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News Release - May 21, 2008
Abbott Presents Long-Term Data From Extension Study Showing Adult Crohn's Patients Treated With HUMIRA(R) (Adalimumab) Maintained RemissionThree of Four HUMIRA Patients from CHARM Study in Remission at One Year
Maintained Remission at Two Years
ABBOTT PARK, Illinois, May 21 (HSMN NewsFeed) -- Results from an open-label extension study of two Abbott pivotal studies, CHARM and GAIN, demonstrate that adult moderate-to-severe Crohn's patients treated with HUMIRA® (adalimumab) achieved long-term clinical remission and clinical response, respectively, according to data presentations today at Digestive Disease Week® (DDW) in San Diego. DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Patients from CHARM and GAIN were followed through into a non-placebo controlled, ongoing open-label extension (OLE) trial. Patients from CHARM were followed a total of two years, and patients from the 4-week GAIN study were followed a total of one year.
The CHARM extension data demonstrated that three out of four patients (77 percent) taking HUMIRA, who were in remission at the end of the one-year pivotal study, maintained clinical remission for an additional year. The GAIN data showed that, of patients with a clinical response at four weeks, approximately 65 percent remained in clinical response at one year, and 40 percent were in clinical remission at one year. Response was measured by change in Crohn's Disease Activity Index (CDAI), 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, levels of general well-being and other measures. Clinical remission was measured as a score of less than 150 and clinical response was measured as a decline of at least 70 points from baseline.
Crohn's disease is a serious, chronic, inflammatory bowel disease that affects more than 500,000 Americans. It affects people of all ages but it is primarily a disease of young adults, with onset typically before age 40.
Common symptoms of the disease include diarrhea, cramping, abdominal pain, weight loss, fever, and in some cases, rectal bleeding. Over the course of their disease, up to 75 percent of patients with Crohn's will undergo surgery for complications or disease resistant to treatment.
"Crohn's disease is a life-long condition with no known cure. One of the goals of treatment is to induce and maintain remission, which can help patients with their chronic symptoms," said Remo Panaccione, M.D., Associate Professor, and Director of the Inflammatory Bowel Disease Clinic at the University of Calgary and study author. "In this study, many patients taking HUMIRA during a lengthened treatment period showed clinical response and remission, which translates into improvement of disease symptoms."
About the Open-Label Extension Study
The two analyses from the ongoing extension study focused on the efficacy of HUMIRA in maintaining remission and achieving response during long-term follow-up periods. A diverse group of patients with moderate to severe Crohn's disease were represented, including those who were naive to anti-TNF agents or who had previously lost response or were unable to tolerate infliximab.
At the end of CHARM and GAIN, patients were eligible for enrollment in the OLE study (N=467 enrolled). Patients enrolled from the blinded, randomized arms from CHARM and GAIN received HUMIRA 40 mg every other week (EOW) and patients enrolled from the open-label arm of CHARM received their previous open-label regimens [40 mg EOW or every week (EW)]. Patients in the OLE study could be switched to EW dosage for flare or non-response. The results from both HUMIRA doses were pooled for the analyses.
About the CHARM Trial
The CHARM (Crohn's trial of the fully Human antibody Adalimumab for Remission Maintenance) study enrolled 854 patients, both anti-TNF naive and anti-TNF experienced, with moderate to severe Crohn's disease to study the safety and efficacy of HUMIRA in maintaining clinical remission up to 56 weeks. After week four, 778 patients were randomized to placebo, HUMIRA 40 mg every other week (EOW) or 40 mg weekly (EW) in blinded fashion. At or after week 12, patients with flares or non-responders could receive open-label 40 mg EOW and 40 mg EW for continued flare or nonresponse.
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.
About the GAIN Trial
In the GAIN (Gauging Adalimumab effectiveness in Infliximab Nonresponders) study, a four-week induction trial of 325 patients who lost response or were intolerant to infliximab, three times as many patients taking HUMIRA achieved clinical remission at week four versus placebo (21 percent versus 7 percent, respectively).
"HUMIRA's ability to effectively treat the chronic symptoms of Crohn's disease makes it an important option for gastroenterologists and patients looking for improved disease management," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott.
HUMIRA is indicated for reducing 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 indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
The recommended HUMIRA dose regimen for adult patients with Crohn's disease is 160 mg initially at Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later (Day 15). Two weeks later (Day 29) patients begin a maintenance dose of 40 mg every other week. 5-aminosalicylates, corticosteroids, and/or immunomodulatory agents (e.g. 6-mercaptopurine and azathioprine) may be continued during treatment with HUMIRA.
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 three-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.
In the placebo-controlled clinical studies of adult patients with rheumatoid arthritis, the most frequent adverse reactions 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.
In HUMIRA clinical trials for ankylosing spondylitis, psoriatic arthritis, Crohn's disease and plaque psoriasis, the safety profile for adult patients treated with HUMIRA was similar to the safety profile seen in adult patients with rheumatoid arthritis. In the placebo-controlled clinical trials in plaque psoriasis, the incidence of arthralgia was 3 percent in HUMIRA-treated patients versus 1 percent in controls.
In general, adverse reactions in pediatric patients were similar in frequency and type to those seen in adult patients. Severe adverse reactions reported in the clinical trial of juvenile idiopathic arthritis (JIA) included neutropenia, streptococcal pharyngitis, increased aminotransferases, herpes zoster, myositis, metrorrhagia and appendicitis. Serious infections were observed in 4 percent of patients within approximately 2 years of initiation of treatment with HUMIRA and included cases of herpes simplex, pneumonia, urinary tract infection, pharyngitis, and herpes zoster. Safety of HUMIRA in pediatric patients for uses other than JIA has not been established.
As with any treatment program, the benefits and risks of HUMIRA should be carefully considered before initiating therapy.
In addition to its use in Crohn's disease, HUMIRA is also 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 rheumatoid arthritis. HUMIRA is indicated as a treatment to reduce signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients four years of age and older.
HUMIRA is indicated for reducing 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 indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
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 some autoimmune diseases.
To date, HUMIRA has been approved in 75 countries and more than 250,000 patients worldwide are currently being treated with HUMIRA. Clinical trials are currently under way evaluating the potential of HUMIRA in other immune-mediated diseases.
Abbott's Commitment to Immunology
Abbott is focused on the discovery and development of innovative treatments for immunologic diseases.
More information about HUMIRA, including full prescribing information and Medication Guide, 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.
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 17-22, 2008, at the San Diego Convention Center, San Diego, CA. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit http://www.ddw.org.
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.
Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com.
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