Humira Gets Expanded Approval for Psoriatic Arthritis

The Abbott Laboratories drug Humira (adalimumab) has been given expanded approval by the U.S. Food and Drug Administration to slow structural joint damage in people with psoriatic arthritis. The condition affects people who have skin psoriasis.

Humira was initially approved for overall treatment of psoriatic arthritis in October 2005. It's also been sanctioned to treat moderate-to-severe rheumatoid arthritis, and an inflammatory disease of the spine called ankylosing spondylitis.

Psoriatic arthritis combines symptoms of arthritis—including joint pain and inflammation—with those of psoriasis, including painful red lesions on the skin. Clinical testing on 313 people who hadn't responded to NSAID therapy found that people given Humira had significantly less joint damage than study participants who took a non-medicinal placebo, Abbott said in a statement.

People who took Humira also demonstrated increased ability to perform daily functions such as getting dressed, walking, and climbing stairs, the company said.

HealthDay News, November 14, 2006

New Study Finds Allergy-Like Reaction May Trigger Rosacea Bumps and Pimples

The bumps (papules) and pimples (pustules) of rosacea, a poorly-understood facial disorder affecting an estimated 14 million Americans, may be the result of an allergy-like reaction to environmental and emotional triggers, according to new study results presented at the National Rosacea Society (NRS) research workshop during the annual meeting of the Society for Investigative Dermatology and reported in Rosacea Review.

"We are very excited about these findings because they may provide the basis for improving the treatment and management of this condition," said Dr. Richard Gallo, chief of the division of dermatology at the University of California-San Diego and lead investigator of the NRS-funded study. "By defining the process leading to the inflammation, new medications might be developed to block these effects."

Dr. Gallo explained that when the normal immune system is faced with any of a broad range of potential dangers—such as sun exposure, emotional stress, heat and spicy foods, among many others—receptors recognize potential threats and protect the body by prompting the production of protective substances that isolate and neutralize any harmful effects. With rosacea, however, these protective substances turn the body on itself like overzealous guards, leading to inflammation.

Using advanced mass spectrometry technology to analyze the biochemical composition of proteins in rosacea patients, the researchers discovered an abnormality in the production of protective molecules known as cathelicidins, Dr. Gallo said. In normal patients, the cathelicidins are found in a form that is inactive and would not lead to bumps and pimples. In rosacea patients, the forms of cathelicidins are different and lead to skin inflammation. The cause of this abnormality in cathelicidins seems to be due to an equally important problem in rosacea—an overabundance of yet another substance, called kallikrein, which can spur dormant cathelicidins into action.

"It appears that the combination of these two substances at abnormally high levels is a double whammy for rosacea patients," Dr. Gallo noted.

The researchers recently completed the picture when they were able to demonstrate that this process is linked to the actual formation of rosacea signs and symptoms. The skin of mice injected with the cathelicidins found in rosacea patients showed a dramatic inflammatory response—including bumps and pimples—while mice injected with normal cathelicidins showed no inflammation, either visually or under a microscope.

"The next step is to test these findings in human subjects through various therapeutic interventions," Dr. Gallo said. "As we gain a thorough understanding in humans, we can look for new medications that block this process in order to treat or prevent the inflammation associated with rosacea."

Rosacea is a chronic disorder that primarily affects the cheeks, nose, chin or forehead, and is often characterized by flare-ups and remissions. It typically begins as a flushing or redness that comes and goes, and visible blood vessels may also appear. Inflammatory bumps and pimples often develop, and in severe cases, the nose may become swollen and enlarged from excess tissue.

In addition to long-term medical therapy to bring the condition under control and maintain remission, patients are advised to keep a diary to identify and avoid lifestyle and environmental factors that may affect their individual cases. Some of the most common rosacea triggers include sun exposure, emotional stress, hot or cold weather, wind, heavy exercise, alcohol, hot baths and spicy foods.

Dual Drug Therapy Effective Against Pemphigus Vulgaris

A new combination treatment offers hope to people who have the blistering, potentially fatal skin disease known as pemphigus vulgaris.

By combining the cancer-fighting drug rituximab with intravenous immune globulin, Harvard doctors have discovered a therapy that can effectively treat people with cases of pemphigus vulgaris that haven't responded to other treatments.

"We got a home run with this combination," said study co-author Dr. Marshall Posner, medical director of the head and neck oncology program at the Dana-Farber Cancer Institute and Harvard Medical School.

"These patients were extremely ill and on multiple medications," he said. "This therapy resulted in complete eradication of the disease for nine patients." The remaining two patients in the study required additional doses of the treatment before they, too, went into remission. All of those involved in the study had sustained remissions, some as long as 37 months, by the end of the study.

Results of the study are published in the Oct. 26 issue of the New England Journal of Medicine.

Pemphigus vulgaris is a rare autoimmune disease that causes the skin cells to stop adhering to one another. Blisters and lesions form, usually beginning in the mouth and then spreading to the skin.

"Before the discovery of corticosteroids, it was fatal within five years. People lost the surface of their skin, and died horrible deaths," explained Dr. John Stanley, chairman of the department of dermatology at the University of Pennsylvania School of Medicine. "This is an instructive disease about the power of the immune system. While it's usually used for good, it can actually destroy you."

Stanley co-authored a review article in the same issue of the journal about pemphigus and other dermatological diseases.

Currently, the first line of treatment for this devastating skin condition is prednisone, a corticosteroid. While it's often an effective treatment, it has numerous side effects that can be serious, so people generally can't stay on high doses for a long time. Other medications used are immune-suppressing agents that also carry the risk of serious side effects, such as infection.

Posner said most deaths from pemphigus occur as a result of immune-system suppression. But without suppressing the immune system, people with pemphigus would continue to develop blisters and erosions in their skin, giving bacteria an easy entry into the body.

Another treatment option is intravenous immune globulin. This option is usually reserved for those who don't respond to the other treatment options. Stanley said scientists aren't sure how this therapy works, but it may be that it replaces the immune-system antibodies that are attacking the skin cells with healthy antibodies.

For most people, these treatments options have proved lifesaving, and people with the disease often do well, said Stanley.

However, there are people who don't respond to any of the currently available treatments. And, the 11 people treated in the new Harvard study fell into that category. None of the available treatments had worked for them, and the disease was covering more than 30 percent of their body's surface area.

Each study volunteer received two cycles of rituximab weekly for three weeks. During the fourth week, they received a dose of intravenous immune globulin. Then, they received monthly infusions of both rituximab and IV immune globulin for four months.

During the initial treatment, nine of the 11 study participants went into remission for an average of 32 months. The remaining two required additional treatments about six months after treatment, but subsequently went back into remission.

While previous research on rituximab has sometimes found serious side effects, such as allergic reaction, Posner said there were virtually no side effects seen in this trial.

He said he thinks this drug combination would likely be helpful in less severe cases of pemphigus vulgaris, and he added that it could potentially be useful for treating other autoimmune diseases, such as rheumatoid arthritis, systemic lupus and type 1 diabetes.

"This therapy offers hope for this disease, and it could lead the way to treatment for other diseases that have a big impact on people's lives -- it needs to be investigated in other diseases so we can see how it works in other situations," Posner said.

Stanley said he doubted that rituximab would become a first-line treatment for pemphigus vulgaris anytime soon because the medication is quite costly and insurance companies would likely balk at paying for an expensive drug that isn't FDA approved specifically for treating pemphigus. The problem, he added, is that because pemphigus is so rare, it would be difficult to conduct a large enough trial to get such approval.

But, Posner suggested that while the rituximab/immune globulin combination treatment is more expensive initially, a cost analysis comparing all of the costs, including hospitalizations, might find the combination treatment is the cheaper alternative in the long run.

By Serena Gordon, HealthDay Reporter, October 26, 2006

Ethnic Skin Care

By: Heather Woolery-Lloyd, MD

Discover the unique skin care challenges of various ethnic skin types and about some treatment options.

New Skin Cancer Drug Zolinza Approved

The FDA has approved a new drug to treat a rare and slow-growing type of skin cancer.

The agency approved Zolinza capsules for the treatment of cutaneous T-cell lymphoma (CTCL), a type of lymphoma that affects the skin.

The drug is approved for treatment when the disease gets worse, persists, or comes back during or after treatment with other medicines.

Researchers say about three in a million people are diagnosed with the skin cancer each year, mostly middle-aged men.

Zolinza was approved as part of FDA's Orphan Drug program, which offers companies financial incentives to develop medicines for diseases that affect fewer than 200,000 Americans a year.

Benefits and Risks

The safety and effectiveness of Zolinza were evaluated in two clinical trials involving 107 people with CTCL, who received the drug after their disease came back or other treatments had failed.

Of patients receiving the drug, 30% saw improvement, with the benefit lasting an average of 168 days.

The most common serious side effects of Zolinza were blood clots in the lungs (pulmonary embolism), dehydration, deep vein thrombosis (blood clots in deep veins) and anemia.

Other side effects included diarrhea, nausea, anorexia, vomiting, constipation, fatigue, chills, and taste disorders.

The drug has not been studied in pregnant women, but animal studies suggest Zolinza may harm the fetus if used during pregnancy.

Zolinza is manufactured by Pantheon Inc. for Merck & Co. Inc.

By Jennifer Warner, WebMD Medical News, October 11, 2006

Women's Skin May Age Faster

Women's skin ages faster than men's, suggests a study that used an experimental laser device to measure skin damage.

Researchers in Germany used the device to determine collagen and elastin levels beneath the skin's surface. Collagen and elastin are the proteins responsible for the elasticity, tone, and texture of skin, and levels typically decline with age.

There is no good way to assess skin aging, as measured by collagen and elastin composition, short of removing skin and analyzing it in a lab.

The laser procedure shows promise for making the process a whole lot simpler. That could one day help consumers better evaluate the effectiveness of the antiaging skin products they buy, researcher Martin Johannes Koehler, of Germany's Schiller University, tells WebMD.

"Some cosmetics are thought to change the content of collagen to the skin, but until now to measure that you had to cut out a piece of skin," he says.

Multiphoton Laser Imaging

The search for a noninvasive test to measure damage to the skin from sun exposure and aging is the Holy Grail of the cosmetics industry.

But proving that a skin cream that promises to turn back the clock really is worth $100 an ounce is only one potential application for the experimental laser technique, Koehler says.

It may also prove useful for evaluating skin diseases like that seen in scleroderma, which is a serious autoimmune disease, as well as a skin complication that can occur in transplant recipients, known as graft vs. host disease.

Koehler and colleagues used the technique, called multiphoton laser imaging, on the inner forearms of seven women and 11 men between the ages of 21 and 84.

The researchers used the information gathered from the imaging to develop an aging index of the dermis, an inner layer of the skin. Skin aging was more evident in women than in men of similar age. It was most marked in older women who had been through menopause.

The researchers wrote that menopause-related declines in the sex hormones estrogen and progesterone might explain this acceleration in skin aging.

More Study Needed

But they added that more research is needed to confirm the finding that men and women's skin ages at different rates. The researchers also note that studies comparing their aging index measurements need to be compared to established measures such as skin surface hydration and wrinkle number and depth.

The study is published in the Oct. 1 issue of the journal Optics Letters.

Cosmetic dermatologist Eliot Battle, MD, tells WebMD that the laser procedure is one of several promising experimental techniques that could help clinicians more easily diagnose and treat skin diseases.

"Diagnostic tools like this have been used in every area of medicine, but they are only beginning to be used in dermatology," he says. "This [technique] is an attempt to use the latest and greatest in laser imaging, but much more research is needed. This is just the very beginning of what could be an exciting journey."

SOURCES: Koehler, M.J. Optical Letters, Oct. 1, 2006; vol 31: pp 2879-2881. Martin Johannes Koehler, department of dermatology and allergology, Friedrich Schiller University, Jena, Germany. Eliot Battle Jr., MD, cosmetic dermatologist and laser surgeon, Cultura Cosmetics Medical Spa, Washington, D.C.

By Salynn Boyles, WebMD, October 4, 2006

Drug-resistant Acne Runs in the Family

An antibiotic-resistant acne germ can spread among family members, Swedish researchers find.

The germ is Propionibacterium acnes. Skin colonized by P. acnes tends to erupt into the blotches and pustules of acne. Since the 1960s, doctors have fought P. acnes with antibiotics. The bug fought back. It's now common to find P. acnes strains resistant to several common antibiotics.

Doctors hoped that the only people carrying the drug-resistant acne bugs would be patients on long-term antibiotic therapy. That isn't the case, find Carl Eric Nord, MD, PhD, and colleagues at Karolinska Institute in Stockholm, Sweden.

Nord and colleagues took skin samples from 10 acne patients, all on antibiotic therapy, and from two close family contacts of each patient. Twelve healthy, acne-free volunteers -- who were not taking antibiotics and did not have family members with acne -- served as a comparison group.

Nord and colleagues found that nearly half of the family members carried drug-resistant acne bacteria on their skin. Genetic analysis showed that these family members carried the same strain of P. acnes as the acne patient among them.

The good news is that the family members fought off the drug-resistant germs -- but only after the acne patient in their family stopped using antibiotics.

On the other hand, you apparently can't avoid drug-resistant acne germs by avoiding people with acne. A third of the healthy comparison group also carried drug-resistant P. acnes on their skin.

Nord reported the findings at last week's 46th Interscience Conference on Antimicrobial Agents and Chemotherapy, held Sept. 27-30 in San Francisco.

SOURCES: 46th Interscience Conference on Antimicrobial Agents and Chemotherapy, San Francisco, Sept. 27-30, 2006.

By Daniel DeNoon, WebMD, October 2, 2006

Beauty is Easy on the Brain

"Easy on the mind" rather than "easy on the eyes" may be a better way to describe something that’s beautiful, according to a new study.

Researchers found objects and animals that conform to a prototype rather than deviate from it are easier for the brain to process and, therefore, are perceived as more pleasing to the eye.

"What you like is a function of what your mind has been trained on," says researcher Piotr Winkielman of the University of California, San Diego, in a news release. "A stimulus becomes attractive if it falls into the average of what you've seen and is therefore simple for your brain to process. In our experiments, we show that we can make an arbitrary pattern likeable just by preparing the mind to recognize it quickly."

Researchers say the findings build a phenomenon known as "beauty-in-averageness effect," which was discovered in the late 1800s. The theory holds that prototypical images are rated as more beautiful or appealing than variations of the same thing.

'Beauty' Experiments

To test the theory, researchers had groups of students undergo different experiments. In one experiment, a group of students were presented prototypes of random groupings of dots. Then distortions of the dots in these prototypes were created and presented to the students.

In a second experiment, a group of students rated the attractiveness of random dot patterns and those that conformed to common geometric patterns, like a diamond or square.

The results, published in Psychological Science, showed that the participants categorized patterns quicker and rated them as more attractive when they were closer to their respective prototypes.

A third experiment had students looking at dots also, but this time also examined cheek muscle for smiling action and brow muscle for frowning action.

Researchers also found that the less time it took participants to classify a pattern, the more attractive they found it.

"This parsimonious explanation," says Winkielman, "accounts for cultural differences in beauty -- and historical differences in beauty as well -- because beauty basically depends on what you've been exposed to and what is therefore easy on your mind."

SOURCES: Winkielman, P. Psychological Science, September 2006; vol 17: pp 799-806. News release, University of California, San Diego.

By Jennifer Warner, WebMD, September 29, 2006