FDA News & Approvals

Remicade: Psoriatic Arthritis Approval
The more than 1 million men and women who suffer from psoriatic arthritis now have a new treatment to turn to for relief.
Infliximab (Remicade) was recently approved by the FDA to reduce the signs and symptoms of active arthritis in patients with psoriatic arthritis. This anti-TNF therapy is administered for psoriatic arthritis via a 2-hour infusion in the clinic or office setting. Patients receive treatment every 8 weeks following an initial course of therapy at weeks 0, 2 and 6.
Approval was based on data from the Induction and Maintenance of Psoriatic Arthritis Clinical Trial 2 (IMPACT 2). In this study, patients achieved significant improvements in both ACR 20 (American College of Rheumatology scoring criteria) and PASI 75 as early as week 2. Further improvements were seen through 24 weeks, including the following:
• At week 14, 58% of patients treated with Remicade experienced at least a 20% improvement in arthritis symptoms; only 11% of those treated with placebo saw this level of improvement.
• At week 24, 27% of Remicade-treated patients had at least a 70% improvement vs. 2% taking placebo.
Remicade is the second biologic approved for treating psoriatic arthritis. In January 2002, etanercept (Enbrel) was approved for this indication. Adalimumab (Humira), another biologic, is currently in clinical trials for the indication of psoriatic arthritis.

Other Drug News: New Candidate for Eczema Treatment
A new agent, known as Nf-kappaB Decoy has demonstrated a dramatic decrease in inflammation and swelling in preclinical models of atopic dermatitis, according to Corgentech, the company performing the research.
The agent not only reduced the proliferation of pro-inflammatory cells, but it also induced the death of cells relating to inflammation, which was reported last month at the meeting of the Society for Investigative Dermatology.

Common Cosmetic and Perfume Ingredients May Adversely Affect Male Babies
Chemicals called phthalates, commonly found in cosmetics and fragrances, have been found to harm reproductive development (resulting in smaller genitals and incomplete testicular descent) in male babies of pregnant women. According to the Phthalates Information Center, this family of chemicals makes a wide range of consumer products work better. “The smaller-molecule phthalates . . . act as fixatives for perfume, slowing down evaporation and making the scent linger longer.” The organization states that these chemicals also make nail polish flexible.
In a paper based on their research (published in Environmental Health Perspectives), scientists say that the more frequently pregnant women are exposed to high, but common, levels of these chemicals, the higher the risk to their male babies’ reproductive development.
The changes described in this study were seen at phthalate levels found in one-quarter of the U.S. female population.

CMS Tweaks Surgery Center Codes
Last November, the Centers for Medicare & Medicaid Services (CMS) proposed deleting countless entries from the list of procedures for which Medicare will reimburse in the ambulatory surgery center (ASC) setting. Fortunately for physicians, CMS dropped its plan after hearing complaints from various physician organizations. Instead, according to American Medical Association (AMA) Chair J. James Rohack, M.D., CMS recently chose to delete only five codes and to add an additional 65 codes to the ACS list. Says Jack Egnatinsky, M.D., President of the Federated Ambulatory Surgery Association, the CMS has not received any comments calling for the preservation of the five procedures it deleted, which, according to Dr. Egnatinsky, are likely performed almost exclusively in the physician office setting.

Cosmetic Plastic Surgery Procedures Continue to Rise
New statistics from the American Society of Plastic Surgeons showed that more than 9.2 million cosmetic plastic surgery procedures were performed in 2004, a 5% increase from 2003. While minimally invasive procedures increased by 7%, surgical cosmetic procedures decreased by 2%.
Of the nearly 7.5 million minimally invasive procedures performed in 2004, the most popular were:
• Botox (3 million)
• Chemical peels (1.1 million)
• Microdermabrasion (859,000)
• Laser hair removal (574,000)
• Sclerotherapy (545,000).
The biggest growth in the minimally invasive procedures was seen in injectable wrinkle fillers. Hyaluronic acid filler, such as Restylane and Hylaform, increased 927% last year, while Botox increased 4%, up 280% since 2000.
Of the more than 1.7 million surgical cosmetic procedures done, the five most popular were:
• Liposuction (325,000)
• Nose reshaping (305,000)
• Breast augmentation (264,000)
• Eyelid surgery (233,000)
• Facelift (114,000).

The Origin of Leprosy
According to a recent report in the journal Science, leprosy likely originated in East Africa and spread to Asia and Europe before being imported into West Africa by explorers. The research team, which included scientists from the United States, France and seven other countries, scanned the genetic material of 171 specimens of Mycobacterium leprae for tiny variations known as single nucleotide polymorphisms (SNPs). The researchers used these SNPs to trace the lineage of M. leprae and to develop a picture of how leprosy spread from its point of origin. Scientists looked at specimens from 21 countries, representing five continents.
Investigators discovered four types of SNPs in the samples, but found the distribution was not random — they found a close correlation between SNP type and geographic location of the leprosy patient. Type 2, predominant in a small region of East Africa and Central Asia, is the rarest and oldest, researchers believe. Type 1, present in Asia and the Pacific region, represents the eastward migration of leprosy, while type 3, found in Europe, North Africa and the Americas, is the form that migrated west. The most recently evolved, type 4, is predominant in West Africa. Because type 4 is most closely related to type 3, the researchers concluded that North Africans or Europeans most likely brought the disease to West Africa.

Online Communication with Docs is in Demand
According to recent Harris Interactive research, most (90%) patients who have access to e-mail want to be able to have more communication via e-mail with their physicians.
Participants in a recent survey indicated that the following online functions would be most desirable:
• fix appointments (71%)
• ask questions where no visit is necessary (77%)
• refill prescriptions (71%)
• receive diagnostic test results (70%) over the Internet.
Harris Interactive research revealed that more than one-third (37%) of all those online say they would be willing to pay out-of-pocket for the ability to communicate online with their physicians (see Tables 1 and 2).

Interestingly, most (55%) of those online say that if one health plan enabled them to communicate with their doctors online and another did not it would influence their choice of plans either a great deal (12%), somewhat (43%), not much (26%), or not at all (12%). Six percent of the survey participants weren’t sure whether this factor would influence their decision. When asked how much it would influence their decision to pick between two doctors, one of whom allowed them to send and receive e-mails, 14% of survey respondents said that having the option to communicate with a physician in this manner would influence their choice of physician a great deal, 42% responded that it would somewhat influence their decision, 25% said “not much,” 14% replied “not at all,” and 5% didn’t know.
Interest is growing; will you embrace this as an opportunity to grow your practice?

In brief...
New Research Grants Available…from the National Rosacea Society to support research into the potential causes and other key aspects of rosacea. There are six grants available totaling $146,419. Application forms are available through the society. Call (847) 382-8971 or e-mail rosaceas@aol.com. Applications are due by September 15. Grants will be awarded following selection by the medical advisory board.

Coria Laboratories Announces…that a roundtable discussion during this year’s annual American Academy of Dermatology meeting found clocortolone pivalate 0.1% cream (Cloderm) useful in treating and managing a wide range of dermatoses. Roundtable participants found the mid-potency steroid effective in treating seborrheic dermatitis, atopic dermatitis, xerotic eczema, psoriasis and more.

The 3M Foundation Awarded…the Women's Dermatologic Society a $1 million community service grant to use in developing educational activities targeted to raising awareness of skin health and sun safety. WDS will put the money toward a 3-year program of activities targeting 15 metropolitan cities across the country.

The Dermatology Foundation is Accepting…nominations for the 2005 Clark W. Finnerud Award and the 2005 Practitioner of the Year Award. The Clark W. Finnerud Award is for an individual who has devoted extraordinary time and talent as a part-time teacher and clinician. The Practitioner of the Year Award is for a dermatologist who has shown exemplary service. Letters of nomination, including background information of the nominee that would qualify him or her for the award and the nominee’s curriculum vitae, should be submitted by August 1. Send letters to Finnerud/Practitioner Award, Dermatology Foundation, 1560 Sherman Avenue, Suite 870, Evanston, IL 60201.