ABBOTT PARK, Ill., March 15, 2012 /PRNewswire/ -- Abbott (NYSE: ABT) today announced the initiation of two Phase 3 clinical trials designed to evaluate the safety and efficacy of an investigational use of HUMIRA® (adalimumab) in adult patients with moderate to severe hidradenitis suppurativa (HS).
Hidradenitis suppurativa is a difficult-to-treat, chronic, inflammatory skin disease characterized by painful, recurrent abscesses, and nodules that primarily appear in the groin or under the armpits or breasts and start out as tender, swollen bumps. Over time, these lesions can fill with fluid, burst, and result in scars. This can lead to pain and discomfort.
"Treating hidradenitis suppurativa has remained a challenge for specialists and patients, since there is no FDA-approved therapy available," said Francisco Kerdel, M.D., Miami, Fla. "This investigation of adalimumab in HS patients is potentially a significant step for this underserved patient population."
The Phase 3 trials (M11-313 and M11-810) are 36-week, multinational, randomized, double-blind, placebo-controlled studies designed to evaluate clinical outcomes and safety of adalimumab in approximately 600 patients with moderate to severe HS. They will be conducted at approximately 50 sites worldwide, including sites in Australia, Canada, Europe and the United States.
Selected inclusion criteria include: participants who have been diagnosed with moderate to severe HS for at least one year prior to enrollment with stable disease for the last two months, lesions in two distinct areas, and have had an inadequate response to at least a three-month trial of an oral antibiotic for treatment of HS. At baseline, subjects must have a total abscess and inflammatory nodule count of greater than or equal to three.
"Ten years ago, HUMIRA was approved for moderate to severe rheumatoid arthritis and since then has achieved five additional indications to treat millions of patients across a range of immune diseases," said John Medich, Ph.D., divisional vice president, Clinical Development, Immunology, Abbott. "Abbott is committed to investigating adalimumab as a treatment option for patients with hidradenitis suppurativa, and these studies represent another important step in continuing this exploration."
Results of these Phase 3 trials are expected in 2013. More information on the trials is available at www.clinicaltrials.gov (NCT01468207 and NCT01468233).
About HUMIRA® (adalimumab)
HUMIRA is a prescription medicine used to:
- Reduce the signs and symptoms of:
- Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
- Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 4 years of age and older. HUMIRA can be used alone, with methotrexate, or with certain other medicines.
- Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
- Ankylosing spondylitis (AS) in adults.
- Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in adults who have not responded well to conventional treatments. HUMIRA is also for these adults who have lost response to or are unable to tolerate infliximab.
- Treat moderate to severe chronic plaque psoriasis (Ps) in adults 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.
Important Safety Information for approved indications
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.
This is not a complete list of the Important Safety Information for HUMIRA.
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.