Factors Associated with Eczema Clinical Trial Awareness, Interest, and Participation in Adults.

Despite the need for improved eczema therapies and a rapid increase in available eczema clinical trials, participation remains low. The aim of this study was to identify factors associated with clinical trial awareness, interest, and barriers to enrolment and participation. An online survey, administered 1 May to 6 June 2020 to adults (≥ 18 years) with eczema in the USA, was analysed. Among 800 patients included, mean age was 49.4 years, most respondents were female (78.1%), White (75.4%), non-Hispanic (91.4%), and geographically living in an urban/suburban area (Rural-Urban Continuum Codes (RUCC) 1-3, 90.8%). Only 9.7% of respondents reported previous participation in clinical trials, while 57.1% had considered participation and 33.2% never considered participation. Higher satisfaction with current eczema therapy, clinical trial literacy, and confidence in finding eczema trial information were all associated with clinical trial awareness, interest, and successful participation. Younger age and having atopic dermatitis were associated with increased awareness, while female gender was a barrier to interest and successful participation.

Demystifying pharmaceutical patient assistance programs.

Prescription drug costs impose a significant financial burden on the United States healthcare system. Patients with chronic dermatologic diseases often require long-term and expensive prescription drugs. In an effort to expand drug availability, pharmaceutical companies fund patient assistance programs (PAPs) to assist disadvantaged patients in gaining access to high-priced brand name medications with no suitable therapeutic alternative. Patients and clinical staff often face difficulty navigating the various PAPs. Herein, we seek to explore the utility, criteria, and challenges in PAPs and provide a practical discourse for dermatologists caring for medically indigent patients.

Medicare and medicaid spending trends for immunomodulators prescribed for dermatologic conditions.

Immunomodulators are the most expensive prescription medications used in dermatology for chronic skin conditions. Each year, rising costs for immunomodulators pose significant financial burdens on patients and the healthcare system as a whole. Using the Centers for Medicare and Medicaid Services (CMS) we collected Medicare Part D (Medicare-D) and Medicaid spending data for immunomodulators with dermatologic indications or off-label use from 2012-2018. The average annual spending and average annual spending per dosage unit (AASPDU) was calculated for each of the thirteen included medications. Combined Medicare-D and Medicaid spending increased 319.9% from $2.5B in 2012 to $10.6B in 2018, with an average of $6.2B spent annually. For both Medicare-D and Medicaid, adalimumab ($1.8B, $968.8 m), etanercept ($1.4B, $467.5 m), and ustekinumab ($258.8 m, $131.0 m) had the highest overall annual spending. Additionally, ustekinumab ($16,825, $15,576), guselkumab ($10,132, $9,543), and ixekizumab ($4,895, $4,673) had the highest AASPDU for both Medicare-D and Medicaid. Medicare-D and Medicaid spending for immunomodulators has grown substantially (319.9%) from 2012-2018 and is likely to continue to rise. Given this increase in federal spending and continued emergence of new immunomodulators, it is important to learn how we can counteract the trends and reduce future expenses for patients and our healthcare system.

Medicaid and Medicare Part B spending on immunomodulators and biosimilars.

INTRODUCTION: Prices for immunomodulators used in dermatological conditions are rising in the United States. While Medicare Part-D solely covers medication costs, Medicare Part-B covers outpatient infusion and injection costs given by medical professionals. We aim to analyze recent trends in Medicare Part-B spending on immunomodulators and their biosimilars used in the treatment of common chronic inflammatory dermatoses. METHODS: The 2012-2018 Medicare Part-B spending data on immunomodulators commonly used for dermatologic conditions were extracted from the Centers for Medicare and Medicaid Services database. Inflation was adjusted to reflect 2012-dollar amounts using the Consumer Price Index. RESULTS: Medicare Part-B spending has increased by 27.5% from 2012 to 2018 ($2.5B, $3.2B). Average annual total spending (AATS) is greatest for rituximab ($1,522,757,520), and average annual spending per maintenance dose (AASPMD) is greatest for ustekinumab-90 mg ($12,976). The percent change in AASPMD increased for all immunomodulators with Etanercept-50 mg having the greatest percent change (+64.6%, +$285.70). Infliximab had a greater AATS and AASPMD than its biosimilars. DISCUSSION: Medicare Part-B spending is often overlooked but plays a big role in federal healthcare spending. Exploring the strategic use of less expensive biosimilars could help mitigate spending.

Antihistamine safety in older adult dermatologic patients.

Twenty percent of Americans will be older than 65 years by 2030, and without a dedicated geriatrics curriculum in many residency trainings programs, dermatologists may be less familiar with age-associated adverse effects of common dermatologic medications. Herein, we provide a practical guide and clinical safety pearls for the use of antihistamines in older adults. This Review aims to address the risks of antihistamines, anticholinergic burden and polypharmacy, pertinent preexisting medical conditions, and safe alternatives for aging adult patients.

Gender gaps in National Institutes of Health dermatology grant recipients.

BACKGROUND: Understanding the demographics and scholarly merit among National Institutes of Health (NIH) award recipients can help guide future applicants in the field of dermatology. OBJECTIVE: Herein, we aimed to explore gender gaps in NIH award recipient demographics and scholarly merits for dermatology-related projects. METHODS: Projects funded by the National Institutes of Arthritis and Musculoskeletal and Skin Diseases between 2015 and 2019 related to dermatology were extracted using the NIH Research Portfolio Online Reporting Tools database. The number of publications and h-index of each award recipient were collected using the Scopus database. The 2019 Blue Ridge Institute for Medical Research report was used to determine the top 20 NIH-funded dermatology departments/divisions. RESULTS: Between 2015 and 2019, there were 35.1% more unique male than unique female recipients. Award recipients had an average of 116.7 total publications and an average h-index of 37.1. However, men also had more than half as many publications and a >37% higher average h-index. Gender gaps in research merit, as well as number and type of awards, are reduced among recipients affiliated with a top 20 NIH-funded institution. CONCLUSION: A higher number of awards were granted to male recipients. Men had a higher mean publication number and h-index compared with their female counterparts. Increased support, resources, and mentorship opportunities to women in research may help mitigate these gaps.

Art of prevention: Practical tips for improving adherence to treatments for older patients in dermatology.

Given demographic changes and increases in longevity, physicians will see increasing numbers of patients over the age of 65 years. As the population ages, adapting and optimizing patient care to better serve the needs of older patients should be a priority. The goal of this review is to shed light on potential barriers affecting treatment adherence and to improve clinical care for older adults with dermatologic conditions. We provide practical strategies to help overcome these barriers and provide suggestions to address the impact of functional limitations on topical medication adherence. Some less apparent risks of treatment, such as fall risks with topical treatments, are also discussed, along with issues such as cost of treatments and prescribing considerations for patients who reside in facilities.

Diabetes control is associated with environmental quality in the USA.

Environmental parameters, including built and sociodemographic environments, can impact diabetes control (DC). Epidemiological studies have associated specific environmental factors with DC; however, the impact of multidimensional environmental status has not been assessed. The Environmental Quality Index (EQI), a comprehensive quantitative metric capturing five environmental domains, was considered as an exposure. Age-adjusted rates of DC prevalence for each county in the United States were used as an outcome. DC was defined as the proportion of adults aged 20+ years with a previous diabetes diagnosis who currently do not have high fasting blood glucose (≥126 mg/dL) or elevated HbA1c (≥6.5). We conducted county-level analyses of DC prevalence rates for the years 2004-2012 in association with EQI for 2006-2010 and domain-specific indices using random intercept multilevel linear regression models clustered by state and controlled for county-level rates of obesity and physical inactivity. Analyses were stratified by rural-urban strata, and results are reported as prevalence rate differences (PRD) with 95% CIs comparing highest quintile/worst environmental quality to lowest quintile/best environmental quality. The association of DC with cumulative environmental quality was negative after control for all counties (PRD -0.32, 95% CI: -0.38, -0.27); suggesting that rates of DC worsen as environmental quality declines. While overall environmental quality exerts effects on DC that vary across the rural-urban spectrum, poor sociodemographic, and built environmental factors are associated with decreased DC nationally. These data suggest improvements in environmental quality mediated by larger-scale policy and practice interventions may improve glycemic control and reduce the morbidity and mortality arising from hyperglycemia.

Physician perspectives on complementary and alternative medicine in hidradenitis suppurativa.

Hidradenitis suppurativa (HS) is a chronic and often debilitating inflammatory condition characterized by frequent nodules, abscesses, sinus tracts, and scars impacting the intertriginous areas. Many patients with HS often report limited treatment success and symptom coverage with conventional therapies. Recent studies have reported the widespread use of complementary and alternative medicine (CAM) among patients with HS. In this study, our aim was to examine current physician practice patterns, opinions, and comfort with recommending CAM. Our results indicate that provider comfort and opinions on CAM varied based on the provider's experiences, demographics, and the CAM modality itself. Overall, nearly two-thirds (n = 30, 61.2%) of respondents agreed that CAM and conventional medicine were more effective together than either alone. Meanwhile, 44.9% (n = 22) of respondents routinely recommend CAM while 64.6% (n = 31) of respondents reported that they are routinely asked about CAM. The majority (n = 41, 83.7%) of respondents indicated a lack of scientific evidence in the medical literature as a barrier to recommending CAM along with efficacy concerns (n = 34, 69.4%) and ability to recommend reputable CAM products (n = 32, 65.3%) and practitioners (n = 32, 65.3%). Future investigations are warranted to establish a better understanding of the efficacy and benefit of CAM methods in conjunction with conventional methods.

Race and Ethnicity Gaps in Global Hidradenitis Suppurativa Clinical Trials.

BACKGROUND: Hidradenitis suppurativa (HS) is an often-debilitating disease characterized by chronic and recurrent painful nodules, abscesses, and sinus tracts affecting the intertriginous areas. Despite evidence in the literature of varying prevalence of HS among different racial and ethnic groups, no studies have evaluated the overall generalizability of clinical trial results considering the increased prevalence of HS among African American populations. Additionally, there is a paucity of data exploring the distribution of race and ethnicity in randomized controlled trials (RCTs) for HS. The goal of this analysis is to explore the distribution of race and ethnicity in recent HS RCTs. SUMMARY: Using ClinicalTrials.gov and PubMed, race and ethnicity demographics were extracted from phase II and III trials published from 2000 to August 2019. Fifteen trials were included and among these trials 669 (68.0%) participants were Caucasian and 138 (14.0%) were of African descent. Asians, American Indian or Alaskan Natives, and Native Hawaiian or other Pacific Islanders comprised 29 (2.9%), 3 (0.3%), and 1 (0.1%) participant respectively. Only 15 participants were reported as Hispanic as only three trials reported ethnicity data. The remaining 144 (14.6%) participants were recorded as "other/unspecified" (36 self-identified, 108 lacked race reporting). None of the trials included sub-analysis of treatment efficacy based on race or ethnicity.

Proceeding report of the Fourth Symposium on Hidradenitis Suppurativa Advances 2019.

The Fourth Annual Symposium on Hidradenitis Suppurativa (SHSA) took place on November 1-3, 2019, at the Westin Book Cadillac Hotel in Detroit, Michigan. This symposium was a joint meeting of the US Hidradenitis Suppurativa Foundation and the Canadian Hidradenitis Suppurativa Foundation. This cross-disciplinary meeting with experts from around the world was an opportunity to discuss the most recent advances in the study of hidradenitis suppurativa (HS) pathogenesis, clinical trials, classification, scoring systems, complementary/alternative medical treatments, diet, pain management, surgical and laser treatment, and ultrasonographic assessment. A special preconference workshop was held on the use of neodymium-doped yttrium-aluminum-garnet laser hair reduction, sinus tract deroofing, and carbon dioxide laser excision with ultrasonographic mapping and tumescent anesthesia for the treatment of HS. The focused workshops on establishing an HS clinic, setting up an HS support group, the Hidradenitis Suppurativa Prospective Observational Registry and Biospecimen Repository, and wound care were held during the meeting. A special program called HS Ambassadors was established for patients who may have questions about the conference presentations, and in addition, a meet and greet for patients and HS Ambassadors was arranged. To facilitate networking between those early in their careers and clinical and research experts, a mentoring reception was held.