34794 Long-term safety and disease control of ruxolitinib cream among Black or African American patients with atopic dermatitis: Pooled results from 2 phase 3 studies

Atopic dermatitis (AD) is an inflammatory skin disease with a prevalence in the United States of approximately 20%/5%–10% in Black or African American children/adults. In 2 phase 3 studies (TRuE-AD1/TRuE-AD2), 1249 patients (≥12 years old, Investigator’s Global Assessment [IGA] score 2/3, 3%–20% affected body surface area [BSA]) were randomized (2:2:1) to twice-daily 0.75% ruxolitinib (Janus kinase [JAK] 1/JAK2 inhibitor) cream, 1.5% ruxolitinib cream, or vehicle for an 8-week, double-blind vehicle-controlled period, followed by a double-blind long-term safety period (LTS; as-needed treatment; assessments every 4 weeks) up to Week 52. Patients initially randomized to ruxolitinib remained on their regimen during the LTS; patients initially on vehicle were rerandomized to either ruxolitinib strength. During the LTS, patients treated areas with active AD only, stopped treatment 3 days after lesion clearance, and restarted treatment at recurrence. Among self-identifying Black or African American patients in the 0.75%/1.5% ruxolitinib groups for the full study in this pooled analysis (n = 91/n = 97), 53.8%/61.9% achieved clear/almost clear skin (IGA 0/1) at Week 8. From Week 12–52, 55.2%–73.3%/59.3%–78.7% of patients (range) achieved IGA 0/1. Mean affected BSA was 8.6%/8.3% at baseline, 3.8%/3.6% at Week 8, and 1.7%–3.3%/1.3%–2.5% (range of mean values) through Week 52. Over 52 weeks, treatment-emergent adverse events were reported in 59.3%/56.7% of patients; treatment-related adverse events were reported in 4.4%/6.2%. Incidence of application site reactions was low. In summary, the majority of Black or African American patients achieved clear/almost clear skin using ruxolitinib cream monotherapy, which was well tolerated

Misconceptions of photoprotection in skin of color

Terrestrial sunlight is the portion of electromagnetic radiation that is emitted by the sun and reaches Earth\u27s surface. It encompasses 3 major components: UV radiation (290-400 nm), visible light (400-700 nm), and infrared radiation. The deleterious effects of UV radiation have been appreciated for decades, particularly among those with light skin tones (Fitzpatrick skin types I-II) who primarily manifest with burns of varying degrees of severity with sun exposure. In recent years, studies have increasingly shown the negative impact of visible light on skin health, particularly in individuals with skin of color (Fitzpatrick skin types IV-VI), including the exacerbation of hyperpigmentation disorders such as melasma and post-inflammatory hyperpigmentation, as well as induction of the former. Recommendations from medical societies and the US Food and Drug Administration for photoprotection have been evolving along with the knowledge base. Yet, misconceptions about skin damage related to sunlight and the benefits of photoprotection (particularly among those with Fitzpatrick skin types V-VI) are still prevalent among both clinicians and patients. Among patients with skin of color, disorders of hyperpigmentation and other consequences from sun exposure have been associated with impaired skin health and negative burden on quality of life. This review summarizes currently available evidence of the impact of both UV and visible wavelengths and the low utilization of photoprotection measures among people with skin of color, with the goal of providing recommendations to help educate patients

Epidemiology and Burden of Sleep Disturbances in Atopic Dermatitis in US Adults

BACKGROUND: The relationship between atopic dermatitis (AD) severity, sleep disturbance (SD), and health-related outcomes is not fully elucidated. OBJECTIVE: The aim of the study was to determine the prevalence of SD in adult AD and its relationship with AD severity and health outcomes among the US population. METHODS: A cross-sectional, US population-based survey study of 2893 adults was performed. RESULTS: Among adults meeting the UK Diagnostic Criteria for AD, 255 (40.7%) reported 1 or more, 67 (11.1%) reported 3 to 4, and 57 (9.5%) reported 5 to 7 nights of SD in the past week; 475 (79.7%) reported at least some trouble sleeping in the past 3 days. Moderate and severe Patient-Oriented Scoring AD, Patient-Oriented Eczema Measure, and Numeric Rating Scale-itch and Numeric Rating Scale-skin pain scores were associated with more severe SD compared with those without AD. More frequent and severe SDs were associated with higher Dermatology Life Quality Index, lower 12-item Short-Form Health Survey, and higher Hospital Anxiety and Depression Scale (HADS) scores. Significant mediation by SD severity was observed between Patient-Oriented Eczema Measure and Numeric Rating Scale-itch with Dermatology Life Quality Index, 12-item Short-Form Health Survey physical and mental component scores, HADS-anxiety and HADS-depression scores, diagnosed anxiety, and heart disease. CONCLUSIONS: Atopic dermatitis and AD severity are associated with SDs. Sleep disturbances considerably impact quality of life and other health outcomes in adults with AD

Baricitinib 2 mg for the treatment of atopic dermatitis in North America: Long-term efficacy and patient-reported outcomes

BACKGROUND: To address the need for long-term efficacy and patient-reported outcomes (PROs) data for patients with atopic dermatitis (AD) treated with baricitinib 2 mg, a study was conducted to evaluate the efficacy of baricitinib 2 mg in adult patients with moderate-to-severe AD. Data presented here provided efficacy and outcomes data for patients treated for 52 weeks. METHODS: Patients who participated in the originating study, BREEZE-AD5 (NCT03435081), and met additional eligibility criteria could enroll in the multicenter, open-label, Phase 3, long-term extension study BREEZE-AD6 (NCT03559270). Patients received baricitinib 2 mg for the duration of BREEZE-AD6. In BREEZE-AD6, the proportion of patients who achieved a 75% improvement in the Eczema Area and Severity Index (EASI75) and validated Investigator Global Assessment for AD (vIGA-AD™) of 0 (clear) or 1 (almost clear) were assessed through 52 weeks, in addition to several PROs. RESULTS: At week 52, the proportion of patients treated with baricitinib 2 mg daily achieving EASI75 was 48.6% (70/144), and 31.3% (45/144) of patients achieved a vIGA-AD score of 0 or 1 (clear or almost clear). Improvements in PROs such as SCORing Atopic Dermatitis (SCORAD, itch and sleep) scores, Dermatology Life Quality Index (DLQI) total score, and DLQI ≤5 response were observed, and these responses were sustained through 52 weeks. CONCLUSION: Long-term efficacy of baricitinib in patients with AD was demonstrated by both clinician and patient-reported outcome measures

Baricitinib 2 mg for the treatment of atopic dermatitis in North America: Long-term efficacy and patient-reported outcomes

To address the need for long-term efficacy and patient-reported outcomes (PROs) data for patients with atopic dermatitis (AD) treated with baricitinib 2 mg, a study was conducted to evaluate the efficacy of baricitinib 2 mg in adult patients with moderate-to-severe AD. Data presented here provided efficacy and outcomes data for patients treated for 52 weeks. Patients who participated in the originating study, BREEZE-AD5 (NCT03435081), and met additional eligibility criteria could enroll in the multicenter, open-label, Phase 3, long-term extension study BREEZE-AD6 (NCT03559270). Patients received baricitinib 2 mg for the duration of BREEZE-AD6. In BREEZE-AD6, the proportion of patients who achieved a 75% improvement in the Eczema Area and Severity Index (EASI75) and validated Investigator Global Assessment for AD (vIGA-AD™) of 0 (clear) or 1 (almost clear) were assessed through 52 weeks, in addition to several PROs. At week 52, the proportion of patients treated with baricitinib 2 mg daily achieving EASI75 was 48.6% (70/144), and 31.3% (45/144) of patients achieved a vIGA-AD score of 0 or 1 (clear or almost clear). Improvements in PROs such as SCORing Atopic Dermatitis (SCORAD, itch and sleep) scores, Dermatology Life Quality Index (DLQI) total score, and DLQI ≤5 response were observed, and these responses were sustained through 52 weeks. Long-term efficacy of baricitinib in patients with AD was demonstrated by both clinician and patient-reported outcome measures

Photoprotection for skin of all color: Consensus and clinical guidance from an expert panel

The negative effects of sun exposure have become better accepted among health care professionals and the lay public over recent decades. Most attention has been focused on the effects of UV light, particularly UVB wavelengths (290-320 nm). Accordingly, products to protect skin from sunlight-associated harm (sunscreens) have been developed to minimize UVB exposure. The effects of longer wavelengths, including UVA (320-400 nm) and visible light (VL, 400-700 nm), are increasingly appreciated. VL accounts for approximately half of the solar radiation that reaches the earth\u27s surface and understanding of its effects on the skin is improving. Studies have shown that VL can induce hyperpigmentation in individuals with dark skin types (Fitzpatrick skin types IV-VI). In addition, VL can contribute to the exacerbation of pigmentary disorders, including melasma. Because these findings are relatively new, there are gaps in understanding the needs for photoprotection and guidance for clinicians. A panel of dermatologists and photobiologists was convened to develop consensus recommendations and clinical guidance about sunscreen use relevant to the current understanding of risks associated with sun exposure using a modified Delphi method

In utero or early in life exposure to antibiotics and the risk of childhood atopic dermatitis, a population-based cohort study.

BACKGROUND: Atopic dermatitis (AD) is a common inflammatory disease of the skin that begins early in life and can be lifelong. The purpose of our study was to evaluate whether fetal exposure and/or early life exposure of a child to antibiotics increases the risk of early onset AD. OBJECTIVE: We hypothesize that antibiotic exposure in utero or early in life (e.g., first 90 days) increases the likelihood that children develop AD. METHODS: Utilizing a large prospectively collected electronic medical records database, we studied the association of antibiotic exposure received in utero or very early in life and the relative risk of onset of AD in a population-based cohort study. Associations were estimated using proportional hazards models as hazard ratios (HR) with 95% confidence intervals (CI). RESULTS: The risk of AD in childhood was increased after in utero or early life antibiotic exposure. For any in utero AB exposure the HR was 1.38 (1.36,1.39). However, penicillin demonstrated the strongest association with AD for both in utero exposure, 1.43 (1.41,1.44), and for childhood exposure, 1.81(1.79,1.82). HRs were higher in children born to mothers without AD than those with AD pointing to effect modification by maternal AD status. CONCLUSION: Children born to mothers exposed to antibiotics while in utero had, depending on the mother's history of AD, approximately a 20 to 40% increased risk of developing AD. Depending on the antibiotic, children who received antibiotics early-in-life had a 40 to 80% increased risk of developing AD. Our study, supports and refines the association between incident AD and antibiotic administration. It also adds population-based support to therapeutic attempts to treat AD by modifying skin microbiome

Atopic Dermatitis in US Adults: From Population to Health Care Utilization

© 2019 American Academy of Allergy, Asthma & Immunology Background: Little is known about the predictors of health care utilization among US adults with atopic dermatitis (AD). Objective: To determine the proportion and predictors of utilization in outpatient, urgent care, emergency department (ED), and hospital settings in US adults with AD. Methods: A cross-sectional, population-based study of 3495 adults was performed. AD was determined using modified United Kingdom Working Party criteria. AD severity was assessed using the Patient-Oriented Eczema Measure (POEM), the Patient-Oriented Scoring AD (PO-SCORAD), and the Numeric Rating Scale (NRS)-itch. Weighted frequency and prevalence (95% CIs) of utilization were determined. Results: Overall, 10.42% (95% CI, 8.55%-12.28%; weighted frequency, 25,844,871) reported a diagnosis of AD or eczema, 7.39% (95% CI, 5.81%-8.97%; weighted frequency, 18,324,869) met United Kingdom Working Party criteria, and 3.56% (95% CI, 2.40%-4.72%; weighted frequency, 8,830,095) met both. A total of 31.8% (2,711,690) had a severe score for POEM, PO-SCORAD, and/or NRS-itch, with 4.0% (337,586) having severe scores for all 3. Outpatient utilization for AD was low for mild disease (29.3%-34.7%) and increased by severity (moderate: 36.2%-49.8%; severe: 50.6%-86.6%). Timeliness of appointments, expenses, and insurance coverage were also predictors of outpatient utilization. Severe POEM, PO-SCORAD, and/or NRS-itch were associated with being uninsured, not having full prescription coverage, AD prescriptions being denied by insurers, and costs of AD medications being problematic. One in 10 adults with AD had 1 or more urgent care, ED, or hospital visit in the past year. Urgent care or ED visits were significantly more common among blacks and Hispanics, those with lower household income, those with lower education level, and those with AD prescriptions being denied by the insurance company. Conclusions: Adults with AD had low rates of outpatient and high rates of urgent care, ED, and hospital visits. The major predictor of outpatient utilization for AD care was AD severity. Racial/ethnic, socioeconomic, and/or health care disparities reduce outpatient utilization and increase urgent care, ED, and hospital utilization