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