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News Release - October 5, 2006
New Phase III Data Show Abbott's HUMIRA(R) (Adalimumab) Was Statistically Superior to Methotrexate in Patients With PsoriasisFirst psoriasis study to feature a head-to-head comparison between a biologic agent versus standard systemic treatment
RHODES, Greece, Oct. 5 (HSMN NewsFeed) -- Positive Phase III data presented today at the European Academy of Dermatology and Venereology Congress showed that HUMIRA was statistically superior to methotrexate in patients with psoriasis. More than twice the percentage of patients (80 percent) with moderate to severe psoriasis receiving Abbott's HUMIRA (adalimumab) achieved at least 75 percent improvement in disease extent and severity after 16 weeks compared to patients receiving methotrexate (36 percent), a standard systemic treatment for psoriasis. The study met its primary efficacy endpoint, which was to determine whether HUMIRA would reduce disease activity more than methotrexate or placebo, as measured by a well- known psoriasis assessment tool. This is the first psoriasis study to feature a head-to-head comparison between a biologic agent and a standard systemic treatment.
Psoriasis is a chronic, non-contagious autoimmune skin disease characterized by very dry, scaly and cracked skin, skin pain, and patches of red, raised skin known as "plaques". There is currently no cure for the disease, which affects an estimated 125 million people worldwide, with approximately 25 percent of patients experiencing moderate to severe disease symptoms.
"The results of this study strongly suggest the potential HUMIRA may have as a new treatment for psoriasis," said the study's primary investigator, Professor Jean-Hilaire Saurat, M.D., chairman, department of dermatology, University of Geneva, Switzerland. "The scales and plaques of psoriasis can cause both physical and emotional distress, making it essential to identify new treatment options for these patients."
About the CHAMPION Study
CHAMPION (Comparative Study of HUMIRA vs. Methotrexate vs. Placebo In PsOriasis PatieNts) included 271 patients from eight European countries and Canada who were candidates for systemic therapy or phototherapy. The three- arm, 16-week study evaluated the treatment effect of HUMIRA in comparison to methotrexate (MTX) or placebo, each dosed as monotherapy. The comparison of HUMIRA and MTX was a non-inferiority analysis. Patients were randomized to receive either HUMIRA in its standard dose of 40 mg subcutaneous injection every other week (eow), beginning at one week following an initial single dose of 80 mg, or MTX or placebo.
The primary efficacy endpoint was the percentage of patients achieving at least a 75 percent reduction in disease activity at week 16 as measured by the Psoriasis Area and Severity Index score (PASI 75), which is a score ranging from 0-72 and measures the extent and severity of psoriasis. Physician's Global Assessment (PGA), another measurement tool used by physicians to assess disease severity, also was used in the study.
Results at week 16 showed that nearly 80 percent of patients receiving HUMIRA achieved PASI 75, compared to 35.5 percent receiving MTX (p<0.001) and 18.9 percent receiving placebo (p<0.001). Patient response to HUMIRA was rapid, with a mean PASI improvement of 57 percent achieved at week four, compared to baseline. PGA results, the study's secondary efficacy endpoint, showed 73 percent of patients taking HUMIRA had physician assessments of their psoriasis of "clear" or "minimal" compared to 30 percent of patients taking MTX (p<0.001) and 11 percent of patients taking placebo (p<0.001) at week 16.
The safety profile of the study was consistent with previously reported studies of HUMIRA. Adverse events occurring in more than five percent of HUMIRA patients included injection site reaction, hepatic events, nasopharyngitis (inflammation of the nose and pharynx), arthralgia (joint pain) and headache.
"These study results are very promising for patients whose lives continue to be negatively impacted by the effects of psoriasis," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development at Abbott. "We remain encouraged and optimistic about the potential of HUMIRA in the treatment of psoriasis."
Abbott expects to submit a regulatory application for a psoriasis indication in Europe and the United States during the first half of 2007.
Psoriasis is a disorder of the immune system that speeds the growth cycle of skin cells and results in dry, thick, scaly skin. The most common form of psoriasis appears as red, raised areas of skin covered with flaky white scales, which may itch or be painful. Psoriasis can be limited to a few lesions or can involve moderate to large areas of skin and often appears on the scalp, knees, elbows and torso, although it can develop anywhere on the skin. It may even occur in the fingernails and toenails. While psoriasis can occur in people of all ages, it typically appears in patients between the ages of 15 and 35. The severity of the disease can vary from person to person.
Important Global Safety Information
Globally, prescribing information varies; refer to the individual country product label for complete information. For U.S. safety information, visit http://www.HUMIRA.com .
Serious infections, sepsis, rare cases of tuberculosis (TB), and opportunistic infections, including fatalities, have been reported with the use of TNF-antagonists, including HUMIRA. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their rheumatoid arthritis (RA), could predispose them to infections. Patients must be monitored closely for infections, including TB, before, during and after treatment with HUMIRA. Treatment should not be initiated in patients with active infections until infections are controlled. HUMIRA should not be used by patients with active TB or other severe infections such as sepsis and opportunistic infections.
Patients who develop new infections while using HUMIRA should be monitored closely. HUMIRA should be discontinued if a patient develops a new serious infection until infections are controlled. Physicians should exercise caution when considering use of HUMIRA in patients with a history of recurring infection or with underlying conditions that may predispose patients to infections.
TNF-blocking agents have been associated with reactivation of hepatitis B (HBV) in patients who are chronic carriers of the virus. Some cases have been fatal. Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating HUMIRA.
The combination of HUMIRA and anakinra is not recommended.
TNF-antagonists, including HUMIRA, have been associated in rare cases with demyelinating disease and serious allergic reactions. Rare reports of pancytopenia including aplastic anemia have been reported with TNF-blocking agents. Adverse events of the hematologic system, including medically significant cytopenia, have been infrequently reported with HUMIRA.
More cases of malignancies including lymphoma have been observed among patients receiving a TNF-antagonist compared with control patients in clinical trials. The size of the control group and limited duration of the controlled portions of studies precludes the ability to draw firm conclusions. Furthermore, there is an increased background lymphoma risk in RA patients with long-standing, highly active, inflammatory disease, which complicates the risk estimation. During the long-term open label trials with HUMIRA, the overall rate of malignancies was similar to what would be expected for an age, gender and race matched general population. With the current knowledge, a possible risk for the development of lymphomas or other malignancies in patients treated with a TNF-antagonist cannot be excluded.
In clinical studies with another TNF-antagonist, a higher rate of serious congestive heart failure (CHF) related adverse events including worsening CHF and new onset CHF have been reported. Cases of worsening CHF have also been reported in patients receiving HUMIRA. Physicians should exercise caution when using HUMIRA in patients who have heart failure and monitor them carefully. HUMIRA should not be used in patients with moderate or severe heart failure.
Common adverse events (>1/100 and >1/10) at least possibly causally related to HUMIRA include lower respiratory infections (including pneumonia, bronchitis), urinary tract infection, herpetic viral infection (including simplex and zoster), influenza, superficial fungal infections (including skin, nail and foot), lymphopenia, anemia, headache, dizziness, paresthesias, hypertension, cough, nasopharyngeal pain, nasal congestion, nausea, abdominal pain, diarrhea, dyspepsia, mouth ulceration, rash, pruritus, rash erythematous, rash pruritic, hair loss, arthritis, fatigue (including asthenia and malaise), influenza like illness and hepatic enzymes increased (including alanine aminotransferase and aspartate aminotransferase). Injection site reaction (including pain, swelling, redness or pruritus) and upper respiratory infection were reported by >1/10 patients.
HUMIRA is approved for the treatment of RA, psoriatic arthritis (PsA), and ankylosing spondylitis (AS) in Europe and the U.S. HUMIRA resembles antibodies normally found in the body. It works by blocking tumor necrosis factor alpha (TNF-a), a protein that plays a central role in the inflammatory responses of autoimmune diseases. To date, HUMIRA has been approved in 67 countries and more than 160,000 people worldwide are currently being treated with HUMIRA. Clinical trials are currently under way evaluating the potential of HUMIRA in other autoimmune diseases.
In Europe, HUMIRA, in combination with MTX, is indicated for the treatment of moderate to severe, active RA in adult patients when the response to disease-modifying anti-rheumatic drugs (DMARDs) including MTX has been inadequate, and for the treatment of severe, active and progressive RA in adults not previously treated with MTX. HUMIRA can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. HUMIRA has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function, when given in combination with MTX. Additionally, HUMIRA is indicated for the treatment of active and progressive PsA in adults when the response to previous DMARD- therapy has been inadequate and for the treatment of severe, active AS in adults who have had an inadequate response to conventional therapy.
In the U.S., HUMIRA is approved by the Food and Drug Administration for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active RA. HUMIRA is also indicated for reducing the signs and symptoms of active arthritis in patients with PsA. In RA and PsA, HUMIRA can be used alone or in combination with MTX or other DMARDs. HUMIRA is also approved for reducing signs and symptoms in patients with active AS.
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 65,000 people and markets its products in more than 130 countries.
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