Learn more about what treatments are on the rise for plaque psoriasis, the latest management advice and what trends are shaping the future of the disease. 

The changing treatment landscape of plaque psoriasis

Armand Butera is the assistant editor for 

. He attended Fairleigh Dickinson University and graduated with a degree in communications with a concentration in journalism. Prior to graduating, Armand worked as the editor-in-chief of his college newspaper and a radio host for WFDU. He went on to work as a copywriter, freelancer, and human resources assistant before joining 

. In his spare time, he enjoys reading, writing, traveling with his companion and spinning vinyl records. Email him at 

Investigators in France developed and validated a dermatologic specific burden score called the Vitiligo Impact Treatment (VIT) score.

 population and patient acceptable symptom state (PASS) was calculated and defined to help identifying patients overwhelmed by the treatment.

Investigators led by Julien Senechal, MD, PhD, Service de Dermatologie, Centre de Référence des Maladies Rares de la Peau, Hôpital Saint André, CHU de Bordeaux, believed the questionnaire would be used to develop patient-centered approaches to vitiligo management involving the personalized adaptation of treatment regimens to find a balance between treatment benefit and burden.

They also noted the “devastating” impact on the quality of life and self-esteem and psychiatric comorbidities vitiligo can have on the 0.1% to 2% of the world’s population who are affected by the disease, and the challenges regarding appropriate treatment.

Their study occurred in the framework of an ongoing e-cohort project called ComPare. In it, the investigators aimed to develop and validate a patient reported measurement of the burden of treatment in vitiligo patients.

Senechal and colleagues utilized a multistep method to develop a questionnaire to measure the burden of patients with vitiligo.

The investigators initially conducted a literature search on PebMEd to identify published questionnaires or scoring systems related both to the quality-of-life impact and burden of treatment of vitiligo.

Among vitiligo quality of life scales, several instruments such as the vitiligo impact scale, the vitiligo impact patient scale, and the vitiligo life quality index related to treatment burden.

As of December 2020, the ComPaRe cohort consisted of 42,000 patients with chronic conditions. A total of 343 adult patients with vitiligo from the cohort were included in the current study.

Each participant from the cohort was tasked with answering an online survey with open ended questions that explored the different aspects of vitiligo. Their responses would be analyzed and used to identify 24 themes related to the burden of the disease.

Each theme was transformed in a questionnaire and evaluated with a 4-point Likert scale: "Disagree" (1), “Slightly agree" (2), "Agree" (3), "Strongly Agree" (4) and "Not concerned" (0).

Construct validity of the instrument was assessed by comparing the instrument’s score to the Dermatology Life Quality Index (DLQI), Vitiligo Impact Patient score (VIPs) and Treatment Burden Questionnaire (TBQ) scores.

By the end of the study, a 19-item questionnaire was developed that assessed the burden of treatment in patients with vitiligo through 4 pertinent dimensions: finding a doctor, topical treatments, light treatment, and impact on outdoor activities and photoprotection.

The team noted that their instrument complemented existing measures of dermatologic quality of life such as the DLQI and VIP, and that they believed their score fulfilled an unmet need in the clinical research of vitiligo by defining the burden of treatment as the core outcome.

Additionally, they believed it could be used in clinical practice as a validated global score that is easy to calculate to identify patients overwhelmed by their treatment and demonstrated that patients with a VITs score above 48.5 (PASS) were at risk of being overwhelmed.

Though the study was conducted based on the burdens of vitiligo, Senechal and investigators stated that “future studies could explore how our patient reported instrument could be generalized to other chronic inflammatory skin diseases.”

“Vitiligo Treatment Impact score (VITs): development and validation of a vitiligo burden of treatment questionnaire using the ComPaRe Vitiligo e-cohort,”

 was published online in the Journal of The European Academy of Dermatology and Venereology.

This article was initially published by our sister publication

Articles

Investigators believe the new instrument could be generalized to other chronic inflammatory skin diseases in future studies.

Investigators Develop New Vitiligo Impact Treatment Score

Cash balance plans (CBPs) are often referred to as today’s “modern retirement plans” because their use has grown rapidly in closely held businesses, including medical practices, during recent years. CBPs are a solution for high-income practice owners looking for tools that can provide them with significant short-term tax deductions along with strong long-term economics.

A CBP is a qualified retirement plan (QRP) that can provide dermatologists with a way to increase tax deductions and simultaneously boost retirement savings.

In a CBP, a participating employee will have access to a certain sum upon reaching retirement. Let’s use $100,000 as an example. To get to $100,000 at retirement, the plan assumes a combination of employer contributions and compound interest overtime. When the employee retires, they can take the $100,000 either as a lump sum or as an annuity that pays a portion of the $100,000 in periodic payments.

CBPs are like traditional defined benefit plans in terms of the funding and reporting requirements. Minimum funding standards apply; there is a minimum annual employer contribution that is reported on the CBP’s tax form 5500. An actuary is required to calculate this contribution amount using a reasonable actuarial funding method and actuarial assumptions specified by the IRS. The employer can decide to con- tribute an amount between the minimum funding requirement and the maximum permitted deduction but should attempt to fund to the actuary’s recommended contribution level to meet the plan’s current benefit liability.

On the other hand, CBPs are different from traditional defined benefit plans that promise a specified monthly benefit amount at retirement (ie, 3% of pay per year of employment, payable at the retirement age of 67). CBPs define benefits in the form of an account balance, rather than a periodic amount. This can be helpful because employees always understand what they are entitled to under the CBP because it is a specific amount. Owners and employees both know what is going into the plan on their behalf and what will come out when they leave.

CBPs and 401(k)s are not mutually exclusive. In fact, a dermatology practice can typically utilize both types of plans simultaneously, “layering” a CBP on top of its existing 401(k).

There are 4 compelling reasons why dermatology practices are inter- ested in CBPs:


In 2021, 401(k)s are subject to maximum deductible contribution limits of $19,500, with profit-sharing plan limits at $58,000. (The catch-up contribution for those over age 50 is an additional $6,500 annually.) These limits increase slightly each year. Properly structured CBPs, on the other hand, can allow business owners to make tax-deductible contributions of $200,000 or more, potentially saving them $80,000 to more than $100,000 in income taxes annually.

2. Additional Costs Are Much Lower Than Additional Tax Savings


CBPs usually involve higher annual administration costs and higher employer contribution amounts for employees than 401(k)s and/or profit-sharing plans. Nonetheless, the tax savings typically dwarf these additional expenses, making the CBP extremely attractive.

3. Possible Second Level of Tax Deduction


For those whose income puts them above the new tax code’s 

qualified business income (QBI) threshold limits, a CBP can be a tool to reduce taxable income enough to qualify for the QBI deduction, creating 1 deduction that leads to a second deduction

CBPs are powerful planning tools that provide larger contribu- tions than the QRPs most medical practices use today. CBPs can be attractive to practice owners who are looking for greater tax deduc- tions, asset protection, and superior retirement savings.

4. Greater Access to Top (+5) Asset Protection Level

As an exempt asset under federal law and most state laws, ERISA-qualified QRPs are protected at the highest (+5) level. Unless a CBP is put in place for only 1 owner, with no other employees, this ERISA protection will usually also apply to the CBP. With larger contribution levels allowed in the CBP, this means more wealth can be protected in the CBP than in most other QRPs.

OJMGroup,LLC(OJM) is an SEC registered investment adviser with its principal place of practice in the state of Ohio. SEC registration does not constitute an endorsement of OJM by the SEC nor does it indicate that OJM has attained a particular level of skill or ability. OJM and its representatives are in compliance with the current notice filing and registration requirements imposed upon registered investment advisers by those states in which OJM maintains clients. OJM may only transact practice in those states in which it is registered or qualifies for an exemption or exclusion from registration requirements.

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O’Dell is the managing partner with OJM Group in Cincinnati, Ohio, a financial consultant, and the author of more than a dozen books on wealth management for doctors. Foos is a partner and lead tax consultant with OJM Group in Cincinnati, Ohio.

Tap the Tax, Savings Potential of Cash Balance Plans

Last week, Boehringer Ingelheim announced that the US Food and Drug Administration (FDA) approved the supplemental Biologics Liscense Application for adalimumab-adbm (Cyltezo), which will become the first interchangeable biosimilar with adalimumab (Humira).

Adalumumab-adbm was originally approved by the FDA for the treatment of multiple chronic 

back in 2017, but the latest approval will deem it as interchangeable across all of these indications.

Approval for interchangeability was prompted by the positive data seen in the phase 3 randomized VOLTAIRE-X clinical trial, which studied the effects of multiple switches from adalimumab to adalimumab-adbm.

The study found that adalimumab-adbm was equivalent to adalimumab, with no clinically meaningful differences in pharmacokinetics, efficacy, safety, and immunogenicity recorded between the switching and continuous treatment groups.

In a statement made by Boehringer Ingelheim, Martin Menter, MD, chairman of the Division of Dermatology at Baylor University Medical Center, stated that the approval represented “an important step” towards offering more affordable treatment options for complex and expensive biologic reference products to patients in need.

“This is incredibly important for patients, who can be confident that once available, citrate-free Cyltezo® has the same efficacy and safety as the originator medicine with the added benefit of cost savings,” Menter said.

Additionally, senior vice president of Medicine and Regulatory Affairs at Boehringer Ingelheim Thomas Seck said that the interchangeability status of the biosimilar “reinforces (the company’s) goal of expanding overall treatment options and contributing to the quality and sustainability of the US healthcare system.”

Though it is not commercially available in the US, the commercial license of adalimumab-adbm will begin on July 1, 2023.

The approval was supported by promising phase 3 data of the VOLTAIRE-X clinical trial.

FDA Approves Adalimumab-adbm as First Interchangeable Biosimilar with Adalimumab

and joined the MJH Life Sciences team in April 2021. She graduated from Kent State University in 2018 with a bachelor's degree in journalism and a minor in sociology. Linda used to work as a creative writer for 

 and was a technical writer/regulatory specialist/purchasing agent at GM Industrial before coming on to the team. She enjoys reading, traveling, and learning new perspectives. You can reach her at 

It has been 25 years since the launch of Galderma’s Restylane line of hyaluronic acid (HA) fillers in Europe.

Since becoming the first HA filler approved by the FDA in 2003, Restylane’s portfolio has continued to grow with 13 dermal filler product approvals and launches. They offer 2 complementary gel technologies—Nasha and XpreHAn (globally referred to as the OBT technology (Optimal Balance Technology)—to help patient satisfaction.

 for chin augmentation and correction for mild to moderate chin retrusion for adults over 21 years old and in June of this year, 

 was approved for cheek augmentation and correction of midface contour deficiencies in adults over the age of 21. It became the first and only product in the US to use proprietary XpresHAn technology for the cheeks, according to Galderma.

"The depth of experience from Restylane over the last 25 years has enabled us to build upon our expertise to innovate and develop new formulations and treatments," said Flemming Ørnskov, MD, MPH, chief executive officer at Galderma, Fort Worth, Texas. "With over 30 ongoing pipeline projects in aesthetics alone, we will continue to enhance our diverse and broad portfolio of sophisticated brands to advance dermatology for every skin story."

1. Restylane celebrates 25 years of natural-looking results with its signature line of hyaluronic acid fillers. Cision PR Newswire. Press release. Published September 30, 2021. Accessed October 13, 2021. https://www.prnewswire.com/news-releases/restylane-celebrates-25-years-of-natural-looking-results-with-its-signature-line-of-hyaluronic-acid-fillers-301388779.html

On September 30, 2021, Galderma celebrated its 25th anniversary of its Restylane line of hyaluronic acid fillers. 

Galderma Celebrates Restylane’s 25th Anniversary

Morgan Petronelli is an associate editor for 

and joined the MJH Life Sciences team in December 2019. She graduated from Youngstown State University in 2019 with a bachelor's degree in journalism and a minor in political science. Prior to graduating, Morgan worked as the editor-in-chief of her college newspaper. She went on to work as an assignment editor at a broadcast news station in Youngstown, Ohio before joining 

She enjoys working out, listening to music, and playing with her dog Scout. You can reach her at 

Adelaide Hebert, MD, chief of pediatric dermatology at the McGovern Medical School at UTHealth Houston, Texas drilled down into the intricate details of eczema, sharing her experience of the disease in pediatric patients.

To listen to what she had to say, watch the video below. 

 Well thank you so much for joining me today. My name is Morgan Petrelli, Associate Editor with dermatology times and today I'm joined by Dr. Adelaide Hebert, Dr. Hebert if you want to introduce yourself and any of the research that you're currently conducting.

 I'm Dr. Adelaide Hebert. I work at the University of Texas Medical School in Houston, Texas. I've been chief of pediatric dermatology here for 37 years, and have been actively engaged in clinical research for the past 36 years. The research interests that I have include atopic dermatitis, psoriasis, hyperhydrosis, acne, rosacea, skin, soft tissue infections, and diaper dermatitis. We really will study almost anything that deals with skin in both pediatric and adult realms. I don't typically do IV antibiotics studies, but we're very interested in biologic therapy and the new Janus kinase (JAK) inhibitors. We do the full scope we feel of research within the adult and pediatric realm.

 How does the prevalence of eczema differ based on age, gender, and race and or ethnicity?

 We see a vast difference in atopic dermatitis (AD) in different groups. One of the examples that I often use is that if the parents have eczema, asthma, or hay fever, the child is more prone to developing this skin condition. We do see a trend in families, but we do see children who have no family history who can develop severe eczema as well.

We certainly see different characteristics [in different demographic groups]. Asian people tend to have very severe eczema; they really suffer with this disease state. In the Black population, we may or may not have the genetic basis influencing the skin findings and the barrier effect, but we can still see profound AD.

Asthma is often associated with eczema. In the state of Texas, the number 1 drug written for children is an asthma drug. We also see eczema in patients if, for example, 1 or both parents have been born overseas and they immigrated to the United States. That child can have worse eczema. It's not just immigrating to the United States. This is known in other countries as well. It's about immigrating to a country where the skin has not been accommodated to, and then the eczema can be more profound. 

That’s something I make parents aware of. I don’t suggest that they go home to their country of origin, but they will often relay to me that, if they go home for a holiday and come back, the eczema goes away magically. That's not something they observed while in the United States. 

So, we do see very variations in the amount of eczema across the different ethnicities, but also against the against the different Fitzpatrick skin types.

 What is eczema’s impact on quality of life? What about its effect on comorbidities?

 We feel that eczema is 1 of the most impactful disease dates in terms of quality of life [QoL]. It impacts not just the child but also the family. One of the impacts in terms of QoL is itching. These patients don't sleep well, and their parents don't sleep well. There's co-sleeping where the child gets in bed with the parent and the parent’s sleep is disrupted by the child's itching. 

The concern we have with this is aging status. Not only do the children disrupt the skin barrier by scratching, they also disrupt their deep sleep so their growth hormone is not secreted, and their linear growth can be impacted unfavorably. There are many arenas in QoL that are affected.

These children have a difficult time going out during very hot summers as the protein and sweat serves as a trigger for furthering the condition. Also, dust mites can play a role. Unfortunately, because we have a very moist environment, they can survive even in the cleanest of homes. There can be associated conditions such as metabolic syndrome. There also may be a slight increase of cardiovascular events in our more aged patients. All these things impact QoL.

The QoL is greatly impacted because we have difficulties in controlling this ongoing relapsing disorder that is visible for patients with psychosocial development, even when they are adults. We know because it's such a visible disorder, and the patients have concurrent scratching, it can be extremely problematic. Another factor that we should consider is these patients get more cutaneous infections, both bacterial and viral. 

There's not a realm of the patient’s life that AD doesn't touch upon. This is 1 of the discussions we often have with patients and their parents when they come in for their initial or ongoing evaluations for this disease.

Make sure to stay tuned for the other 2 parts in this 3 part series. 

Videos

In this episode of DermView, Adelaide Hebert, MD, explains how eczema can lead to growth issues in pediatric patients, how environmental factors may play a role in flare ups, and more. 

DermView Episode 1: Environmental Factors and Ezcema

Phase 3 studies show efficacy and good tolerance of a drug–device combination containing cantharidin 0.7% (VP-102; Verrica) used to treat molluscum contagiosum.

VP-102 eliminates most challenges associated with treating molluscum with cantharidin, according to VP-102 study author Lawrence Eichenfield, MD, who presented data on the topical at the Fall Clinical Dermatology conference held October 21-24, in Las Vegas, Nevada.

If FDA approved, VP-102 could be an emerging standard for molluscum treatment, which currently lacks a standard of care, according to Eichenfield, who is chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego and professor of dermatology and pediatrics and vice-chair of the Department of Dermatology at University of California San Diego School of Medicine, both in California.

“Recent Cochrane reviews looking at treatment of molluscum contagiosum concluded, ‘No single intervention has been shown to be convincingly effective in the treatment of molluscum contagiosum,’” Eichenfield said. “Most of the evidence was low quality, other than the well-done studies showing that imiquimod worked no better than vehicle.”

VP-102 offers standardization of cantharidin in unit dose vials, allowing direct, controlled application on molluscum, with stable concentration and good shelf life, Eichenfield said.

“An FDA approved multi-lesion, single use cantharidin product could increase the ease and consistency of treating with cantharidin, and the strong evidence in controlled trials should help establish this as a useful and, hopefully, accessible product,” he said.

Dermatologists Use a Mixture of Approaches with Limited Success

Dermatologists, pediatricians, and other providers use a mixture of approaches today.

“Some don’t treat, some use liquid nitrogen, some use topical retinoids, many use imiquimod—even though the studies were negative on its utility—a few do curettage, and others use other methodologies without a good evidence basis for their effectiveness,” he said. “Cantharidin has been difficult to get for many dermatologists, given that compounded products do not have specific approval by the FDA, and compounded products do not appear to have consistent concentrations over time and ‘multiple dips’ into the bottle create risks of contamination.”

Application of cantharidin with a cotton swab or other applicator can be intimidating for dermatologists and patients. The dosage is hard to control, which sometimes can cause severe blistering, pigment changes, and even scarring, according to Neal Bhatia MD, director of clinical dermatology at Therapeutics Clinical Research in San Diego, California, who presented at Fall Clinical with Eichenfield but focused on molluscum pathogenesis and the efficacy of current treatments.

“The applicator and delivery system of the cantharidin 0.7% is very precise and is easier to apply,” Bhatia said. “This will be useful for treating both children and adults.” While many believe that molluscum can resolve on its own, Bhatia said it often does not and can “spread like wildfire.”

Since molluscum tends to occur in patches, or groups, imiquimod cream treatment is likely to cause local skin reactions and flare-ups in patients who have atopic dermatitis. Commonly used treatment is sinecatechins 15% ointment (Veregen) and while it’s effective, the treatment can be slow acting, taking about 4 months to heal molluscum.

“There is anecdotal evidence for the combination of curettage and imiquimod. What is interesting about molluscum is if you scrape it off, it tends to go away, but it can be painful and can leave scars,” he said.

If it becomes commercially available, cantharidin 0.7% would likely become dermatologists’ go-to therapy, taking place of the older cantharidin treatment approaches and could reduce the use of liquid nitrogen, according to Bhatia.

Eichenfield has served as an investigator, consultant, and member of the board of directors for Verrica.

Bhatia has served as an investigator and consultant for Verrica.

Eichenfield L, Bhatia N. Molluscum: has this unmet need found a standard of care? Fall Clinical Dermatology Conference; October 21-24, 2021; Las Vegas, Nevada and virtual.

Safety and efficacy of vp-102 (Cantharidin, 0.7% w/v) in molluscum contagiosum by body region: post hoc pooled analyses from two phase iii randomized trials. 

Cantharidin 0.7% could be an emerging standard for molluscum treatment.

If Approved, Cantharidin 0.7% Could be Standard of Molluscum Care

Genetic expression profiling (GEP) may be helpful to physicians in melanoma diagnosis. Darrel S. Rigel, MD, MS, a clinical professor and director of the Melanoma Surveillance Clinic at the Mount Sinai Icahn School of Medicine, New York, New York, postulated the accuracy of melanoma diagnosing at the Fall Clinical Dermatology Conference 2021, held October 21 to 24 in Las Vegas, Nevada.

 In his presentation, Rigel explained the potential of the technique.

 in which a noninvasive pigmented lesion assay (PLA) using a 2-GEP technique was evaluated in 555 pigmented lesions (157 training and 398 validation samples) that were obtained via adhesive patch biopsy. The technique searches for either a Long Intergenic Non-Coding (LINC) or Preferentially Expressed Antigen in Melanoma (PRAME) gene and determines melanoma from nonmelanoma samples with a 91% sensitivity and a specificity of 69% with a 95% confidence interval. The conclusion of this trial was assay can classify pigmented lesions into melanoma and nonmelanoma groups and may serve as a tool to help with diagnostic challenges.

Newer research could also support this claim, Rigel continued. In a 2021 trial,

 3,418 lesions were tested using 2-GEP by 90 licensed clinicians. The median patient age was 48 years with 62% female and 39% male patients. Of the 3,418 lesions, 324 (9.48%) were determined to be positive by 2-GEP testing—90.5% avoided unnecessary biopsy—and 316 were biopsied (97.5%) with 313 pathology reports available for analysis. Of the 316 biopsied lesions, 18.7% were melanoma and 43% were dysplastic nevi which was determined histopathologically. 

134/195 (61.7%) expressed a single gene (L+/P- or L-/P+)

61/195 (31.3%) expressed both genes (L+/P+)

When focusing solely on the melanomas, it was found:

31/59 (52.5%) confirmed melanomas expressed a single gene (L+/P- or L-/P+)

14/59 (23.7%) expressed LINC only (L+/P-)

17/59 (28.8%) expressed PRAME only (L-/P+)

28/59 (47.5%) confirmed melanomas expressed both genes (L+/P+)

Rigel quoted the study authors, “Lesions clinically suspicious of melanoma exist along a spectrum of genomic atypia... there is a correlation between increasing genomic atypia and melanoma-associated pathology atypia.”

Rigel detailed a trial in which GEP was shown to increases both the real-world negative predictive value (NPV) and positive predictive value (PPV) of the melanoma diagnostic pathway and reduced biopsy burden.

 researchers investigated 1,233 2-GEP-negative pigmented lesions for evidence of malignancy for up to 36 months and also retested a separate prospective cohort of 302 2-GEP-negative lesions up to 2 years after initial testing. These results demonstrated that in this real-world intended use population, the 2-GEP has an NPV of greater than 99%, confirming the high NPV established in previous clinical studies.

A PPV of 18.7% was determined by using a US-based registry of 3,418 2-GEP-tested cases, identifying the melanoma diagnoses based off the 2-GEP-positive lesions. Of the 5,993 lesions tested with the 2-GEP from both the TRUST study and registry cases, most 2-GEP tests were negative and not subjected to surgical biopsy. The 2-GEP test reduced surgical biopsies by 83.5% to 86.5% in the TRUST study and US registry cohorts, respectively (N=5993).

Rigel went on to describe the DermTech PLA kit, which uses 2-GEP analysis. First the doctor holds an initial appointment to assess the patient’s skin. Then, if needed, the physician orders the PLA and the kit will be shipped directly to the patient. After, a follow up appointment needs to be scheduled so the doctor can supervise the patient collecting the sample. This could be done via virtual appointment. Finally, the lab will analyze the sample and report the results to the physician.

There is an additional test besides 2-GEP that uses genetics. A 3-GEP test (PLAplus) also tests for the Telomerase Reverse Transcriptase (TERT) gene. Rigel explained that TERT promoter mutations are detected in 70% of histopathologically confirmed melanomas

 and 97% of histopathologically confirmed melanomas express TERT and/or LINC and/or PRAME.

Mutations in the cell can lead to oncogenesis through functional increases in TERT protein, telomerase activity, telomere length, cell immortalization, and proliferation, according to Rigel. It is associated with histopathologic features of aggressiveness and poor survival in melanoma.

The 3-GEP data showed a 97% sensitivity with a 62% specificity, leading to a 99.6% NPV.

Rigel concluded the presentation with 3 points:

Efficiency and accuracy are critical in MM diagnosis.

2-GEP and 3-GEP testing can be a useful adjunct to this process in a clinical setting.

Rigel is on the advisory board, honoraria, and investigator for DermTech and Castle BioSciences.

Rigel, D. Apply GEP to melanoma detection. Presented at: Fall Clinical Dermatology Conference 2021; October 21-24, 2021; Las Vegas, Nevada and virtual.

Gerami P, Yao Z, Polsky D, et al. Development and validation of a noninvasive 2-gene molecular assay for cutaneous melanoma. 

Journal of the American Academy of Dermatology

. 2017;76(1):114-120.e2. doi:10.1016/j.jaad.2016.07.038

Brouha B, Ferris L, Skelsey M, et al. Genomic atypia to enrich melanoma positivity in biopsied lesions: gene expression and pathology findings from a large u. S. Registry study. 

. 2021;5(1):13-18. doi:10.25251/skin.5.1.3

Skelsey M, Brouha B, Rock J, et al. Non-invasive detection of genomic atypia increases real-world npv and ppv of the melanoma diagnostic pathway and reduces biopsy burden. 

. 2021;5(5):512-523. doi:10.25251/skin.5.5.9

Cullison SRJ, Jansen B, Yao Z, Ferris LK. Risk stratification of severely dysplastic nevi by non-invasively obtained gene expression and mutation analyses. 

. 2020;4(2):124-129. doi:10.25251/skin.4.2.5

Ferris LK, Moy RL, Gerami P, et al. Noninvasive analysis of high-risk driver mutations and gene expression profiles in primary cutaneous melanoma. 

. 2019;139(5):1127-1134. doi:10.1016/j.jid.2018.10.041

How can GEP be applied to melanoma diagnosis and treatment? Darrel Rigel, MD, MS, answers these questions and dives into the data at Fall Clinical Dermatology Conference 2021. 

Applying GEP to Melanoma Detection

The growing array of topical therapies available and in development for inflammatory skin conditions may require dermatologists to shift how they think about topical treatments.

“The key is to reduce the use of the phrase ‘nonsteroidal alternatives’ and start to think of nonsteroidal approaches, or even mechanisms that address the disease process,” said Neal Bhatia, MD, director of clinical dermatology at Therapeutics Clinical Research in San Diego, California, at the Fall Clinical Dermatology Conference, held October 21 to 24, in Las Vegas, Nevada, and virtual. “That’s where some of these new topical therapies are headed.”

When topical calcineurin inhibitors (TCIs) debuted, he said, dermatologists thought in terms of steroid alternatives. “Now, phosphodiesterase 4 (PDE4) inhibitors, JAK inhibitors, and tapinarof are all dedicated approaches to the disease process,” he said.

Several new compounds under development avoid the atrophy, tachyphylaxis, and tolerability issues associated with steroids while offering versatility for treating multiple disease states, he said. “The best potential indications down the road for these therapies include vitiligo and alopecia areata (AA), where we haven’t had successful or safe management strategies for areas such as the face or scalp,” Bhatia explained.

In September 2021, the JAK1/2 inhibitor ruxolitinib 1.5% cream (Opzelura; Incyte) earned FDA approval for short-term use in mild to moderate atopic dermatitis (AD) in patients at least 12 years old. The drug also possesses significant potential for patients with vitiligo and AA, Bhatia said. In a 57-patient dose-ranging study, 30% of patients with vitiligo achieved 75% reductions in Vitiligo Area Scoring Index scores at week 24.

“Even after a year,” Bhatia added, “almost 50% of patients achieved a 75% improvement in their vitiligo. Those are numbers we haven’t had before. That’s very encouraging for the long run.”

One day, he said, dermatologists could offer treatment that is safe for patients—who typically use intralesional steroids, long-term topical steroids, and/or TCIs, with little relief—to use for a year without safety concerns.

Regarding the PDE4 inhibitor roflumilast, Bhatia said, future indications could include AD, psoriasis, and seborrheic dermatitis. In 2 phase 3 psoriasis cohorts, the proportions of patients on roflumilast cream 0.3% who achieved investigator ratings of clear or nearly clear (with 2-grade improvement) remained consistent for up to 64 weeks, with safety and tolerability similar to those of vehicle.

The ayrl hydrocarbon inhibitor tapinarof has shown success in psoriasis

 due to its broadly acting mechanism. In a 12-week phase 2b AD study, the most common treatment-emergent adverse events included mild to moderate folliculitis, application site pain, and AD.

“We need safer long-term approaches for topical management, as well as short-term, immediate benefits for treating itch and controlling inflammation,” Bhatia said. Such therapies may be adjunctive to systemic or biologic therapies, he added.

Bhatia expects ruxolitinib, roflumilast, and tapinarof to work well for patients on biologics who need spot therapy or experience breakthrough flares. The new medications are very safe, he said, “and patients still like to treat from the top down.” Even patients on systemic therapies often like applying topical medications, he explained, because they feel like they are taking an active role in their care.

Bhatia N, Stein Gold L. Unmet needs with current topical therapies for inflammatory diseases. Fall Clinical Dermatology Conference; October 21, 2021; Las Vegas.

Rosmarin D, Pandya AG, Lebwohl M, et al. Ruxolitinib cream for treatment of vitiligo: a randomised, controlled, phase 2 trial. 

. 2020;396(10244):110-120. doi:10.1016/S0140-6736(20)30609-7

Stein Gold L, Gooderham MJ, Papp KA, et al. Long-term safety and efficacy of roflumilast cream 0.3% in adult patients with chronic plaque psoriasis: results from a 52-week, phase 2b open-label study. Innovations In Dermatology Virtual Spring Conference; March 16-20, 2021.

Lebwohl M, Stein Gold L, Strober B, et al. Tapinarof cream 1% QD for the treatment of plaque psoriasis: efficacy and safety in two pivotal phase 3 trials. Fall Clinical Dermatology Virtual Meeting; October 29-November 1, 2020.

Peppers J, Paller AS, Maeda-Chubachi T, et al. A phase 2, randomized dose-finding study of tapinarof (GSK2894512 cream) for the treatment of atopic dermatitis. 

. 2019;80(1):89-98.e3. doi:10.1016/j.jaad.2018.06.047

Bhatia has been a speaker, investigator, and/or advisor for AbbVie, Almirall, Biofrontera, Bristol Myers Squibb, Boehringer Ingelheim, EPI Health, Ferndale, Foamix, Galderma, Incyte, ISDIN, Johnson & Johnson, LaRoche-Posay, Leo, Eli Lilly, Ortho Dermatologics, Pfizer, Procter & Gamble, Regeneron, Sanofi, Sun Pharma, VYNE Therapeutics, and Vyome Therapeutics.

Neal Bhatia, MD, gives a thumbs down on the phrase “steroid alternatives”.

Nonsteroidal Topical Therapies

 podcast, Gary Linkov, MD, board-certified facial plastic and hair surgeon and founder and medical director of 

 in New York, New York sits down with to discuss the world of hair loss. He describes not only how to treat and prevent the condition, but how his own experience with hair loss helps him treat patients. 

If you would like to hear more from Linkov, you can follow his Youtube channel linked 

Podcasts

This episode of The Cutaneous Connection podcast, Gary Linkov, MD, dives into the topic of hair loss. 

The Cutaneous Connection: Hair Loss Trends, Challenges, and Prevention

Dustin Portela, DO, a board-certified dermatologist and dermatologic surgeon at Treasure Valley Dermatology in Boise, Idaho.

Dustin Portela, DO, a board-certified dermatologist and dermatologic surgeon at Treasure Valley Dermatology in Boise, Idaho, explains what keratosis pilaris (KP) is and how to improve the condition. After going through his best tips to try to show improvement, he describes when it would be best to go to the dermatologist.

To hear what he has to say, watch the video below.

Opinions expressed are that of Portela and do not express the views or opinions of Dermatology Times®.

In this week’s Pointers with Dr Portela, the 208SkinDoc explains what keratosis pilaris is and whether or not it can be cured.

If Approved, Cantharidin 0.7% Could be Standard of Molluscum Care

Applying GEP to Melanoma Detection

Nonsteroidal Topical Therapies

The Cutaneous Connection: Hair Loss Trends, Challenges, and Prevention

Pointers With Dr Portela: Can Keratosis Pilaris Be Cured?

The changing treatment landscape of plaque psoriasis