Healthcare Industry News: Methotrexate
News Release - November 8, 2007
Abbott Study Examines Rates of Uveitis (Inflammation of the Eye) in Ankylosing Spondylitis Patients Treated with HUMIRA(R) (adalimumab)Painful Eye Condition Can Occur in Up to 40 Percent of People with Ankylosing Spondylitis (Spinal Arthritis)
ABBOTT PARK, Ill., Nov. 8 (HSMN NewsFeed) -- A study of ankylosing spondylitis (AS) patients treated with Abbott's HUMIRA® showed a decrease in the rate of uveitis flares by approximately half compared to patients treated with placebo. Ankylosing spondylitis is an inflammatory disease of the spine, and may also be associated with other inflammatory diseases of the skin, eyes, and intestines. Uveitis, or inflammation of the eye, occurs in up to 40 percent of people with AS, and can lead to severe and painful symptoms, including eye damage and blindness. These data were presented today at the American College of Rheumatology Annual Scientific Meeting in Boston.
The RHAPSODY (Review of safety and effectiveness witH Adalimumab in Patients with active ankylosing SpOnDYlitis) trial was designed to examine the effectiveness of HUMIRA in treating the signs and symptoms of AS in patients with active disease despite previous standard treatment. The 1,250 patient trial also included a subset of patients (n=274) with uveitis. Results of the trial suggested that the number of uveitis flares was reduced in patients with active AS treated with HUMIRA.
In the prospective, multi-national, open-label trial, adult patients with active AS who had insufficient responses to prior non-steroidal anti-inflammatory drug (NSAID) therapy received open-label HUMIRA 40 mg subcutaneously every other week for 12 weeks. Patients with symptomatic uveitis at baseline and/or in the previous year received the same regimen for a total of 20 weeks. Evaluations of treatment effects were measured at weeks 2, 6, 12 and week 20, if applicable.
This analysis measured the number of acute flares during treatment with HUMIRA both for all patients in the trial and for patients with pre-known history of uveitis. The rate was calculated as flares per 100-patient-years (100-PYs), which represent the number of flares that would occur in 100 patients observed or treated for one year. The rate of uveitis flares was reduced by approximately half during treatment with HUMIRA compared with the rate prior to the trial (15 flares/100-PY to 7.4 flares/100-PY in the entire trial population, 68.4 flares/100-PY to 28.9 flares/100-PY in the subset with a history of uveitis).
Overall, 27 adverse events of uveitis were reported for 25/1,250 patients. Two of the 25 patients experienced an attack of uveitis for the first time. In both patients, the general AS disease activity was high at time of the anterior uveitis episode.
"Uveitis is a fairly common and potentially serious complication of ankylosing spondylitis," said Martin Rudwaleit, M.D., of the Charite University Hospital in Germany and lead author of the trial. "This study is an example of the research needed to better understand this condition and the impact it has on these patients."
RHAPSODY (Review of safety and effectiveness witH Adalimumab in Patients with active ankylosing SpOnDYlitis) is a prospective, multi-national, open-label trial designed to examine the effectiveness of HUMIRA in treating the signs and symptoms of the disease in a large number of patients (n=1,250) with active AS despite previous standard treatment, including patients with uveitis (n=274), in real-life clinical practices.
There are three different types of uveitis based on the part of the eye involved, including anterior, posterior or intermediate. Acute anterior uveitis occurs in up to 40 percent of patients with AS. Symptoms include pain, light sensitivity, blurry vision or reduced vision; severe complications may include high eye pressure, cataracts, or glaucoma, which can lead to permanent loss of vision.
About Ankylosing Spondylitis
Ankylosing spondylitis (AS) is a type of arthritis that primarily causes inflammation of the spine. Ankylosing means "stiff or rigid" and spondylitis means "inflammation of the spine." Advanced AS can lead to new bone formation on the spine causing the spine to fuse in a fixed position. Typically, the first symptoms of AS are gradual and can include frequent pain and stiffness in the lower back and buttocks. In addition to back pain, other symptoms can include inflammation of joints or tendons, weight loss, fatigue, and eye inflammation (uveitis).
AS affects an estimated 129 out of 100,000 people in the United States and commonly develops between the ages of 15 and 40. Men are three times more likely than women to develop AS. Although the course and severity of AS varies from person to person, some patients with progressive AS can develop spinal deformities leading to significant disability.
The cause of AS is not known, though genetics may play a role: 90 percent of people with AS share a common genetic marker, but having this genetic marker does not mean a person will develop the disease.
Important Safety Information
Serious infections, sepsis, tuberculosis (TB) and opportunistic infections, including fatalities, have been reported with the use of TNF-blocking agents, including HUMIRA. Many of these serious infections have occurred in patients also taking other immunosuppressive agents that in addition to their underlying disease could predispose them to infections. Infections have also been reported in patients receiving HUMIRA alone. Treatment with HUMIRA should 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 anakinra is not recommended and patients using HUMIRA should not receive live vaccines.
More cases of malignancies have been observed among patients receiving TNF blockers, including HUMIRA, compared to control patients in clinical trials. These malignancies, other than lymphoma and non-melanoma skin cancer, were similar in type and number to what would be expected in the general population. There was an approximately 3.5 fold higher rate of lymphoma in combined controlled and uncontrolled open-label portions of HUMIRA clinical trials. The potential role of TNF-blocking therapy in the development of malignancies is not known. 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.
Worsening congestive heart failure (CHF) has been observed with TNF-blocking agents, including HUMIRA, and new onset CHF has been reported with TNF-blocking agents. Treatment with HUMIRA may result in the formation of autoantibodies and rarely, in development of a lupus-like syndrome.
The most frequent adverse events seen in the placebo-controlled clinical trials in adults with rheumatoid arthritis (HUMIRA vs. 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 percent vs. 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 HUMIRA should be carefully considered before initiating therapy.
In HUMIRA clinical trials for ankylosing spondylitis, psoriatic arthritis and Crohn's disease, the safety profile for adult patients treated with HUMIRA was similar to the safety profile seen in adult patients with rheumatoid arthritis.
HUMIRA is approved for the treatment of adults with rheumatoid arthritis, psoriatic arthritis (PsA), ankylosing spondylitis (AS) and Crohn's disease in the United States and in Europe. HUMIRA resembles antibodies normally found in the body. It works by blocking tumor necrosis factor alpha (TNF-alpha), an inflammatory protein that, when produced in excess, plays a key role in the inflammatory responses of autoimmune diseases.
Earlier this year, HUMIRA received FDA approval of data in the Clinical section of the label regarding the long-term maintenance of efficacy to 5 years with respect to clinical response, physical function and radiographic response in patients with rheumatoid arthritis. To date, HUMIRA has been approved in 67 countries and more than 190,000 people worldwide are currently being treated with HUMIRA. Clinical trials are currently under way evaluating the potential of HUMIRA in other immune-mediated diseases.
In the U.S., HUMIRA is approved by the FDA for 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. HUMIRA is indicated for reducing the signs and symptoms of active arthritis, inhibiting the progression of structural damage and improving physical function in patients with psoriatic arthritis. HUMIRA can be used alone or in combination with Methotrexate or other disease-modifying anti-rheumatic drugs (DMARDs). HUMIRA is also approved for reducing signs and symptoms in patients with active AS.
Earlier this year, HUMIRA was approved for reducing the signs and symptoms and inducing and maintaining clinical remission in adults with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy, and reducing the signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
Abbott's Commitment to Immunology
Abbott is focused on the discovery and development of innovative treatments for immunologic diseases. The Abbott Bioresearch Center, founded in 1989 in Worcester, Mass., United States, is a world-class discovery and basic research facility supporting research and development of biologic treatments. Abbott Biotechnology Limited, which opened April 10, 2007, in Barceloneta, Puerto Rico, is the main production facility for HUMIRA.
More information about HUMIRA, including full prescribing information, is available on the Web site http://www.rxabbott.com or in the United States by calling Abbott Medical Information at 1-800-633-9110.
Abbott (NYSE: ABT ) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals and devices. The company employs 65,000 people and markets its products in more than 130 countries.
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