Recent Developments

Improving Representation: Beyond Brown Bandages

There’s increasing attention to disparities in medicine, but medical student Linda Oyesiku, MPH has been aware of them from a young age. She vividly recalls as a child coloring in a “flesh colored” bandage with marker so that it would better match her skin. That experience is a cornerstone of the article the student member of the Society for Pediatric Dermatology (SPD; PedsDerm.net) recently wrote for the journal Pediatric Dermatology. In “A plea for making brown bandages stick,” Ms. Oyesiku addresses issues of inclusion, representation, and visibility in the specialty.

Speaking to Practical Dermatology® magazine, Ms. Oyesiku says there have been strides to improve representation in recent years, including efforts by some of her own mentors. There is more work to do, she says. She notes that at the start of the COVID-19 pandemic, even though patients of color were disproportionately affected, there was a paucity of images depicting skin manifestations of the disease in skin of color.

Change “often requires people to ask questions about why something is a certain way, such as why we don’t see enough images of COVID-19 appearing in these publications on COVID Toes. Or why is there only one version of something that we use, or one particular measurement that has two different distinctions for African American patients and non-African American patients,” Ms. Oyesiku observes. “Being able to ask those questions and think a little bit deeper about those issues is really important. It also allows us to ask those questions of our patients and figure out how we can best cater to their needs and see them as individuals of importance that we want to help individually.”

In pediatric dermatology especially, a lack of inclusion can have a significant impact, Ms. Oyesiku suggests. Limitations on access to providers—especially providers who look like them, support, and insurance, produces, “a significant health disparity” that impacts the ability of black and brown patients to receive diagnoses and treatments. “So they often can present with worse dermatological conditions to an emergency room seeking care,” she says. “Or they may not have providers in their area, particularly pediatric dermatologists, which is an underserved subspecialty with a really high referral rate and really long wait times. We know from studies that people of color have a higher utilization of emergency room and urgent care services for something like eczema.”

Although change has been slow, examples from business show that those who take an inclusive approach succeed. “By catering to different populations, you won’t lose out. You won’t suffer from a market perspective or business perspective,” Ms. Oyesiku says, noting that decades ago Crayola changed its “flesh” colored crayon to “peach” and has since developed crayons to reflect a range of skin tones. Closer to the dermatology community, the drive for widely applicable physical sunscreens presented a challenge. “It’s taken a number of years for this to happen and a number of black owned businesses, I know particularly who’ve made it their mission to create sunscreen that is acceptable,” Ms. Oyeshiku says. “I think that improves both the industry and the field by being able to have things that work by including all people with different colors into the development and product design.”

SPD is publishing a special edition of Pediatric Dermatology this summer dedicated to issues of diversity, equity, and inclusion. Also, be sure to read the supplement to this edition of Practical Dermatology® magazine and part one from February (online at PracDerm.com/InclusionFeb21) to hear from a panel of dermatologists and industry representatives about improving diversity and inclusion in dermatology.

Klisyri Launches for Treatment of AKs

Klisyri (tirbanibulin) ointment 1% is now available from Almirall, SA for the topical treatment of actinic keratosis (AK) of the face and scalp. Klisyri is supplied in boxes of five single-use sachets and is applied to the treatment area once daily for five days.

“Klisyri will help address unmet needs for many AK patients,” says George Martin, MD, an expert in actinic keratosis and skin cancer. “Early diagnosis and a safe and highly effective topical for treatment of actinic keratosis is critical. Patients with actinic keratoses are at higher risk for developing non-melanoma skin cancer. Actinic keratosis can progress into squamous cell carcinoma (SCC), a common and sometimes invasive and deadly form of skin cancer.”

The FDA approved the novel, topical, first-in-class microtubule inhibitor in December 2020 based on data from one of the largest Phase III clinical study programs ever conducted for a topical AK treatment, consisting of two pivotal, randomized, double-blind, vehicle-controlled Phase III studies (KX01-AK-003 and KX01-AK-004) that evaluated the efficacy and safety of Klisyri in adults with AKs on the face or scalp.

Klisyri met the primary endpoint and achieved a significantly higher number of patients with complete (100 percent) clearance of AK lesions at day 57 in the treated area compared to vehicle (44 percent vs. five percent in study 1 and 54 percent vs. 13 percent in study 2; p<0.0001 for both studies). It also met the secondary endpoint of partial (≥75%) clearance of lesions at day 57 compared to vehicle. The most common adverse events were application-site pruritus and pain seen in nine percent and 10 percent of patients treated with Klisyri.

Galderma and Aklief Unveil “Me Being Me” Campaign, Survey Results on Acne Zoom Burden

Galderma Laboratories, L.P. and Aklief (trifarotene) Cream, 0.005% are launching “Me Being Me,” a new consumer campaign that was crafted in response to today’s increasingly digital-focused world.

The campaign is designed to inspire those living with acne to feel confident in their own skin by sharing stories of real people with acne who are living their best lives while arming them with the information they need to talk to their dermatology provider. The multi-channel effort includes paid and organic social media, influencer activations and strategic content partnerships as well as a new creative advertising campaign and online hub launching in spring 2021.

A recent survey conducted by Galderma, in collaboration with Wakefield Research, revealed that 86 percent of people with acne have been distracted by their acne on a video call, often missing what others are saying. That’s if they even turn the camera on at all, as 62 percent opt to turn their cameras off during video calls, sometimes even faking technical glitches to avoid the on-screen time.

Fifty percent of students with acne say their acne has had a negative impact on their grades and academic achievement, and more than three in five (62 percent) young professionals who have had a video call say their acne has hindered their professional growth, the survey found. Fortunately, despite the distraction, 64 percent of respondents who are spending more time on video calls are also now feeling more motivated to seek help from a dermatologist.

“Many people think acne is just a teenage disease – but I’ve seen a significant rise in adult-onset acne in my practice, particularly in young women,” says Julie Harper, MD, board-certified dermatologist and Galderma consultant in Birmingham, AL, in a news release. “They are juggling virtual school, online dating and trying to start their careers, and they’re coming to me on the verge of tears, feeling like this is something they should have outgrown. With an acne treatment like Aklief Cream, I’m able to offer an option that’s proven effective and safe. With clearer skin, my patients are able to focus less on their acne and more on these pivotal moments in their lives.”

The online survey, conducted in December 2020 among 2,000 US consumers ages 14-29 with facial and truncal acne, was developed by Galderma Laboratories, L.P and Wakefield Research.

CLOSE UP with James A Solomon, MD, PhD, FAAD

A 2016 report by the United States Preventative Services Task Force (USPSTF) called the current body of evidence “insufficient to assess the balance of benefits and harms of visual skin examination by a clinician to screen for skin cancer in asymptomatic adults.’’ But these recommendations are based on studies evaluating the ability of primary care physicians to diagnose melanoma through total body skin exams (TBSE), not dermatologists and therein lies the problem, explains James A Solomon, MD, PhD, FAAD, Director of Ameriderm Research in Ormond Beach, FL and Professor of Dermatology at the University Central Florida College of Medicine in Orlando. He is also the Director of Resident Research at the KCU-GME Consortium/ADCS Orlando Dermatology Residency.

To better inform decision making on the topic, Dr. Solomon and colleagues looked at the effectiveness of TBSE versus partial skin exam screenings when performed by dermatologists and concluded that skin cancer is detected at significantly higher rates using total-body skin cancer exams. The finding appear in the Journal of Clinical Oncology. Dr. Solomon spoke toPractical Dermatology® magazine about the findings and their implications.

Why is this topic important to study?

James A Solomon, MD, PhD: Skin cancer has become an epidemic, affecting people of all races and ethnicities. In the US, approximately every hour one person will die from melanoma and another will die from either a basal cell carcinoma (BCC) or a squamous cell carcinoma (SCC). Unlike cancers of internal organs, these cancers are visible on the skin surface, which facilitates the ability to be caught early and subsequently cured.

Describe the research and your findings.

Dr. Solomon: This study, presented at ASCO 2020, explored the clinical efficacy of dermatology providers performing total-body skin cancer exams (TBSEs) as a screening tool to detect malignant melanoma (MM), squamous cell carcinoma, and basal cell carcinoma. A search was performed of the electronic medical record from a large multi-state dermatology group practice with over 145 offices assessing nearly one million new and established patient office visits occurring from January 1, 2018 to December 31, 2019. These offices use Modernizing Medicine’s EMA, an EMR whose clinical entries can be searched in detail. The practice has full-time informatics programmers who worked with programmers at Modernizing Medicine to create the code to specifically query the relationship between the type of skin exam performed associated with the skin cancers identified by those exams. Each office visit was categorized as a TBSE or as a partial skin exam (PSE). The number of MM, SCC, and BCC diagnoses made within the context of each class of skin exam was analyzed. The results of this analysis were:

• 930,706 total exams were performed of which 438,027 were TBSE and 429,679 were PSE
• One MM was detected per 161 TBSEs VS 371 PSEs
• One SCC was detected per 57 TBSEs vs. 108 PSEs
• One BCC was detected per 10 TBSEs vs. 18 PSEs

Thus, a dermatologist will find 2.3 more melanomas by performing a TBSE compared to performing a partial exam. Compared to other preventative medicine, a TBSE performed by a dermatologist is 23.5 times more likely to find a melanoma than a Pap Smear will be to identify a cervical cancer.

What Is The Next Step?

Dr. Solomon: This data supports the policy of this dermatology practice to offer a TBSE to all patients at all visits; a policy that should be encouraged to be instituted at all dermatology practices. The American Academy of Dermatology should be encouraged to present to government agencies and insurers, that dermatologists, as opposed to primary care physicians, are trained in finding skin cancers. Thus, TBSEs are preventative measures that should be supported and encouraged when a TBSE is performed by a dermatologist. We are in the process of analyzing the EMR more thoroughly to determine whether the skin cancers found by TBSE are also at earlier stages than when found by PSE. Furthermore, we are assessing the data to determine the best frequency to perform TBSEs in various patient subpopulations; these subpopulations not only relate to diverse ethnicities and races, but also to underlying dermatologic diseases, lifestyle, other medical problems, medications, etc.

Our goal is to continue to search the EMR for the medical information entered by a large nationwide dermatology practice wherein patients are not only from multiple locations with various climates and air quality, but also have various associated dermatologic problems, lifestyles, general health problems, and take various medications. Any and all of these factors may alone or in combination affect the risks of skin cancer as well as the need to perform TBSE at appropriate frequencies.

FDA Grants Priority Review of NDA for Incyte’s Ruxolitinib Cream for AD

The FDA has accepted the New Drug Application (NDA) of Incyte’s ruxolitinib cream for atopic dermatitis (AD) for priority review. The Prescription Drug User Fee Act (PDUFA) target action date is June 21, 2021.

Ruxolitinib cream is a selective JAK1/JAK2 inhibitor designed for topical application, as a treatment for AD. It is currently in Phase 3 development for the treatment of atopic dermatitis (TRuE-AD) and for the treatment of adolescents and adults with vitiligo (TRuE-V). Incyte has worldwide rights for the development and commercialization of ruxolitinib cream.

The NDA is supported by data from the Phase 3 TRuE-AD clinical trial program, which included more than 1,200 people, aged 12 years and older. Primary efficacy and safety results from both TRuE-AD trials were presented at the Revolutionizing Atopic Dermatitis Virtual Symposium in April 2020. Additional safety and efficacy data from the 44-week, open-label, long-term extension of both TRuE-AD1 and TRuE-AD2 were included in the NDA.

Project IMPACT from VisualDX Aims to Reduce Disparities in Medicine

Project IMPACT (Improving Medicine’s Power to Address Care and Treatment) is a new global effort from VisualDX created to reduce disparities in medicine and highlight ways to bridge gaps of knowledge and improve healthcare outcomes for patients of color. Inaugural members include thought leaders on skin of color and diagnostic accuracy from renowned organizations such as the Skin of Color Society (SOCS) and New England Journal of Medicine (NEJM) Group.

Dark skin is significantly underrepresented in medical literature and curricula, comprising an average of just 4.5 percent of images in medical textbooks. Consequently, clinicians of all licensures and specialties are often insufficiently trained to recognize disease patterns in patients of color. To confront this issue, VisualDx, SOCS, and NEJM Group organized a webinar series in the fall of 2020 to educate providers on structural racism in medicine, disease patterns in dark skin types, and culturally competent care. Due to the overwhelmingly positive response from more than 32,000 registrants from close to 100 countries, VisualDx created Project IMPACT to raise awareness and adoption of educational and clinical resources and solutions that bolster clinicians’ ability to accurately diagnose disease in black and brown skin and improve health equity.

“Dermatologic and systemic diseases present with varying shades of color, erythema, and patterns in patients of color with melanin-rich skin. The Skin of Color Society (SOCS) has been working to advance healthcare equity, education, research and mentoring since our founding in 2004. We now are honored to collaborate and share the expertise of our members with VisualDx and NEJM Group on this vitally important initiative,” commented Lynn McKinley-Grant, MD, FAAD, board-certified dermatologist, SOCS President, Associate Professor, Department of Dermatology, Howard University College of Medicine and Former Vice-Chair for Diversity and Community Engagement at Duke University College of Medicine, Department of Dermatology.

VisualDX announced the launch at the Accreditation Council for Graduate Medical Education’s Annual Education Conference. For more than 20 years, VisualDx has worked with board-certified physicians across the globe to collect hundreds of thousands of professional medical images displaying the full spectrum of disease presentations across skin types. As a result, more than 30% of images in its platform represent dark skin types. Studies also indicate that clinicians leveraging VisualDx at the point of care can improve diagnostic accuracy as well as patient education and engagement, particularly for traditionally marginalized groups.

“Lack of sufficient medical education on darker skin has had direct implications on health disparities in patients of color,” said Nada Elbuluk, MD, MSc, FAAD, a board-certified dermatologist and Director of Clinical Impact at VisualDx. “Project IMPACT was created with the understanding that a far-reaching, collaborative effort is needed to eliminate systemic racism in health care. I’m honored to lead this charge and help build a global community dedicated to transforming medicine for the good of all patients.”

Students, educators, clinicians, and patients working toward greater health equity are encouraged to take the pledge to make an impact and to share their stories on social media using the hashtag #ProjectIMPACT. To learn more and join Project IMPACT, visit www.projectimpact.org.

Amgen Seeks Approval for Otezla in Mild to Moderate Psoriasis

Amgen has submitted a supplemental New Drug Application (sNDA) to the FDA for Otezla (apremilast) for the treatment of adults with mild to moderate plaque psoriasis who are candidates for phototherapy or systemic therapy. The sNDA is based on data from the Phase 3 ADVANCE trial that demonstrated oral Otezla 30mg twice daily achieved a statistically significant improvement in the primary endpoint of the static Physician’s Global Assessment (sPGA) response at week 16 compared to placebo.

Otezla also demonstrated statistically significant improvements in key secondary endpoints compared to placebo, including achieving at least a 75 percent improvement from baseline in the percent of affected body surface area (BSA), change in BSA total score from baseline and change in Psoriasis Area and Severity Index (PASI) total score from baseline at week 16. Adverse events observed in the ADVANCE trial were consistent with the known safety profile of Otezla.

Otezla is currently approved in the US for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, adult patients with active psoriatic arthritis, and for adult patients with oral ulcers associated with Behçet’s Disease.

Five-Year Data for Ilumya Show Long-term Efficacy, Safety

Long-term data from Phase 3 extension trials for Sun Pharma’s Ilumya (tildrakizumab) in psoriasis show the treatment provided sustained disease control over five years among subjects who were week 28 tildrakizumab responders and etanercept partial responders/nonresponders. Ilumya provided a durable safety profile regardless of baseline level of skin disease, age, or background illness, including in those with metabolic syndrome.

Findings, which represent the longest complete dataset of an IL-23 inhibitor reported to date, appear in the British Journal of Dermatology. The ReSURFACE 1 and ReSURFACE 2 extension studies reflect a total Ilumya exposure of more than 5,400 patient-years.

Findings from the five year analysis show that median improvement from baseline PASI score was 95.5 percent, and 65.5 percent of patients achieved PGA 0/1 at Week 244. Patients achieved a median absolute PASI score of 1.1 on the 72-point PASI disease activity scale at Week 244. A median absolute PASI score of 1.1 indicates that patients treated with ILUMYA had low residual disease following treatment.

The safety profile of ILUMYA was further investigated in analyses of incidence rates for severe infections, malignancies, major adverse cardiovascular events, and in patients over 65 years of age. No new safety signals were reported in any of these sub-groups.