Abbott Laboratories (chiselling a**holes) Announce Positive Results of Phase II HUMIRA(R) (adalimumab) Study in Psoriasis
WASHINGTON, Feb. 9 /PRNewswire-FirstCall/ -- New Phase II data demonstrate that patients with moderate to severe chronic plaque psoriasis receiving HUMIRA® (adalimumab) achieved statistically significant results after 12 weeks, with more than 50 percent of patients achieving at least a 75 percent improvement in measurements of disease extent and severity with 40 mg every other week (eow) dosing, and some patients achieving this level of improvement as early as four weeks.
Additionally, at 12 weeks, 49 percent and 76 percent of patients taking HUMIRA 40 mg eow or 40 mg weekly, respectively, were "clear" or "almost clear" of their disease activity as measured by the Physician's Global Assessment (PGA).
The data, presented this week at the American Academy of Dermatology annual meeting, were from a study designed to evaluate two dosing regimens of HUMIRA. The data also show that HUMIRA was well tolerated.
"In treating patients with psoriasis, decreasing or clearing the physical manifestations of the disease are key to improving the quality of life of our patients," said Kenneth Gordon, M.D., Associate Professor of Medicine, Loyola University, Chicago Stritch School of Medicine, lead study investigator. "These data are encouraging and give us an understanding of the potential adalimumab may have in treating psoriasis."
Psoriasis is a non-contagious, chronic skin disease where the turnover of skin cells is rapid and the affected skin is thick, red and scaly. Psoriasis affects more than 4.5 million people in the U.S. and currently has no cure.
Trial Information
Trial participants (n=148) with a diagnosis of moderate to severe chronic plaque psoriasis for at least one year and an affected body surface area of greater than or equal to 5 percent were randomized to receive HUMIRA or placebo administered by subcutaneous injection (under the skin). Patients received 80 mg of HUMIRA at week 0 followed by 40 mg eow beginning at week 1 (placebo was administered on alternate weeks) (40 mg eow regimen), 80 mg of HUMIRA at week 0 and 1, followed by 40 mg weekly at week 2 (40 mg weekly regimen), or placebo administered weekly beginning at week 0.
The primary efficacy endpoint was the percentage of patients achieving at least a 75 percent reduction in disease activity at week 12 as measured by the Psoriasis Area and Severity Index Score (greater than or equal to PASI 75), which is a score ranging from 0-72 and measures the extent and severity of psoriasis. Results at 12 weeks show that response rates for both doses of HUMIRA were statistically significantly greater than placebo. Fifty-three percent of patients achieved at least a PASI 75 with 40 mg of HUMIRA eow compared to four percent of placebo patients and 80 percent of patients achieved greater than or equal to PASI 75 with 40 mg of HUMIRA weekly.
The percentages of patients on HUMIRA therapy with a PASI 75 response were statistically significantly greater than those for patients on placebo as early as four weeks (eow =18 percent (p=0.003), weekly =28 percent (p<0.001) vs. placebo = 0 percent ). Additionally, patients taking HUMIRA experienced a statistically significantly greater mean percentage change in PASI score relative to baseline compared to placebo (p<0.001) as early as one week after the initial dose (eow = -14 percent, weekly = -15 percent vs. placebo = -1 percent).
The rates of adverse events were comparable between HUMIRA and placebo. There were no new safety concerns in the psoriasis population compared with those observed in the rheumatoid arthritis (RA) population.
"It is encouraging to see patients in this trial responded to treatment with HUMIRA," said Jim Lefkowith, M.D., divisional vice president, Immunosciences Development, Abbott Laboratories. "These preliminary results give us confidence as we continue to move forward with our clinical development program in psoriasis."
Important Safety Information
Cases of tuberculosis (TB), frequently disseminated or extra pulmonary at clinical presentation, have been observed in patients receiving HUMIRA. Serious infections and sepsis, including fatalities, have been reported with the use of TNF-blocking agents, including HUMIRA. Many of these infections occurred in patients on concomitant immunosuppressive therapy that in addition to their underlying disease could predispose them to infections. Other invasive opportunistic fungal infections have also been observed in patients treated with TNF-blocking agents, including HUMIRA.
TNF-blocking agents, including HUMIRA, have been associated in rare cases with exacerbation of demyelinating disease. 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.
About Psoriasis
Common symptoms of psoriasis include very dry, scaly skin, skin pain, cracking, and "plaques" -- or well-defined areas of red, raised skin. According to a 2001 survey conducted by the National Psoriasis Foundation, 75 percent of people with moderate to severe psoriasis report that their disease has a moderate to large impact on their everyday lives with 26 percent of people altering their normal daily activities and 21 percent of people stopping their normal daily activities.
About HUMIRA
On December 31, 2002, HUMIRA became the first fully human monoclonal antibody approved by the U.S. Food and Drug Administration (FDA) for reducing the signs and symptoms and inhibiting the progression of structural damage in adults with moderately to severely active RA who have had insufficient response to one or more traditional disease modifying antirheumatic drugs (DMARDs). HUMIRA can be used alone or in combination with methotrexate (MTX) or other DMARDs. The efficacy and safety of HUMIRA have been studied in 23 clinical trials and in more than 2,300 patients, making it the most studied TNF antagonist for RA at the time of regulatory submission.
HUMIRA is the first fully human monoclonal antibody approved in Europe for RA, and the first tumor necrosis factor alpha (TNF-a) antagonist approved with an indication for use with methotrexate or as monotherapy. HUMIRA 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 methotrexate, has been inadequate. To date, HUMIRA has been approved in 37 countries, launched in eight (including the U.S.) and prescribed to more than 40,000 patients suffering from rheumatoid arthritis.
HUMIRA was created using phage display technology, resulting in an antibody with human-derived heavy and light chain variable regions and human IgG1:K constant regions. HUMIRA offers convenient every other week dosing by subcutaneous injection (shot beneath the skin) via a specially designed pre-filled syringe.
Clinical trials are also currently underway evaluating the potential of HUMIRA in other autoimmune diseases.
HUMIRA was discovered through a broad scientific collaboration between Abbott and Cambridge Antibody Technology (CAT). As part of the collaboration, Abbott had the right to select several target antigens for which a joint Abbott/CAT research team would discover human antibody therapeutics. HUMIRA was isolated and optimized by Abbott and CAT as part of this collaboration. Abbott owns exclusive worldwide rights to HUMIRA, including responsibility for clinical development, manufacturing, sales and marketing. Abbott will book all revenues for HUMIRA, and CAT will receive a royalty fee based on HUMIRA sales... |
