Healthcare Industry News: Humira
News Release - June 13, 2008
HUMIRA(R) (adalimumab) Data Show That Treating Early Rheumatoid Arthritis With Combination Treatment Resulted in Cost Savings From Improved Work ProductivityRheumatoid Arthritis is the Leading Cause of Work Disability in Europe
PARIS, June 13 (HSMN NewsFeed) -- New data announced today showed that treating patients with early, active rheumatoid arthritis (RA) with Abbott's Humira® (adalimumab) and methotrexate (MTX) resulted in an indirect cost savings of euro 4,845 (or approximately USD$6,086 using exchange rates at the time of the study) per patient per year compared to MTX treatment alone. These cost savings were attributed to improved work performance, ability to gain or regain employment and a reduction in the number of missed workdays. A separate analysis found that joint damage in the early stages of RA is a predictor of a patient's ability to gain or retain employment. These data were presented at the European League Against Rheumatism (EULAR) annual meeting in Paris.
"While rheumatoid arthritis is a progressive and chronic disease, patients may be able to continue productive work lives with the help of treatment options such as adalimumab," said Ronald F. van Vollenhoven, M.D., Ph.D., Karolinska University Hospital, Stockholm, Sweden.
More than five million people worldwide have RA, and most of them are considered to be in the prime of their working lives (between 30-50 years of age). The data are from DE032, an economic companion study to PREMIER, a two-year, randomized, double-blind, comparator-controlled study that compared the effectiveness of Humira and MTX to MTX alone in treating early RA. At baseline, a total of 433 patients with early, active RA were identified, including 235 active, paid workers. Patients were evaluated on three measures: number of missed days of work due to RA, degree of work performance affected by RA and employment status.
The study found that:
-- For paid and household workers, estimated indirect cost savings in patients with early RA treated with Humira plus MTX (compared to MTX alone) were euro 4,845 (or approximately USD$6,086) per patient per year. -- Among paid workers only, indirect cost savings in patients treated with Humira plus MTX were attributed as follows:
- 79 percent to improved work performance;
- 12 percent to the patient's improved ability to gain or retain employment;
- 9 percent to the reduced number of missed workdays.
In a separate analysis of the same study, researchers identified that in patients with early RA treated with Humira plus MTX, baseline joint damage (assessed by joint space narrowing, joint space erosion and total sharp score, or TSS) is an independent predictor of a patient's ability to maintain or gain employment. TSS is a measure of joint damage progression. A smaller change in TSS reflects less progression of joint damage, with a positive score indicating worse radiographic damage. A total of 664 patients were included in this analysis, with average disease duration of eight months. Key findings included:
-- The likelihood of failing to gain or retain employment was significantly associated with baseline joint damage (extent of joint erosion and joint space narrowing), as measured by TSS at baseline (p<0.0001), as well as poor scores on other measures evaluating physical and mental well-being.
-- The number of missed work days and degree of work performance were not associated with baseline joint damage.
-- Missing work due to early RA was significantly associated with scores on the Health Assessment Questionnaire (HAQ), which evaluates the level of pain and disability caused by RA (p<0.0001). Therefore, those with better HAQ scores tended to miss less work.
-- Performance at work was also significantly associated with HAQ scores (p<0.0001) in addition to other measures evaluating disease activity and physical and mental well-being. Again, those with better HAQ scores had improved performance while at work.
About Rheumatoid Arthritis
Unlike osteoarthritis, the most common form of arthritis, RA is a chronic, autoimmune disease characterized by joint inflammation, joint pain and stiffness, which can lead to long-term joint damage. The joints most commonly affected early in the disease are the smaller joints of the fingers, feet and wrists. The elbows, knees, ankles and hips can also be affected. Although there is no cure for RA, people continue to seek treatments that help alleviate pain and inflammation and slow disease progression.
More information on RA and current treatment options can be found at http://www.RA.com.
Important Safety Information
Globally, prescribing information varies; refer to the individual country product label for complete information.
Serious infections, sepsis, rare cases of tuberculosis (TB), and opportunistic infections, including fatalities, have been reported with the use of TNF antagonists, including Humira. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease could predispose them to infections. Patients must be monitored closely for infections, including tuberculosis, before, during and after treatment with Humira. Treatment should not be initiated in patients with active infections until infections are controlled. Humira should not be used by patients with active TB or other severe infections such as sepsis and opportunistic infections. Patients who develop new infections while using Humira should be monitored closely. Humira should be discontinued if a patient develops a new serious infection until infections are controlled. Physicians should exercise caution when considering use of Humira in patients with a history of recurring infection or with underlying conditions that may predispose patients to infections.
TNF-blocking agents have been associated with reactivation of hepatitis B (HBV) in patients who are chronic carriers of the virus. Some cases have been fatal. Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating Humira.
The combinations of Humira and anakinra as well as Humira and abatacept is not recommended.
TNF antagonists, including Humira, have been associated in rare cases with demyelinating disease and serious allergic reactions. Rare reports of pancytopenia including aplastic anemia have been reported with TNF-blocking agents. Adverse events of the haematologic system, including medically significant cytopenia have been infrequently reported with Humira.
More cases of malignancies including lymphoma have been observed among patients receiving a TNF antagonist compared with control patients in clinical trials. The size of the control group and limited duration of the controlled portions of studies precludes the ability to draw firm conclusions. Furthermore, there is an increased background lymphoma risk in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates the risk estimation. During the long-term open-label trials with Humira, the overall rate of malignancies was similar to what would be expected for an age, gender and race matched general population. With the current knowledge, a possible risk for the development of lymphomas or other malignancies in patients treated with a TNF antagonist cannot be excluded. All patients, and in particular patients with a medical history of extensive immunosuppressant therapy or psoriasis patients with a history of Psoralen Ultra-Violet A (PUVA) treatment, should be examined for the presence of non-melanoma skin cancer prior to and during treatment with Humira.
In clinical studies with another TNF antagonist, a higher rate of serious congestive heart failure (CHF) related adverse events including worsening CHF and new onset CHF have been reported. Cases of worsening CHF have also been reported in patients receiving Humira. Physicians should exercise caution when using Humira in patients who have heart failure and monitor them carefully. Humira should not be used in patients with moderate or severe heart failure.
The most frequently reported adverse event (>1/10 patients) at least possibly causally related to Humira is injection site reaction (including pain, swelling, redness or pruritus). Other common adverse events (reported by >1/100 patients) at least possibly causally related to Humira include lower respiratory infections (including pneumonia, bronchitis), viral infections (including influenza, herpes infections), candidiasis, bacterial infection (including urinary tract infections), upper respiratory infection, dizziness (including vertigo), headache, neurologic sensation disorders (including paraesthesias), cough, nasopharyngeal pain, diarrhea, abdominal pain, stomatitis and mouth ulceration, nausea, hepatic enzymes increased, rash, pruritus, musculoskeletal pain, pyrexia, fatigue (including asthenia and malaise).
Humira is the only fully human monoclonal antibody approved for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), plaque psoriasis, ankylosing spondylitis (AS) and Crohn's disease in the United States and Europe. Humira resembles antibodies normally found in the body. It works by blocking tumor necrosis factor alpha (TNF-alpha), a protein that, when produced in excess, plays a central role in the inflammatory responses of many immune-mediated diseases. To date, Humira has been approved in 75 countries and more than 250,000 people worldwide are currently being treated with Humira. Clinical trials are also under way evaluating the potential of Humira in ulcerative colitis.
In Europe, Humira in combination with methotrexate, is indicated for the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. Humira is also indicated for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Humira has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. In the United States, Humira is also approved for the treatment of juvenile idiopathic arthritis (JIA).
Humira is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Humira has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function.
Humira is indicated for the treatment of adults with severe, active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Humira is indicated for treatment of severe, active Crohn's disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. For induction treatment, Humira should be given in combination with corticosteroids. Humira can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inappropriate.
Humira is indicated for the treatment of moderate-to-severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA.
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 committed to finding new treatments for autoimmune diseases.
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, devices and diagnostics. The company employs more than 68,000 people and markets its products in more than 130 countries.
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