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Second Phase 3 Study Shows Positive Results for Adalimumab in Psoriasis
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).