Abbott's HUMIRA® (Adalimumab) Meets Primary Endpoints in Phase III Ulcerative Colitis Study
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.
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.