Abbott Announces Data Evaluating Reduction of Steroid Usage with HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis

AMSTERDAM, Oct. 24, 2012 /PRNewswire/ -- Abbott today announced results from a post-hoc analysis of the 52-week HUMIRA® (adalimumab) ULTRA 2 study.  Results of the analysis showed that patients with moderately to severely active ulcerative colitis (UC) who failed, were intolerant or had contraindications to certain other medicines and achieved a response to HUMIRA at eight weeks, were able to reduce corticosteroid doses at week 52.  In addition, results showed:

• Of those patients who were randomized to HUMIRA and responded at eight weeks, the rate of patients able to discontinue steroids was 45.6 percent vs. 22.9 percent of placebo-treated patients.
• 20 percent of the HUMIRA-treated eight-week responders were able to discontinue steroids for over 90 days and achieve remission defined by a Full Mayo score (Mayo score ≤2 with no sub scores >1) vs. 5.7 percent of patients receiving placebo.

The data 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.

"The cumulative dosage of steroids used to help manage ulcerative colitis has been associated with steroid toxicity—which may induce several metabolic disorders and complications in various organ systems.  This is a major concern in patients of all ages, but particularly in young adults," said lead investigator Gert Van Assche, M.D., Ph.D., professor of medicine, University of Toronto and University of Leuven.  "These data suggest that adalimumab-treated patients were able to reduce steroid usage, which is an important goal in the long-term management of this 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.

"HUMIRA is one of the most comprehensively studied biologics on the market. Our scientific experience with HUMIRA serves as a strong foundation to help fulfill unmet clinical needs in the management of ulcerative colitis," said John Medich, Ph.D., divisional vice president, clinical development, Immunology, Abbott.  "Abbott continues to support the medical community with research to explore treatments that will help improve patient outcomes."

Study Details

The sub-analysis of ULTRA 2 evaluated corticosteroid (CS)-free remission and reduction in CS use in adult patients with moderately to severely active UC who failed conventional therapy but responded to induction therapy with HUMIRA after eight weeks 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 the Full Mayo score does.

Of the 150 HUMIRA-treated patients using CS at baseline, 45.6 percent responded to treatment per FMS (n=90, versus 22.94 percent of the 140 placebo patients) and 47.8 percent per PMS (n=90, versus 22.9 percent of the 140 placebo patients) and were able to discontinue steroids by week 52.  Patients who responded to HUMIRA at week eight achieved clinically meaningful rates of CS-free remission at week 52 (responders per FMS=20.0 percent; responders per PMS=21.1 percent; placebo 5.7 percent) and CS-free status (responders per FMS=45.6 percent; responders per PMS=47.8 percent; placebo 22.9 percent) at week 52.  The results demonstrated that treatment with HUMIRA provided clinically meaningful reductions in CS doses at week 52 and patients were able to discontinue steroids for 90 days and achieve clinical remission.  Similar results were observed regardless of history 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 sub score 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 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.

Abbott's news releases and other information are available on the company's website at www.abbott.com.