Healthcare Industry News: Humira
News Release - June 15, 2007
Three Studies Suggest Abbott's HUMIRA(R) (adalimumab) May Improve Work Productivity in Patients with Rheumatoid ArthritisOne Groundbreaking Study Showed 11 Percent Fewer RA Patients Reported Job Loss When Treated With Humira Combination Therapy Compared to Methotrexate Alone
BARCELONA, Spain, June 15 (HSMN NewsFeed) -- Rheumatoid arthritis (RA) is one of the most common causes of disability in the Western world. New data released today show that rheumatoid arthritis (RA) patients treated with Abbott's Humira® (adalimumab) stayed working longer, had fewer absences and reported greater improvements in work performance.
Results from three studies were presented today at the European League Against Rheumatism (EULAR) annual congress in Barcelona. One groundbreaking study, PRevention Of Work Disability (PROWD), investigated the effect that Humira therapy can have on the length of time RA patients remain at work. This was the first prospective, placebo-controlled, anti-tumor necrosis factor (TNF) study that investigated this effect. PROWD showed that significantly more patients taking methotrexate (MTX) alone reported job loss or imminent job loss after 56 weeks compared with those treated with a combination of Humira and MTX.
A second study of patient-reported measures in paid workers and homemakers with early RA suggested that treatment with Humira and MTX significantly improved their ability to perform their responsibilities at two years. A third study showed that RA patients treated with Humira worked significantly longer compared with patients taking disease-modifying anti-rheumatic drugs (DMARDs).
"The data show that treatment with Humira may allow patients to be more productive both at home and in the workplace," said Paul Emery, M.D., professor of rheumatology, Leeds University, UK.
Five million people worldwide -- mostly between the ages of 25 and 55 -- are currently living with RA, which most often affects the hands, feet and wrists. Typically, joint damage can occur within two years of the onset of the disease. RA can interfere with a person's ability to work due to joint pain, fatigue and joint tenderness and damage. Several studies have shown that patients with RA have limited employment possibilities and reduced productivity at work.
-- PROWD is a multi-center, randomized, 56-week controlled trial that examined the effect of Humira plus MTX versus placebo plus MTX on job loss due to all causes and imminent job loss in 148 early RA patients. Although the changes in job loss related to all causes -- not specific to disability alone -- did not reach significance between weeks 16 and 56, results showed that significantly more patients on MTX alone reported job loss compared to patients taking Humira plus MTX during the entire period of 56 weeks (40 percent vs. 19 percent). The investigators concluded that Humira plus MTX reduced RA-related job loss and reduced work time lost in patients with early RA more than MTX alone.
-- DE032 is an economic companion study to PREMIER, a two-year, double-blind controlled study that compared the effectiveness of Humira, MTX and the combination of the two drugs in treating early RA. The DE032 study compared Humira plus MTX (n=219) to MTX alone (n=214) on patient-reported measures of work performance in both paid workers and homemakers. Results showed that after two years, paid workers and homemakers taking MTX alone missed significantly more workdays than patients taking Humira plus MTX (26 vs. 15 and 14 vs. 7, respectively). In addition, patients on Humira plus MTX were 21 percent more likely to gain or retain employment compared to patients on MTX alone at the end of two years.
-- DE033, an open label DMARD registry controlled study, examined the long-term impact on employment tenure and likelihood of stopping work over 24 months for RA patients on Humira versus those on a DMARD. Multivariate regression analyses controlled for the baseline characteristic differences between the two populations while comparing the outcomes. Over the two-year period, patients working at the time of study enrollment in the Humira group worked more than seven months longer and were 36 percent less likely to stop working than the patients in the DMARD registry.
"Rheumatoid arthritis can have a profound impact on the lives of patients. Within three years of diagnosis some people who develop the condition have to give up full-time employment," said Rebecca Hoffman, M.D., divisional vice president, Immunology Development, Abbott. "The results of the studies suggest the benefit of Humira combined with MTX extends beyond the clinical scope."
Humira is approved to treat adult patients with moderately to severely active rheumatoid arthritis. More than 190,000 patients worldwide are currently being treated with Humira.
About Rheumatoid Arthritis
Unlike osteoarthritis, the most common form of arthritis, RA is an autoimmune disease where joints are inflamed, which may lead to damage of the joints' interior and the surrounding bone. The joints most commonly affected during the beginning of the disease are the smaller joints of the fingers, feet and wrists. The elbows, knees, ankles and hips can be affected, but less often. Although there is no cure for RA, people continue to seek treatments that not only alleviate the pain and inflammation but also slow disease progression, thereby inhibiting the joint damage that can hinder patients from performing daily activities.
More information on RA and current treatment options can be found at http://www.RA.com.
Important Safety Information About Humira
Globally, prescribing information varies; refer to the individual country product label for complete information. For U.S. safety information, visit http://www.Humira.com.
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 RA 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 combination of Humira and anakinra 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.
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, lymphopenia, dizziness (including vertigo), headache, neurologic sensation disorders (including paraesthesias), infection, irritation or inflammation of the eye, cough, nasopharyngeal pain, diarrhea, abdominal pain, stomatitis and mouth ulceration, nausea, hepatic enzymes increased, rash, dermatitis and eczema, pruritus, hair loss, 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), ankylosing spondylitis (AS, an arthritis of the spine) and Crohn's disease in the U.S. 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 immune-mediated diseases. To date, Humira has been approved in 67 countries with more than 190,000 people worldwide currently treated with Humira. Clinical trials are currently under way evaluating the potential of Humira in other immune-mediated diseases.
In Europe, Humira, in combination with methotrexate (MTX), is indicated for the treatment of moderate to severe, active RA in adult patients when the response to disease-modifying anti-rheumatic drugs (DMARDs) including MTX has been inadequate, and for the treatment of severe, active and progressive RA in adults not previously treated with MTX. Humira can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. Humira has been shown to reduce the rate of progression of joint damage as measured byx-ray and to improve physical function, when given in combination with MTX. Additionally, Humira is indicated for the treatment of active and progressive PsA in adults when the response to previous DMARD-therapy has been inadequate and for the treatment of severe, active AS in adults who have had an inadequate response to conventional therapy.
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 65,000 people and markets its products in more than 130 countries.
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