Tuesday, March 6, 9 a.m.
Clinical trial results bode well for new psoriasis treatments

Promising new treatments are under development for psoriasis -- therapies that may offer safer alternatives to what is now available for treating moderate to severe disease, according to Alice R. Gottlieb, M.D., Ph.D., director of the Clinical Research Center at the Robert Wood Johnson Medical School at the University of Medicine and Dentistry of New Jersey. In a session titled �Psoriasis: Novel Treatments Available Soon,� Dr. Gottlieb and other speakers shared early study results with an audience of dermatologists and industry representatives.

�The challenge for people with moderate to severe psoriasis is we need to find safe and effective treatments that are good for the long-term treatment of the disease,� Dr. Gottlieb said.

The presentation covered four experimental treatments, all of which target the immune system response in psoriasis in some way. These drugs are designed to specifically impact certain cells and cellular interactions that lead to the development of psoriasis -- as opposed to many of today�s most potent psoriasis therapies, which improve the skin but also can result in side effects in other parts of the body.

Dr. Gottlieb reviewed a drug called anti-cd11a, a humanized monoclonal antibody that is being developed by Genentech and XOMA. This drug blocks the movement of immune system cells (called T cells) from the bloodstream into the skin and the activation of those cells within the skin. T-cell activation is a critical step in the misfired immune response that results in psoriasis. Anti-CD11a is now in a phase III clinical trial involving the treatment of 950 patients.

Infliximab (brand name Remicade) is a drug that is approved for treating Crohn�s disease (inflammation of the bowel and colon) and rheumatoid arthritis (in combination with the drug methotrexate). It targets tumor necrosis factor alpha (TNF), a protein in the body involved in inflammatory processes. When used alone for psoriasis, infliximab showed strong, rapid results, according to Umesh Chaudhari, M.D., a colleague of Dr. Gottlieb�s.

In a phase II study of infliximab, 82 percent to 91 percent of patients were judged to have excellent results or clearing, depending on the dose. Response time was as quick as four to six weeks, and many patients had remissions of six months or more, Dr. Gottlieb said.

Mark Lebwohl, M.D., professor and chairman of the dermatology department at Mount Sinai Medical Center in New York, discussed a phase II study for alefacept (brand name Amevive), which also aims to prevent the activation of T cells. Patients (229 total) had 12 weekly intravenous doses at one of three doses or of a placebo, then they were tracked for 12 weeks.

At some point after treatment began, 48 percent of patients saw their psoriasis improve by 75 percent, and 76 percent saw an improvement of at least 50 percent. Twenty-three percent of patients were clear of psoriasis after one 12-week course of therapy, and patients stayed clear for between five and 17 months. Alefacept, which is manufactured by Biogen, is now in phase III clinical trials.

Dr. Gottlieb also presented data from an early clinical trial of a drug called IDEC-114, yet another immune-system therapy. This experimental drug, manufactured by IDEC Pharmaceuticals, is entering phase II trials.

There are more than 40 experimental drugs now being investigated for psoriasis and psoriatic arthritis. The two closest to being available to patients are anti-CD11a from Genentech/XOMA and alefacept from Biogen.

Monday, March 5, 1:45 p.m.
Quality of life issues examined in psoriasis

Psoriasis has a bigger impact on social functioning and other quality of life measures than other illnesses such as back pain, arthritis and hypertension. This comparison was made in a presentation by Stefan C. Weiss, a fourth-year medical student at Duke University, in a paper on �Health-Related Quality of Life and Psoriasis� at the �Residents/Fellows Symposium,� which features research by young investigators.

�The subjective experience of psoriasis is substantial,� said Mr. Weiss, who opened his talk by reading a passage from author John Updike, who has written compellingly about living with psoriasis. �The impact on self-image is dramatic and must be addressed.�

The study was conducted in conjunction with a clinical trial at the National Institutes of Health. Thirty five patients completed a questionnaire and the results were used to demonstrate the impact of psoriasis on quality of life, using three different established measures. Among the findings:

• 85 percent of patients said they always or often feel the need to hide their psoriasis
• Psoriasis always or often affected self-confidence in 75 percent of patients
• One half said they are always or often depressed because of their psoriasis
• 85 percent always or often avoid activities like swimming or sports
• Sexual relations were often inhibited in one-third of patients

Patients with other diseases fare better in social functioning and other measures, Mr. Weiss said. Other diseases get more attention and more funding, yet it is psoriasis that is causing greater impairment in quality of life. �Even when a patient has only a few asymptomatic plaques, the impact of the disease is far more than it appears,� he said.

Mr. Weiss collaborated on his study with Andrew Blauvelt, M.D., an investigator in the dermatology branch of the National Cancer Institute's Division of Clinical Sciences; Alexa B. Kimball, M.D., of the Stanford University School of Medicine; and Maria L. Turner, M.D., from the National Institutes of Health.

Sunday, March 4, 9 a.m.
Psoriasis symposium draws overflow crowd

A group of doctors who are among the leading psoriasis researchers in the world presented the latest treatment and research information to a standing-room-only audience during a symposium dedicated to the disease.

�We have learned so much about psoriasis in the last 50 years,� said Gerald Weinstein, M.D. In certain areas, however, �we are missing whole pieces of information,� he said.

Dr. Weinstein, a professor of dermatology at the University of California College of Medicine in Irvine, CA, is considered the country�s leading expert on methotrexate (MTX), a systemic drug used to treat moderate to severe psoriasis. Dr. Weinstein said the goals for any psoriasis therapy, new or old, are to be safe, effective and allow maintenance of the disease.

�Methotrexate fits that bill better than any other,� he said. Dr. Weinstein discussed the history of MTX, new approaches to monitoring side effects of the drug, and new and effective combinations.

Alan Menter, M.D., of the Psoriasis Research Center at Baylor College of Medicine, gave physicians tips for dealing with difficult cases of psoriasis and for better communication with all of their psoriasis patients. �All psoriasis patients are difficult to treat,� Dr. Menter said, and dermatologists must be creative and consider all the issues before deciding on a treatment regimen.

Along with the percentage of the body covered by psoriasis, physicians need to consider the quality of life of the patient, his or her commitment to the treatment and likelihood of following through with it, as well as issues like insurance coverage and pregnancy.

Dr. Menter shared a tip for topical steroid application that he finds useful. A topical steroid is applied to the plaque and Mastisol adhesive is used to adhere Topiclude (a surgical dressing). The patch is left on for a week. A product called Detachol is then used to remove the adhesive and the dressing. Dr. Menter finds this method very successful for removing stubborn lesions.

In a presentation by Gail Zimmerman, NPF president and CEO, dermatologists were urged to use the NPF as a resource for educating their patients. She discussed the efforts of the NPF on behalf of physicians to increase phototherapy reimbursement rates. Because insurance reimbursement is so low, many dermatologists are ceasing to offer phototherapy as a treatment.

�The National Psoriasis Foundation is committed to protecting old treatments, as well as making sure new ones are available to patients,� Zimmerman said.

Michael Zanolli, M.D., a dermatologist at St. Thomas Hospital in Nashville, TN, discussed ultraviolet light therapies, including narrow-band UVB. In clinical trials, narrow-band UVB has proven as effective as PUVA therapy -- the use of skin-sensitizing drug psoralen and ultraviolet light A -- and more effective than broadband phototherapy, he said. When psoralen is used with narrow-band, remission rates are longer than in patients treated with PUVA, he said.

Steven R. Feldman, M.D., Ph.D., highlighted �Treatments that Patients Like.� He emphasized the importance of physicians setting realistic expectations for the outcome of a treatment so patients will stick with it. Studies indicate that at least 40 percent of psoriasis patients are not compliant in their treatment, which can mean they are not giving the treatment a real chance to work.

�Patients with psoriasis want a physician who is empathetic, who will take the time to talk to them and who helps them feel like they have some control over their disease,� said Dr. Feldman, associate professor of dermatology at Wake Forest University in North Carolina.

He recommended combination topical therapy for its quick response and for providing long-term management of psoriasis -- both of which patients like. The newest form of phototherapy, the Xtrac laser from PhotoMedex, has been popular with Dr. Feldman�s patients. He also suggests home UVB and, for those patients who cannot access phototherapy in a traditional setting, tanning beds.

Several new biologic drugs that target the immune system were covered by Alice Gottlieb, M.D., Ph.D., director of the Clinical Research Center at the Robert Wood Johnson Medical School at the University of Medicine and Dentistry of New Jersey. There are more than three dozen drugs now being studied and tested for psoriasis and psoriatic arthritis, and biologic agents represent the cutting-edge of treatment research.

�For moderate to severe patients, we need to find treatments that are safe and effective over the long term, and that�s where I think the new biotech drugs will fill a niche,� Dr. Gottlieb said.

She presented the results of a phase II clinical trial of infliximab (brand name Remicade), a drug that is approved for Crohn�s disease and rheumatoid arthritis. Thirty-three patients were split into three treatment groups: one received placebo and two received different doses of Remicade by intravenous infusion. In the lower dose group, 82 percent of patients saw their psoriasis improve by 75 percent, and 73 percent in the higher-dose group had 75 percent improvement.

Mark Lebwohl, M.D., professor and chairman of the department of dermatology at Mount Sinai Medical Center in New York, offered some insights into topical treatment of psoriasis, including:

• New foam-based steroid products appear to penetrate better than other types of steroids and are equally or more effective. Patients like them because they are not messy, and while approved only for the scalp, these foams are also useful for psoriasis on the rest of the body.
• Combination therapy with calcipotriene (brand name Dovonex) and topical steroids (particularly the brand Ultravate) works quickly, even on stubborn areas. Dovonex should not be mixed with salicylic acid and some other common topical agents for psoriasis because it can be inactivated.
• One of the drawbacks of tazarotene (brand name Tazorac) is the irritation many patients suffer when they use it. Dr. Lebwohl said �short-contact therapy� -- applying it for as little as a few minutes a day and then washing it off -- eliminates much of the irritation but does not diminish the drug�s effectiveness for psoriasis.

Dr. Lebwohl moderated the three-hour "Psoriasis Symposium." Other presenters included Enno Christophers, M.D., a dermatologist and geneticist from Kiel, Germany; John Y.M. Koo, M.D., from the University of California-San Francisco; and Klaus Wolff, M.D., professor and chairman of the dermatology department at the University of Vienna in Austria.

Saturday, March 3, 2 p.m.
Narrow-band UVB offers advantages

Narrow-band UVB is generally better than traditional broadband UVB in its effectiveness as well as its risk profile, according to Thomas Schwarz, M.D., professor in the department of dermatology at the University of Muenster in Germany. Dr. Schwarz presented an overview of narrow-band therapy at the �Phototherapy and Photochemotherapy� symposium.

Broadband UVB therapy includes ultraviolet light from 290-320 nanometers. The shorter wavelengths are more likely to produce a burn because they deliver more energy to the skin, according to Dr. Schwarz. Narrow-band UVB is delivered at a precise wavelength -- 311 nanometers (nm). The burning risk is reduced by eliminating the shorter wavelengths.

The long-term risks of phototherapy include skin cancer and skin aging. Patients treated with narrow-band UVB are exposed to a smaller cumulative doses of ultraviolet light than those who receive broadband, Dr. Schwarz said. In theory, this means the cancer risk with narrow-band could be lower, although long-term data with this treatment is not available to confirm that.

Most dermatologists in the United States who offer UVB to their patients are still using broadband equipment. Narrow-band UVB is becoming more common, but the high cost of the equipment and low insurance reimbursement rates have proven to be barriers to its widespread use.

Saturday, March 3, 2 p.m.
High-dose UVA tested in patients with psoriasis

UVA-1, high-dose ultraviolet light A phototherapy, may be effective in clearing psoriasis, according to Jean Krutmann, M.D., a professor of dermatology from the University of Duesseldorf in Germany.

During a symposium titled �Phototherapy and Photochemotherapy,� Dr. Krutmann described a recent study of UVA1 in HIV patients with psoriasis. HIV is the virus that causes AIDS. AIDS and psoriasis are diseases associated with the immune system, particularly with the action of T cells. Many patients who are infected with the HIV virus also develop psoriasis. In the study, three patients completely cleared of psoriasis after 20 to 30 radiation treatments.

UVA-1 is still experimental. European doctors are primarily evaluating its use in the treatment of eczema.

Saturday, March 3, 12:15 p.m.
New topical ointment may be effective for psoriasis patients

Protopic®, a topical ointment recently approved by the U.S. Food and Drug Administration for the treatment of eczema, is proving to be effective for patients with psoriasis in areas difficult to treat with other topical treatments, according to Mark Lebwohl, M.D., professor and chairman of the department of dermatology at Mount Sinai Medical Center in New York.

Speaking at a press conference, Dr. Lebwohl explained that Protopic® is a non-steroid drug that is safe to use in areas where steroids may cause harmful side effects, such as thinning of the skin and the formation of stretch marks. When used around the eyes, steroids may cause cataracts and glaucoma. The drug, developed by Fujisawa Healthcare, Inc., of Deerfield, IL, has only been available for several weeks.

�In areas where the skin is thin, this works most of the time,� Dr. Lebwohl said. Studies in psoriasis patients to compare Protopic® to other treatments are underway, he said.

In addition, Dr. Lebwohl discussed new combination therapies and several new drugs under development that block interactions between antigen presenting cells and T cells, immune system cells that play a major role in psoriasis.

Saturday, March 3, 9 a.m.
Emerging new choices for ultraviolet treatment

A panel of dermatologists reviewed �Ultraviolet: the Good, the Bad and the Ugly� in a symposium attended by an audience of several hundred. The speakers highlighted how phototherapy is used to treat various diseases and the potential side effects, including aging of the skin and skin cancer.

Charles R. Taylor, M.D., assistant professor in the department of dermatology at Harvard University, presented information about the newest UV therapies being used in doctors� offices, in particular narrow-band UVB, UVA-1, photodynamic therapy and UVB delivered by laser.

According to Dr. Taylor, narrow-band UVB is superior to broadband in most cases and is roughly equal to PUVA (UVA combined with the drug psoralen), providing similar results without the use of psoralen. He concluded that narrow-band is a useful adjunct to ultraviolet light therapy. However, he added that it is difficult to determine if narrow-band has a reduced risk of skin cancer than other forms of ultraviolet light therapy.

UVA-1, although not approved in the United States for psoriasis, is used for the short-term treatment of atopic dermatitis. Dr. Taylor said UVA-1 could be an alternative to PUVA for pregnant women and children because no psoralen is used. However, more research needs to be done regarding the use of this treatment in psoriasis.

Saturday, March 3, 9:30 a.m.
Experts discuss new psoriasis treatments

Researchers conducting clinical studies of new drugs for psoriasis met with approximately 35 dermatologists in a discussion group to share information and discuss how these new drugs may change the way doctors approach treating the disease.

Diane Baker, M.D., a clinical professor of dermatology at Oregon Health Sciences University, described her research with monoclonal antibodies in psoriasis patients and answered questions from dermatologists. These new drugs appear to work by inhibiting specific molecules known to be associated with psoriasis, according to Dr. Baker. For instance, she explained, even though patients develop antibodies against one of them, anti-CD11, the drug still appears to work. Anti-CD11, a drug under development by Genentech and XOMA, inhibits a receptor on T cells, immune system cells that play a role in psoriais.

However, Dr. Baker said, anti-CD 11 and drugs like it will likely be very expensive and so far have not proven successful enough in clinical trials to warrant replacing currently approved therapies, such as methotrexate and cyclosporine.

Friday, March 2, 12 p.m.
Basic scientists advancing understanding of psoriasis

German researchers and an American colleague updated dermatologists on advances in the understanding of important cellular mechanisms controlling psoriasis in a forum titled "T-cell and Antigen Presenting Cells in the Skin."

Richard Granstein, M.D., chairman of dermatology at Cornell University in New York, opened the session by describing that the initiation of the immune response involved in psoriasis requires that T cells encounter antigen presenting cells. The skin and the immune system are involved in a close relationship, Dr. Granstein explained. Under certain conditions, however, the skin "becomes a target of the immune system," he said.

Two German researchers -- Martin Rocken, M.D., of the University of Munich and Thomas Schwarz, M.D., of the University of Muenster -- went on to describe the intricate interactions between these cells and the possibility that inhibiting these reactions may prove to be an effective approach to treating psoriasis. Additionally, Dr. Schwarz discussed the mechanisms underlying the suppression of the immune system by ultraviolet light.

Friday, March 2, 9 a.m.
New laser effective in preliminary trial

Steve Feldman, M.D., Ph.D., associate professor of dermatology and pathology at Wake Forest University in North Carolina, updated several hundred of his colleagues about new and effective treatments for psoriasis during a session titled �Therapeutic Hotline.�

Dr. Feldman reported preliminary results from a study of a new ultraviolet B (UVB) device. The device, called the Xtrac® Laser by its manufacturer, PhotoMedex, is a high-intensity UVB unit. The �laser� emits a beam of UVB rays at 308 nanometers.

Results of the study in patients with localized psoriasis show that the laser requires fewer treatments than other UVB units to achieve clearance for patients, according to Dr. Feldman. Out of 80 patients who completed the trial, 72 percent achieved 75 percent clearance, while 50 percent reached 90 percent improvement, he said. The participants received 10 treatments with the laser.

Dr. Feldman, also an NPF Medical Advisory Board member, said the newly approved treatment meets a patient need by providing treatment with a reduced risk of burning side effects associated with other UVB treatments. �The treatment works,� he said, �just as we expected it would.�

Thursday, March 2, 7:30 a.m.
AAD Psoriasis Task Force

The American Academy of Dermatology (AAD) devotes special attention to psoriasis in many ways, including through the Psoriasis Task Force. This year, the members of the Task Force met to discuss several issues, including:

• NPF and AAD lobbying over the past year for higher insurance reimbursement for phototherapy (UVB and PUVA). Next year, the two groups are also considering seeking increased rates for narrow-band UVB, which costs more than traditional UVB because of more expensive equipment.
• The need to address training and education for physicians and nurses on the delivery of drugs that are now in clinical. These drugs could be approved within the next few years, and they will require injections or infusions not commonly given in a dermatologist�s office.
• Support for fair reimbursement for laser therapy and encouragement that this emerging therapy continue to be investigated.

Thursday, March 1, 6 p.m.
NPF Medical Advisory Board

The NPF Medical Advisory Board (MAB) reviewed the hard work the NPF has undertaken to maintain access to phototherapy for people with psoriasis. The MAB, which is chaired by Gerald G. Krueger, M.D., from the University of Utah, comprises experts in psoriasis who advise the NPF on scientific and medical issues.

Starting early in 2000, the NPF has worked closely with the American Academy of Dermatology (AAD) to boost the insurance payments made to physicians who provide phototherapy (UVB and PUVA). Low reimbursement has reduced the financial feasibility of phototherapy, which has resulted in decline in the number of doctors who offer this treatment to their patients. Patients, therefore, are losing access to this valuable treatment option.

The NPF and the AAD recently testified before a committee of the American Medical Association that advises the federal government on Medicare reimbursement issues. Mark Lebwohl, M.D., professor and chairman of the dermatology department at Mount Sinai Medical Center in New York and a member of the NPF MAB, led the charge. He provided extensive data to the committee to make the case for higher Medicare payments for phototherapy.

�I think we did well,� Dr. Lebwohl said. �A lot of credit goes to the NPF for beginning the work on this issue.�

The MAB discussed several other topics pertinent to the treatment and care of people with psoriasis. The board meets twice annually, including once in association with the AAD conference.

Thursday, March 1, 2:30 p.m.
Society for Pediatric Dermatology

The NPF�s new Youth Program was warmly received at a meeting of the Society for Pediatric Dermatology. Gail M. Zimmerman, the NPF�s president and CEO, provided details on the program, a recently launched endeavor by the NPF to provide education, age-appropriate information and support to children and teenagers.

"We were very gratified to highlight the Youth Program,� Zimmerman said. �The NPF is making a concerted effort to reach out to young people with psoriasis, and pediatric dermatologists are an important audience. They care for these children and can direct the children and their parents to the NPF�s new valuable resources.�