Recent Developments

Meet the Newest AAD Officers and Board Members

Suzanne M. Olbricht, MD, FAAD, a Boston-based dermatologist, took the helm of the American Academy of Dermatology (AAD) as the new president—her one-year term officially began on Tuesday, February 20, at the conclusion of the 2018 AAD Annual Meeting in San Diego.

Dr. Olbricht is an associate professor of dermatology at Harvard Medical School and chief of dermatology at Beth Israel Deaconess Medical Center in Boston. She previously served the AAD as secretary-treasurer, assistant secretary-treasurer, and a member of its board of directors. She has also served as chair of the AAD’s Scientific Assembly Committee. Dr. Olbricht is a past president of the New England Dermatology Society.

In addition, Ted Rosen, MD, FAAD began his one-year term as vice president. Dr. Rosen is a professor of dermatology at Baylor College of Medicine and chief of dermatology service at Michael E. DeBakey Veterans Affairs Medical Center in Houston. He is also a trustee of the Dermatology Physician Assistant Foundation. He is a past president and past secretary-treasurer of the Houston Dermatological Society and a past vice president of the Texas Dermatological Society.

The New Board of Directors includes New York City dermatologist Diane S. Berson, MD, FAAD; Plano, TX dermatologist Seemal R. Desai, MD, FAAD; Scott M. Dinehart, MD, FAAD, a dermatologist in Little Rock, AK; and Norfolk, VA dermatologist Abby S. Van Voorhees, MD, FAAD. All will serve four-year terms.

Galderma Enters into Long-term Research Agreement on AD

Galderma has signed a joint research agreement on atopic dermatitis (AD) with two leading academic institutions—Icahn School of Medicine at Mount Sinai in New York City and Northwestern University Feinberg School of Medicine in Chicago. This seven-year collaborative agreement aims to enhance the scientific understanding of the underlying mechanisms driving atopic dermatitis in order to pave the way for developing better healthcare solutions to improve the quality of life of patients with the disease, the company explains.

“While there are many exciting novel treatments moving into atopic dermatitis, these are based on increasing knowledge of pathogenic disease mechanisms in adults. However, we recently learned that atopic dermatitis disease initiation in children shows a different phenotype than that of adults with many years of chronic disease activity. In order to be able to better advance treatments into children, we must understand what are the factors that influence the progression of AD from children to adults. We are looking forward to studying molecular and cellular mechanisms underlying this progression,” says Emma Guttman-Yassky, MD, PhD, Professor and Vice-Chair, Department of Dermatology, Icahn School of Medicine at Mount Sinai, in a release

There are still many unknowns in the pathogenic pathways driving atopic dermatitis. It is not known why the disease persists in some pediatric patients but clears in others before they reach adulthood. It is of critical importance to understand age-specific alterations in skin immunity and the epidermal barrier that promote disease onset, persistence, or clearance of atopic dermatitis, especially in children where the disease often starts. Researchers from these collaborating institutions will work to shed light on the development and the course of pediatric atopic dermatitis through this long-term longitudinal study.

“We have recently learned much about the cause of atopic dermatitis, which is driving new therapies. But all of this understanding is based on studies of adults; our recent studies have suggested that the immune and skin barrier changes in early atopic dermatitis in infants and young children are different from those in adults. We are looking forward to further dissecting the skin immune system as children age in both normal infants and children and in atopic dermatitis,” says Amy Paller, MS, MD, Walter J. Hamlin Professor and Chair of Dermatology at Northwestern University Feinberg School of Medicine and a physician at the Ann and Robert H. Lurie Children’s Hospital of Chicago.

The research grant reportedly represents one of the largest financial contributions provided by a single biopharmaceutical company in recent years dedicated for pure academic research and discovery in dermatology.

Vit D Levels Elevated in Acne

Levels of vitamin D are higher in acne patients, compared to age/sex matched controls. Researchers found a significant inverse relation between level of 25 hydroxy vitamin D and severity of acne vulgaris before treatment, according to a study in the Journal of Cosmetic Dermatology.

The study showed that serum levels of 25 hydroxy vitamin D were significantly higher in patients with acne vulgaris than healthy controls. Serum levels of 25 hydroxy vitamin D were significantly increased after isotretinoin treatment in patients with acne vulgaris.

The study authors say further studies are needed to confirm these potential relations. Get more updates on acne from our Acne Resource Center: PracticalDermatology.com/acne-resource-center/

DermTech: Research Validates Assay for Diagnosis of Melanoma

DermTech, Inc. presented a late breaking abstract—“Validation of Noninvasive Gene Expression (PLA) Against High Risk Driver Mutations (BRAF, NRAS, and TERT) in Cutaneous Melanoma”—at the 76th Annual Meeting of the AAD in San Diego.

The late breaking research by Clay Cockerell, MD, of Cockerell Dermatopathology in Dallas, validated the high performance of the Pigmented Lesion Assay (PLA) against key driver mutations in melanoma. These mutations are found to correlate with histopathologic criteria on prognosis. Ninety-seven percent of the histopathologically confirmed melanoma samples were either PLA positive or mutation positive. Statistically significant differences in mutation frequency were observed between melanoma positive/PLA positive and melanoma negative/PLA negative samples for hotspot mutations (75 vs. 15 percent). Mutations in the adhesive patch samples were also concordant with mutations in FFPE tissue blocks.

Real-world PLA results in more than 500 patients showed that 89 percent of PLA negative results were mutation negative, while 60 percent of PLA positive results were mutation positive, demonstrating that PLA positive tests identify high-risk lesions with driver mutations, while PLA negative tests do not harbor these mutations.

“This work further validates the PLA for the non-invasive identification of melanoma risk. In addition, it confirms the high real-world performance of the test and accuracy to rule out melanoma risk in pigmented lesions. This work also provides the foundation for our Nevome product, which will help physicians manage lesions with atypical histopathology findings, improve risk stratification, and provide valuable prognostic information. DermTech’s PLA and Nevome are rapidly becoming the standard for assessment of pigmented lesions,” says John Dobak MD, DermTech’s CEO.

Some Parents Underestimate Risks of Indoor Tanning

Dads, parents who had used indoor tanning devices themselves, and those who reported that they had never received skin cancer prevention counseling from their child’s doctor are less likely to believe adolescent indoor tanning is harmful, a new survey shows.

To investigate parents’ attitudes toward their children’s tanning behaviors, Maryam Asgari, MD, MPH, FAAD, an associate professor in the department of dermatology at Massachusetts General Hospital and the department of population medicine at Harvard Medical School in Boston and colleagues conducted a national survey of 1,205 parents of children age 11-17.

Parents of males, older adolescents (16- and 17-year-olds), and adolescents whose skin was less reactive to the sun were also less inclined to see indoor tanning as dangerous.

“Parents who have never seen their children get sunburned or discussed skin cancer prevention with a doctor may not be aware of the dangers of unprotected exposure to ultraviolet light,” Dr. Asgari says in a news release. “Since mothers are often the ones to take their children to the doctor, fathers may be less likely to receive skin cancer prevention counseling from their child’s provider.”

Asthma and Allergy Foundation: High Prevalence and QoL Impact of Adult Atopic Dermatitis

The Asthma and Allergy Foundation of America (AAFA) shared data demonstrating the high rate of prevalence of atopic dermatitis (AD) in the US adult population and a greater impact on health-related quality of life and mental health symptoms, such as depression and anxiety, for patients with moderate to severe disease, compared to those with mild disease. These results are from the Atopic Dermatitis in America Study, an independent research project of the Asthma and Allergy Foundation of America in partnership with the National Eczema Association (NEA) and sponsored by Sanofi Genzyme and Regeneron.

Results of the study, presented at the AAD Annual Meeting, found:

• Using UK Working Group Criteria (UKWGC) for AD, the prevalence of atopic dermatitis in US Adults was 7.3 percent, which is in line with those of a prior study reporting a similar prevalence of AD.

• When compared to those with mild disease, persons with moderate to severe disease reported significantly poorer health related quality of life such as itching and sleep loss as well as mental health symptoms such as depression and anxiety.

Burt’s Bees Nature-Based Sensitive Skin Regimen Trumps Dermatologist-recommended Regimen

Burt’s Bees nature-based sensitive line outperformed a dermatologist-recommended synthetic control regimen in a study of 120 people with clinically diagnosed sensitive skin from rosacea, atopic dermatitis/eczema, or cosmetic intolerance.

The nature-based regimen consisted of Burt’s Bees Sensitive Facial Cleanser, Sensitive Eye Cream, Sensitive Daily Moisturizing Cream, and Sensitive Night Cream.

Findings were reported at the Annual Meeting of the AAD.

The National Eczema Society (NEA) recently awarded Burt’s Bees’ Sensitive skin care line the NEA’s Seal of Acceptance, which maintains rigorous standards for approval.

“It is exciting to see these data validate the nature-based approach for achieving skin benefits that many patients with sensitive skin seek,” says Zoe Draelos, MD, Dermatology Consulting Services, High Point, NC, principal investigator of the study, in a news release.

In the double-blind randomized, controlled trial. Burt’s Bees Sensitive Skin Regimen clinically and statistically improved investigator-rated overall skin appearance by 34 percent with similar improvements in visual and tactile smoothness, clarity, and radiance. Similar improvements were absent with a dermatologist recommended synthetic regimen. Improvements occurred in each skin condition.

Overall appearance improved in subjects with atopic dermatitis/eczema by 38 percent, rosacea by 34 percent, and cosmetic intolerance by 31 percent. The maximum improvement in subjects with any skin condition treated with the synthetic regimen was 11 percent (atopic dermatitis/eczema). Notably, tolerability parameters did not worsen and most improved with the Burt’s Bees Sensitive Skin Regimen. Both regimens improved epidermal barrier function in each condition as measured by transepidermal water loss where increases were seen ranging from 9 to 20 percent.

Could the Skin Microbiome Protect Against Skin Cancer?

Beneficial skin bacteria may protect against skin cancer, according to a new study in Science Advances. “We have identified a strain of Staphylococcus epidermidis, common on healthy human skin, that exerts a selective ability to inhibit the growth of some cancers,” says Richard Gallo, MD, PhD, Distinguished Professor and chair of the Department of Dermatology at University of California San Diego School of Medicine, in a news release. “This unique strain of skin bacteria produces a chemical that kills several types of cancer cells but does not appear to be toxic to normal cells.”

The University of California San Diego School of Medicine researchers discovered the S. epidermidis strain produces the chemical compound 6-N-hydroxyaminopurine (6-HAP). Mice with S. epidermidis on their skin that did not make 6-HAP had many skin tumors after being exposed to cancer-causing ultraviolet rays (UV), but mice with the S. epidermidis strain producing 6-HAP did not.

6-HAP is a molecule that impairs the creation of DNA and prevents the spread of transformed tumor cells as well as the potential to suppress development of UV-induced skin tumors.

Mice that received intravenous injections of 6-HAP every 48 hours over a two-week period experienced no apparent toxic effects, but when transplanted with melanoma cells, their tumor size was suppressed by more than 50 percent compared to controls, the study showed.

In the case of S. epidermidis, it appears to be adding a layer of protection against some forms of cancer, says Dr. Gallo. Further studies are needed to understand how 6-HAP is produced, if it can be used for prevention of cancer or if loss of 6-HAP increases cancer risk.

SkinCeuticals US Taps Christina Fair as New GM

Christina (Tina) Fair is the new General Manager at SkinCeuticals US.

Ms. Fair joins the US team from the SkinCeuticals DMI, where she has been the Vice President of Global Marketing since 2015. During her time in the DMI, Ms. Fair led the development of two of the brand’s most successful product launches, Triple Lipid Restore 2:4:2 and HA Intensifier. Additionally, she has spearheaded the SkinCeuticals expansion into medical devices, with the introduction of CryoCorrect, and personalization services with Custom DOSE.

FDA Grants Priority Review for Genentech’s Rituxan for Pemphigus Vulgaris

The FDA has accepted Genentech’s Supplemental Biologics License Application (sBLA) and granted Priority Review for the use of Rituxan (rituximab) for the treatment of pemphigus vulgaris (PV). Genentech is a member of the Roche Group.

The FDA previously granted Breakthrough Therapy Designation and Orphan Drug Designation to Rituxan for the treatment of PV. Presently, there are limited approved treatment options available for patients with PV.

The sBLA submission is based on data from a Roche-supported randomized trial conducted in France which evaluated Rituxan plus a tapering regimen of low dose oral corticosteroid (CS) treatment compared to a standard dose of CS alone as a first-line treatment in patients with newly diagnosed moderate to severe pemphigus. Results of the study show that Rituxan provides substantial improvement in pemphigus vulgaris remission rates and successful tapering and/or cessation of CS therapy. Results were published in The Lancet this month.

Genentech is conducting another Phase III study in PV, which is evaluating Rituxan plus a tapering regimen of CS compared to Cellcept (PEMPHIX, NCT02383589).

Olumacostat Glasaretil for Acne Misses Co-Primary Endpoints in Phase 3

Dermira, Inc.’s investigational treatment olumacostat glasaretil (formerly DRM01) did not meet the co-primary endpoints in its two Phase 3 pivotal trials (CLAREOS-1 and CLAREOS-2) in patients ages nine years and older with moderate to severe acne vulgaris. The co-primary endpoints of CLAREOS-1 and CLAREOS-2 were absolute changes from baseline in inflammatory and non-inflammatory lesion counts and the proportion of patients achieving at least a two-grade improvement from baseline to a final grade of zero or one on the five-point Investigator’s Global Assessment (IGA) scale. Each endpoint was measured on the face at the end of the 12-week treatment period.

“We are surprised and extremely disappointed by the results of the Phase 3 program,” says Tom Wiggans, chairman and chief executive officer of Dermira. “This is disappointing not only for the company, but also for patients who are living with this condition and dermatologists who have been looking for novel therapies to treat them.”

Safety and tolerability were also evaluated.

Based on the data, Dermira suggests it will likely discontinue the development program for olumacostat glasaretil.

FDA Accepts Ortho Dermatologics’ NDA For Jemdel Plaque Psoriasis Treatment

The FDA has accepted the New Drug Application for Jemdel (halobetasol propionate 0.01%, formerly IDP-122) lotion from Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. If approved, Jemdel will be the first high-potency topical steroid treatment for plaque psoriasis with dosing for as long as eight weeks. In the clinical trials, the most common adverse event was upper respiratory tract infection. The PDUFA action date is Oct. 5, 2018.

“The impact of psoriasis can be devastating for the millions of patients who live with the pain and stigma of this lifelong chronic condition,” says Joseph C. Papa, chairman and CEO, Valeant, in a release. “If approved, we believe Jemdel will be an important option for patients with plaque psoriasis.”

OSCAR Data: Epiduo Forte Helps Prevent, Reduce Acne Scars

Results from Galderma’s Phase 4 OSCAR study presented at the 42nd Hawaii Dermatology Seminar, reveal that Epiduo Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5% decreased acne lesions, as measured over a period of 24 weeks, and reduced the risk of atrophic acne scars in patients with moderate to severe acne.

The spilt-face study compared Epiduo Forte to vehicle only in a cohort of patients with at least 25 inflammatory lesions and at least 10 acne scars at baseline, evenly distributed over the face. In addition to investigator and patient assessment, 2D photography was used to assess scars.

“We always realized that if you treat acne well and early, and therefore make the acne better, that people are less likely to scar, because scarring occurs from inadequate treatment,” observes study investigator Hillary Baldwin, MD. “The more severe your acne, the more likely you are to scar. And the sooner you treat the patient and more efficiently, the less scars they form.

“But what we found was that not only were there fewer scars forming—in fact no scars forming on the treated side—but there was actually a reduction in existing scars.” At the conclusion of the study, there was a 30% difference in scars between the treated and untreated sides.

Though the study did not evaluate the mechanism of scar improvement, Dr. Baldwin suspects the anti-inflammatory and collagen remodeling actions of the retinoid adapalene likely play a key role.

The study offers a new way of thinking about acne care, Dr. Baldwin says. “The fact that you can make acne better and help reduce the risk of scars at the same time I think is the new concept.”

Aqua Pharmaceuticals Supports Camp Discovery

Aqua Pharmaceuticals, LLC is demonstrating its commitment to the dermatology community by supporting American Academy of Dermatology’s Camp Discovery and is making a donation up to $5,000 to support the camp.

Camp Discovery is a summer camp designed exclusively for kids undergoing treatment for chronic skin conditions, with five locations throughout the US. Pennsylvania-based Aqua, an Almirall company, is also considering providing employee volunteer opportunities at the in-state camp.

Medical Spa Show 2018 Highlights Market Opportunities

The America Med Spa Association (AmSpa) hosted the first ever Medical Spa Show in Las Vegas last month. The program featured presentations on trends, technologies, techniques, and regulations that affect medical spa practice.

At the Medical Spa Show 2018, Nicole Simpson and Jasmine Hill from Aesthetic Influencer gave a presentation that resonated with attendees called Millennials + Retail: Building Lifelong Clients. “Millennials function in experiential currency and the aesthetics practice that will survive the influx of the reported 80 million cosmetic-procedure loving millennials, will put as much thought into the treatments they offer as they will the experiences they create. Since millennials are not brand loyal, as aesthetic providers we have to open our minds and meet them where they are,” Ms. Simpson and Ms. Hill say. “This includes things such as beautiful, Instagrammable spaces in the waiting room as much as digitizing as much of the practice experience as possible.”

The Medical Spa Show 2019 will be February 7-10 in Las Vegas.

UCB: Promising Data on Psoriasis Portfolio at Annual AAD Meeting

UCB presented positive Phase 2b results for bimekizumab for the treatment of psoriasis, as well as safety data on pregnancies exposed to certolizumab

Late-breaking research on bimekizumab, an investigational humanized monoclonal IgG1 antibody that neutralizes IL-17A and IL-17F, was presented at the Annual AAD meeting. A total of 250 patients were randomized in roughly equal numbers to receive bimekizumab at 64mg, 160mg, 160mg with a 320mg loading dose, 320mg, 480mg, or placebo every four weeks, for 12 weeks.

Results showed that treatment with bimekizumab provided “significant” improvement in psoriasis severity, as measured by an Investigator’s Global Assessment (IGA) 0/1 (“clear” or “almost clear”) response at weeks 8 and 12. In the highest dosing groups, 75-86 percent of patients achieved IGA 0 or 1. When measuring PASI 90 responses to bimekizumab, 72-79 percent of patients in the highest dosing groups achieving PASI 90 at 12 weeks.

PASI 100 at week 12 was achieved by 27.9, 28.2, 49.8, 55.8, and 60 percent of the patients in the five dosing groups (from lowest to highest).

In addition, a poster presentation highlighted prospective and retrospective data on the characteristics and outcomes from 1,541 maternal certolizumab pegol (CZP)-exposed pregnancies, the largest cohort of pregnant women exposed to an anti-TNF for management of a chronic inflammatory disease. Women surveyed in this study were living with psoriatic arthritis, Crohn’s disease, rheumatoid arthritis, and ankylosing spondylitis, among others (excluding psoriasis).

Findings do not indicate a malformative effect of CZP compared to the US general population (three percent) or any increased risk of fetal death. Additional postmarketing surveillance data are being collected to confirm the findings.

AbbVie Presents Positive Data for Risankizumab and Humira at AAD

AbbVie presented new positive results from the pivotal Phase 3 ultIMMa-1 and ultIMMa-2 replicate clinical trials that evaluated the safety and efficacy of risankizumab (150 mg) compared to placebo or ustekinumab (45 or 90mg, based on patient weight) at the 2018 American Academy of Dermatology Annual Meeting in San Diego.

Risankizumab is an investigational interleukin-23 (IL-23) inhibitor being evaluated for the treatment of patients with moderate to severe plaque psoriasis.

In October of 2017, AbbVie announced positive top-line results from these two pivotal trials, an evaluation of the primary and ranked secondary endpoints, including the Psoriasis Area and Severity Index (PASI 90 and PASI 100) at 16 weeks and one year and clear or almost clear skin (sPGA 0/1) at 16 weeks.

In the newly presented data, additional ranked secondary endpoints showed significantly higher rates of skin clearance at week 16 and at one year of treatment, compared with ustekinumab, as measured by static Physician Global Assessment (sPGA 0). These skin clearance rates are consistent with the previously reported PASI 100 rates at one year.

In addition, through one year of treatment, significantly more patients receiving risankizumab self-reported a Dermatology Life Quality Index (DLQI) score of 0 or 1 compared with ustekinumab.

In addition, a poster presentation at the Annual Meeting showed positive long-term data on adalimumab (ADA, Humira) for moderate to severe psoriasis. The poster reported eight-year interim results from the ESPRIT 10-year post-marketing surveillance registry of Humira in patients with moderate to severe chronic plaque psoriasis, which will include real-world effectiveness of skin clearance data. No new safety signals were observed. The number of treatment-emergent deaths in the registry was below the expected rate compared with the general population.

Get additional psoriasis news in our Therapeutics Focus in this issue.