An increasing body of literature describes underreporting of race and ethnicity, and overrepresentation of White individuals in clinical trials. We aimed to evaluate the racial and ethnic diversity of US participants in clinical trials for acne, atopic dermatitis (AD), and psoriasis. We performed a comprehensive review of clinical trials for these common dermatologic diseases that were published between January 2014 and July 2019. Race and ethnicity reporting among all trials, and the racial and ethnic distribution of US participants were compared by skin disease, intervention type, and trial phase. In total, 103 articles representing 119 unique trials were evaluated. Race and ethnicity were reported in only 22.7% of trials. The proportion of White participants (77.5%) was higher than that of the US population (72.5%, p < .01); a finding largely driven by psoriasis trials (84.7% White). The proportions of non-White and Hispanic individuals in non-topical (21.0 and 16.3%, respectively) and Phase III (20.5 and 18.7%, respectively) trials were lower than those in topical (23.5 and 23.3%, respectively; p < .01) and Phase I/II trials (25.6 and 22.3%, respectively; p < .01). Race and ethnicity remain underreported in dermatologic clinical trials, and US trial participant diversity differs by skin disease, intervention type, and trial phase.
Objectives: Fumaric acid esters (FAEs) are a well-established treatment option for long-term therapy of moderate to severe plaque psoriasis. This study examines effectiveness of FAEs for the treatment of plaque psoriasis in real-world practice at 12 months and if patient characteristics affect the odds of clinical response.
Methods: A descriptive, multivariable logistic regression analysis was conducted in a cohort drawn from the German registry PsoBest. Baseline patient characteristics were assessed as potential treatment effect modifiers.
Results: 444 patients (mean age 47.0 years, 39.0% female) were eligible for response analysis using nonresponder imputation at month 12. Of these, 39.6% achieved clinical response, i.e. Psoriasis Area and Severity Index (PASI) ≤ 3 or skin clearance. In logistic regression analysis (R2 = 0.114), only baseline PASI was a significant factor: patients with PASI < 10 had a 4 times higher odds (p ≤ .001, OR 4.088), patients with PASI of 10-20 a twofold higher odds of response (p ≤ .044, OR 1.961) compared to those with PASI > 20. Neither sex, age, body weight, disease duration, comorbidity nor pretreatment had an impact on the odds of response (p > .05).
Conclusions: FAEs showed a favorable response at 12 months, largely independent of patient characteristics.
Objectives: To undertake a comparison of Cal/BDP cream versus foam for the treatment of plaque psoriasis, with cross-trial population differences accounted for.
Materials and methods: An anchored matching-adjusted indirect comparison was undertaken, using individual patient data for Cal/BDP cream and published aggregated data for Cal/BDP foam. Altogether, 11 outcomes were analyzed, including PGA success, mPASI75, DLQI-related outcomes and treatment satisfaction across numerous domains. For each outcome an odds ratio or mean difference was calculated to represent the relative efficacy of Cal/BDP cream versus foam. Methods were guided by NICE Decision Support Unit recommendations.
Results: After adjustment, baseline characteristics were balanced across treatment arms in each analysis. There were no statistically significant differences in PGA success, mPASI75 or DLQI outcomes between Cal/BDP cream and foam when they were compared after their recommended treatment durations (8 weeks for cream and 4 weeks for foam). For treatment satisfaction after 1 week of treatment, Cal/BDP cream was significantly superior to the Cal/BDP foam in all but one domain of the questionnaire.
Conclusions: Cal/BDP cream and Cal/BDP foam have equivalent efficacy and HRQoL (measured in DLQI) outcomes when used for the topical treatment of plaque psoriasis at their recommended treatment durations. A comparison of treatment satisfaction assessments after 1 week of treatment demonstrated that patients find Cal/BDP cream to be more convenient than foam.
Background: Acne can be a highly debilitating disease. There is a high prevalence in adults, yet treatment rates in this population are low.
Objectives: An online survey was created to determine the main reasons why adults with acne do not seek treatment.
Methods: University students and staff 20 years of age and older were emailed a link to an online survey that asked them if they have facial acne, if they see a provider for it, and how they self-treat their acne.
Results: 1,136 complete surveys were returned. Top reasons for not seeing a provider include not being bothered enough to seek treatment (n = 418, 53.7%), believing that their acne will eventually resolve on its own (n = 351, 45.1%), concerned about costs of treatment (n = 274, 35.2%), and currently satisfied with over-the-counter (OTC) treatment (n = 261, 33.5%).
Conclusion: Most adults with acne do not see providers because they are not bothered enough by it or are satisfied with OTC treatments. However, of the population that has acne and does not seek treatment, a significant portion (n = 234, 30.1%) indicated it was for a reason that could be classified as a treatment barrier.
Lichen planus (LP) is an auto-inflammatory skin disorder identified by a presence of T-cell lymphocytes at the dermal-epidermal junction. It is hypothesized that the INF-γ/CXCL10 axis fulfills a major role in the onset and persistence of chronic inflammation in LP. Since Janus kinases (JAKs) are involved in the transduction of INF-γ signals, they may be good targets for LP treatment. Several case reports and case series described the safety and efficacy of upadacitinib (2 articles), tofacitinib (6 articles), baricitinib (4 articles), and Ruxolitinib (1 Article) in the treatment of LP variants. The predominant variants that JAK inhibitors improved were lichen planopilaris, nail LP, and erosive LP. Considering the role of the JAK pathway in LP pathogenesis and the evidence provided by these reports, it seems JAK inhibitors would be effective therapeutic agents for LP treatment. Hence, these agents should be trialed and evaluated further.
Background: Alopecia areata (AA) is a non-scarring hair loss mediated by T lymphocytes. Recently, a growing number of studies have shown that Janus kinase inhibitors are effective in the treatment of AA in children.
Methods: A systematic review and meta-analysis were performed according to the PRISMA guidelines. Good response was defined as more than 50% decrease in Severity of Alopecia Tool (SALT) score or complete regrowth or more than 50% regrowth. Partial response was defined as 5-50% decrease in SALT score. Any response to treatment was defined as more than 5% in SALT score decrease.
Results: There were 81.9% responders, 68.5% good responders, and 7.7% partial responders among the 10 included studies. The treatment duration was longer in good responders than in partial responders (p = .009). Oral route was linked to a better response to topical medication, with an odds ratio of 7.8 (95%CI 1.655-36.76). In terms of toxicity, reported adverse events included only mild symptoms. Liver transaminase elevation, upper respiratory tract infection, and eosinophilia were the most common adverse events.
Conclusions: Janus kinase inhibitors demonstrated promise in the treatment of AA in children, with the most common side effects being minor and reversible.
Objective: To describe real-world baseline characteristics and patient-reported outcomes (PROs) at 6-month and 12-month follow-up visits among patients with psoriasis who initiated and maintained secukinumab, stratified by prior exposure to biologics.
Methods: This real-world study included patients enrolled in the CorEvitas (formerly Corrona) Psoriasis Registry who initiated and maintained secukinumab through 6-month and/or 12-month follow-up. Demographics, clinical characteristics, and PROs were collected. PROs included Dermatology Life Quality Index (DLQI); itch, skin pain, fatigue, and EuroQol visual analog scales; and Work Productivity and Activity Impairment. Mean (SD) differences between baseline and follow-up visits were calculated for all outcomes.
Results: Overall, 652 patients had a 6-month follow-up visit, 460 (70.6%) were biologic experienced and 192 (29.4%) were biologic naive. Biologic-experienced and biologic-naive patients reported mean (SD) improvements in all PROs measured at 6-month follow-up. Similar improvements were seen among patients with a 12-month follow-up visit (n = 390) and both 6-month and 12-month follow-up visits (n = 326).
Conclusions: Biologic-experienced and biologic-naive patients with psoriasis who initiated and maintained secukinumab treatment reported improvements in PROs at 6-month and/or 12-month follow-up visits. These findings suggest that secukinumab is a potential biologic for psoriasis at any point along the patient treatment journey.
The field of dermatology is met with many subjective analysis methods. Due to the relative nature of subjective analysis methods, objective analysis methods with greater accuracy and reliability were developed. Many of these devices are either inaccessible to patients without being a part of a clinical trial, bulky, or costly. However, with the advances in artificial intelligence and handheld devices, measurement methods have become simplified. The purpose of our study was to validate an objective skin analysis software available on a handheld device by comparing it to a board-certified dermatologist's assessment. Participants of various ages and skin types were analyzed with the facial analysis system on an iPad Pro. The same photographs were ranked by a physician based on 14 common skin characteristics. The facial analysis system and the physician's rankings had a good agreement rate of 69%. The greatest agreement rates were with the assessment of erythema (83.7%) and wrinkles (81.6%) and the lowest with oiliness (53.1%). The analysis system's high re-test reliability and good agreement rates with physician assessment support its potential use in the clinical setting.