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News Release - May 22, 2007
New Analysis of Data Shows Treatment With Abbott's HUMIRA(R) (Adalimumab) Significantly Reduced Disease-Related Hospitalization for Patients with Crohn's DiseaseHUMIRA Data Showed 57 Percent Reduction in Risk of Hospitalization from Crohn's Disease vs. Placebo at One Year
ABBOTT PARK, Ill., May 22 (HSMN NewsFeed) -- Abbott (NYSE: ABT ) today announced results from a post-hoc analysis of a pivotal study presented at the Digestive Disease Week annual meeting in Washington, D.C. showing patients with moderate to severely active Crohn's disease treated with HUMIRA® (adalimumab) maintenance therapy were almost 60 percent less likely than patients on placebo to be hospitalized due to their disease at one year (5.9 percent versus 13.9 percent; p<0.01).
Crohn's disease is a serious, chronic, inflammatory disease of the gastrointestinal (GI) tract that affects more than one million people in North America and Europe. It affects people of all ages but it is primarily a disease of young adults, with onset typically before age 40. There is no medical or surgical cure for Crohn's disease, so maintenance of remission from disease flares is one of the primary goals of treatment.
People with Crohn's disease may be hospitalized for a variety of reasons, from fever and vomiting to intestinal obstruction and infections, sometimes leading to surgery. Previous studies have shown that hospitalization is responsible for approximately 60 percent of the direct cost of Crohn's disease and that the average cost per hospital stay is estimated (based on published cost data from 1997) to be about $37,000 per patient in 2006 dollars. Hospitalization is also associated with a negative impact on health-related quality of life in patients with Crohn's disease.
Data from the Phase III, pivotal study, called CHARM, were evaluated to assess the effect of ongoing treatment with HUMIRA on the risk of hospitalization. At one year, this analysis showed that patients taking placebo (13.9 percent) were more than twice as likely as patients on HUMIRA (5.9 percent; p<0.01) to be hospitalized from Crohn's disease.
"Patients on HUMIRA throughout the one-year analysis were significantly less likely to be hospitalized because of their Crohn's disease. Maintaining treatment with HUMIRA was the only independent factor in this analysis that helped patients reduce the risk of Crohn's related hospitalization," said Brian G. Feagan, M.D., lead investigator of the analysis, Department of Medicine, Epidemiology and Biostatistics, University of Western Ontario, London Health Sciences Centre, London, ON, Canada.
About HUMIRA Hospitalization Data
In this analysis, week 4 randomized responders on either dose of HUMIRA (40 mg every week or 40 mg every other week) were analyzed for hospitalization risk as a single group versus placebo. Results were generated using Kaplan-Meier estimates, a tool for measuring the timing of significant events from real-life data. A Cox proportional-hazards model, which is a model used to determine the underlying rate of risk, was used to control for other factors, such as demographics, disease duration, presence of draining cutaneous fistula (abnormal connections that form between the intestine and the skin in patients with Crohn's disease), steroid use at baseline, stenosis (narrowing of the bowel), and CDAI at week 4. A Cox proportional-hazards model showed HUMIRA was associated with a significantly lower risk of hospitalization (hazard ratio=0.31, p < 0.01).
At 56 weeks, Crohn's disease-related hospital admission rates for patients treated with HUMIRA were 5.9 percent, compared to 13.9 percent for those on placebo (p<0.01). A difference in the risk of hospitalization between HUMIRA and placebo was also observed at two weeks after patients were randomized into treatment groups. At three months, patients on either dose of HUMIRA had a 78 percent lower risk (1.6 percent) of being hospitalized for Crohn's-related symptoms than those on placebo (7.3 percent; p<0.01).
"A flare-up of Crohn's disease that requires hospitalization can take a heavy toll on a person's life," said Richard J. Geswell, president of the Crohn's & Colitis Foundation of America (CCFA). "The average length of hospitalization is about nine days. In addition to suffering from the pain of the flare, patients lose time with their families, miss work and incur medical costs for the hospital stay."
CHARM was a 56-week trial that assessed the effectiveness of HUMIRA in maintaining clinical remission (CDAI<150). CDAI is the Crohn's Disease Activity Index, a weighted composite score of eight clinical factors that evaluate patient wellness, including daily number of liquid or very soft stools, severity of abdominal pain, level of general well-being, and other measures.
CHARM enrolled 854 adult patients with moderately to severely active Crohn's disease. The 499 patients who demonstrated clinical response (a CDAI decrease >70 from baseline) to HUMIRA during a four-week open-label induction phase were randomized to receive either HUMIRA or placebo. The co-primary endpoints evaluated the maintenance of clinical remission at weeks 26 and 56 for each HUMIRA group compared to those on placebo. A significantly greater percentage of patients treated with HUMIRA maintained clinical remission at one year compared to placebo.
Approval of HUMIRA for Crohn's disease
In February 2007, the U.S. Food and Drug Administration approved HUMIRA as a treatment for reducing the signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy. HUMIRA is also indicated for reducing the signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab, the only other approved biologic for treatment of Crohn's disease. In the U.S., the recommended HUMIRA dose regimen for adult patients with Crohn's disease is 160 mg initially at week 0, 80 mg at week 2, followed by a maintenance dose of 40 mg every other week beginning at week 4.
HUMIRA is the first and only self-administered biologic for the treatment of moderate to severe Crohn's disease. Crohn's disease is the fourth FDA approval in immune-mediated diseases for HUMIRA.
On April 26, 2007, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency granted a positive opinion recommending approval of HUMIRA for the treatment of severe Crohn's disease.
"For people with Crohn's disease, hospitalization can disrupt their active lives," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development at Abbott. "The recent FDA approval of and positive opinion for HUMIRA was based on clinical data showing that HUMIRA induced and maintained remission in people with Crohn's disease. This hospitalization data further demonstrates the importance of maintaining remission in these patients."
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 infection should be evaluated for prior evidence of HBV infection 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 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 patients treated with HUMIRA was similar to the safety profile seen in patients with rheumatoid arthritis.
HUMIRA is the only fully human monoclonal antibody approved for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS, an arthritis of the spine) in the U.S. and Europe, and the only fully human monoclonal antibody approved for Crohn's disease in the U.S. 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 180,000 people worldwide currently 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 is also indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. HUMIRA is also indicated for reducing the signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy, and reducing 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.HUMIRA.com or in the United States by calling Abbott Medical Information at 1-800-633-9110.
Abbott 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. Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com.
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