Trends in price for topical corticosteroids from 2017 to 2021 and the opportunity for cost savings identifiable at the point of care: A retrospective cross-sectional study.

BACKGROUND: Topical corticosteroids possess numerous generics and similar-strength substitutes. Affordability can impact obtaining the medication prescribed. OBJECTIVE: To determine recent trends in topical corticosteroid pricing and potential for cost saving. METHODS: A retrospective cross-sectional study analyzing all prescriptions dispensed for topical corticosteroids from January 1, 2017 through December 31, 2021, using a US all-payer pharmacy-claims database and commercial coupon dataset, was performed. RESULTS: Two hundred thirty-seven unique drug products (≥1 claim) were identified. Factors that predicted for higher cost (P < .05) were branded products (105% more expensive than generics) and ultrapotent class (55% more expensive than low potency) while ointments predicted for lower cost (19% less expensive than creams). Cash prices remained relatively stable, except for ultrapotent branded topical corticosteroids (63% increase). Cost savings were available for both brand-to-generic ($14.75 per unit) and generic-to-generic ($6.82 per unit) switching. Coupon prices were consistently lower than cash prices (r = 0.89). LIMITATIONS: Contracted rates through insurance plans were not included. CONCLUSIONS: Topical corticosteroid prices over the past 5 years have stabilized, the exception being branded ultrapotent corticosteroids. Savings from switching among similar-strength substitutes remain significant despite price stabilization. Coupon prices mirror the hierarchy of cash prices and can help assess real-time costs.

The risk of ultraviolet exposure for melanoma in Fitzpatrick skin types I-IV: A 20-year systematic review with meta-analysis for sunburns.

Within the last two decades, no studies have comprehensively reviewed the risk of varying types of ultraviolet (UV) exposure on melanoma in fairer skinned individuals. Our research objective was to determine whether or not there was a change in the risk of UV exposure with development of melanoma in Fitzpatrick skin types I-IV based on more recent data over the past 20 years. We performed a systematic review from January 2002 to December 2021 analysing UV exposure and melanoma risk in Fitzpatrick type I-IV individuals. Out of 19,852 studies, 26 met inclusion criteria. Data spanned subjects from national and multinational cohorts (USA, Europe, Australia, Asia and South America). Twenty studies (77%, 20/26) identified a significant association between UV exposure and melanoma incidence. Sunburn was the most commonly assessed risk factor. Sunburn studies encompassed 3417 melanoma and found positive significant odds ratios (OR [95% CI]) in 11 out of 13 studies, ranging from 1.23 [1.01-1.49] to 8.48 [4.35-16.54]. Pooled analysis of the risk of melanoma with sunburn history found an unadjusted odds ratio of 1.66 [1.40-1.97] and adjusted odds ratio of 1.23 [1.04-1.46]. Cumulative sun exposure, measured as number of hours of sun exposure or calculated UV flux, was the second most common risk factor, encompassing 913 melanomas with positive significant ORs ranging from 1.1 [1.0-1.2] to 5.2 [2.1-12.5]. For other forms of UV exposure, a majority of studies showed an association with UV index (6/9), outdoor leisure activity (3/3) and left-sided laterality (1/1). Overall, UV exposure should continue to be considered a modifiable risk factor for melanoma in individuals of fairer skin.

Ultraviolet filters in the United States and European Union: A review of safety and implications for the future of US sunscreens.

BACKGROUND: Availability of new UV filters in the United States lags behind the European Union (EU), partly due to differing approval processes. OBJECTIVE: To review available human safety data of all US- and EU-approved UV filters. METHODS: Data from Food and Drug Administration and EU regulatory guidelines, federal governmental documentation, databases, reviews, and opinions for approval and ongoing safety evaluation were analyzed. RESULTS: Currently, there are 17 US UV filters and 29 EU UV filters (18 EU-approved only filters). Almost all US filters possessed sensitization data (94%, 16/17) with the majority (76%, 13/17) showing minimal skin sensitization. The minority of EU-approved only filters (33%, 6/18) possessed sensitization data, all showing no sensitization. Some filters possessed dermal absorption data (US: 76%, 13/17; EU: 44%, 8/18). Oxybenzone, octinoxate, octisalate, homosalate, and octocrylene, approved in the US and EU, were shown to have plasma levels exceeding the Food and Drug Administration exposure threshold. LIMITATIONS: Proprietary manufacturer human data were unavailable. CONCLUSIONS: Many new UV filters are available in the EU, but not yet in the United States. Rigorous US and EU guidelines ensure that UV filters provide adequate photoprotection assuming consumers follow American Academy of Dermatology SPF (sun protection factor) and broad-spectrum recommendations. Human data are limited, but known human risks of sunscreen appear minimal.

Janus kinase inhibitors in dermatology: Part I. A comprehensive review.

The Janus kinase-signal transducer and activator of transcription (JAK-STAT) intracellular signaling pathway is utilized by many proinflammatory molecules to mediate downstream effects and activate gene transcription. Activation of the JAK-STAT pathway contributes to a number of inflammatory dermatoses. Clinical trials and smaller studies have demonstrated the efficacy of JAK inhibitors in the treatment of a variety of dermatologic conditions. Here, we review the use of JAK inhibitors for the treatment of a wide range of dermatologic diseases in a two-part review series.

A Rare Case of Primary Cutaneous Signet-Ring Cell Melanoma With Discrepant Findings on Gene Expression Profiling and Chromosomal Microarray Analysis.

ABSTRACT: Melanoma with signet ring cell features is an exceptionally rare variant of primary cutaneous and metastatic melanoma. The molecular mechanisms underlying this unusual cytologic phenotype in malignant melanocytes are largely unknown. In this report, we aim to add to the literature by describing the histomorphological, immunophenotypic, gene expression, and cytogenetic findings in 1 recently encountered case.

Cardiovascular and cerebrovascular comorbidities of juvenile dermatomyositis in US children: an analysis of the National Inpatient Sample.

Objective: JDM is associated with multiple potential risk factors for cardiovascular disease, including reduced heart rate variability, systolic/diastolic cardiac dysfunction, abnormal brachial artery reactivity and metabolic syndrome. However, little is known about cardiovascular risk in JDM. We sought to examine the association between JDM and cardiovascular risk factors and disease in US children. Methods: Data from the 2002-12 National Inpatient Sample was analysed, including ∼20% of all US hospitalizations (n = 14 535 620 paediatric hospitalizations). Results: JDM was significantly associated with 12 of 13 comorbidities, including hypertension [survey logistic regression; crude odds ratio (95% CI): 22.25 (15.51, 31.92)], obesity [5.87 (3.44, 10.02)], uncomplicated diabetes [7.95 (4.21, 15.00)], lipid abnormalities [5.84 (2.77, 12.31)], particularly lipodystrophy [151.08 (38.24, 596.86)], peripheral and visceral atherosclerosis [10.09 (3.70, 27.56)], late effects of cerebrovascular disease [15.49 (2.37, 101.43)], personal history of transient ischaemic attack and cerebral infarction [10.82 (2.46, 47.65)], pulmonary circulatory disorder [12.23 (2.59, 57.73)], arrhythmia [3.93 (2.80, 5.52)], bradycardia [4.22 (2.65, 6.74)] and hypotension [2.62 (1.27, 5.39)]. Conclusions: There are significantly higher odds of cardiovascular and cerebrovascular comorbidities among inpatients with JDM, with adolescents, girls and racial/ethnic minorities being at highest risk.

Adverse events reported to the Food and Drug Administration from 2004 to 2016 for cosmetics and personal care products marketed to newborns and infants.

BACKGROUND/OBJECTIVES: Despite their ubiquitous use and several recent health controversies involving cosmetics and personal care products for children, the Food and Drug Administration has little oversight of these products and relies on consumer-submitted adverse event reports. We assessed the recently released Center for Food Safety and Applied Nutrition's Adverse Event Reporting System database for adverse event reports submitted to the Food and Drug Administration for baby personal care products and to determine whether useful insights can be derived. METHODS: We extracted the Center for Food Safety and Applied Nutrition's Adverse Event Reporting System data file from 2004 to 2016 and examined the subset classified according to the Food and Drug Administration-designated product class as a baby product. Events were manually categorized into product type and symptom type to assess for trends. RESULTS: Only 166 total adverse events were reported to the Food and Drug Administration for baby products from 2004 to 2016. The majority of reports indicated rash or other skin reaction; 46% of reported events led to a health care visit. CONCLUSION: Pediatric dermatologists should consider submitting cosmetics and personal care product adverse event reports and encouraging consumers to do so likewise in situations in which a product adversely affects a child's health.

Cardiovascular comorbidities of pediatric psoriasis among hospitalized children in the United States.

BACKGROUND: Psoriasis has been shown to be associated with cardiovascular disease in adults. Little is known about cardiovascular risk in pediatric psoriasis. OBJECTIVE: To determine if there is an association between pediatric psoriasis and cardiovascular comorbidities. METHODS: Data were analyzed from the 2002-2012 Nationwide Inpatient Sample, which included 4,884,448 hospitalized children aged 0-17 years. Bivariate and multivariate survey logistic regression models were created to calculate the odds of psoriasis on cardiovascular comorbidities. RESULTS: In multivariate survey logistic regression models adjusting for age, sex, and race/ethnicity, pediatric psoriasis was significantly associated with 5 of 10 cardiovascular comorbidities (adjusted odds ratio [95% confidence interval]), including obesity (3.15 [2.46-4.05]), hypertension (2.63 [1.93-3.59]), diabetes (2.90 [1.90-4.42]), arrhythmia (1.39 [1.02-1.88]), and valvular heart disease (1.90 [1.07-3.37]). The highest odds of cardiovascular risk factors occurred in blacks and Hispanics and children ages 0-9 years, but there were no sex differences. LIMITATIONS: The study was limited to hospitalized children. We were unable to assess the impact of psoriasis treatment or family history on cardiovascular risk. CONCLUSION: Pediatric psoriasis is associated with higher odds of multiple cardiovascular comorbidities among hospitalized patients. Strategies for mitigating excess cardiovascular risk in pediatric psoriasis need to be determined.

Pemetrexed-Induced Pseudocellulitis: A Diagnostic Conundrum.

Pemetrexed, an anti-folate, antineoplastic agent, effectively treats various malignancies such as non-small cell lung cancer (NSCLC) and mesothelioma. Here, we report two cases of recurrent pemetrexed-induced lower extremity erythema and edema, one in a 60-year-old male and the other in a 47-year-old male, who were both treated for recurrent cellulitis on multiple occasions before finally being diagnosed with pemetrexed-induced pseudocellulitis (PIP), a rarely reported adverse effect. This is an important diagnostic pitfall for clinicians to be aware of, as early recognition may minimize patient morbidity and prevent unnecessary hospitalization and antibiotic use for presumed cellulitis.

The relationship between the number of available therapeutic options and government payer (medicare part D) spending on topical drug products.

The cost of prescription drugs has increased at rates far exceeding general inflation in recent history, with topical drugs increasing at a disproportionate rate compared to other routes of administration. We assessed the relationship between net changes in the number of therapeutic options, defined as any approved drug or therapeutic equivalent on the market, and prescription topical drug spending. Drugs were divided based on the category of use through pairing of Medicare Part D Prescriber Public Use and Food and Drug Administration (FDA) approved drug products databases. Across drug classes, we modeled the log of the ratio of total spending per unit in 2015 to total spending per unit in 2011 as a linear function of net number of topical therapeutic options over this time period. Primary outcomes include total Medicaid Part D spending on topical drugs and net change in the number of available therapeutic options within each category of use. Total spending on topical drugs increased by 61%, while the number of units dispensed increased by only 18% from 2011-2015. The greatest total spending increases were in categories with few new therapeutic options, such as topical corticosteroid and antifungal medications. Each net additional therapeutic option during 2011-2015 was associated with an reduction in how much relative spending per unit increased (95% CI 2.5%-14.4%, p = 0.013). Stimulating greater competition through increasing the net number of therapeutic options within each major topical category of use may place downward pressure on topical prescription drug spending under medicare Part D.

Inpatient burden of juvenile dermatomyositis among children in the United States.

BACKGROUND: Juvenile dermatomyositis (JDM) is a rare autoimmune disease that causes significant morbidity and quality of life impairment. Little is known about the inpatient burden of JDM in the US. Our goal was to determine the prevalence and risk factors for hospitalization with juvenile dermatomyositis and assess inpatient burden of JDM. METHODS: Data on 14,401,668 pediatric hospitalizations from the 2002-2012 Nationwide Inpatient Sample (NIS) was analyzed. ICD-9-CM coding was used to identify hospitalizations with a diagnosis of JDM. RESULTS: There were 909 and 495 weighted admissions with a primary or secondary diagnosis of JDM, respectively. In multivariable logistic regression models with stepwise selection, female sex (logistic regression; adjusted odds ratio [95% confidence interval]) (2.22 [2.05-2.42]), non-winter season (fall: 1.18[1.06-1.33]; spring (1.13 [1.01-1.27]; summer (1.53 [1.37-1.71]), non-Medicaid administered government insurance coverage (2.59 [2.26-2.97]), and multiple chronic conditions (2-5: 1.41[1.30-1.54]; 6+: 1.24[1.00-1.52]) were all associated with higher rates of hospitalization for JDM. The weighted total length of stay (LOS) and inflation-adjusted cost of care for patients with a primary inpatient diagnosis of JDM was 19,159 days and $49,339,995 with geometric means [95% CI] of 2.50 [2.27-2.76] days and $7350 [$6228-$8674], respectively. Costs of hospitalization in primary JDM and length of stay and cost in secondary JDM were significantly higher compared to those without JDM. Notably, race/ethnicity was associated with increased LOS (log-linear regression; adjusted beta [95% confidence interval]) (Hispanic: 0.28 [0.14-0.41]; other non-white: 0.59 [0.31-0.86]) and cost of care (Hispanic: 0.30 [0.05-0.55]). CONCLUSION: JDM contributes to both increased length of hospitalization and inpatient cost of care. Non-Medicaid government insurance was associated with higher rates of hospitalization for JDM while Hispanic and other non-white racial/ethnic groups demonstrated increased LOS and cost of care.

Cosmetics and Cancer: Adverse Event Reports Submitted to the Food and Drug Administration.

There have been numerous controversies surrounding cosmetic products and increased cancer risk. Such controversies include associations between parabens and breast cancer, hair dyes and hematologic malignancies, and talc powders and ovarian cancer. Despite the prominent media coverage and numerous scientific investigations, the majority of these associations currently lack conclusive evidence. In 2016, the US Food and Drug Administration (FDA) made publically available all adverse event reports in Center for Food Safety and Applied Nutrition's Adverse Event Reporting System (CAERS), which includes complaints related to cosmetic products. We mined CAERS for cancer-related reports attributed to cosmetics. Between 2004 and 2017, cancer-related reports caused by cosmetics represented 41% of all adverse events related to cosmetics. This yielded 4427 individual reports of cancer related to a cosmetic product. Of these reports, the FDA redacted the specific product names in 95% of cancer-related reports under the Freedom of Information Act exemptions, most likely due to ongoing legal proceedings. For redacted reports, ovarian cancer reports dominated (n = 3992, 90%), followed by mesothelioma (n = 92, 2%) and malignant neoplasm unspecified (n = 46, 1%). For nonredacted reports, or those reports whose product names were not withheld (n = 218), 70% were related to ovarian cancer attributed to talc powders, followed by skin cancer (11%) and breast cancer (5%) attributed to topical moisturizers. Currently, CAERS is of limited utility, with the available data having been subjected to significant reporter bias and a lack of supportive information such as demographic data, medical history, or concomitant product use. Although the system has promise for safeguarding public health, the future utility of the database requires broader reporting participation and more complete reporting, paired with parallel investments in regulatory science and improved molecular methods.

Association Between Inflammatory Skin Disease and Cardiovascular and Cerebrovascular Co-Morbidities in US Adults: Analysis of Nationwide Inpatient Sample Data.

BACKGROUND: Psoriasis, atopic dermatitis or eczema (AD-E), pemphigus, bullous pemphigoid (BP), and hidradenitis are chronic inflammatory skin disorders associated with systemic immune activation, considerable symptom burden, stigma, functional disturbances, and mental health symptoms. All of these might increase cardiovascular risk. OBJECTIVE: The objective of this study was to determine whether these inflammatory skin diseases are associated with increased cardiovascular/cerebrovascular risk and/or disease. METHODS: We analyzed data from the 2002-2012 National Inpatient Sample, including a representative 20% sample of all US hospitalizations (n = 72,108,077 adults). RESULTS: In multivariate logistic regression models with propensity score matching, patients hospitalized with versus without a diagnosis the inflammatory skin diseases examined had higher odds of obesity (odds ratio [95% confidence interval] for pemphigus: 1.16 [1.05-1.29]; BP 1.14 [1.06-1.23]; AD-E: 1.82 [1.79-1.86]; psoriasis: 2.36 [2.32-2.41]; hidradenitis: 2.79 [2.59-3.01]). Inflammatory skin disease was also associated with significantly higher odds of different cardiovascular risk factors, including hypertension (pemphigus: 1.39 [1.31-1.48]; BP 1.96 [1.88-2.05]; AD-E: 1.19 [1.17-1.21]; psoriasis: 1.61 [1.59-1.64]), and diabetes mellitus with complications (pemphigus: 1.34 [1.18-1.52]; BP: 2.06 [1.90-2.24]; AD-E: 1.13 [1.10-1.17]; psoriasis: 1.39 [1.35-1.44]), as well as vascular, cardiovascular, and cerebrovascular disease, including peripheral vascular disease (pemphigus: 1.14 [1.00-1.30]; BP: 1.83 [1.69-1.98]; AD-E: 1.18 [1.14-1.22]; psoriasis: 1.32 [1.28-1.35]), peripheral and visceral atherosclerosis (BP: 1.67 [1.53-1.81]; AD-E: 1.16 [1.12-1.20]; psoriasis: 1.27 [1.24-1.30]), pulmonary circulation disorders (pemphigus: 1.67 [1.39-2.01]; BP: 2.17 [1.92-2.45]; AD-E: 1.39 [1.33-1.45]; psoriasis: 1.37 [1.31-1.43]), congestive heart failure (pemphigus: 1.75 [1.60-1.90]; BP: 2.82 [2.68-2.98]; AD-E: 1.10 [1.07-1.13]; psoriasis: 1.05 [1.02-1.07]), history of transient ischemic attack (pemphigus: 1.36 [1.14-1.62]; BP: 2.03 [1.83-2.26]; AD-E: 1.19 [1.15-1.23]; psoriasis: 1.31 [1.26-1.36]), and cerebrovascular disease. In stratified analyses, multiple inflammatory skin diseases were associated with significantly higher rates of obesity, hypertension, and/or diabetes in patients aged <50 years and females. CONCLUSIONS: Psoriasis, pemphigus, BP, AD-E, and hidradenitis were all associated with increased cardiovascular and cerebrovascular risk, especially at younger age.

Predictors of Hospitalization, Length of Stay, and Cost of Care Among Adults With Dermatomyositis in the United States.

OBJECTIVE: To determine the prevalence and risk factors for hospitalization with dermatomyositis and assess inpatient burden of dermatomyositis. METHODS: Data on 72,651,487 hospitalizations from the 2002-2012 Nationwide Inpatient Sample, a 20% stratified sample of all acute-care hospitalizations in the US, were analyzed. International Classification of Diseases, Ninth Revision, Clinical Modification coding was used to identify hospitalizations with a diagnosis of dermatomyositis. RESULTS: There were 9,687 and 43,188 weighted admissions with a primary or secondary diagnosis of dermatomyositis, respectively. In multivariable logistic regression models with stepwise selection, female sex (logistic regression: adjusted odds ratio 2.05 [95% confidence interval (95% CI) 1.80, 2.34]), nonwhite race (African American: 1.68 [1.57, 1.79]; Hispanic: 2.38 [2.22, 2.55]; Asian: 1.54 [1.32, 1.81]; and multiracial/other: 1.65 [1.45, 1.88]), and multiple chronic conditions (2-5: 2.39 [2.20, 2.60] and ≥6: 2.80 [2.56, 3.07]) were all associated with higher rates of hospitalization for dermatomyositis. The weighted total length of stay (LOS) and inflation-adjusted cost of care for patients with a primary inpatient diagnosis of dermatomyositis was 80,686 days and $168,076,970, with geometric means of 5.38 (95% CI 5.08, 5.71) and $11,682 (95% CI $11,013, $12,392), respectively. LOS and costs of hospitalization were significantly higher in patients with dermatomyositis compared to those without. Notably, race/ethnicity was associated with increased LOS (log-linear regression: adjusted ß [95% CI] for African American: 0.14 [0.04, 0.25] and Asian: 0.38 [0.22, 0.55]) and cost of care (Asian: 0.51 [0.36, 0.67]). CONCLUSION: There is a significant and increasing inpatient burden for dermatomyositis in the US. There appear to be racial differences, as nonwhites have higher prevalence of admission, increased LOS, and cost of care.

Validation of International Classification of Diseases Codes for the Epidemiologic Study of Dermatomyositis.

OBJECTIVE: To assess the validity of using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code 710.3 to identify adult patients with dermatomyositis in outpatient and inpatient settings. METHODS: Electronic medical records of adult patients with ICD-9 code 710.3 between January 2001 and November 2014 (n = 511) were examined. Physician diagnosis, clinical findings, and diagnostic testing results were recorded. A dermatomyositis rating scale was assigned based on classic cutaneous findings and at least 2 additional clinical and diagnostic findings from the Bohan criteria. Sensitivity and positive predictive values (PPVs) were determined. Sensitivity analyses were performed to evaluate the accuracy of multiple ICD-9 codes in the outpatient setting, as well as primary and secondary inpatient codes. RESULTS: The sensitivity and PPV for multiple 710.3 ICD-9 codes in the outpatient setting were 0.89 and 0.35, respectively. The PPV for primary and secondary 710.3 inpatient codes was 0.95 and as high as 0.8. However, the sensitivity of ICD-9 code 710.3 was poor in the inpatient setting (primary 0.23 and secondary 0.26). The most common reason for failure to meet appropriate dermatomyositis criteria was miscoding as diabetes mellitus (32%), followed by diagnosis at an outside institution (19%), dermatomyositis as a rule-out diagnosis (10%), cutaneous dermatomyositis (8%), and juvenile dermatomyositis (6%). CONCLUSION: One or more occurrences of ICD-9 code 710.3 is insufficient to support the diagnosis of dermatomyositis in the outpatient setting. However, ICD-9 710.3 codes appear to be valid in the inpatient setting.