated at 70. Six months after therapy, notable differences were observed: In the Orthokine-treated group, 57 % of patients had a greater than 50-percent reduction of their pain, compared to only 29 % and 28 % of patients in the hyaluronic-acid-treated and placebo-treated groups. The WOMAC test also showed an improvement of symptoms of over 50 per cent in the Orthokine-treated group. In the comparison groups, improvements of only 20 per cent were obtained. "In total, the effect of Orthokine therapy in osteoarthritis of the knee was found to be significantly superior when compared to injection of hyaluronic acid or placebo", said Krauspe, as these results were published in the scientific journal "Biodrugs". In addition, very few patients experienced mild side effects - with the Orthokine-treated group experiencing the fewest of all.

Two-year results

The two-year results also support the Orthokine therapy against OA. Since OA is a chronic disease, the long-term therapeutic success is of particular interest to patients. 310 patients took part in the two-year assessment of the osteoarthritis trial; 188 of these still benefited from the first therapy after two years, and 122 patients demanded further therapeutic options (operation, injections, drugs, acupuncture) in the meantime. The group with the lowest number of patients requiring after-treatment was the Orthokine-treated group.

Including all 310 patients in the analysis yielded the following results: Two years after the treatment, the VAS value in the Orthokine-treated group was approx. 30 (mild pain). Pain intensity in the hyaluronic-acid-treated and saline-treated groups was found to be 39 and 37 respectively. The WOMAC test revealed an even more pronounced difference. Starting from a baseline value of approx. 124, the Orthokine-treated group was lowered to a WOMAC value of 58 with notable improvements in joint function and mobility, whereas in the comparison groups the WOMAC values were significantly higher, with scores of 88 and 84 respectively. "The two-year results show that the therapeutic success using Orthokine is significantly better than the compared medications", said Professor Peter Wehling, of the Center for Molecular Orthopaedics in Düsseldorf, Germany.

Osteoarthritis therapy using protective proteins

The Orthokine therapy, developed by the german orthopaedic surgeon Professor Peter Wehling, MD, and the molecular biologist Julio Reinecke, PhD, is based on known facts about the biological mechanisms of osteoarthritis. The protein Interleukin-1 (IL-1) is released in osteoarthritic conditions, and is jointly responsible with other factors for the degradation of the cartilage tissue. Its biological antagonist, Interleukin-1 receptor antagonist (IL-1Ra), is used to decelerate or stop this process. IL-1Ra neutralises the IL-1 effect, and has anti-inflammatory, pain-relieving, and cartilage-protective effects. During the Orthokine procedure, several anti-inflammatory proteins and growth factors such as IL-1Ra and TGF-ß are isolated from the patient's blood and injected into the affected joint.

Publication

Biodrugs is an international scientific journal for biotechnology and clinical innovations, exclusively publishing peer-reviewed original work on new biotechnological applications and medicine. http://biodrugs.adisonline.com

Figures

In Germany, approx. ten million people suffer from osteoarthritic joint diseases, and five million of these from osteoarthritis of the knee. The knee is therefore the joint most frequently affected by degenerative processes. Six million osteoarthritis patients are under constant medical treatment every year, with 1.2 million affected people receiving regular injections into their joints. According to WHO reports, in Germany the direct costs relating to orthopaedic diseases amount to 20 billion euros, corresponding to 30 billion euros on the national-economic level.

http://www.orthokine.com




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