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Abbott's HUMIRA(R) (adalimumab) Receives FDA Approval For Moderate to Severe Chronic Plaque Psoriasis Fifth Disease Indication for HUMIRA Provides Patients with Visible Clearance of Inflamed Skin Lesions Caused by Chronic Autoimmune Disease January 18, 2008: 04:25 PM EST
ABBOTT PARK, Ill., Jan. 18 /PRNewswire-FirstCall/ -- Abbott announced today it has received U.S. Food and Drug Administration (FDA) approval to market HUMIRA(R) (adalimumab) as a treatment for adult patients with moderate to severe chronic plaque psoriasis, an autoimmune disease characterized by skin lesions that are sometimes painful and itchy. HUMIRA has been approved for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
The approval is based on two pivotal trials, REVEAL and CHAMPION, showing that nearly 3 in 4 patients achieved 75 percent clearance or better at week 16 of treatment versus placebo. HUMIRA has 10 years of clinical trial experience beginning with rheumatoid arthritis patients. It was approved for moderate to severe rheumatoid arthritis in 2002, psoriatic arthritis in 2005, ankylosing spondylitis in 2006, and moderate to severe Crohn's disease in 2007.
"The approval of HUMIRA for psoriasis is welcome news for people living with this challenging, lifelong disease," said Pam Field, acting president and CEO, National Psoriasis Foundation. "We are pleased to let people with plaque psoriasis know they now have a new treatment option available to them."
Psoriasis affects an estimated 125 million people worldwide, with approximately 25 percent of patients experiencing moderate to severe disease. Psoriasis is a serious, sometimes painful autoimmune disease resulting in inflamed, scaly, red skin lesions known as plaques, which may crack and bleed. In addition to visible symptoms, people with psoriasis may suffer from poor self-image and social isolation, and even feelings of depression, such as sadness and despair. Recent research also suggests psoriasis may be associated with other serious health risks. Up to 30 percent of psoriasis patients develop psoriatic arthritis, which combines skin symptoms with arthritis symptoms, including joint pain and inflammation.
"The approval of HUMIRA is excellent news for patients suffering from psoriasis, which can have a profound physical and emotional impact on a person's life," said Alan Menter, M.D., chairman, division of dermatology, Baylor University Medical Center, Dallas. "HUMIRA offers dermatologists an important new therapeutic option that has been shown to help alleviate a range of psoriasis signs and symptoms, including redness, scaling and itching, in many psoriasis patients."
HUMIRA for Plaque Psoriasis
The approval of HUMIRA is based on data from more than 1,400 adult patients in two pivotal trials -- REVEAL and CHAMPION. Both studies evaluated the efficacy and safety of HUMIRA in clearing skin in moderate to severe adult plaque psoriasis patients versus placebo. In addition, CHAMPION compared a biologic medication to methotrexate, a standard systemic treatment for psoriasis. REVEAL results were published in the Journal of the American Academy of Dermatology in January 2008 and CHAMPION results were published online in the British Journal of Dermatology.
In each trial, reduction in disease activity was determined by the Psoriasis Area and Severity Index (PASI) and Physician's Global Assessment (PGA). The PASI score measures the extent and severity of psoriasis. PASI may be calculated before and after a treatment period to determine efficacy; for example, a PASI 75 correlates to a 75 percent improvement in signs and symptoms of psoriasis. PGA also measures efficacy of therapy. On a six-point scale, a zero score means no signs, one means minimal and a five means signs of very severe psoriasis.
In REVEAL, a pivotal 52-week trial, the short-term and sustained clinical efficacy and safety of HUMIRA were evaluated in more than 1,200 patients from the United States and Canada with moderate to severe chronic plaque psoriasis. Patients experienced a significant reduction in the signs and symptoms of their disease at 16 weeks when treated with HUMIRA. Specifically,-- Almost 3 out of 4 patients (71%) receiving HUMIRA achieved PASI 75 compared to 7 percent of patients receiving placebo at week 16. -- At week 16, 62 percent of HUMIRA-treated patients achieved a PGA scoreof clear or minimal (0 or 1) compared to 4 percent of placebo-treated patients.
In CHAMPION, a pivotal 16-week study evaluating 271 psoriasis patients from eight European countries and Canada, HUMIRA-treated patients experienced a significant reduction in the signs and symptoms of their disease compared with methotrexate or placebo-treated patients.-- Nearly 80 percent (78%) of patients treated with HUMIRA (n=99)achieved a PASI 75 response, compared to 19 percent of patientstreated with placebo (n=48). -- More than 70 percent (71%) of patients treated with HUMIRA achieved aPGA score of clear or minimal at 16 weeks of treatment, compared with only 10 percent of placebo-treated patients.
The safety profile of HUMIRA in the plaque psoriasis clinical trials was similar to that seen in HUMIRA clinical trials for rheumatoid arthritis (RA). The most commonly reported adverse events in HUMIRA psoriasis trials were upper respiratory tract infection, nasopharyngitis (inflammation of the nose and pharynx), headache, sinusitis and arthralgia. HUMIRA is self-administered as an injection. Patients are treated with an initial 80 mg dose of HUMIRA (two 40 mg injections) followed by one HUMIRA injection (40 mg) one week later. After that, a maintenance dose of 40 mg is administered every other week.
"HUMIRA has demonstrated its versatility in effectively treating multiple autoimmune diseases, and this approval expands the therapeutic resources available to dermatologists and other physicians who take care of patients with psoriasis and psoriatic arthritis," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott.
In April 2007, Abbott simultaneously submitted a supplemental Biologics License Application (sBLA) with the FDA and a Type II Variation to the European Medicines Agency (EMEA) seeking approval to market HUMIRA (adalimumab) as a treatment for chronic plaque psoriasis. EMEA approval was received in December 2007, and the U.S. approval makes psoriasis the fifth autoimmune disease indication for HUMIRA.
More Information on Psoriasis
While psoriasis can occur in people of all ages, it typically appears in patients between the ages of 15 and 35, and currently has no cure. In a recent survey from the National Psoriasis Foundation, nearly 40 percent of psoriasis respondents reported feelings of helplessness and self-consciousness as a result of their disease.
Psoriasis varies from person to person and treatment depends largely on type, location, severity, age and medical history, and the primary treatment goals are to reduce the thickness, redness, scaling and itching of the skin. Treatment may include topical agents, phototherapy or medication taken by pill or injection.
Important Safety Information
Serious infections, sepsis, tuberculosis (TB) and opportunistic infections, including fatalities, have been reported with the use of TNF-blocking agents, including HUMIRA.
Many of these serious infections have occurred in patients also taking other immunosuppressive agents that in addition to their underlying disease could predispose them to infections.
Infections have also been reported in patients receiving HUMIRA alone. Treatment with HUMIRA should not be initiated in patients with active infections. TNF-blocking agents, including HUMIRA, have been associated with reactivation of hepatitis B (HBV) in patients who are chronic carriers of this virus. Some cases have been fatal. Patients at risk for HBV infections should be evaluated for prior evidence of HBV infections before initiating HUMIRA. The combination of HUMIRA and anakinra is not recommended and patients using HUMIRA should not receive live vaccines.
More cases of malignancies have been observed among patients receiving TNF blockers, including HUMIRA, compared to control patients in clinical trials. These malignancies, other than lymphoma and non-melanoma skin cancer, were similar in type and number to what would be expected in the general population. There was an approximately 3.0 fold higher rate of lymphoma in combined controlled and uncontrolled open-label portions of HUMIRA clinical trials. The potential role of TNF-blocking therapy in the development of malignancies is not known. TNF-blocking agents, including HUMIRA, have been associated in rare cases with demyelinating disease and severe allergic reactions. Infrequent reports of serious blood disorders have been reported with TNF-blocking agents.
Worsening congestive heart failure (CHF) has been observed with TNF-blocking agents, including HUMIRA, and new onset CHF has been reported with TNF-blocking agents. Treatment with HUMIRA may result in the formation of autoantibodies and rarely, in development of a lupus-like syndrome.
The most frequent adverse events seen in the placebo-controlled clinical trials in adults with rheumatoid arthritis (HUMIRA vs. placebo) were injection site reactions (20 percent vs. 14 percent), upper respiratory infection (17 percent vs. 13 percent), injection site pain (12 percent vs. 12 percent), headache (12 percent vs. 8 percent), rash (12 percent vs. 6 percent) and sinusitis (11 percent vs. 9 percent). Discontinuations due to adverse events were 7 percent for HUMIRA and 4 percent for placebo. As with any treatment program, the benefits and risks of HUMIRA should be carefully considered before initiating therapy.
In HUMIRA clinical trials for ankylosing spondylitis, psoriatic arthritis, Crohn's disease and plaque psoriasis, the safety profile for adult patients treated with HUMIRA was similar to the safety profile seen in adult patients with rheumatoid arthritis. In placebo-controlled clinical trials in plaque psoriasis, the incidence of arthralgia was 3 percent in HUMIRA-treated patients versus 1 percent in controls.
In addition to its approval for chronic plaque psoriasis, HUMIRA is approved by the FDA for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of joint structural damage, and improving physical function in adult patients with moderately to severely active RA. HUMIRA is indicated for reducing the signs and symptoms of active arthritis, inhibiting the progression of structural damage and improving physical function in patients with psoriatic arthritis. HUMIRA resembles antibodies normally found in the body. It works by blocking tumor necrosis factor alpha (TNF-alpha), an inflammatory protein that, when produced in excess, plays a key role in the inflammatory responses of some autoimmune diseases.
To date, HUMIRA has been approved in 72 countries and more than 250,000 people worldwide are currently being treated with HUMIRA. Clinical trials are currently under way evaluating the potential of HUMIRA in other immune-mediated diseases.
In May 2007, Abbott announced it had also submitted an FDA regulatory application for HUMIRA to treat juvenile rheumatoid arthritis and an EMEA regulatory application for HUMIRA to treat juvenile idiopathic arthritis. Clinical trials are currently underway evaluating the potential of HUMIRA in ulcerative colitis. HUMIRA is also approved for reducing signs and symptoms in patients with active AS. HUMIRA is approved for reducing the signs and symptoms and inducing and maintaining clinical remission in adults with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy and reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.