Press Release

Abbott Announces New Data Evaluating Mucosal Healing with HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis

Date: October 23, 2012

AMSTERDAM, Netherlands — Abbott today announced results from a post-hoc sub-analysis of the 52-week HUMIRA® (adalimumab) ULTRA 2 study.  Results of the analysis showed clinically meaningful rates of mucosal healing at week 52 in patients with moderately to severely active ulcerative colitis (UC) who failed, were intolerant or had contraindications to certain other medications and achieved a response to HUMIRA induction therapy at eight weeks.

Of the 494 patients included in the analysis and who responded at eight weeks, significantly more patients treated with HUMIRA vs. placebo achieved clinically relevant rates of mucosal healing at week 52 (responders per Full Mayo score=40.8 percent; responders per Partial Mayo score=43.1 percent; placebo=15.4 percent, p<0.001).  Similar treatment effects at week 52 were observed regardless of prior anti-TNF use.

The full post-hoc analysis results were presented this week at the United European Gastroenterology Week (UEGW) Annual Meeting in Amsterdam, The Netherlands and the American College of Gastroenterology (ACG) Annual Scientific Meeting in Las Vegas, Nevada.

"Mucosal healing is an objective measure of disease activity in the management of ulcerative colitis," said lead study investigator, Dr. Geert D'Haens, professor of gastroenterology and inflammatory bowel diseases at the Academic Medical Center in Amsterdam.  "This data is encouraging.  Treatment options that may help heal the mucosa are welcomed by the patient and medical community to help manage this long-term and difficult-to-treat disease."

UC is an inflammatory bowel disease marked by ulcers in the colon and that may lead to life-threatening complications.  It is estimated that 25 percent of patients with UC may undergo surgical removal of the colon during their lifetimes, leaving patients with a permanent colostomy or ileal pouch.

"This analysis underscores Abbott's commitment to help advance the scientific and clinical understanding of ulcerative colitis and support the evolving standards of care for patients living with this disease," said John Medich, Ph.D., divisional vice president, clinical development, Immunology, Abbott.  "The results provide additional data about the clinical benefits of HUMIRA in achieving and maintaining mucosal healing."

Study Details

The analysis of ULTRA 2 investigated mucosal healing, defined as Mayo endoscopy subscore of 0 or 1, in adult patients with moderately to severely active UC who failed conventional therapy and who responded to induction therapy with HUMIRA after eight weeks.  Results were based on Full Mayo score (FMS) or Partial Mayo score (PMS).  Partial Mayo score evaluates stool frequency, rectal bleeding, and physician's global assessment as a measure of disease activity that ranges from 0 to 9 but does not include endoscopic findings while a Full Mayo score does.

Of the 494 patients included in the analysis and who responded at eight weeks, significantly more patients treated with HUMIRA vs. placebo achieved clinically relevant rates of mucosal healing at week 52 (responders per FMS=40.8 percent; responders per PMS=43.1 percent; placebo=15.4 percent, p<0.001).  Similar treatment effects at week 52 were observed regardless of prior anti-TNF use.  The results are based on a post-hoc analysis and are hypothesis-generating only.

About ULTRA 2

ULTRA 2 was a 52-week, double-blind, randomized, placebo-controlled phase 3 trial of 494 adult patients who had moderately to severely active UC despite concurrent or prior treatment with immunosuppressants (i.e., corticosteroids, azathioprine, or 6-mercaptopurine).  Patients were randomized 1:1 to placebo or HUMIRA (160 mg, week zero; 80 mg, week two; 40 mg every other week starting at week four).  Patients, including those randomized to placebo, continued concurrent therapy such as corticosteroids, aminosalicylates and immunosuppressants.  Co-primary endpoints were the proportion of patients with clinical remission at week eight and clinical remission at week 52.  Clinical remission was defined as a Mayo score of two or less with no individual subscore greater than one.

Of the 248 patients treated with HUMIRA in ULTRA 2,17 percent achieved clinical remission compared to 9 percent on placebo at week eight (p<0.05).  At week 52, 17 percent achieved clinical remission compared to 9 percent on placebo (p<0.05). These results were statistically significant compared to placebo.  The safety results from ULTRA 2 were consistent with the known safety profile of HUMIRA and no new safety signals were identified.

About UC

UC is an inflammatory bowel disease marked by inflammation in the rectum and colon, resulting in diarrhea, rectal bleeding and abdominal cramping.  Typically, people are diagnosed with UC in their mid-30s, though the disease can occur at any age. The symptoms of UC tend to come and go, with varying periods of clinical stability punctuated by episodic flares of disease activity.  Severe flares of UC can necessitate hospitalization and can be life-threatening.  Treatment may include medication and/or surgery.

About HUMIRA

Globally, uses and prescribing information vary; please refer to the individual country label for complete information.

HUMIRA is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.

Important Safety Information

HUMIRA is a TNF blocker medicine that affects the immune system and can lower the ability to fight infections.  Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections.  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.  People should tell their doctor if they live in or have been to a region where certain fungal infections are common, have had TB, hepatitis B, are prone to infections, or have symptoms such as fever, fatigue, cough, or sores.

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. If using TNF blockers including HUMIRA, the chance of getting two types of skin cancer (basal cell and squamous cell) may increase.  These types are generally not life-threatening if treated.

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.

HUMIRA is given by injection under the skin.

The benefits and risks of HUMIRA should be carefully considered before starting therapy.

About Abbott

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 approximately 91,000 people and markets its products in more than 130 countries.


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