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 www.arthritis.org. Following are summaries of the top 10 arthritis advances of 2004, according to the Arthritis Foundation:
1. New Therapeutic 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 therapeutic 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 Analgesics 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 therapeutic 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 therapeutic 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 www.arthritis.org