When Back Pain Is More Serious

Wednesday, March 1, 2006

(NAPSA)—Back pain is one of the most common medical problems, affecting an estimated four out of five people in the United States. Back pain can range from a dull, constant ache to a sudden, sharp pain that can leave a sufferer incapacitated. It can come on suddenly—from an accident, a fall or lifting something too heavy—or develop slowly, perhaps as the result of age-related changes to the spine. Common back pain may be an indication of different diseases such as osteoarthritis, rheumatoid arthritis or ankylosing spondylitis (AS). AS is a type of arthritis that primarily causes inflammation of the spine and spinal joints but is also associated with other inflammatory diseases of the skin and intestines. Ankylosis means “fusion,” and spondylitis means “inflammation of the spine.” AS is an autoimmune disorder that affects at least half a million people in the United States. Typically, the first symptomsof AS are gradual and can include frequent pain and stiffness in the lower back and buttocks. Over time, this may progress into the upper spine, chest and neck. As the condition progresses and inflammation persists, new bone forms on the spine causing it to fuse in a fixed position, often resulting in limited mobility. In its severe form, AS can result in complete spinal fusion, which may cause extreme physical limitation. Additional symptoms may include fatigue, fever, weight loss and anemia. Early symptoms of AS, such as frequent pain and stiffness, are indistinguishable from the symptoms experienced by those who are suffering from common back pain. ASis difficult to diagnose in Differences Between AS & Common Back Pain Attributes Ankylosing Spondylitis CommonBack Pain Pain/Stiffness Lasts for more than an hour in the morning, often improving throughout the day Lasts for less than 45 minutes in the morning, often worsening throughoutthe day Exercise/Activity Improves symptoms Worsens symptoms Duration Chronic Acute or chronic OnsetCriteria Develops between ages of 15 and 40 Occurs in people over the age of 40 the early stages and is one of the most overlooked causes of persistent back pain in young adults. Diagnosis can be delayed seven to 10 years from the onset of initial symptoms. There is no cure for AS, but there are medications that may reduce inflammation andstiffness of the joints, manage the pain and potentially inhibit the progression of disease in somepeople. Current treatment goals for AS include relief of symptoms; e.g., reducing pain, inflammation and spine stiffness, as well as slowing progression of the disease. Medical treatment options include nonsteroidal anti-inflammatory drugs (NSAIDs), disease-modifying antirheumatic drugs (DMARDs) and biologics. Exercise, physical therapy, posture techniques, heat/cold, surgery, acupuncture, massage or yoga are also recommended to improve symptoms. “There is a large unmet need for effective AS therapies,” said Katherine Culpepper, Spondylitis Association of America Executive Director. “For people suffering from AS whoare dissatisfied with their current treatments, the availability of biologic medications provides patients with othertreatment options that can help to managetheir disease.” For people with severe disease, a class of medications called biologics, including anti-tumor necro- @ sis factor (TNF) agents, has been shown to be effective in reducing the signs and symptoms of AS in some people. These certain biologic medications, known as antiTNF agents, work by blocking the actions of TNF-a, a naturally occurring protein that can cause inflammation. This group of medications includes HUMIRA(adalimumab), recently approved to reduce signs and symptoms in patients with active ankylosing spondylitis. “Being diagnosed with AS was overwhelming. I’m a young guy, but I felt like an old man. I had trouble getting out of bed or in and out of the car and soon hadto stop some of my physical activities due to the severe pain and swelling in my hips and back,” says Peter Kahn, a 31-year-old with AS. “Since starting on HUMIRA, my symptoms have begun to improve, and I have been able to resume someofthe activities I enjoy, such as biking and kayaking.” For more information about ankylosing spondylitis, visit the Spondylitis Association of America Website at www.spondylitis.org. More information about HUMIRA, including full prescribing information, is available on the Web site www.rxabbott.com or in the United States by calling Abbott Medical Information at (800) 633-9110. HUMIRAis the only fully human monoclonal antibody approved by the FDAfor reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. HUMIRAcan be used aloneor in combination with methotrexate or other diseasemodifying anti-rheumatic drugs (DMARDs). HUMIRAis indicated for reducing the signs and symptoms ofactive arthritis in patients with psoriatic arthritis. HUMIRA can be used aloneor in combination with DMARDs. HUMIRAisindicated for reducing signs and symptoms in patients with active ankylosing spondylitis. Important Safety Information Cases of tuberculosis (TB) have been observed in patients receiving HUMIRA.Serious infections and sepsis, including fatalities, have been reported with the use of TNF-blocking agents, including HUMIRA.Manyof these infections occurred in patients also taking other immunosuppressive agents that in addition to their underlying disease could predispose them to infections. Treatment with HUMIRAshould not be initiated in patients with active infections. TNF-blocking agents, including HUMIRA,have been associated with reactivation of hepatitis B (HBV) in patients who are chronic carriers of this virus. Some cases have been fatal. Patients at risk for HBV infections should be evaluated for prior evidence of HBV infections before initiating HUMIRA. The combination of HUMIRA and anakinrais not recommended. TNF-blocking agents, including HUMIRA,have been associated in rare cases with demyelinating disease and severe allergic reactions. Infrequent reports of serious blood disorders have been reported with TNF-blocking agents. More cases of malignancies have been observed amongpatients receiving TNF blockers, including HUMIRA, comparedto control patients in clinical trials. These malignancies, other than lymphoma and non-melanomaskin cancer, were similar in type and number to what would be expected in the general population. There was an approximately four-fold higher rate of lymphoma in combined controlled and uncontrolled open label portions of HUMIRAclinical trials. The potential role of TNF-blocking therapy in the development of malignancies is not known. The most frequent adverse events seen in the placebo-controlled clinical trials in rheumatoid arthritis (HUMIRAvs. placebo) were injection site reactions (20 percent vs. 14 percent), upper respiratory infection (17 percent vs. 13 percent), injection site pain (12 percent vs. 12 percent), headache (12 percentvs. 8 percent), rash (12 percent vs. 6 percent) and sinusitis (11 percent vs. 9 percent). Discontinuations due to adverse events were 7 percent for HUMIRA and 4 percent for placebo. As with any treatment program, the benefits and risks of HUMIRAshould becarefully considered before initiating therapy. In HUMIRAclinical trials for ankylosing spondylitis and psoriatic arthritis, the safety profile for patients treated with HUMIRAwassimilar to the safety profile seen in patients with rheumatoid arthritis.

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