New Drug May Be Better Psoriasis Treatment

Dennis Thompson wrote . . . . . . . . .

A breakthrough psoriasis drug is better at treating the itchy and painful skin disease than medicines already on the market, according to results from two clinical trials.

There was a “night and day difference” in the results from bimekizumab compared against two established psoriasis drugs, secukinumab (Cosentyx) and adalimumab (Humira), said Dr. Mark Lebwohl, a co-researcher in one of the clinical trials.

“We’ve never had a drug which in its phase 3 trials had more than 50% of patients achieve” a 100% reduction in their psoriasis symptoms, said Lebwohl, dean for clinical therapeutics at the Icahn School of Medicine at Mount Sinai in New York City.

“We’re now at a point where we can clear the vast majority of psoriasis patients with medications that are very effective and very safe,” he added.

Based on these results, Lebwohl expects the Belgian pharmaceutical company UCB Pharma to pursue quick approval of bimekizumab with the U.S. Food and Drug Administration.

“I would hope it would be on the market this summer,” he said.

Psoriasis affects more than 8 million people in the United States, according to the National Psoriasis Foundation.

It’s an autoimmune disease that speeds up skin cell growth, causing cells to pile up on the surface of the skin and form plaques that itch, burn and sting. These plaques can appear on any part of the body, but are most often found on the elbows, knees and scalp.

A pro-inflammatory biochemical called interleukin-17 (IL-17) has been implicated in the development of psoriasis, Lebwohl said. Secukinumab and adalimumab work by blocking the chemical’s most potent form, called IL-17A.

Bimekizumab blocks both IL-17A and another form of the chemical called IL-17F, Lebwohl said. The injectable drug is administered once a month.

“The biology [of the two forms of IL-17] is overlapping — 17A is more potent but 17F is more abundant,” Lebwohl said. “Even though 17A is stronger at causing psoriasis, there is more of 17F. By blocking both, you get the full effect.”

After 48 weeks of treatment, about 67% of bimekizumab patients had complete clearing of their psoriasis plaques, compared with 46% of patients receiving secukinumab, according to results of the trial that Lebwohl co-authored. A total 743 patients participated.

The other clinical trial, involving 478 patients, offered similar results. After 16 weeks, 86% of patients on bimekizumab had experienced a 90% reduction in their psoriasis plaques, nearly double the 47% who achieved the same response with adalimumab.

“They block IL-17A, while this blocks both IL-17A and IL-17F,” Lebwohl said. “That’s probably why it’s so effective. Blocking that extra little bit of IL-17 actually gets you the added effectiveness.”

Bimekizumab also has been shown to effectively treat psoriatic arthritis, a condition that affects 1 in 3 people with psoriasis, Lebwohl said.

People taking bimekizumab were four to 10 times more likely to have a reduction in their arthritis symptoms than a placebo group, with the response growing with the size of the dose, according to results published in The Lancet.

Blocking IL-17 does cause a greater risk of yeast infections, and the risk is stronger with bimekizumab than the other two drugs, results showed.

“Nature has done an experiment for us by giving us people who are deficient in IL-17, and they get awful yeast infections,” Lebwohl said. “We anticipated before the study is that the only side effect we’d see was yeast infections, and that’s what happened.”

The mild to moderate cases of yeast infection that occurred in the clinical trials were “easily treated with fluconazole,” an oral anti-fungal drug, Lebwohl said.

Dr. Michele Green, a dermatologist with Lenox Hill Hospital in New York City, reviewed the findings.

“This is an impressive study showing significant results using an interleukin-17 inhibitor to treat plaque psoriasis,” she said.

However, Green sounded a note of caution, urging further study of the drug.

“A larger sample size needs to be used since in addition to candidiasis, interleukin inhibitors have been associated with higher rates of other opportunistic infections, severe infections and cancer,” Green said.

The clinical trial results were published in the New England Journal of Medicine, and also were presented at an online meeting of the American Academy of Dermatology.

Source: HealthDay

Skin Diseases are Common in Older Adults

As we age, our skin changes in ways that can make it more prone to disease. That’s because older skin is less oily, less elastic, and thinner. It bruises easily and can take a long time to heal when cut.

Although skin disorders are common in older adults, few studies have examined the connection between aging and skin disease. The studies we do have are mostly collected from specific groups of older adults, such as nursing home residents or those who have been treated in hospitals.

However, we do know that two studies of health records for large groups of older adults show that the most common skin diseases in older people are eczema, skin infections, and pruritus (severely dry and itchy skin). Recently, a research team designed a study to learn more about how common skin diseases are in adults aged 70 and older. They published their study in the Journal of the American Geriatrics Society.

The scientists used information taken from The Northern Finland Birth Cohort 1966, a research program conducted in northern Finland (Oulu and Lapland). Researchers from that study followed 12,058 participants regularly since their birth. The parents of these study participants also served as a subset of the study and participated in separate skin examinations to learn more about skin diseases in older adults

By the end of the skin study, researchers sent a health questionnaire to the parents. Of these, 46 percent responded and some 1200 people who lived in Oulu were invited to participate in the clinical examination. Researchers gave whole-body skin examinations to 552 people.

All areas of the skin including the nails, hair, and scalp were examined during a 20-minute visit. All skin diseases which could be seen during the visit were recorded. Researchers counted all the skin tumors and then examined them more closely with a special instrument called a dermatoscope.

The researchers learned that nearly 76 percent of the participants had at least one skin disease that required treatment or follow-up. Over one-third of the participants had three or more skin diseases, with fungal skin infections being the most common. The researchers reported that almost half the participants had tinea pedis (athlete’s foot) and 30 percent had onychomycosis (nail fungus).

Other skin diseases found during the examinations included:

  • Rosacea, a condition that causes people to blush or flush easily, found in 25 percent of participants.
  • Asteatotic eczema, characterized by dry, itchy, and cracked skin, found in 21 percent.
  • Seborrheic dermatitis, which causes dandruff, found in 10 percent.
  • Nummular eczema, which features coin-shaped itchy, reddened patches, found in 9 percent.
  • Previously undiagnosed actinic keratosis, a precancerous skin lesion, found in 22 percent of the population.

Overall, benign (non-cancerous) skin tumors were the most common skin findings in this study.

To the best of their knowledge, the researchers said that this is the largest study to date in the field of geriatric dermatology to be based on a whole-body skin examination.

The researchers concluded that this study provides new data about skin diseases in older adults. “We learned that dermatological disorders are extremely common in older individuals, and this should be taken into account by physicians treating geriatric patients,” said the researchers. “A whole-body clinical skin examination may reveal hidden skin diseases and can ensure timely diagnoses and appropriate treatment.”

Source: HealthinAging

A Woman’s Guide to Skin Care During and After Menopause

People sometimes refer to menopause as “the change of life,” but many women are surprised that one of the things that changes is their skin, an expert says.

“Although fluctuating hormones during menopause can result in a number of skin changes, these don’t need to be disruptive to daily life,” said New York City dermatologist Dr. Diane Berson. “With the right care, women can continue to have healthy, blemish-free skin during midlife and beyond.”

During menopause, declining estrogen levels result in dryness and itching. Wash with a mild cleanser, as regular soap may be too drying, Berson suggested in an American Academy of Dermatology news release. After bathing or showering and throughout the day, apply a moisturizer with hyaluronic acid or glycerin.

To help soothe itchy skin, apply a cool, wet compress, then a moisturizer.

Another way to relieve itchy skin is to take a colloidal oatmeal bath. Colloidal oatmeal is available in most drug and beauty stores. Use warm, not hot, water and pat your skin dry — instead of rubbing — to avoid further irritation, Berson advised.

If fluctuating hormones leave you with acne, wash with a cleanser containing benzoyl peroxide. However, if the cleanser dries out your skin, switch to a milder cleanser or a product containing adapalene.

Age spots and larger areas of darker skin can appear on your face, hands, neck, arms or chest during menopause. Applying a broad-spectrum sunscreen with an SPF 30 or higher to exposed skin when you go outside can help fade age spots, prevent new ones and reduce your risk of skin cancer, Berson said.

Use other methods of sun protection, too, such as seeking shade and wearing a long-sleeved shirt, pants, a wide-brimmed hat and sunglasses.

“Remember, since skin cancer can sometimes look like an age spot, and since your risk of skin cancer increases with age, it’s important to perform regular skin self-exams during menopause,” Berson said.

Source: HealthDay

The Effects of Skin Aging Vary Depending on Ethnicity

The population in the United States is expected to become increasingly older, with estimates indicating that by the year 2030, nearly 40 percent of Americans will be over the age of 65.

As people are living longer, their skin is not only chronologically, or biologically aging, but it is also being exposed to environmental factors, such as sunlight, which can cause age-related damage to the skin.

Neelam Vashi, MD, director of the Center for Ethnic Skin at Boston Medical Center, has published a review paper in Clinics in Dermatology that discusses how aging presents in patients, and the differences that are attributed to skin type, exposures and genetic factors.

For the review, the researchers examined 41 peer-reviewed published articles between 1970 and 2018 that focused on aging in ethnic skin through PubMed. The data included in the articles demonstrate that all skin types will show signs of damage from exposure to Ultraviolet rays from the sun, which include skin discoloration, loss of collagen and/or skin cancer.

Here are some key findings from the review:

  • Melanin is a key difference in those of light and dark skin types
  • Patients of color are more likely to experience changes in pigmentation (dyschromia)
  • Key differences in fibroblasts (cells that promote wound healing and collagen production) account for increased skin thickness of African-American patients, resulting in wrinkles that appear several years later than white counterparts
  • Patients of East Asian descent have a higher likelihood of experiencing hyperpigmentation, but wrinkles don’t form as early in the aging process
  • Patients of Hispanic descent also experience fewer wrinkles earlier in the aging process
  • Patients of Caucasian descent (European, North African, Southwest Asian ancestry) more commonly have thinner skin and experience wrinkles, loss of skin elasticity, and reduced lip volume

“Aging is inevitable, and each person will have a unique experience with how their skin changes as it ages,” said Vashi, who is also an associate professor of dermatology at Boston University School of Medicine.

As a dermatologist, Vashi treats a large number of patients for a variety of skin conditions related to aging. The one treatment she always recommends is UV protection, which helps shield all skin types from the sun’s harmful rays. “Skin cancer is the most common type of cancer in the US, and using sunscreen is an extremely important practice to protect your skin,” added Vashi.

Some of the other available treatments for skin aging include:

  • Topical agents, antioxidants, chemical peels and lasers can be effective to treat dyschromia
  • Botulinum and toxin and soft-tissue fillers can help treat wrinkles and sagging skin

Source: EurekAlert!


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FDA Strengthens Sunscreen Rules

The U.S. Food and Drug Administration took steps to tighten regulation of over-the-counter sunscreen products.

Included in the proposed rule are updates on sunscreen safety, sun protection factor (SPF) requirements, and the effectiveness of insect repellent/sunscreen combinations.

“The proposed rule that we issued today would update regulatory requirements for most sunscreen products in the United States, to better ensure consumers have access to safe and effective sun care options in line with the latest science,” FDA Commissioner Dr. Scott Gottlieb said during a media briefing Thursday morning.

The proposal “applies only to sunscreen active ingredients currently on the market in the United States without FDA-approved application. And that’s actually the vast majority of sunscreens available in the United States,” added Dr. Theresa Michele, director of the division of nonprescription drug products at the FDA’s Center for Drug Evaluation and Research (CDER).

Under the proposed rule, two of the 16 active ingredients in sunscreens — zinc oxide and titanium dioxide — are now considered safe and effective, while two others (PABA and trolamine salicylate) are not. No sunscreens sold in the United States contain PABA or trolamine salicylate.

Safety data for 12 other sunscreen ingredients is not sufficient to determine if they are safe and effective, the agency added.

“Therefore,” said Dr. Janet Woodcock, director of the CDER, “we are asking for additional clinical and non-clinical data on these 12 ingredients.”

The Environmental Working Group (EWG), a watchdog organization for consumer health, called the new initiative way overdue.

“After more than 40 years, the FDA is at last taking serious steps to finalize rules that would require sunscreen companies to make products that are both safe and effective,” David Andrews, senior scientist at EWG, said in a news release.

He pointed to one ingredient, oxybenzone, in particular.

“For a decade, EWG has worked to raise concerns about sunscreens with oxybenzone, which is found in nearly all Americans, detected in breast milk and potentially causing endocrine disruption,” Andrews said. “Today the FDA recognized those concerns.”

Woodcock noted that labeling changes will also make it easier for consumers to understand what they are buying.

“Since 1999, new scientific evidence has helped to shape FDA’s perspective on what active ingredients could be considered safe and effective, among other things,” Woodcock said in a CDER statement.

“I want to emphasize that the proposed rule does not require any sunscreen products to be removed from the market at this time,” she added. “Manufacturers will be able to provide comment and submit data on the proposals contained in the proposed rule, including safety data for active ingredients for which insufficient data [now] exist.”

Types of sunscreen generally considered safe and effective include sprays, oils, lotions, creams, gels, butters, pastes, ointments and sticks.

Meanwhile, “we have found sunscreen powders eligible … but are requesting additional safety and efficacy data on powders before they can be included [in the proposed rule]. We are proposing to exclude wipes, towelettes, body washes, shampoos and other dosage forms,” Woodcock said.

Also, products that combine sunscreens with insect repellents are not generally considered safe and effective, the agency stated.

Under the rule, the maximum sun protection factor on sunscreen labels would be raised from SPF 50+ to SPF 60+.

“We are proposing to permit the marketing of sunscreen products formulated with SPF values up to 80, but not above, unless the product has an approved [new drug application],” Woodcock explained.

Sunscreens with SPF values of 15 and higher will be required to be broad spectrum, and broad spectrum protection against UVA radiation must also increase as SPF increases, the rule states.

“This will ensure that these products provide consumers with the protections they expect against skin cancer and early skin aging,” Woodcock said.

New sunscreen label requirements will include listing of active ingredients on the front of the bottle and other requirements for the front of sunscreen bottles — all meant to help consumers better understand what the sunscreens they are buying can actually do.

Source: HealthDay


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