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American Academy of Dermatology Dispatches
First posted March 21, 2003
More than 13,000 people attended the American Academy of Dermatology's (AAD) 61th Annual Meeting in San Francisco from March 21-26. Editorial staff members from the National Psoriasis Foundation were on the scene as well, providing reports on scientific sessions, the latest research results and meetings with psoriasis experts. All times noted are Pacific Standard Time.
Sunday, 2:00 p.m.
Enbrel results show promise for psoriasis
Results from a phase III study for Enbrel showed benefits for psoriasis. Enbrel, a biologic therapy, is currently approved for the treatment of psoriatic arthritis, rheumatoid arthritis and juvenile rheumatoid arthritis.
Alice Gottlieb, M.D., Ph.D., professor of medicine at the University of Medicine and Dentistry at New Jersey, Robert Wood Johnson Medical School, presented the study on Sunday, March 23. The study included more than 650 patients. Of those given 50 milligrams (mg) of Enbrel twice weekly for three months, nearly half�49 percent�improved by at least 75 percent compared to those on placebo. After six months of treatment, the number of patients achieving 75 percent improvement in their psoriasis rose to 60 percent.
Patients given half of the dose�25 mg�also achieved significant improvement in their psoriasis. More than one-third of patients improved at least 75 percent after three months, and nearly half achieved at least 75 percent improvement after six months.
The side effects were similar to those on placebo, and the most common side effects were injection site reactions.
Enbrel works by inhibiting part of the immune response that leads to the inflammatory process in psoriasis. It binds TNF-alpha proteins, which are present in excess amounts in psoriasis, and renders them inactive. Enbrel is given subcutaneously (under the skin). Patients can inject themselves at home. Amgen and Wyeth, the companies that market Enbrel, will conduct further tests for its effectiveness in psoriasis treatment, and expect approval from the U.S. Food and Drug Administration in 2004.
Sunday, March 23, 9:40 a.m.
New therapies summarized for dermatology nurses
In a session presented at the Dermatology Nurses' Association on Sunday, March 23, dermatology nurses and other medical professionals listened to a presentation on the role of biologics in treating psoriasis.
Approximately 70 attendees listened to Craig Leonardi, M.D., associate clinical professor of dermatology at St. Louis University, and Linda Daus, RN, CCRC, both from Central Dermatology in St. Louis. Dr. Leonardi reviewed the available therapies used to treat psoriasis and gave an overview of biologics for psoriasis. He also summarized the reasons behind a new treatment paradigm of treating patients either with topical medicines or by the steroids, systemics and biologics currently available.
Dr. Leonardi, who has treated more than 400 patients with biologics,
explained that it's important to define the new treatments for
dermatology professionals because "I live and breathe this stuff every day. But it's a drink of water out of a fire hydrant for a lot of people."
Dr. Leonardi also discussed the changing role of psoriasis treatments. The existing "step" process involves treating patients with more aggressive therapies only after they fail previous steps. However, some treatments on the ladder, such as phototherapy, could be considered inconvenient and not readily available for many patients. Because of this, patients may stop following doctor's orders in using the treatment.
Instead, he summarized a new proposed paradigm of two categories of
patients: those who can use topical treatments, and those with more
severe psoriasis who are eligible for more aggressive treatments. "After topical treatments, all other therapies are fair game," he explained. Biologics, he said, will play an important role in quickly treating patients with more severe psoriasis.
Saturday, March 22, 9 a.m.
Psoriasis and depression studied
An ongoing European study suggests people with psoriasis are more likely than the general population to experience depression, according to French researchers who presented data on Saturday, March 22.
The researchers mailed 1,500 surveys to people with psoriasis and received 653 back. Participants were asked to answer about 20 questions about how they feel. According to scale used in the study, approximately 47 percent of men and 49 percent of women were considered depressed. The rate of depression in the general population is approximately 20 percent.
Fifty-four percent of the individuals who responded to the survey had active psoriasis compared to those whose disease was in remission. The study is ongoing in Spain and Italy, with additional results to follow.
People with psoriasis suffer from self-image problems, the researchers suggested. They concluded that dermatologists should consider the mental health of their patients in addition to treating the skin disease.
Saturday, March 22, 9 a.m.
Amevive study for psoriatic arthritis trial presented
Researchers from the Netherlands presented a small study on Saturday for evaluating the use of Amevive for the treatment of psoriatic arthritis. The trial followed 11 patients for 16 weeks following treatment with Amevive. The patients had plaque psoriasis and moderate to severe psoriatic arthritis.
Joints were assessed at the beginning of the study, at 4 and 12 weeks
of treatment by intravenous injection, and four weeks after the last dose. The degree of psoriasis was assessed using the Psoriasis Area and Severity Index (PASI) every two weeks during treatment and follow-up.
The researchers reported that Amevive significantly improved the tender and swollen joints associated with psoriatic arthritis. They also reported that psoriasis levels decreased for 7 patients, with a mean reduction in disease of 42 percent, and three patients lowered their PASI score by half or greater after the last dose.
Amevive is a biologic drug that blocks steps in the immune system
involved in psoriasis. It was approved in January 2003 by the U.S. Food and Drug Administration for the treatment of moderate to severe psoriasis. Biogen is seeking approval in Europe.
In February 2003, Biogen announced that the European scientific
advisory in charge of approving treatments requested more information relating to Amevive�s effectiveness compared to other treatments. Biogen withdrew its application and plans to develop additional clinical information to obtain approval.
Saturday, March 22, 9 a.m.
Initial results from long-term Raptiva trial
Preliminary results from an open-label efalizumab (brand name Raptiva) study were presented on Saturday. The study focused on the safety and tolerability of continuous Raptiva treatment in patients with moderate to severe psoriasis.
Alice Gottlieb, M.D., director of the Clinical Research Center at the
Robert Wood Johnson Medical School at the University of Medicine and
Dentistry of New Jersey, presented the data. In a multicenter study, 339 patients were followed for approximately 18 months. Raptiva was administered subcutaneously (under the skin) once per week. At 12 weeks of treatment, 41 percent achieved 75 percent improvement in their psoriasis, and 82 percent improved at least by half.
These patients were followed for the open-label study, and the dose was reduced by half. In the next three months after the initial 12-week treatment, more than 77 percent of patients improved in their psoriasis by half, and half of the patients improved by 75 percent. More than 22 percent improved by 90 percent.
Nearly one year after treatment, nearly 80 percent of patients improved by half, and over 64 percent improved by 75 percent. Of those, more than 31 percent improved by 90 percent.
The most common side effects during the initial 12-week treatment were chills, pain, nausea, asthenia and fever. No new side effects were observed during long-term Raptiva therapy.
Raptiva is a biologic therapy manufactured by Genentech and Xoma. The companies filed in December 2002 with the U.S. Food and Drug Administration for approval for the treatment of moderate to severe psoriasis.
Saturday, March 22, 11 a.m.
Remicade improves psoriasis in phase II study
People given the experimental drug infliximab (brand name Remicade) over 10 weeks achieved dramatic results, according to a study presented Saturday, March 22.
In a study led by Ken Gordon, M.D., a member of the Psoriasis Foundation�s Medical Board, 99 patients received three IV infusions of the drug and were checked for improvement in their plaque psoriasis throughout the course of treatment. After 10 weeks, 87 percent of patients improved by 75 percent or better, and a dramatic 97 percent of patients improved by 50 percent or better.
�These were patients with very serious disease,� said Dr. Gordon, a dermatologist at Loyola University in Chicago.
Short-term side effects occurred in 40 percent of patients and included headaches and reactions at the site of the infusions.
Remicade, made by Centocor, a biotechnology company in Malvern, Pa., is approved for the treatment of rheumatoid arthritis (RA) and Crohn�s disease and is being tested in ongoing clinical trials for the treatment of psoriasis and psoriatic arthritis. Patients receiving the drug for RA or Crohn�s disease are required to undergo tests for tuberculosis before beginning treatment, as the drug has been shown to activate dormant tuberculosis infections.
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Posted on March 21, 2003
Updated on March 22, 2003
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