Tapinarof Cream 1% Once Daily for the Treatment of Plaque Psoriasis: Case Photography of Clinical Outcomes from Three Phase 3 Trials.

Tapinarof cream 1% (VTAMA®; Dermavant Sciences, Inc.) is a non-steroidal, topical, aryl hydrocarbon receptor agonist approved by the US Food and Drug Administration (FDA) to treat plaque psoriasis in adults and under investigation for the treatment of psoriasis in children down to 2 years of age, and for atopic dermatitis in adults and children down to 2 years of age. The PSOARING phase 3 clinical trial program evaluated tapinarof cream 1% once daily (QD) in adults with mild to severe plaque psoriasis for up to 52 weeks (NCT03956355, NCT03983980, NCT04053387). Here we present case photography documenting outcomes in the PSOARING trials. Cases illustrate various outcomes across different body areas, including responses meeting the formal FDA-mandated regulatory endpoint of a Physician Global Assessment (PGA) score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points from baseline at week 12, meaningful clinical improvement not meeting this formal endpoint, patient-reported outcomes, and pre-specified adverse events of special interest (AESIs). Tapinarof cream 1% QD demonstrated rapid and highly statistically significant efficacy, with improvements in disease activity and quality of life. In addition, a high rate (40.9%; n = 312/763) of complete disease clearance (PGA = 0) was achieved, and improvements exceeding National Psoriasis Foundation treatment goals were demonstrated. After first achieving complete disease clearance (PGA = 0), patients treated with tapinarof experienced an approximately 4-month remittive effect off therapy. Incidence and severity of folliculitis and contact dermatitis AESIs were generally mild or moderate, localized to the site of application, and associated with low discontinuation rates. Medical images are of importance in trials of dermatologic therapies to inform clinical decision-making and enhance patient assessment. Tapinarof cream 1% QD is efficacious and well tolerated in patients with mild to severe plaque psoriasis, with clinically relevant improvements seen early in the course of treatment.Clinicaltrials.gov numbers: NCT03956355, NCT03983980, NCT04053387.

Implementation of a dermatology skin of color educational module for medical students.

Research in dermatology education highlights the lack of skin of color (SOC) instruction for medical students, leading to concerning healthcare outcomes. Because of the already limited opportunity for students to have dedicated teaching in pathophysiology, management, and treatment of dermatologic diseases in medical school, we developed an educational module that addresses these gaps. We created a one-hour virtual lecture for medical students focused on common skin diseases tested on the United States Medical Licensing Examination with visual images across all skin types. A questionnaire was administered before and after the educational module to assess outcomes comparing disease identification in lighter (Fitzpatrick scale I-III) versus darker (Fitzpatrick scale IV-VI) skin tones and to determine medical school student attitudes. An analysis of 43 examination scores before, and after attending the educational module determined rosacea, psoriasis, and basal cell carcinoma to be conditions in SOC patients that demonstrated the most significant improvement (47.3%, 54.9%, and 30.8%, respectively). Our results also highlighted worse performance outcomes for diseases in SOC in the pre-examination questionnaire. Thus, our study indicates that a concise education module focused on disease presentations inclusive of all skin types may efficiently increase students' ability to identify diseases commonly misdiagnosed in the clinical setting.

Is This Medication Safe for My Child? How to Discuss Safety of Commonly Used Medications With Parents.

All drugs have potential side effects, but thoughtful use can maximize benefits while minimizing risks. Children should not be considered just small adults regarding drug safety because their growth and development are discordant with their ability to sense and self-report drug side effects. Detecting side effects requires vigilance and education from prescribers to parents, who are tasked with monitoring their child over time. A drug's safety profile is published in the package label after pivotal trials are conducted in relatively small and sometimes narrow segments of the population during the U.S. Food and Drug Administration approval process. Drug safety profiles can change as data from postmarketing reports and long-term monitoring during phase IV trials emerge. As such, prescribers are obligated to maintain current understanding of any changes to drug labels. Discussing potential side effects, monitoring, and when to report concerns can be a time-consuming process during patient encounters. This review offers current information regarding potential side effects of some of the most commonly used medications for allergic conditions, asthma, and atopic dermatitis. This information and discussion will hopefully assist clinicians in their conversations with parents, including advice surrounding prescribing medication to minimize adverse effects, parental monitoring, and documentation.

Impact of Coding Curriculum on Dermatology Resident Billing.

Background Competent medical coding is key to maintaining a successful dermatology practice. Resident billing performance can have significant financial implications for the academic institutions employing them. During their residency training, dermatology residents commonly find themselves responsible for the billing of patient encounters. However, despite the importance of adequate knowledge and skill in medical coding, recent data show inadequacies in this aspect of resident education. The goal of this study is to evaluate the impact of an interventional coding curriculum on dermatology residents' billing accuracy at our institution. Methodology Billing data, including evaluation and management (E/M) level of service, procedural codes, and current procedural terminology modifiers (if applicable) were queried from the electronic medical records (EMR) at a resident clinic seeing patients on three half-days each week. Billing codes were gathered from patient visits occurring in two separate time periods, before and after the intervention. The intervention consisted of monthly resident lectures on E/M and procedural billing in outpatient dermatology with associated quizzes. Billing accuracy was verified by three attending dermatologists through chart review and compared between the two time periods. Results Overall, billing data from 532 patient visits, 267 from the pre-intervention period and 265 from the post-intervention period, were checked for accuracy. The accuracy of resident-billed E/M levels of service was similar between the pre- and post-intervention periods (44.3% vs. 44.8%). Similar rates of undercoding and overcoding were noted between the pre- and post-intervention periods (35.2% undercoded and 8% overcoded vs. 35.7% and 8.9%, respectively). However, substantial improvements were noted in the rate of errors with procedural codes and modifiers in the post-intervention period. Overall, 21.9% of procedural codes were incorrectly billed pre-intervention compared to 3.7% post-intervention (p < 0.05). Moreover, 55.2% of modifiers were incorrectly billed pre-intervention versus 27.3% post-intervention (p < 0.05). Conclusions Our analysis suggests that billing lectures yielded a clear improvement in resident billing accuracy at our institution. While there was no improvement in E/M coding, there was a significant improvement in the usage of procedural codes and modifiers. Similar analyses can be used by other residency programs to monitor resident billing performance and the efficacy of educational programs on medical billing.

COVID-19 Symptoms Are Attenuated in Moderate-to-Severe Atopic Dermatitis Patients Treated with Dupilumab.

BACKGROUND: In the SARS-CoV-2/COVID-19 pandemic, we need to understand the impact of immunomodulatory medications on COVID-19 symptom severity in patients with inflammatory diseases, including the type 2/Th2 polarized skin disease, atopic dermatitis (AD). OBJECTIVE: Because it is believed that type 1/Th1 immunity controls viral infections and that there is a Th1/Th2 counter-regulation, we hypothesized that Th2 targeting with the IL-4Rα-antagonist, dupilumab, in patients with moderate-to-severe AD would rebalance the Th1/Th2 axis, potentially leading to attenuated COVID-19 symptoms. METHODS: A total of 1237 patients with moderate-to-severe AD in the Icahn School of Medicine at Mount Sinai Department of Dermatology were enrolled in a registry. Patients were screened for COVID-19-related symptoms and assigned a severity score (asymptomatic [0]-fatal [5]). Scores were compared among 3 treatment groups: dupilumab (n = 632), other systemic treatments (n = 107), and limited/no treatment (n = 498). Demographic and comorbid covariates were adjusted by multivariate generalized logistic regression models. RESULTS: The dupilumab-treated group showed reduced incidence and severity of COVID-19 symptoms versus other treatment groups. Dupilumab-treated patients were less likely to experience moderate-to-severe symptoms versus patients on other systemics (P = .01) and on limited/no treatment (P = .04), and less likely to experience any symptoms versus patients on other systemics (P = .01). This effect was seen in our entire cohort and in the subgroup of patients with verified COVID-19 or high-risk exposure. CONCLUSIONS: Patients on dupilumab experienced less severe COVID-19 manifestations and lesser symptoms compared with patients on other systemics and on limited/no treatment. These results suggest that Th2 modulation with dupilumab may have a protective effect on anti-viral immune response in patients with AD.

Scabies: a review of diagnosis and management based on mite biology.

Scabies is a contagious parasitic dermatitis that is a significant cause of morbidity, especially outside of the United States. Scabies is diagnosed most often by correlating clinical suspicion with the identification of a burrow. Although scabies should be on the differential for any patient who presents with a pruritic dermatosis, clinicians must consider a wide range of diagnostic possibilities. This approach will help make scabies simultaneously less over- and underdiagnosed by clinicians in the community. Atypical or otherwise complex presentations may necessitate the use of more definitive diagnostic modalities, such as microscopic examination of KOH prepared skin scrapings, high-resolution digital photography, dermoscopy, or biopsy. Scabies therapy involves making the correct diagnosis, recognizing the correct clinical context to guide treatment of contacts and fomites, choosing the most effective medication, understanding how to use the agent properly, and following a rational basis for when to use and reuse that agent. Although the development of new therapeutic agents is always welcome, tried and true treatments are still effective today. Permethrin is the gold standard therapy, with malathion being an excellent topical alternative. Ivermectin is an effective oral alternative that is especially useful in crusted scabies, patients who are bed ridden, and in institutional outbreaks. Despite the availability of effective therapeutics, treatment failures still occur, mostly secondary to application error (ie, failure to treat the face and scalp or close contacts, failure to reapply medication) or failure to decontaminate fomites. Because increasing resistance to scabies treatments may be on the horizon, we propose that standard of care for scabies treatment should involve routine treatment of the scalp and face and re-treating patients at day 4 on the basis of the scabies life cycle to ensure more efficient mite eradication. Practitioners should attempt to treat all close contacts simultaneously with the source patient. To eradicate mites, all fomites should be placed in a dryer for 10 minutes on a high setting, furniture and carpets vacuumed, and nonlaunderables isolated for a minimum of 2 days, or, for those who wish to be rigorous, 3 weeks.

Psoriasis and the metabolic syndrome.

Psoriasis is an inflammatory, immune-mediated cutaneous disorder that has recently been recognized as systemic disease that is associated with multiple comorbidities such as depression, obesity, and the metabolic syndrome. The metabolic syndrome is the constellation of abdominal obesity, dyslipidemia, hypertension and insulin resistance, and presence of the metabolic syndrome significantly increases a patient's risk for cardiovascular disease, stroke and type 2 diabetes. Recent studies have found that psoriasis patients are at increased risk for metabolic syndrome as well as the individual components of metabolic syndrome, and the two diseases appear linked through a common mechanism of inflammation. Speculation exists as to whether this association is causative or whether it is the result of other habits seen in psoriasis patients, such as increased rates of smoking, alcohol consumption, and sedentary lifestyle, which add to the complexity of the association between psoriasis and the metabolic syndrome. However, psoriasis treatments have been shown to reduce the risk of developing metabolic syndrome components and comorbidities. Future studies are needed to better understand the nature of this relationship and the implications this could have for management and treatment of patients with psoriasis.

In vivo post-transcriptional gene silencing of alpha-1 antitrypsin by adeno-associated virus vectors expressing siRNA.

alpha-1 Antitrypsin (AAT) deficiency is one of the most common genetic diseases in North America, with a carrier frequency of approximately 4% in the US population. Homozygosity for the most common mutation (Glu342Lys, PI(*)Z) leads to the synthesis of a mutant protein, which accumulates and polymerizes within hepatocytes rather than being efficiently secreted. This lack of secretion causes severe serum deficiency predisposing to chronic lung disease. Twelve to fifteen percent of patients with PI(*)ZZ also develop liver disease, which can be severe, even in infancy. This is thought to be due to toxic effects of the accumulated mutant Z-AAT within the hepatocyte. Thus, an approach to reduce AAT-deficient liver disease will likely require some mechanism to decrease the amount of Z-AAT within hepatocytes. In this report, we describe studies of small-interfering RNAs (siRNAs) designed to downregulate endogenous AAT within hepatocytes. Three different siRNA sequences were identified and cloned into a recombinant adeno-associated virus (rAAV) backbone, either singly or as a trifunctional (3X) construct. Each had activity independently, but the levels of AAT expression in cell culture models showed the greatest decrease with the 3X construct, resulting in levels that were five-fold lower than controls. The rAAV-3X-siRNA was then packaged into AAV8 capsids and used in vivo to transduce the livers of human Z-AAT overexpressing transgenic mice. Those studies showed a decrease in total human AAT, a clearing of Z-AAT accumulation by immunohistochemistry, and a decrease in monomer Z-AAT within the liver within 3 weeks after vector injection. The rAAV8-3X-siRNA vector may hold promise as a potential therapy for patients with AAT liver disease.