Rapid Remission of Sunburn-Induced Guttate Psoriasis with Guselkumab.

Guselkumab is an anti-interleukin-23 monoclonal antibody that is approved for plaque psoriasis and psoriatic arthritis. We present a case of a 28-year-old female patient with acute onset of guttate psoriasis after a blistering sunburn. She had no personal or family history of psoriasis or chronic inflammatory skin disease. The guttate psoriasis was refractory to topical treatment. After the first dose of guselkumab (100 mg subcutaneous injection), the patient experienced near-clearance of her guttate psoriasis, with continued improvement and drug-free remission 8 months after cessation of treatment. Dermatologists could consider guselkumab as a treatment option for patients with guttate psoriasis. Future studies should examine the potential for guselkumab to induce drug-free remissions in guttate psoriasis.

Development of SkinTracker, an integrated dermatology mobile app and web portal enabling remote clinical research studies.

Introduction: In-person dermatology clinical research studies often face recruitment and participation challenges due to travel-, time-, and cost-associated barriers. Studies incorporating virtual/asynchronous formats can potentially enhance research subject participation and satisfaction, but few mobile health tools are available to enable remote study conduct. We developed SkinTracker, a patient-facing mobile app and researcher-facing web platform, that enables longitudinal collection of skin photos, patient reported outcomes, and biometric health and environmental data. Methods: Eight design thinking sessions including dermatologists, clinical research staff, software engineers, and graphic designers were held to create the components of SkinTracker. Following iterative prototyping, SkinTracker was piloted across six adult and four pediatric subjects with atopic dermatitis (AD) of varying severity levels to test and provide feedback on SkinTracker for six months. Results: The SkinTracker app enables collection of informed consent for study participation, baseline medical history, standardized skin photographs, patient-reported outcomes (e.g., Patient Oriented Eczema Measure (POEM), Pruritus Numerical Rating Scale (NRS), Dermatology Life Quality Index (DLQI)), medication use, adverse events, voice diary to document qualitative experiences, chat function for communication with research team, environmental and biometric data such as exercise and sleep metrics through integration with an Apple Watch. The researcher web portal allows for management and visualization of subject enrollment, skin photographs for examination and severity scoring, survey completion, and other patient modules. The pilot study requested that subjects complete surveys and photographs on a weekly to monthly basis via the SkinTracker app. Afterwards, participants rated their experience in a 7-item user experience survey covering app function, design, and desire for participation in future studies using SkinTracker. Almost all subjects agreed or strongly agreed that SkinTracker enabled more convenient participation in skin research studies compared to an in-person format. Discussion: To our knowledge, SkinTracker is one of the first integrated app- and web-based platforms allowing collection and management of data commonly obtained in clinical research studies. SkinTracker enables detailed, frequent capture of data that may better reflect the fluctuating course of conditions such as AD, and can be modularly customized for different skin conditions to improve dermatologic research participation and patient access.

Liver Complications in Untreated Treatment-Ineligible versus Treated Treatment-Eligible Patients with Hepatitis B.

BACKGROUND: A substantial number of patients who do not meet treatment criteria for chronic hepatitis B (CHB) later develop adverse outcomes such as cirrhosis and hepatocellular carcinoma (HCC). Our aim was to determine whether current practice guidelines adequately identify CHB patients who will benefit from antiviral therapy. METHODS: We performed a retrospective cohort study comparing the incidence of adverse liver outcomes (cirrhosis and/or HCC) in untreated treatment-ineligible (at baseline and throughout follow-up) versus treated treatment-eligible patients according to standard American Association for the Study of Liver Diseases (AASLD) 2018 guidance (alanine aminotransferase [ALT] >70/50 U/L for men/women plus hepatitis B virus [HBV] DNA >20,000/2,000 IU/mL for HBeAg+/-) and with a sensitivity analyses using a lower threshold (ALT >40 U/L and HBV DNA >2,000 IU/mL). RESULTS: We reviewed records of 5,840 patients from 5 clinics in California and identified 2,987 treatment-naive non-HCC CHB patients. Of those, 271 patients remained untreated treatment-ineligible, 514 patients were treatment-eligible and initiated treatment, with 5-year cumulative adverse liver incidences of 12.5% versus 7.2%, p = 0.074. On multivariable analysis adjusting for age, sex, diabetes, albumin, platelet count, and HBV DNA, compared to treated treatment-eligible patients, untreated treatment-ineligible patients had a significantly higher risk of adverse liver outcomes (adjusted hazard ratio: 2.38, 95% confidence interval 1.03-5.48, p = 0.04) in main analysis by AASLD 2018 criteria but not in sensitivity analysis using the lower treatment threshold (p = 0.09). CONCLUSION: Patients never meeting standard AASLD 2018 criteria for antiviral therapy and never treated had twice the risk of developing cirrhosis and/or HCC when compared to eligible and treated patients.

Ethnoracial representation in hidradenitis suppurativa clinical trials.

BACKGROUND: Hidradenitis suppurativa (HS) is an inflammatory skin disorder characterized by recurring painful and suppurating lesions, with the disease disproportionately affecting black populations in the United States. Ethnoracial representation in clinical trials is vital to ensuring results are generalizable. The purpose of this study is to examine whether ethnic or racial disparities exist in HS clinical trials. METHODS: The US National Library of Medicine clinical trials database (clinicaltrials.gov) was queried to identify HS clinical trials. Trials that did not present ethnic or racial data on either the website or publication were not considered. RESULTS: A total of 57 HS trials were identified. Of these, 23 trials, containing 2530 patients, included racial or ethnic data (Table 1). White patients made up 76.1% (1435/1886) of the study population, followed by Blacks or African Americans (13.7% (238/1732)), Hispanics or Latinos (7.2% (20/279), Asians (2.6% (26/1016)), American Indians or Alaska Natives (1.3% (14/1051)), and Native Hawaiians or Other Pacific Islanders (0.4% (4/926)). DISCUSSION: Our results establish a significant lack of minority ethnoracial representation in HS clinical trials. Since HS prevalence is highest among Blacks or African Americans, it is imperative that future clinical trials are conducted with a larger proportion of this population. Furthermore, clinical trials that did not report racial or ethnic information were conducted in countries with predominantly White populations, which likely skewed the results of this study and caused underreporting of these patients.

Comparing the odds of reported depression in psoriasis patients on systemic therapy: a cross-sectional analysis of postmarketing data.

Patients with psoriasis are more likely to experience depression and suicidality compared to non-psoriatic patients, though systemic therapies have been shown to improve depressive symptoms. It is unclear whether or not biologic or oral agents are more effective at improving such depressive symptoms in psoriasis patients, however. We aimed to determine an estimate of the odds of incident depression in psoriasis patients on different systemic therapies by performing a cross-sectional analysis of postmarketing data. The reporting odds ratio (ROR) for 15 different systemic agents was calculated using reports from the Food and Drug Administration Adverse Events Reporting System (FAERS). After excluding brodalumab and apremilast due to high risk of reporting bias, we found oral agents were associated with a significantly higher ROR of depression compared to biologics (OR = 2.42, 95% confidence interval: 1.93-3.04). These results suggest biologics may be more effective at reducing incident depression than oral agents. Future controlled trials are needed to confirm these findings.

Hidradenitis suppurativa and sleep: a systematic review.

Chronic inflammatory skin disorders are known to affect sleep quality; however, the relationship between hidradenitis suppurativa (HS) and sleep is not well understood. We performed a systematic review of HS and sleep disorders and sleep quality in HS patients. We identified seven studies comprising 343,870 subjects. We found that HS patients have a higher likelihood of having a sleep disorder such as obstructive sleep apnea, as well as other non-sleep apnea. Several studies showed that patients reported worse sleep quality due to symptoms of HS such as pruritus and pain. HS patients may be at risk for additional cardiovascular comorbidities and poorer quality of life secondary to these sleep disorders and poor sleep quality. Further high-quality research evaluating these associations is warranted.

Mindfulness and Meditation for Psoriasis: A Systematic Review.

Psoriasis is a chronic, recurrent inflammatory skin condition in which flares are commonly associated with stress. One important non-pharmacological method for managing stress in patients with psoriasis is mindfulness and/or meditation. The objective of this review is to provide an update on research studies investigating the role of mindfulness and meditation in treating psoriasis symptoms, severity, and quality of life. Of six randomized control trials (RCTs) identified, five demonstrated improvement in self-administered psoriasis area and severity index (saPASI) after 8 or 12 weeks of guided meditation. One RCT and one non-randomized control trial reported mental health benefits in psoriasis patients following guided meditation. These results suggest that meditation can be used as a tool to improve both psoriasis skin severity and patient quality of life in the short term. More research is needed to evaluate the effect of meditation on psoriasis severity and quality of life in the long term.

A critical review of halobetasol propionate foam (0.05%) as a treatment option for adolescent plaque psoriasis.

INTRODUCTION: Halobetasol propionate foam has been established as an efficacious and easy-to-use topical treatment for adults with plaque psoriasis. Its recent approval in the United States expanded its use for adolescents from ages 12 to 17 years old. AREAS COVERED: We briefly summarize the chemistry of halobetasol and review clinical trials involving halobetasol propionate 0.05% foam to evaluate its efficacy and safety profile with a specific focus on adolescents with plaque psoriasis. EXPERT OPINION: Halobetasol propionate 0.05% foam is an effective and cosmetically elegant superpotent topical corticosteroid, with a tolerable safety profile in adolescents. The use of this foam offers another option to address patient-specific needs and preferences, adding to the toolbox of currently available treatments for adolescent psoriasis.

Psoriasis and Exercise: A Review.

Psoriasis is a prevalent inflammatory skin disorder that is associated with a number of comorbidities including cardiovascular disease and metabolic syndrome. Exercise can influence the outcomes of chronic inflammatory diseases, and the presence of these diseases can also influence physical activity in afflicted patients. We reviewed the available literature published on exercise in psoriasis patients and aimed to explore physical activity levels, barriers to exercise, physical fitness, exercise as a prevention strategy as well as a treatment modality. Overall, patients with moderate to severe psoriasis are more sedentary than the general population and experience barriers to exercise secondary to their skin disease. Moderate to vigorous exercise may be an independent preventative factor in reducing the incident risk of developing psoriasis and the utilization of exercise as a weight loss strategy may improve disease severity especially in overweight patients. Expert panels agree that exercise can be beneficial as an adjunct treatment in patients with psoriasis who are overweight; however, more randomized clinical trials are needed to establish these links.

Dietary Intervention and Supplements in the Management of Psoriasis: Current Perspectives.

Nutrition is a complex topic encompassing diet and a variety of supplements including vitamins, fish oil, herbal products, and probiotics. Patients with psoriasis display high interest in understanding the potential impact of nutritional modifications on their psoriasis. In this review, we examine the evidence for nutritional interventions in psoriasis and summarize important concepts. We found that certain diets, such as low-calorie diets for obese patients, gluten-free diets for patients with comorbid celiac disease, and the Mediterranean diet, may have benefits for psoriasis patients. Supplements in general do not show strong evidence of benefit, though more studies are required given the heterogeneity of these trials. Finally, the gut microbiome has drawn considerable interest in recent years, with specific probiotics showing promising results for psoriasis patients and warranting further exploration.

Combined Single Cell Transcriptome and Surface Epitope Profiling Identifies Potential Biomarkers of Psoriatic Arthritis and Facilitates Diagnosis via Machine Learning.

Early diagnosis of psoriatic arthritis (PSA) is important for successful therapeutic intervention but currently remains challenging due, in part, to the scarcity of non-invasive biomarkers. In this study, we performed single cell profiling of transcriptome and cell surface protein expression to compare the peripheral blood immunocyte populations of individuals with PSA, individuals with cutaneous psoriasis (PSO) alone, and healthy individuals. We identified genes and proteins differentially expressed between PSA, PSO, and healthy subjects across 30 immune cell types and observed that some cell types, as well as specific phenotypic subsets of cells, differed in abundance between these cohorts. Cell type-specific gene and protein expression differences between PSA, PSO, and healthy groups, along with 200 previously published genetic risk factors for PSA, were further used to perform machine learning classification, with the best models achieving AUROC ≥ 0.87 when either classifying subjects among the three groups or specifically distinguishing PSA from PSO. Our findings thus expand the repertoire of gene, protein, and cellular biomarkers relevant to PSA and demonstrate the utility of machine learning-based diagnostics for this disease.

Changes in Renal Function in Patients With Chronic HBV Infection Treated With Tenofovir Disoproxil Fumarate vs Entecavir.

BACKGROUND & AIMS: It is unclear whether drugs used to treat chronic hepatitis B virus (HBV) infection cause significant renal impairment. We compare adjusted mean estimated glomerular filtration rates (eGFR; mL/min/1.73 m2) of patients with chronic HBV infection treated with tenofovir disoproxil fumarate (TDF) vs patients treated with entecavir. METHODS: We performed a retrospective study of patients with chronic HBV infections treated with TDF (n = 239) or entecavir (n = 171), from 2000 through 2016, followed for a mean time of 43-46 months. Levels of serum creatinine were measured ≥12 months while patients received treatment. Patients did not have prior exposure to adefovir or HCV, HDV, or HIV co-infection. We performed propensity score matching (PSM) for age, sex, presence of hypertension, diabetes mellitus, baseline eGFR, cirrhosis, and follow-up duration. We performed multivariate generalized linear modeling, adjusting for cirrhosis, diabetes, and hypertension, to estimate adjusted mean eGFR for matched and unmatched cohorts. Cox regression was used to identify predictors of renal impairment. RESULTS: eGFRs were ≥60, after PSM, in 116 patients given entecavir and in 116 patients given TDF; eGFRs were <60 in 32 patients given entecavir and 26 patients given TDF. Multivariate generalized linear modeling of the unmatched overall and <60 eGFR cohorts revealed significantly lower adjusted mean eGFRs in patients given TDF (all P < .001). However, in the eGFR ≥60 PSM cohort, the adjusted mean eGFR was similar between patients receiving either treatment. In Cox regression analysis, TDF was not associated with mild or moderate renal impairment compared with entecavir. CONCLUSION: In a retrospective study of patients with chronic HBV infections treated with TDF vs entecavir, we found that TDF was not associated with higher risk of worsening renal function during short- or intermediate-term follow-up periods, among patients without significant renal impairment. Additional studies, with longer follow-up periods, are needed because treatment for chronic HBV infection is generally long term or life-long. For patients with baseline renal impairment, significant renal decline was among patients given TDF compared to patients given entecavir.

Poor Adherence to Guidelines for Treatment of Chronic Hepatitis B Virus Infection at Primary Care and Referral Practices.

BACKGROUND & AIMS: The American Association for the Study of Liver Diseases (AASLD) guidelines for treatment of chronic hepatitis B virus (HBV) infection have changed with time. We assessed rates of treatment evaluation and initiation in patients with chronic HBV infection from different practice settings in the past 14 years. METHODS: Treatment-naive patients with chronic HBV infection were recruited from different practice settings in California from January 2002 through December 2016. The study population comprised 4130 consecutive, treatment-naive patients with chronic HBV infection seen by community primary care physicians (n = 616), community gastroenterologists (n = 2251), or university hepatologists (n = 1263). Treatment eligibility was assessed using data from the first 6 months after initial presentation based on AASLD criteria adjusted for changes over time. RESULTS: Within the first 6 months of care, the proportions of patients evaluated by all 3 relevant tests (measurements of alanine aminotransferase, hepatitis B virus e antigen, and HBV DNA levels) were as follows: 36.69% in community primary care, 59.80% in gastroenterologist care, and 79.97% in hepatology care (P < .0001 among the 3 groups). Higher proportions of patients were eligible for treatment in specialty practices: 12.76% in community primary care, 24.96% in gastroenterologist care, and 29.43% in hepatology care (P < .0001). Among treatment-eligible patients, there was no significant difference in the proportions of patients who began antiviral therapy between those receiving treatment from a gastroenterologist (55.65%) vs a hepatologist (57.90%; P = .56). Of 243 evaluable patients receiving community primary care, only 31 were eligible for treatment and only 12 of these (38.71%) received treatment. CONCLUSIONS: In an analysis of patients receiving care for chronic HBV infection, we found the proportions evaluated and receiving treatment to be suboptimal, according to AASLD criteria, in all practice settings. However, rates of evaluation and treatment were lowest for patients receiving community primary care.

Randomized pilot trial of bariatric surgery versus intensive medical weight management on diabetes remission in type 2 diabetic patients who do NOT meet NIH criteria for surgery and the role of soluble RAGE as a novel biomarker of success.

OBJECTIVE: To compare bariatric surgery versus intensive medical weight management (MWM) in patients with type 2 diabetes mellitus (T2DM) who do not meet current National Institutes of Health criteria for bariatric surgery and to assess whether the soluble form of receptor for advanced glycation end products (sRAGE) is a biomarker to identify patients most likely to benefit from surgery. BACKGROUND: There are few studies comparing surgery to MWM for patients with T2DM and BMI less than 35. METHODS: Fifty-seven patients with T2DM and BMI 30 to 35, who otherwise met the criteria for bariatric surgery were randomized to MWM versus surgery (bypass, sleeve or band, based on patient preference). The primary outcomes assessed at 6 months were change in homeostatic model of insulin resistance (HOMA-IR) and diabetes remission. Secondary outcomes included changes in HbA1c, weight, and sRAGE. RESULTS: The surgery group had improved HOMA-IR (-4.6 vs +1.6; P = 0.0004) and higher diabetes remission (65% vs 0%, P < 0.0001) than the MWM group at 6 months. Compared to MWM, the surgery group had lower HbA1c (6.2 vs 7.8, P = 0.002), lower fasting glucose (99.5 vs 157; P = 0.0068), and fewer T2DM medication requirements (20% vs 88%; P < 0.0001) at 6 months. The surgery group lost more weight (7. vs 1.0 BMI decrease, P < 0.0001). Higher baseline sRAGE was associated with better weight loss outcomes (r = -0.641; P = 0.046). There were no mortalities. CONCLUSIONS: Surgery was very effective short-term in patients with T2DM and BMI 30 to 35. Baseline sRAGE may predict patients most likely to benefit from surgery. These findings need to be confirmed with larger studies.ClinicalTrials.gov ID: NCT01423877.