Healthcare Industry News: Methotrexate
News Release - February 2, 2007
Psoriasis Patients Show Significant Improvement in Symptoms with Abbott's HUMIRA(R) in New Phase III StudyNearly Three Out of Four Patients Showed 75 Percent Skin Clearance or Better in REVEAL, a Pivotal Study of HUMIRA in Moderate to Severe Psoriasis
ABBOTT PARK, Ill., Feb. 2 (HSMN NewsFeed) -- Psoriasis patients experienced a significant reduction in the signs of their disease when treated with Abbott's HUMIRA® (adalimumab), and they were significantly less likely to have their disease signs worsen when they used HUMIRA continuously, new study results show. The safety profile of HUMIRA was found to be consistent with earlier clinical studies of HUMIRA in psoriasis and rheumatoid arthritis. These findings from the REVEAL study of patients with moderate to severe psoriasis were presented today at the American Academy of Dermatology annual meeting in Washington, D.C.
REVEAL is the second Phase III study to show positive results for HUMIRA in psoriasis. Abbott will submit REVEAL results as part of a regulatory application for a psoriasis indication in the United States and Europe, expected during the first half of 2007.
Psoriasis is a non-contagious, often painful autoimmune disease characterized by raised, inflamed, scaly, red skin lesions known as plaques, which may crack and bleed. In addition to these visible symptoms, people with psoriasis may suffer from poor self-image, social isolation and even depression. There is currently no cure for psoriasis, which affects an estimated 125 million people worldwide, with approximately 25 percent of patients experiencing moderate to severe disease. While psoriasis can occur in people of all ages, it typically appears in patients between the ages of 15 and 35.
"An important goal of psoriasis treatment is to not only clear the skin initially but to help patients maintain clearance over time," said the study's primary investigator, Alan Menter, M.D., chairman of the Division of Dermatology at Baylor University Medical Center, Dallas. "In this study, the majority of patients receiving HUMIRA achieved both of those goals. These results, combined with previous studies and convenient dosing, make HUMIRA a promising potential treatment for psoriasis patients."
About the REVEAL Study
REVEAL (Randomized Controlled EValuation of Adalimumab Every Other Week Dosing in Moderate to Severe Psoriasis TriAL) evaluated both the short-term and sustained clinical efficacy and safety of HUMIRA in 1,200 patients with moderate to severe chronic plaque psoriasis.
The REVEAL study had two independent primary endpoints. The first endpoint was the proportion of patients achieving 75 percent improvement in skin clearance after 16 weeks. The second endpoint was the proportion of patients who lost adequate response through week 52 after stopping treatment with HUMIRA at week 33. Signs of psoriasis were evaluated using the Psoriasis Area and Severity Index (PASI), among other measures.
In the first 16 weeks of the study, researchers evaluated short-term efficacy and safety. Patients were randomized to receive either HUMIRA (40 mg every other week beginning at week one after a starting dose of 80 mg at week zero) or placebo. Results showed that nearly three out of four patients (71 percent) achieved at least 75 percent improvement in disease signs (PASI 75) after 16 weeks of HUMIRA treatment, compared to just 6.5 percent of patients who achieved PASI 75 after receiving placebo. Nearly half of the patients (45 percent) achieved 90 percent improvement (PASI 90), versus 1.8 percent of patients receiving placebo.
HUMIRA patients showed an average 52 percent improvement in psoriasis symptoms at four weeks, the first point at which improvement was evaluated, versus an average 9 percent improvement for patients receiving placebo.
HUMIRA patients who achieved at least a PASI 75 response at week 16 continued to receive HUMIRA on an open-label basis. At week 33, the 490 patients who maintained PASI 75 were randomized to receive placebo or continue receiving HUMIRA.
In the second primary endpoint measured at week 52, 28 percent of patients receiving placebo lost adequate response, compared to 5 percent of patients receiving HUMIRA. Loss of adequate response was defined as less than 50 percent improvement at any time between week 33 and 52, compared to the beginning of the study and as worsening extent and severity of disease from week 33 to week 52, as measured by a six-point increase in the PASI score.
The safety profile observed in REVEAL was consistent with that seen in previous psoriasis and rheumatoid arthritis studies. HUMIRA was generally well tolerated with the most commonly reported adverse events being upper respiratory tract infection, nasopharyngitis and headache.
HUMIRA has more than nine years of clinical experience with more than 180,000 patients worldwide currently treated with HUMIRA. HUMIRA is currently approved to treat psoriatic arthritis, a form of arthritis that affects up to 30 percent of people with psoriasis. More than 1,000 dermatologists have prescribed HUMIRA.
"Results of the REVEAL study, along with previously reported results from the CHAMPION study that showed HUMIRA was statistically superior to the standard systemic psoriasis treatment, Methotrexate, demonstrate that HUMIRA has great promise as a possible treatment for psoriasis," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott. "The results of these studies, as well as the convenience and established safety profile of HUMIRA, will be well-received by patients and physicians."
The CHAMPION study, presented last October 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 HUMIRA achieved at least 75 percent improvement in disease extent and severity after 16 weeks compared to patients receiving Methotrexate (36 percent).
Important Safety Information
Serious infections, sepsis, tuberculosis (TB) and rare cases of 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. 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.
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. 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 four 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.
The most frequent adverse events seen in the placebo-controlled clinical trials in 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 and psoriatic arthritis, the safety profile for patients treated with HUMIRA was similar to the safety profile seen in patients with rheumatoid arthritis.
HUMIRA is the only fully human monoclonal antibody approved for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS, an arthritis of the spine) in the U.S. and Europe. HUMIRA resembles antibodies normally found in the body. It works by blocking tumor necrosis factor alpha (TNF-alpha), 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 180,000 people worldwide are currently being treated with HUMIRA. Clinical trials are currently under way evaluating the potential of HUMIRA in other autoimmune diseases. Abbott plans to initiate clinical trial protocols of HUMIRA in children and adolescents with psoriasis in 2007.
In the U.S., 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 is also indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. HUMIRA can be used alone or in combination with Methotrexate or other disease-modifying anti-rheumatic drugs (DMARDs).
Abbott's Commitment to Immunology
Abbott is focused on the discovery and development of innovative treatments for immunologic diseases. The Abbott Bioresearch Center, founded in 1989 in Worcester, Mass., United States, is a world-class discovery and basic research facility committed to finding new treatments for autoimmune diseases.
More information about HUMIRA, including full prescribing information, is available on the Web site http://www.HUMIRA.com or in the United States by calling Abbott Medical Information at 1-800-633-9110.
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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