Abbott's HUMIRA® (Adalimumab) Meets Primary Endpoints in Phase III Ulcerative Colitis Study
ABBOTT PARK, Ill., May 10, 2011 /PRNewswire/ -- Abbott's (NYSE: ABT) HUMIRA® (adalimumab) met its primary endpoint of clinical remission in a Phase III study of adult patients with moderate to severe ulcerative colitis. Results were presented at the Digestive Disease Week (DDW) scientific conference in Chicago.
Ulcerative colitis (UC) is a chronic autoimmune disease that causes inflammation and ulceration in the lining of the colon or large intestine. It is estimated that approximately 700,000 people in the United States have UC. Symptoms include abdominal cramping, rectal bleeding, increased bowel movements and diarrhea.
"There is an unmet need for patients living with ulcerative colitis," said William J. Sandborn, M.D., division chief, Gastroenterology, University of California, San Diego and primary investigator for the study. "Unmanaged disease lends itself to painful symptom flares that can negatively impact patients, so the potential for new treatments is important for people managing this condition."
The study analysis included 494 adult patients with UC who had not responded well to conventional therapy, such as corticosteroids and/or immunosuppressants. Patients were randomized 1:1 to placebo or HUMIRA (160 mg, week 0; 80 mg, week 2; 40 mg every other week starting at week 4). Co-primary endpoints were the proportion of patients with clinical remission at week 8 and clinical remission at week 52. Clinical remission was defined as a Mayo Score of 2 or less with no individual subscore greater than 1. The Mayo Score uses a 12-point scoring system to measure disease activity which is evaluated by scoring the following parameters: stool frequency, rectal bleeding, endoscopy findings and physicians global assessment. A higher Mayo Score indicates greater disease severity.
Of the 248 patients treated with HUMIRA in the study, 16.5 percent achieved clinical remission compared to 9.3 percent on placebo at week 8 (p=0.019). At week 52, 17.3 percent achieved clinical remission compared to 8.5 percent on placebo (p=0.004). These results were statistically significant compared to placebo.
The safety results were consistent with the known safety profile of HUMIRA. Incidence of injection site reaction-related adverse events and hematologic adverse events were greater in HUMIRA-treated patients compared to placebo-treated patients.
"People living with ulcerative colitis currently have very few treatment options to help them manage their disease," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott. "We are encouraged by these study results with HUMIRA and the potential they may have for patients."
HUMIRA is not approved for the treatment of UC. Abbott recently submitted applications to both the U.S. Food and Drug Administration and the European Medicines Agency seeking approval to market HUMIRA for the treatment of moderate to severe UC.
About Ulcerative Colitis
On average, people are diagnosed with ulcerative colitis in their mid-30s, though the disease can occur at any age. The symptoms of UC tend to come and go, with fairly long periods of remission between flare-ups. Common complications include bleeding, perforation of the bowel and abdominal distension. Treatment may include medication, restoring and maintaining proper nutrition, and surgery. During their lifetimes, approximately 25 percent of UC patients will undergo surgery to treat their symptoms.
HUMIRA is a prescription medicine used alone, with methotrexate, or with certain other medicines to reduce the signs and symptoms of moderate to severe rheumatoid arthritis in adults, may prevent further damage to your bones and joints, and may help your ability to perform daily activities. HUMIRA is used alone, with methotrexate, or with certain other medications to reduce the signs and symptoms of moderate to severe polyarticular juvenile idiopathic arthritis in children 4 years of age and older. HUMIRA is used alone or with certain other medicines to reduce the signs and symptoms of psoriatic arthritis in adults, may prevent further damage to your bones and joints, and may help your ability to perform daily activities. HUMIRA is used to reduce the signs and symptoms of ankylosing spondylitis in adults.
HUMIRA is used to reduce signs and symptoms, and achieve and maintain clinical remission in adults with moderate to severe Crohn's disease who have not responded well to conventional treatments, and in these adults who have also lost response to or are unable to tolerate infliximab. HUMIRA is used to treat adults with moderate to severe chronic plaque psoriasis who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.
HUMIRA Uses and Important Safety Information
HUMIRA is a TNF blocker that affects the immune system and can lower the ability to fight infections. People treated with HUMIRA are at an increased risk for developing serious infections that may lead to hospitalization or death. Reported serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. People should be tested for TB before HUMIRA use and monitored for signs and symptoms of TB during therapy. People at risk of TB may be treated with medicine for TB. Treatment with HUMIRA should not be started in a person with an active infection, unless approved by a doctor. HUMIRA should be stopped if a person develops a serious infection.
For people taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death.
Other possible serious side effects with HUMIRA include hepatitis B infection in carriers of the virus, allergic reactions, nervous system problems, blood problems, certain immune reactions, including a lupus-like syndrome, liver problems, and new or worsening heart failure or psoriasis. The use of HUMIRA with anakinra or abatacept is not recommended. People using HUMIRA should not receive live vaccines.
Common side effects of HUMIRA include injection site reactions (redness, rash, swelling, itching, or bruising), upper respiratory infections (including sinus infections), headaches, rash, and nausea.
As with any treatment program, the benefits and risks of HUMIRA should be carefully considered before starting therapy.
Full Prescribing Information for HUMIRA is available at http://www.rxabbott/pdf/humira.pdf.
Abbott 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 nearly 90,000 people and markets its products in more than 130 countries.
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