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Arthritis Foundation Announces Top 10 Arthritis Advances of 2004
ProHealthNetwork.com

12-20-2004

Breakthroughs in Research, Public Health and Health Policy Provide Hope
to One in Three Americans with Arthritis

ATLANTA, December 7, 2004 - Cutting-edge biologic therapies and a
predictive marker for rheumatoid arthritis (RA) are among the top 10
arthritis advances of 2004, according to the Arthritis Foundation.

Exciting discoveries of the past year also include a novel treatment
that slows bone erosion and a common genetic link to autoimmune
disorders such as RA, lupus, diabetes and thyroid disease.

Arthritis advocates also scored successes in 2004 with the introduction
of the first arthritis-specific legislation in more than 30 years and
the implementation of a Medicare pilot program allowing thousands of
Americans with RA and psoriatic arthritis to obtain life-changing
biologic medications at a reduced cost.

"As the number of people with arthritis reaches epidemic proportions,
advances in research, public health and public policy are more
important than ever to preventing, controlling and eventually curing
the nation's number one cause of disability," said John H. Klippel,
M.D., president and CEO of the Arthritis Foundation. "Breakthrough
advances in 2004 offer hope to people with arthritis and provide a
glimpse of what is possible in the future."

Other advances include:

Effectiveness of Weight Loss and Physical Activity Confirmed

First-Ever Set of Quality Indicators for Arthritis Developed

Measures to Prevent Wrong-Site Surgery Mandated

Antibiotic Shown to Slow Progression of Knee Osteoarthritis (OA)

To develop its annual list of the top 10 arthritis advances, the
Arthritis Foundation sought input from clinicians with expertise in
different forms of arthritis, scientists from various research
disciplines, as well as from the American College of Rheumatology, the
American Academy of Orthopaedic Surgeons and the Centers for Disease
Control and Prevention.

2004 Advances: A Glimpse of the Future

Advances in 2004 showed that in the near future, people might benefit
from therapies targeted at the root causes of serious forms of
arthritis rather than those aimed at treating disease symptoms. It also
could become routine to screen patients to determine who is at risk for
severe disease progression and, therefore, who is most likely to
benefit from early and aggressive treatment.

The foreseeable future also promises a greater quality of life for
patients with arthritis and related diseases through increased
government funding for research and public health activities, advances
in quality care standards for people with arthritis, and improved
preoperative processes in joint surgery. An increased understanding of
the benefits of weight loss and exercise in reducing pain and improving
physical function, as well as promising research into antibiotic
treatment to slow disease progression, will lead to relief for millions
of Americans suffering from debilitating knee OA.

With one in every two Americans over 50 facing fractures from
osteoporosis or low bone mass by 2020, advances made in slowing the
progressive loss of bone and increasing bone mass have never been more
important. Research conducted in 2004 will serve as the launching pad
for bone health advances in the coming year, with researchers poised
for even more breakthroughs in 2005 and beyond.

How the Arthritis Foundation Helps

The Arthritis Foundation is the single largest non-profit contributor
to arthritis research in the world and the only nationwide, nonprofit
health organization helping people take greater control of arthritis by
leading efforts to prevent, control and cure arthritis and related
diseases - the nation's number one cause of disability. For free
arthritis information, contact the Arthritis Foundation at 800-283-7800
or on the Web at http://www.arthritis.org.

Following are summaries of the top 10 arthritis advances of 2004,
according to the Arthritis Foundation:

1. New The****utic Approaches Show Promise in Rheumatoid Arthritis (RA)


Two experimental biologic agents that selectively target the harmful
immune cells involved in RA have shown promising results in recent
clinical trials. Rituximab (Rituxan®), FDA-approved for non-Hodgkin
lymphomas, is a B-cell-targeting drug that has shown tremendous promise
in treating RA. In 2004, researchers demonstrated that a brief course
of treatment with rituximab, either alone or in combination with
methotrexate or cyclophosphamide, was well tolerated, had an acceptable
safety profile and provided a significant and sustained improvement in
disease symptoms for at least six months (New England Journal of
Medicine, June 2004). In addition, two-year follow-up data showed that
combined rituximab and methotrexate therapy continued to have a
significant benefit (American College of Rheumatology Annual Scientific
Meeting, October 2004).

Other research conducted in 2004 showed that abatacept (CTLA4Ig), part
of a new class of drugs known as co-stimulation modulators that block
the activation of T-cells, appears to be a useful alternative therapy
for those with RA who have failed methotrexate and/or the anti-TNF
biologic agents. Patients treated with monthly intravenous infusions of
abatacept, in combination with either methotrexate or another
disease-modifying antirheumatic drug, achieved a significant
improvement in their disease signs and symptoms. For those who
completed two years of treatment, nearly half sustained a remission.
Abatacept was determined to be generally safe and well tolerated in
these studies (American College of Rheumatology Annual Scientific
Meeting, October 2004).

Bottom line: Cutting-edge, second-generation biologic drug therapies
could soon become available as treatment options for people with RA and
similar autoimmune conditions who have failed currently approved
therapies, bringing us closer to stopping disease progression in its
tracks.

2. Gene Variation Associated with Autoimmunity Discovered

Scientists have discovered a variation in a gene linked with an
increased risk for RA, lupus and other autoimmune disorders, providing
insights about their cause and why such conditions tend to group in
families. The gene helps create an enzyme (PTPN22) that keeps the
immune system from getting out of control. When the gene variant is
present, the immune system overreacts, causing chronic inflammation and
tissue damage. Comparing gene samples from people with RA to matched
controls, researchers found the gene variant was present in 28 percent
of people with RA (American Journal of Human Genetics, August 2004). In
a related study, researchers found the same gene variant in 23 percent
of a large sample of people with lupus (American Journal of Human
Genetics, September 2004) and also associated it with an increased risk
for type 1 diabetes and autoimmune thyroid disease (American College of
Rheumatology Annual Scientific Meeting, October 2004).

Bottom line: Autoimmune conditions may share a common genetic risk
factor and underlying disease mechanism responsible for increased
reactivity of the immune system.These findings point to a potential new
the****utic target aimed at the source of the overactive immune process
and not just the symptoms.

3. Predictive Markers May Improve RA Diagnosis and Outcomes

In 2004, researchers demonstrated that more than 90 percent of a group
of people with "undifferentiated arthritis" who tested positive on
a simple "anti-CCP2" antibody blood test developed RA within three
years. Since RA can be difficult to diagnose, using such a tool can
alert physicians to which patients may require more intensive
monitoring, screening and early treatment (Arthritis & Rheumatism,
March 2004). Because a significant number of RA patients develop
irreversible joint damage shortly after disease onset, doctors need
predictors of disease course so they know when to treat those patients
more aggressively and when to protect patients with mild disease from
over-treatment and unnecessary side effects. Researchers identified
several biological markers that predicted who is at risk for more
severe disease, including a positive rheumatoid factor antibody test,
certain genetic markers and a promising novel marker of a prematurely
aged immune system (Arthritis & Rheumatism, January 2004).

Bottom Line: The use of biological markers could improve early
diagnosis and treatment and reduce joint damage and side effects. Such
markers could allow new approaches to prevention by predicting who is
at increased risk for RA or its progression.

4. Medicare Coverage of Self-Injected Medications Secured

A new law implemented in 2004 allows up to 50,000 people with Medicare
who have serious and life-threatening conditions, including rheumatoid
and psoriatic arthritis, to obtain life-changing medications at a
reduced cost. The inclusion of a pilot program provision in the new
Medicare legislation means patients who take self-injected medications,
such as the biologics etanercept (Enbrel), adalimumab (Humira) and
anakinra (Kineret), can save thousands of dollars on medications to
improve their arthritis. The initiative is designed to increase access
to and lower the costs of self-injected biologics, which have changed
the course of treatment for serious and debilitating forms of arthritis
such as rheumatoid arthritis and psoriatic arthritis.

Bottom Line: The Medicare Replacement Drug Demonstration provides
thousands of Americans with rheumatoid arthritis or psoriatic arthritis
with an opportunity to benefit from life-changing medications that they
might not otherwise be able to access.

5. Effectiveness of Weight Loss and Physical Activity Confirmed

Landmark research in 2004 proved exercise and diet together
significantly improve physical function and reduce knee pain in people
older than 60 who are overweight or obese. The Arthritis, Diet, and
Activity Promotion Trial (ADAPT) was a randomized, single-blind
clinical trial lasting 18 months that was designed to determine whether
long-term exercise and dietary weight loss are more effective, either
separately or in combination, than usual care in improving physical
function, pain and mobility in older overweight and obese adults with
knee osteoarthritis (OA). The combination of modest weight loss plus
moderate exercise provides better overall improvements in self-reported
measures of function and pain and in performance measures of mobility
in older overweight and obese adults with knee OA compared with either
intervention alone (Arthritis & Rheumatism, May 2004).

Bottom line: Research conducted in 2004 lends strong support to the
combination of weight loss and exercise as a cornerstone for the
treatment of overweight and obese patients with knee OA. People with
knee OA who are overweight or obese should consider a combination
weight loss and exercise regimen to help reduce pain and improve
function. [References]

6. Antibiotic Shown to Slow OA Progression

Medications used to treat one condition sometimes end up with
surprising uses elsewhere. Research in 2004 showed that an antibiotic,
doxycycline, which is used to treat a variety of infections, also
inhibits the breakdown of joint cartilage in OA. In a 30-month clinical
trial investigating the effectiveness of doxycycline versus placebo in
women with knee OA, women who took the antibiotic had 33 percent less
joint space narrowing -- indicative of less cartilage loss -- and
also were less likely to report worsening of their knee pain than those
who took placebo (Annual Meeting of the Orthopaedic Research Society,
March 2004).

Bottom line: This research study suggests that doxycycline shows
promise as a potential disease-modifying and pain-relieving knee OA
therapy.

7. Arthritis Prevention, Control and Cure Act of 2004 Introduced

The first arthritis-specific legislation in more than 30 years was
introduced in 2004 and expands the federal government's efforts to
prevent, treat and find a cure for arthritis. The legislation focuses
on three primary areas: Investing in a nationwide public health
initiative designed to reduce the pain and disability of arthritis
through early diagnosis and effective treatment of the disease.

Ensuring the 300,000 children with arthritis in the United States have
access to care by addressing the nationwide shortage of pediatric
rheumatologists (many states do not have a single pediatric
rheumatologist to provide care to children in need). Improving
coordination among federal agencies and the public with regard to the
federal investment in arthritis research and public health activities
through the formation of an Arthritis Interagency Coordinating
Committee.

Bottom Line: With arthritis prevalence at an all-time high, the
Arthritis Prevention, Control and Cure Act of 2004 significantly
increases the government's investment in arthritis research and public
health activities, ensuring a brighter future for the more than 70
million Americans living with arthritis or chronic joint symptoms.

8. First Set of Quality Indicators for OA, RA and ****gesics Use
Introduced

Fifty-one measures of quality health care for people with OA, RA or for
anyone using pain medication were introduced in 2004 by a
multidisciplinary panel of nationally recognized experts. These quality
indicators provide the first step in filling the void of quality
assessment for arthritis, the nation's leading cause of disability.
Compared with other diseases, such as diabetes and heart disease, there
has been relatively little quality assessment in arthritis until now.
One of the measures, which reports the percentage of patients with RA
who are treated with disease-modifying antirheumatic drugs, was
selected by the National Committee for Quality Assurance to be used to
compare performance of doctors in health care plans, helping ensure
quality care for RA patients around the country (Arthritis &
Rheumatism, April 2004).

Bottom Line: The first-ever set of quality measures for arthritis will
ensure that people with arthritis receive quality care and feel
empowered in their own treatment, while providing physicians with
evidence-based indicators to guide them in caring for arthritis
patients.

9. Novel Treatment Demonstrated Effective in Slowing Bone Erosion

The U.S. Surgeon General recently issued the first-ever report on the
nation's bone health, warning that by 2020 one in two Americans over
age 50 will be at risk for fractures from osteoporosis or low bone mass
if no immediate action is taken (Bone Health and Osteoporosis: A Report
of the Surgeon General, October 2004). Bone loss also is a painful and
debilitating problem for many people with RA and those taking
corticosteroids.

Fortunately, data reported in 2004 show the potential value of a novel
the****utic agent based on new insights about bone biology. AMG 162 is
a fully human monoclonal antibody designed to block an inflammatory
chemical (RANKL) that contributes to the destruction of bone in people
with a variety of conditions including osteoporosis, RA and those
taking corticosteroids. Research has shown that this new treatment,
administered every six months to postmenopausal women with low bone
density, appears to rapidly inhibit the bone turnover process,
resulting in improvements in hip bone mineral density (Journal of Bone
and Mineral Research, July 2004; American College of Rheumatology
Annual Scientific Meeting, October 2004).

Bottom line: This therapy offers hope of a powerful new the****utic
alternative -- as a potentially effective means for building bone in
those with low bone mineral density -- and as a means for preventing
bone loss in patients with RA and in those taking corticosteroids.

10. Measures Mandated to Prevent Wrong-Site Surgery

It is estimated that one in five orthopaedic surgeons will have an
occurrence of wrong-site surgery in his or her career. To reduce the
frequency of this troubling incident, effective July 1, 2004,
preoperative surgical site marking became a mandatory intervention in
U.S. hospitals and surgical centers. The procedure is part of the Joint
Commission on Accreditation of Healthcare Organizations' (JCAHO)
implementation of its "Universal Protocol" to enhance patient safety.

With JCAHO's adoption of the elimination of wrong-site, wrong-patient
and wrong-procedure surgery as a National Patient Safety Goal,
healthcare organizations such as critical access hospitals, hospitals,
healthcare networks and office-based surgical practices must implement
such procedures to maintain their JCAHO accreditation. Never before has
such a strong national emphasis been placed on the need for surgical
site marking and a preoperative verification process to help eliminate
the incidence of wrong-site, wrong-patient, wrong-procedure surgery
(American Academy of Orthopaedic Surgeons, 2004).

Bottom Line: Patient safety during orthopaedic and other surgeries was
brought to the forefront in 2004 as a simple but effective solution to
surgical errors became common practice at many surgical facilities.
Source: The Arthritis Foundation, online at http://www.arthritis.org