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

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

Expediting patient appointments with dermatology rapid access clinics

Background: Lengthy wait times for dermatology appointments in the U.S. limit care access. The University of Pennsylvania's Department of Dermatology has established an urgent care clinic (UCC) and an intermediate care clinic (ICC) to expedite appointments for higher acuity patients.Objective: To describe our rapid access clinics' operations, referral patterns, and distributions of diagnoses. Methods: We performed a retrospective review of dermatology consult order and appointment data for UCC, ICC, and routine care to determine the number of orders, consult appointments, and follow-up appointments; appointment wait times; and frequencies of diagnoses in referring provider and consult appointments. Press Ganey patient satisfaction ratings were also analyzed.Results: The median (interquartile range) wait times for UCC, ICC, and routine care, appointments were 3 (1-8) days, 36 (15-64) days, and 45 (12-97) days, respectively (P<0.001). The proportion of referrals originating from subspecialists varied among UCC (47.6%), ICC (20.2%) and routine care (15.8%), (P<0.001). Distributions of diagnoses differed among UCC, ICC, and routine care. Ratings for most satisfaction metrics were similar across clinic settings.Conclusions: Dermatology rapid access clinics within an academic medical center can reduce wait times for higher acuity patients while maintaining patient satisfaction

Expediting patient appointments with dermatology rapid access clinics

Background: Lengthy wait times for dermatology appointments in the U.S. limit care access. The University of Pennsylvania's Department of Dermatology has established an urgent care clinic (UCC) and an intermediate care clinic (ICC) to expedite appointments for higher acuity patients.Objective: To describe our rapid access clinics' operations, referral patterns, and distributions of diagnoses. Methods: We performed a retrospective review of dermatology consult order and appointment data for UCC, ICC, and routine care to determine the number of orders, consult appointments, and follow-up appointments; appointment wait times; and frequencies of diagnoses in referring provider and consult appointments. Press Ganey patient satisfaction ratings were also analyzed.Results: The median (interquartile range) wait times for UCC, ICC, and routine care, appointments were 3 (1-8) days, 36 (15-64) days, and 45 (12-97) days, respectively (P<0.001). The proportion of referrals originating from subspecialists varied among UCC (47.6%), ICC (20.2%) and routine care (15.8%), (P<0.001). Distributions of diagnoses differed among UCC, ICC, and routine care. Ratings for most satisfaction metrics were similar across clinic settings.Conclusions: Dermatology rapid access clinics within an academic medical center can reduce wait times for higher acuity patients while maintaining patient satisfaction

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

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

Validation and Interpretation of Short Form 12 and Comparison with Dermatology Life Quality Index in Atopic Dermatitis in Adults

© 2019 The Authors Quality-of-life assessments are not standardized in atopic dermatitis (AD). We sought to determine the validity of the Short Form (SF)-12, a generic quality-of-life assessment, in AD and compare its measurement properties with the Dermatology Life Quality Index (DLQI). A cross-sectional, population-based study of 3,495 adults was performed, including 602 adults who met the modified United Kingdom Working Party Criteria for AD. The SF-12 mental component score and the SF-Six Dimension (SF-6D) had a strong correlation with each other and moderate inverse correlations with the Patient-Oriented Eczema Measure, the Patient-Oriented Scoring Atopic Dermatitis, the Patient-Oriented Scoring Atopic Dermatitis–itch, the Patient-Oriented Scoring Atopic Dermatitis–sleep, and the Numerical Rating Scale of pain (Pearson correlations, P \u3c 0.0001 for all). The SF-12 mental component score and the SF-6D showed good discriminant validity as judged by the analysis of variance and receiver operating curves. The SF-12 physical component score had weak correlations with AD severity assessments and poor discriminant validity. The DLQI had better convergent and discriminant validity than the SF-12. The SF-12 and the DLQI showed good internal consistency (Cronbach alpha, 0.89 and 0.94, respectively). Differential item functioning was found for items in the SF-12 and the DLQI. Floor effects were observed for the DLQI but not for the SF-12 mental component score, the SF-12 physical component score, and the SF-6D. Severity thresholds were selected. In conclusion, the SF-12 mental component score and the SF-6D showed good validity in AD but inferior construct validity compared with the DLQI