Search

Objective: In July 2022, an outbreak of Raoultella ornithinolytica infection was detected in users of a hemodialysis center in Granada and central venous catheter (CVC) users. The aim of this study was to describe the development of the outbreak and the control measures implemented as well as to identify the risk factors that may have been related to its origin., Methods: A study of a series of thirteen cases with positive blood culture for Raoultella ornithinolytica was conducted during July 2022. Two hypotheses were considered: direct transmission through contamination of the antiseptic product or cross-contamination through the hands of healthcare personnel. A descriptive data analysis was carried out, with the calculation of attack rates and attributable risk in the exposed group (CVC users)., Results: The center performed dialysis on 117 patients. 36 patients had a CVC, and 81 had an arteriovenous fistula (AVF). The total number of infected cases was 13. The attack rate was 11.1%, being 36.1% in patients with CVC and 0% in patients with AVF. The symptoms occurred between 1 and 3 hours after the start of dialysis, except in three cases that occurred after receiving dialysis in other centers. Samples of water, liquids and antiseptics were negative., Conclusions: An outbreak of Raoultella ornithinolytica bacteraemia is confirmed, due to possible cross-contamination in the CVC handling and antisepsis process. Possibly, the germ was carried by a container of alcoholic chlorhexidine that contaminated the catheter and caused bacteremia during the hemodialysis process., Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Introduction: Atopic dermatitis (AD) affects multiple areas of the body, some of which may be more refractory to treatment. We evaluated improvements in the Eczema Area and Severity Index (EASI) by body region and clinical signs for each body region in lebrikizumab-treated patients with moderate-to-severe AD., Methods: ADvocate 1 and ADvocate 2 compared lebrikizumab 250 mg as monotherapy every 2 weeks versus placebo for 16 weeks. Efficacy measures included EASI, which rates the extent and severity of four clinical signs (erythema, edema/papulation, excoriation, lichenification) in four body regions (head/neck, upper extremities, trunk, lower extremities). Analyses are post hoc., Results: Mean baseline EASI, body region EASI subscores, and the severity of clinical signs were consistent across both studies (EASI ranging from 16.0 to 72.0). At week 16 in both studies, patients treated with lebrikizumab showed significantly greater percent improvement in EASI across all body regions versus placebo (p ≤ 0.001), with improvements as early as week 2. In ADvocate 1, all clinical signs significantly improved across all body regions at week 16 with lebrikizumab (51.4-71.6% improvement) versus placebo (23.1-43.5%, p ≤ 0.001), with significant improvements as early as week 2 for all signs. Significant improvements for all clinical signs at week 16 were also seen in ADvocate 2 for lebrikizumab (53.5-75.6%) versus placebo (28.5-41.2%, p ≤ 0.001) and as early as week 2 for all body regions and signs except head/neck erythema and lower extremity erythema, edema/papulation, and lichenification, which showed significant improvement by week 4., Conclusions: Lebrikizumab as monotherapy consistently and rapidly reduced the extent of involvement and severity of AD in all EASI clinical signs and body regions, including the head and neck region and clinical sign of lichenification, compared with placebo., Trial Registration: ClinicalTrials.gov identifier: ADvocate 1 (NCT04146363) and ADvocate 2 (NCT04178967)., (© 2024. The Author(s).)

Introduction: This real-world, cross-sectional study compared sociodemographic, clinical and treatment characteristics, and patient-reported outcomes (PROs) among racial/ethnic groups in patients with atopic dermatitis (AD) who are candidates for systemic therapy., Methods: This study included adults with dermatologist- or dermatology practitioner-diagnosed AD enrolled in the CorEvitas AD Registry (July 2020-July 2021). All patients initiated systemic therapy within 12 months prior to or at enrollment or had moderate-to-severe AD (vIGA-AD ®  ≥ 3 and Eczema Area and Severity Index [EASI] ≥ 12) at enrollment. Patients were categorized into five mutually exclusive racial/ethnic groups: non-Hispanic White, Black, Asian, Other/Multiracial, and Hispanic (any race). Patient, clinical, and treatment characteristics were captured at enrollment. Differences in means or proportions of characteristics among racial/ethnic groups were descriptively summarized using effect sizes. Adjusted prevalence ratios and mean differences were estimated (White race/ethnicity group as the reference category) with 95% confidence intervals (CI)., Results: Among 1288 patients, 64% (n = 822) were White, 13% (n = 167) Black, 10% (n = 129) Asian, 8% (n = 97) Hispanic, and 6% (n = 73) Other/Multiracial. In adjusted analyses, statistically more severe EASI lichenification was noted among Black compared with White patients at the head and neck (mean difference, 0.21, [95% CI 0.06, 0.36]; p = 0.01), trunk (0.32, [0.17, 0.47]; p < 0.001), upper extremities (0.27, [0.09, 0.44]; p = 0.008), and lower extremities (0.39, [0.21, 0.57]; p < 0.001). Statistically more severe EASI lichenification was observed among Asian vs White patients in certain areas (mean difference, head and neck, 0.22 [0.04, 0.39], p = 0.01; trunk, 0.25 [0.07, 0.43], p < 0.001; lower extremities, 0.22 [0.01, 0.43], p < 0.001) and SCORing for AD lichenification (mean difference: 0.34 [0.15, 0.52]; p < 0.001). Significantly higher mean pruritus over the past 7 days for Black (mean difference: 0.63 [0.01, 1.26] and Hispanic patients (0.60 [0.11, 1.09]; p = 0.03) vs White patients was observed. Among AD clinical features, the prevalence of facial erythema was significantly lower among Black compared with White patients (prevalence ratio = 0.38, [0.22, 0.67]; p = 0.007)., Conclusion: Racial/ethnic differences exist in sociodemographic, clinical and treatment characteristics, disease severity, and PROs among real-world AD patients who are candidates for systemic therapy. Recognizing these variations may be of critical importance for dermatologists for the design and delivery of targeted/personalized medicine approaches., (© 2023. The Author(s).)

Introduction: Atopic dermatitis (AD) is a chronic, inflammatory skin disease characterized by heterogeneous clinical phenotypes and high symptom burden, especially through itch. Baricitinib (BARI), an oral Janus Kinase 1/2 inhibitor, is approved in Europe, Japan, and other countries, for treatment of adults with moderate-to-severe AD who are candidates for systemic therapy. This post hoc analysis of a Phase 3 topical corticosteroid (TCS) combination therapy trial (BREEZE-AD7) aims to characterize patients who might benefit most from BARI., Method: Classification and regression tree (CART) analysis was used to identify baseline predictors for patients treated with BARI 4-mg, who achieved ≥ 75% improvement in Eczema Area and Severity Index (EASI75), or EASI75 or Itch Numerical Rating Scale (NRS) ≥ 4-point improvement at week 16 (responders), versus non-responders. Subgroup efficacy analyses were performed based on identified predictor variables, combined with Itch NRS < 7/ ≥ 7. Missing data were imputed as non-responder., Results: Baseline body surface area (BSA) was identified by CART as strongest variable predicting response to BARI at week 16, with a cut-off around 40% (BSA ≤ 40%). When combining BSA with itch severity, highest response rates were achieved by BARI patients with BSA ≤ 40%/Itch NRS ≥ 7 at baseline. In this subgroup, 69% and 58% of patients treated with BARI 4-mg achieved EASI75 and Itch NRS ≥ 4-point response at week 16, respectively. While these response rates were 65% and 50% for BARI 4-mg patients with baseline BSA ≤ 40%/Itch NRS < 7, they were 33% and 11% in BSA > 40%/Itch NRS < 7, and 32% and 49% in BSA > 40%/Itch NRS ≥ 7 subgroups, respectively., Conclusion: Using a machine learning approach, patients with moderate-to-severe AD and a BSA affecting 10-40% and Itch NRS ≥ 7 were characterized as likely to benefit most from BARI 4-mg TCS combination therapy. This was confirmed by subgroup analyses, which showed that these patients are most likely to show favorable response rates in improving AD signs and symptoms, specifically itch, after 16 weeks of treatment., (© 2023. The Authors.)

Background: Tolerability issues including acne, nausea, and headache have been reported with Janus kinase (JAK) inhibitors for moderate-to-severe atopic dermatitis (AD). Objectives: To report outcomes of tolerability adverse events (AEs) for baricitinib, a JAK1/JAK2 inhibitor, in patients with moderate-to-severe AD. Methods: Acne, headache, and gastrointestinal AEs are reported from placebo-controlled and long-term extensions of pooled data in the baricitinib AD clinical trial program. Proportions of patients with AEs, incidence rates (IRs)/100 patient-years at risk, and median time to onset/duration of AEs were calculated. Results: In 2531 patients treated with baricitinib, most AEs were mild to moderate in severity. Headache was the most common AE of tolerability (median of 14-26 days after first dose of baricitinib, lasting ≤3 days). IRs of acne were <5 in any group lasting up to a median of 90 days with no severe AEs. Diarrhea was the most common gastrointestinal AE, lasting a median of ≤7 days. There were few study drug interruptions (n = 6) and permanent discontinuations (n = 5) for tolerability AEs. Conclusions: For the AEs of tolerability analyzed, baricitinib appears to be well tolerated. Overall, the frequency of these AEs in patients being treated for moderate-to-severe AD was low with few leading to study drug interruption or permanent discontinuation. Clinical Trial Registration number: NCT02576938; NCT03334396; NCT03334422; NCT03428100; NCT03435081; NCT03733301; NCT03334435; NCT03559270.

Background : Inappropriate use of the emergency department (IEDU)-consisting of the unnecessary use of the resource by patients with no clinical need-is one of the leading causes of the loss of efficiency of the health system. Specific contexts modify routine clinical practice and usage patterns. This study aims to analyse the influence of COVID-19 on the IEDU and its causes. Methods : A retrospective, cross-sectional study conducted in the emergency department of a high-complexity hospital. The Hospital Emergency Suitability Protocol (HESP) was used to measure the prevalence of IEDU and its causes, comparing three pairs of periods: (1) March 2019 and 2020; (2) June 2019 and 2020; and (3) September 2019 and 2020. A bivariate analysis and multivariate logistic regression models, adjusted for confounding variables, were utilized. Results : In total, 822 emergency visits were included (137 per period). A total prevalence of IEDU of 14.1% was found. There was a significant decrease in IEDU in March 2020 (OR: 0.03), with a prevalence of 0.8%. No differences were found in the other periods. A mistrust in primary care was the leading cause of IEDU (65.1%). Conclusions : The impact of COVID-19 reduced the frequency of IEDU during the period of more significant population restrictions, with IEDU returning to previous levels in subsequent months. Targeted actions in the field of population education and an improvement in primary care are positioned as strategies that could mitigate its impact.

Atopic dermatitis (AD) is a chronic, heterogenous, inflammatory skin disorder associated with a high skin-related health burden, typically starting in childhood and often persisting into adulthood. AD is characterized by a wide range of clinical phenotypes, reflecting multiple underlying pathophysiological mechanisms and interactions between genetics, immune system dysregulation and environmental factors. In this review, we describe the diverse cellular and molecular mechanisms involved in AD, including the critical role of T-cell-driven inflammation, primarily via T helper (Th) 2- and Th17-derived cytokines, many of which are mediated by the Janus kinase (JAK) signaling pathway. These local inflammatory processes interact with sensory neuronal pathways, contributing to the clinical manifestations of AD, including itch, pain and sleep disturbance. The recent elucidation of the molecular pathways involved in AD has allowed treatment strategies to evolve from broad-acting systemic immunosuppressive therapies to more targeted agents, including JAK inhibitors and cytokine-specific biologic agents. Evidence from the clinical development of these targeted therapies has reinforced and expanded our understanding of the pathophysiological mechanisms underlying AD and holds promise for individualized treatment strategies tailored to specific AD subtypes., (© 2022 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.)

Objective: The increase in the demand for healthcare caused by COVID-19 implies a lower availability of health resources and influences the appropriateness of their use. Due to the variability of demand during the pandemic, the study aimed to compare the appropriateness of hospital admissions between the 2 nd and 5 th phases of the pandemic according to the criteria of the Hospital Emergency Service (CiHRyC). These results were compared with those obtained according to the Pneumonity Severity Index (FINE) and the Appropriateness Evaluation Protocol (AEP). As a secondary objective, the clinical and sociodemographic characteristics of the patients studied were described., Methods: 80 patients hospitalized from the Emergency Department were randomly selected in two study periods (2 nd and 5 th pandemic phase) obtained from the registry of hospitalizations of the Preventive Medicine service of Hospital Ramon y Cajal. Prevalences of inappropriateness were estimated according to the CiHRyC, FINE and AEP and an analysis was performed using univariate logistic regression between epidemiological variables of both periods collected through the electronical medical records., Results: Inappropriateness of admissions were 35% and 45% in the 2 nd and 5 th phase of the pandemic according with CiHRyC, 25% and 5/% according with FINE and 0% and 5% according with AEP. Median age was 71.4 and 50.0 years in 2 nd and 5 th phase (p=0.02). 72.5% and 17.5% of the patients in the 2 nd and 5 th phases had at least one risk factor for COVID-19 severe illness (p<0.01)., Conclusions: The measurement tools used identified more inappropriately cases in the 5 th phase of the pandemic than in the 2 nd one. CiHRyC coincided with FINE and AEP in the result of their evaluation., Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Introduction: Alopecia areata (AA) is an autoimmune disorder causing sudden, non-scarring hair loss. There are currently no drugs approved for AA treatment. This study assessed prevalence of comorbidities, treatments, and healthcare costs and resource utilization among patients with AA in the USA., Methods: Patients diagnosed with AA between January 2011 and December 2018 were identified in IBM MarketScan ® Research Databases. Eligible patients had no other hair loss-related disorders and were continuously enrolled with medical and pharmacy benefits at least 12 months before and after AA diagnosis. Descriptive statistics were used to summarize comorbid conditions, treatments related to AA or other autoimmune/inflammatory conditions, and all-cause and AA-specific healthcare costs and resource utilization identified from claims data., Results: A total of 68,121 patients with AA were identified. Mean (SD) age was 40.3 (17.8) years and 61.0% were female. The most common comorbidities included hyperlipidemia (22.4%), hypertension (21.8%), thyroid disorders (13.1%), contact dermatitis or eczema (10.8%), depression (9.5%), and anxiety (8.4%). Comorbid autoimmune diseases included atopic dermatitis (2.8%), psoriasis (2.1%), chronic urticaria (1.5%), and rheumatoid arthritis (1.1%). During the 12-month follow-up period, 37,995 patients (55.8%) were prescribed treatment for their AA or other comorbid autoimmune/inflammatory disease; 44.9% of treated patients were prescribed therapy within 7 days of AA diagnosis. Of patients receiving treatment, 80.3% received topical steroids and 30.0% received oral steroids. Mean (SD) total healthcare costs were $11,241.21 ($43,839.69) for all-causes and $419.12 ($1534.99) for AA. AA-related expenses were driven by outpatient and prescription costs., Conclusion: Patients with AA have a high comorbidity burden and lack of treatment. Current AA treatments, including systemic therapies other than oral steroids, were not frequently utilized in this study population. Healthcare costs incurred by patients with AA went beyond AA-related expenses. Longitudinal data are needed to better understand treatment trajectories and the disease burden in patients with AA., (© 2021. The Author(s).)

Background: Baricitinib is an oral, selective, reversible Janus kinase 1/2 inhibitor approved in the European Union and Japan and under investigation in the United States for treatment of atopic dermatitis (AD)., Objectives: To evaluate the impact of baricitinib plus background topical corticosteroids (TCS) on health-related quality of life (HRQoL), how AD symptoms impact work productivity and life functioning, and treatment benefit using patient-reported outcome (PRO) assessments in patients with moderate-to-severe AD previously experiencing inadequate response to TCS., Methods: Adult patients with AD in BREEZE-AD7, a Phase 3, multicentre, double-blind trial, were randomised 1 : 1 : 1 to daily oral placebo (control) or baricitinib 4- or 2-mg plus TCS. PROs reported Week 1 through Week 16: Dermatology Life Quality Index (DLQI), Work Productivity and Activity Impairment-AD (WPAI-AD); Patient-Reported Outcomes Measurement Information System (PROMIS) Itch and Sleep measures, and Patient Benefit Index (PBI). Data were analysed using logistic regression (categorical) and mixed model repeated measures (continuous). PBI scores were analysed using analysis of variance., Results: A total of 329 patients were randomised. Treatment with baricitinib 4-mg (N = 111) or 2 mg (N = 109) plus TCS led to rapid, statistically significant improvements [vs. TCS plus placebo (N = 109)] in DLQI ≥4-point improvement starting at Week 2 (4-mg plus TCS, P ≤ 0.001; 2-mg plus TCS P ≤ 0.05), change from baseline in WPAI-AD presenteeism at Week 1 (4-mg plus TCS, P ≤ 0.01; 2-mg plus TCS P ≤ 0.05) and PROMIS itch interference at Week 2 (4-mg plus TCS P ≤ 0.01). Improvements were sustained through Week 16 for baricitinib 4-mg. Statistically significant improvements were observed at Week 16 for PBI global score (4-mg plus TCS, P ≤ 0.001; 2-mg plus TCS P ≤ 0.05)., Conclusions: Baricitinib plus TCS vs. placebo plus TCS showed significant improvements in treatment benefit at Week 16 and rapid significant improvements in HRQoL and impact of AD symptoms on work productivity and functioning through 16 weeks., (© 2021 Eli Lilly and Company. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.)

Introduction: Atopic dermatitis (AD) is associated with risk factors for venous thromboembolism (VTE). However, the risk of VTE among this population is unknown. The aim of this study was to assess the risk of VTE among adults with AD and compare the risk vs. matched non-AD controls., Methods: This retrospective study used claims data from the IBM Watson MarketScan ® Commercial Claims and Encounters, Medicare Supplemental, and Medicaid databases to identify adults aged 18 years or older with AD. Incidence rates (IR) per 100 person-years (PY) of VTE were reported for three cohorts: overall AD, moderate-to-severe AD, and non-AD controls matched by age, sex, and calendar time to the overall cohort. Cox proportional hazards regression was used to estimate hazard ratios (HR) for VTE risk., Results: Overall, 198,685 patients with AD were identified. Crude VTE IRs were 0.24 for AD overall, 0.31 for moderate-to-severe AD, and 0.25 for non-AD controls. VTE risk was similar in patients with AD vs. non-AD controls (partially adjusted HR 1.00, 95% confidence interval [CI] 0.92, 1.09). VTE risk was greater in patients with moderate-to-severe AD vs. non-AD controls in partially adjusted models (HR 1.24, 95% CI 1.13, 1.36), but not after adjustment for healthcare use and VTE risk factors (HR 0.95, 95% CI 0.85, 1.07)., Conclusions: AD was not an independent risk factor for VTE, and the risk of VTE among patients with AD was low. These findings provide valuable context for understanding VTE risk among patients with AD, which is particularly relevant as advanced therapies for the treatment of moderate to severe AD, such as janus kinase inhibitors, become available.

Skin pain is increasingly recognized as an impactful symptom in atopic dermatitis (AD) because of its association with patient discomfort, disease burden, and reduced quality of life. Although the nature of skin pain in AD has not been systematically studied and is therefore not well understood, patients report soreness, discomfort, and tenderness that may reflect peripheral and central pain sensitization. The high prevalence of skin pain suggests that it is not adequately addressed by current therapies for AD and may be undertreated compared with other symptoms. This review discusses the clinical relevance of skin pain with respect to its experience, pathophysiology, relationship with itch, and treatment implications. Recent studies suggest that skin pain presents as a neuropathic symptom independent from itch and the &ldquo;itch-scratch cycle&rdquo;, and poses a unique burden to patients. Recognition of the significant consequences of skin pain and discomfort should reinforce the need to assess and treat this symptom in patients with moderate-to-severe AD. J Drugs Dermatol. 2020;19(10)921-926. doi:10.36849/JDD.2020.5498.

Background: Atopic dermatitis (AD) has a negative impact on patients&rsquo; quality of life (QoL)., Objective: To report the impact of specific AD lesion locations on QoL in adult patients with AD using real-world data., Methods: The Adelphi US Disease Specific Programme was conducted between January&ndash;April 2018. Physicians documented patient demographics/characteristics, AD lesion locations, and body surface area; patients completed questionnaires reporting the impact of lesion locations on QoL., Results: AD severity was moderate in 51.6% of patients and severe in 6.0%. Lesions were commonly identified in more than one location. All AD lesion locations impacted QoL. Visible areas were most bothersome, including head/neck (68%), hands/fingers (58%), front (30%), upper extremities (22%), and lower extremities (16%), with statistically significant associations for a number of Dermatology Life Quality Index (DLQI) items. Itch, soreness, pain, and stinging are also associated with a number of body areas but in particular with those that are most visible/accessible. Lesions on the head/neck and hands/fingers (58%) demonstrated an increased impact on the anxiety and depression dimension of the EuroQol 5-Dimension tool., Conclusions: In patients with AD, quality of life was most affected in patients with lesions in visible areas, including head/neck, hands/fingers, and upper extremities, with statistically significant associations for a number of DLQI domains. Physicians should be aware of the burden of AD lesions on QoL and consider having conversations with patients to better understand the impact of these lesions. Prior presentation: 28th Annual European Academy of Dermatology and Venereology Congress; 9&ndash;13 October 2019, Madrid, Spain. Poster number P0233.J Drugs Dermatol. 2020;19(10): 943-948. doi:10.36849/JDD.2020.5422.

For the purpose of assessing the impact of ultrasound in patients with acute shoulder pain, we conducted an analysis of quality health care indicators: need for reevaluation of the pain, rate of referral to specialized medicine and length of time in the emergency department. We reviewed the 1,433 records of patients attended to between 2015 and 2016. Thirty days after the first examination, 90 patients (10.1%) had returned to the control group (56 through the emergency department and 34 because of the), whereas, in the ultrasound (US) group, 14 (2.5%) had returned at least once (12 through the emergency department and 2 because of the PCC) (P<.001). The rate of referral to specialized medicine in the control group was 36.5%, whereas in the US group it was 6.21% (P<.0001). The average length of stay was 94.5 (standard deviation [SD] 34.3) minutes in the control group and 105.4 (SD 40.1) minutes in the US group (P<.0001). Our results suggest that the practice of shoulder ultrasound improves health care quality in these patients, at the cost of a slight increase in health care time., (Copyright © 2018 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.)

Background: Antibiotic resistance presents a threat to public health. In dermatology, antibiotics are used extensively for the treatment of acne, sometimes for extended periods. Thus, awareness of antibiotic resistance among dermatology patients is relevant in clinical practice. Methods: An online survey assessed antibiotic resistance awareness in adults with acne (n=809) and the parents of adolescents with acne (n=210). Results: More than 80 percent of subjects said that they were "somewhat familiar" or "very familiar" with antibiotic resistance. Overall, 86 percent of the survey respondents identified the correct definition of antibiotic resistance, with parents more likely than their children to choose the proper definition of resistance, as follows: "When antibiotics and/or antibacterials are used for a period of time, the infectious organism adapts to them and becomes immune, resulting in less effective treatment" (95% confidence interval). Among subjects who might have been prescribed antibiotic treatment for their acne, including individuals that reported antibiotic treatment and individuals that were not sure, 76.9 percent reported that they would be very or extremely likely to use effective antibiotic-free options if given the opportunity. More than 90 percent of people with acne and their parents agreed that healthcare providers should do more to educate patients about antibiotics and antibiotic resistance. Conclusions: This survey indicated that patients with acne and their parents think more should be done to educate the public about about the potential risks associated with antibiotic use and the availability of antibiotic-free treatment options. Discussions with patients about antibiotic therapies, antibiotic resistance, and alternative therapies represent areas of opportunity for healthcare providers in dermatology., Competing Interests: FUNDING:This study was funded by Galderma Laboratories, LP. DISCLOSURES:Drs. Del Rosso, Rosen, and Palceski are consultants and investigators for Galderma. Dr. Del Rosso has served as a research investigator and speaker for Galderma. Dr. Rueda was an employee of Galderma at the time this article was written.

Introduction: Acne treatment guidelines suggest a combination approach with topical therapy including a topical retinoid, benzoyl peroxide and an oral antibiotic, or oral isotretinoin (OI), as first-line treatment options for severe acne vulgaris (AV). This study evaluated the efficacy and safety of a daily regimen of 0.3% adapalene and 2.5% benzoyl peroxide (0.3% A/BPO) gel and oral doxycycline 100 mg twice daily in severe (nonnodulocystic, non-conglobate) inflammatory AV., Methods: This was a phase 4, 12-week, single-arm, openlabel, multi-center investigational study. Subjects (males and females, 12 or older, with severe inflammatory AV, Investigator Global Assessment [IGA] 4, and less than equal to 4 nodulocystic lesions, n=186) were considered OI candidates at baseline by the investigator. OI candidacy was re-evaluated at each study visit. Efficacy endpoints included inflammatory lesion (IL) reduction (week 12), IGA success (defined as IGA 0 [Clear] or 1 [Almost Clear], weeks 4, 8, and 12), percent reduction in lesions (weeks 4, 8, and 12), and subject questionnaires (week 12). Safety assessments included adverse events (AEs) and tolerability., Results: Mean IL counts were significantly reduced from baseline to the end of the study (mean [SD]; baseline, 44.8 (21.73); week 12, 14.8 (16.11); mean percent reduction, 66.2% [30.47]; P less than .0001). By week 12, 37.1% of subjects achieved IGA Success (n=69, P less than .0001). Most subjects self-reported at least moderate improvement in AV (90.2%), and were "Satisfied" or "Very Satisfied" with the study treatment overall (83.2%). 41.9% of the subjects were no longer considered by their investigator to be OI candidates at week 4. At 12 weeks, only 19.9% were still considered OI candidates., Conclusion: 0.3% A/BPO + DOX is an effective and safe treatment option for severe inflammatory AV, before starting OI treatment, or as an alternative when OI cannot be used. ClinicalTrials.gov identifier: NCT02899000

J Drugs Dermatol. 2018;17(3):264-273.

Objectives: To evaluate the efficacy and safety of adapalene 0.1% benzoyl peroxide 2.5% gel in women aged 25 years or older via subgroup analysis of existing Phase 2 and 3 study data. Methods: Meta-analysis of pooled data from three multicenter, randomized, double-blind, vehicle-controlled, parallel-group, clinical trials compared results of treatment with either adapalene 0.1% benzoyl peroxide 2.5% gel or vehicle gel in adult females and teen-aged females. Efficacy assessments included investigator's global assessment and median percent change in acne lesions. Safety assessments included skin tolerability and adverse events. Results: Two hundred fifty-four adult females and 488 teen-aged females were included in the analyses, and baseline characteristics were comparable between subjects receiving adapalene 0.1% benzoyl peroxide 2.5% or vehicle. Both adult females and teen-aged females in the adapalene 0.1% benzoyl peroxide 2.5% arm were significantly more often rated clear/almost clear compared with those in the vehicle arm at Weeks 8 ( P =0.016) and 12 ( P <0.001); at endpoint, success was achieved in 39.2 percent with adapalene 0.1% benzoyl peroxide 2.5% and 18.5 percent with vehicle. Comparison of the amount of difference between active and vehicle reductions in investigator's global assessment showed that efficacy was similar for adult females versus teen-aged females (20.7% vs. 19.9%, respectively). Adapalene 0.1% benzoyl peroxide 2.5% had a rapid onset of action, with statistically significant reductions in all acne lesion types versus vehicle observed by Week 1. Adapalene 0.1% benzoyl peroxide 2.5% was safe and well-tolerated by adult females with a tolerability profile consistent with that seen in teen-aged females. Conclusions: The once-daily fixed-dose combination product adapalene 0.1% benzoyl peroxide 2.5% is an efficacious, safe, and well-tolerated treatment for adult female acne, with a profile similar to that in teen-aged females.

Introduction: Atrophic scarring occurs throughout the course of inflammatory acne and across the spectrum of severity. This study evaluates perceptions of the general population toward individuals with clear skin and acne scars., Methods: An online survey administered in the USA, UK, Japan, Germany, France and Brazil to respondents 18 years and over presented three facial pictures of clear skin or digitally superimposed acne scars (but no active acne lesions) in a random fashion. At least one clear and one scar picture were presented to each participant., Results: Among the 4618 responders, 33% themselves had facial acne scars. The skin was the first thing noticed about the face by 41% when viewing pictures with scars vs 8% viewing clear skin (p < 0.05). Those with scars were less likely to be considered attractive (17% vs 25%), confident (25% vs 33%), happy (23% vs 30%), healthy (21% vs 31%) and successful (17% vs 24%), and more likely to be perceived as insecure (15% vs 8%) and shy (23% vs 14%) compared with those with clear skin (all p < 0.05). The significance of the responses obtained varied according to the acne and scar status of the respondent. Skin care was cited as the habit most in need of improvement by 59% vs 13% of respondents viewing pictures with scars vs clear skin, respectively (p < 0.05). All respondent subgroups cited skin care irrespective of their own acne and scar status (all p < 0.05 vs pictures with clear skin). Those with scars were thought less likely to have a promising future (78% vs 84%) than those with clear skin (p < 0.05). The majority of respondents reported willingness to pay money to eradicate scars., Conclusion: The results of this multi-national survey demonstrate that facial acne scars are perceived negatively by society, confirming the importance of preventing acne scars with early treatment of inflammatory acne., Funding: Galderma International S.A.S France.

Background: Post-acne atrophic scarring is a major concern for which standardized outcome measures are needed. Traditionally, this type of scar has been classified based on shape; but survey of practicing dermatologists has shown that atrophic scar morphology has not been well enough defined to allow good agreement in clinical classification. Reliance on clinical assessment is still needed at the current time, since objective tools are not yet available in routine practice.
, Objectives: Evaluate classification for atrophic acne scars by shape, size, and facial location and establish reliability in assessments.
, Methods: We conducted a non-interventional study with dermatologists performing live clinical assessments of atrophic acne scars. To objectively compare identification of lesions, individual lesions were marked on a high-resolution photo of the patient that was displayed on a computer during the clinical evaluation. The Jacob clinical classification system was used to define three primary shapes of scars 1) icepick, 2) boxcar, and 3) rolling. To determine agreement for classification by size, independent technicians assessed the investigators' markings on digital images. Identical localization of scars was denoted if the maximal distance between their centers was &le; 60 pixels (approximately 3 mm). Raters assessed scars on the same patients twice (morning/afternoon). Aggregate models of rater assessments were created and analyzed for agreement.
, Results: Raters counted a mean scar count per subject ranging from 15.75 to 40.25 scars. Approximately 50% of scars were identified by all raters and ~75% of scars were identified by at least 2 of 3 raters (weak agreement, Kappa pairwise agreement 0.30). Agreement between consecutive counts was moderate, with Kappa index ranging from 0.26 to 0.47 (after exclusion of one outlier investigator who had significantly higher counts than all others). Shape classifications of icepick, boxcar, and rolling differed significantly between raters and even for same raters at consecutive sessions (P&lt;.001 and P=0.4, respectively). Analysis showed only 65% of scars were identical in both sessions. We also found that there is a threshold of detection in terms of size, with poor agreement among investigators for very small scars (&lt;2 mm). The repeatability of identification of scars &ge; 2.0 mm was acceptable, and we found that increasing scar size was positively correlated with agreement. Reliability was improved when only scars &gt;2 mm were included. For smaller scars (&lt;2 mm), inter-rater reliability was poor.
, Conclusions: While intuitively it makes sense that describing scar morphology could guide treatment, we have shown that shape-based evaluations are subjective and do not readily yield strong agreement. Until there is a more objective way to evaluate morphology that is readily available to practicing clinicians, we propose that size should be considered a primary characteristic for scar classification systems. We further suggest classification of &lt;2 mm, 2-4 mm, and &gt;4 mm based on how the size would likely affect diagnostic and therapeutic choices. Finally, we recommend that scars &lt;2 mm not be included in a clinical classification but should be evaluated by an objective method that may be refined in the future. , , J Drugs Dermatol. 2016;15(6):693-702.

Background: A need exists for topical treatments in managing more severe inflammatory acne., Objectives: The objectives of this study were to evaluate the efficacy and safety of adapalene 0.3 %/benzoyl peroxide 2.5 % (0.3 % A/BPO) topical gel in subjects with moderate and severe inflammatory acne., Methods: This was a multicenter, randomized, double-blind, parallel-group study. Randomization was stratified by acne severity (50 % moderate and 50 % severe). Subjects received 0.3 % A/BPO, 0.1 % A/BPO (benchmark), or vehicle (comparator) once daily for 12 weeks. Co-primary efficacy endpoints were success rate at week 12 (the percentage of subjects rated 'clear' or 'almost clear' with at least a 2-grade improvement on Investigator's Global Assessment [IGA]) and change in inflammatory (IN) and noninflammatory (NIN) lesion counts from baseline to week 12. Secondary efficacy endpoints were percent changes in IN and NIN lesion counts. Safety endpoints were incidence of adverse events (AEs) and local tolerability signs/symptoms., Results: A total of 503 subjects were randomized: 217, 217, and 69 subjects in the 0.3 % A/BPO, 0.1 % A/BPO, and vehicle groups, respectively. For success rate (subjects rated 'clear' or 'almost clear' with ≥2-grade improvement in IGA), 0.3 % A/BPO was superior to vehicle, with a treatment difference of 22.7 % (33.7 vs. 11.0 %; 95 % confidence interval [CI] 12.8-32.6, p < 0.001). At week 12, 0.3 % A/BPO was superior to vehicle for mean reduction from baseline in IN (27.0 vs. 14.4) and NIN lesion counts (40.2 vs. 18.5), as well as for percentage reduction from baseline in IN (68.7 vs. 39.2 %) and NIN lesion counts (68.3 vs. 37.4 %) (all p < 0.001). Among subjects with severe inflammatory acne (IGA = 4), 0.1 % A/BPO did not reach statistical significance for success rate compared with vehicle (p = 0.443), whereas 0.3 % A/BPO demonstrated significantly greater efficacy (p = 0.029, requiring ≥3-point IGA improvement). Additionally, 0.3 % A/BPO was safe and well-tolerated., Conclusions: Results of this clinical trial demonstrate the significantly greater efficacy of adapalene 0.3 % A/BPO topical gel compared with vehicle as well as a good safety profile in the treatment of moderate to severe inflammatory non-nodulocystic acne, which increases patients' treatment options. CLINICALTRIALS., Gov Identifier: NCT01880320.

Purpose: There is strong evidence that exercise training has beneficial health effects in patients with cardiovascular disease. Most studies have focused on moderate continuous training (MCT); however, a body of evidence has begun to emerge demonstrating that high-intensity interval training (HIIT) has significantly better results in terms of morbidity and mortality. The aim of this study was to compare the effects of MCT versus HIIT on functional capacity and quality of life and to assess safety., Methods: Seventy-two patients with ischemic heart disease were assigned to either HIIT or MCT for 8 weeks. We analyzed cardiopulmonary exercise test data, quality of life, and adverse events., Results: High-intensity interval training resulted in a significantly greater increase in (Equation is included in full-text article.)O2peak (4.5 ± 4.7 mL·kg·min) compared with MCT (2.5 ± 3.6 mL·kg·min) (P < .05). The aerobic threshold (VT1) increased by 21% in HIIT and 14% in MCT. Furthermore, there was a significant (P < .05) increase in the distance covered in the 6-minute walk distance test in the HIIT group (49.6 ± 6.3 m) when compared with the MCT group (29.6 ± 12.0 m). Both training protocols improved quality of life. No adverse events were reported in either of the groups., Conclusions: On the basis of the results of this study, HIIT should be considered for use in cardiac rehabilitation as it resulted in a greater increase in functional capacity compared with MCT. We also observed greater improvement in quality of life without any increase in cardiovascular risk.

Background: More effective therapies are needed in the specific treatment of severe inflammatory acne vulgaris., Objectives: To demonstrate superior efficacy of adapalene 0.3%-benzoyl peroxide 2.5% gel (0.3% A/BPO) vs. vehicle, and to assess efficacy of 0.3% A/BPO vs. 0.1% A/BPO in subjects with severe inflammatory acne (Investigator's Global Assessment [IGA] of 4) in the context of a larger trial in a moderate and severe population., Methods: This was a multicenter, randomized, double-blind, parallel-group, 12-week study. Subjects were randomized to receive 0.3% A/BPO, 0.1% A/BPO (benchmark) or vehicle (comparator) once daily for 12 weeks. Co-primary efficacy endpoints were success rate at week 12 (percentage of subjects rated "clear" or "almost clear," ≥ 3-grade IGA improvement), and change in inflammatory (IN) and noninflammatory (NIN) lesion counts from baseline to week 12. Secondary efficacy endpoints were percent changes in IN and NIN lesion counts. Safety endpoints were incidence of adverse events (AEs) and local tolerability signs/symptoms., Results: In the severe inflammatory acne population, a total of 252 subjects were randomized with 106, 112 and 34 subjects in the 0.3% A/BPO, 0.1% A/BPO and vehicle groups, respectively, reaching a high rate of study completion (88.5%). At week 12, both 0.3% A/BPO and 0.1% A/BPO were superior to vehicle in terms of lesion count reduction. However for success rate, only 0.3% A/BPO achieved significantly greater efficacy over vehicle with a treatment difference of 20.1% (31.9% vs. 11.8%; 95% Confidence Interval (CI): [6.0%, 34.2%], P=.029), whereas 0.1% A/BPO did not (treatment difference vs. vehicle of 8.8%; P=.443). This translates to an 11% difference between active treatments in favor of 0.3% A/BPO. Also, 0.3% A/BPO was safe and well tolerated., Conclusions: Availability of this new treatment option should allow clinicians to better customize severe inflammatory acne management, and the high-strength product provides a step-up treatment when needed.

Background: In 2009 a system was introduced for the automatic import (AI) of cases with suspected notifiable diseases (ND) from electronic medical record (EMR) to RedAlerta, an application for surveillance in Andalusia. At present, the contribution of this system to classical active statement has not been determined enough. The main objective of this study is to evaluate the usefulness of IA in the province of Granada, between 2009 and 2014., Methods: During the study period (2009-2014), an epidemiologist assessed whether AI met declaration criteria or not. We calculate the contribution of AI to RedAlerta and the percentage of validation of AI, estimating 95% CI., Results: The contribution of AI was 17.3% (95% CI 16.1 to 18.5); and type of statement, 5.2% (95% CI 4.1 to 6.5) for urgent and 24.4% (95% CI 22.7 to 26.2) for ordinary. The contribution was higher (more than 45%) in Lyme disease, congenital hypothyroidism, genital herpes, hepatitis C and other viral hepatitis. 30% (95% CI 28.1 to 32) of AI were validated; 39.9% (95% CI 33 to 47.2) urgent and 29.1% (95% CI 27.2 to 31.2%) ordinary. The percentage of validation was higher than 45% (between 47.5 and 100%) in vaccine-preventable diseases, sexually transmitted infections and low incidence., Conclusions: Although not replace manual reporting and requires verification, the AI system is useful and increases the completeness of the epidemiological surveillance system.

Introduction: Routine use of doxycycline (DC) 100 mg for the treatment of moderate to severe acne may be associated with gastrointestinal adverse events (AEs), thus potentially impacting patient adherence, and antibiotic resistance. This study evaluated the safety and efficacy of subantimicrobial, modified-release (MR) DC 40 mg compared to DC 100 mg and to placebo for the treatment of inflammatory lesions in moderate and severe acne., Methods: 662 subjects aged 12 years or older with moderate to severe acne received subantimicrobial, MR-DC 40 mg tablets, DC 100 mg capsules, or placebo once daily for 16 weeks., Results: MR-DC 40 mg was superior to placebo in the mean reduction of the number of inflammatory lesions, median percent reduction in inflammatory and total lesions, and success rate. MR-DC 40 mg was also comparable to DC 100 mg in the reduction of the number of inflammatory lesions, and percent reduction of total lesions. Incidence of drug-related AEs for MR-DC 40 mg was similar to placebo and was markedly smaller compared to DC 100 mg., Discussion: MR-DC 40 mg demonstrated comparable efficacy and superior safety to DC 100 mg in the treatment of moderate to severe inflammatory acne.

Optimal management of acne vulgaris requires incorporation of several components including patient education, selection of a rational therapeutic regimen, dedicated adherence with the program by the patient, and integration of proper skin care. Unfortunately, the latter component is often overlooked or not emphasized strongly enough to the patient. Proper skin care may reduce potential irritation that can be associated with topical acne medications and prevents the patient from unknowingly using skin care products that can actually sabotage their treatment. This article reviews the effectiveness, skin tolerability, safety, and patient satisfaction of an open label study in which a specified skin care regimen is used in combination with topical therapy. The study was designed to mirror "real world" management of facial acne vulgaris clinical practice. The skin care regimen used in this study included a brand foam wash and a brand moisturizer with SPF 30 photoprotection, both of which contain ingredients that are included to provide benefits for acne-prone and acne-affected skin.

Rosacea is a chronic inflammatory disease with a complex pathophysiology that manifests with central facial redness with or without papulopustular lesions. Often, patients with rosacea present with a constellation of signs and symptoms; for best results, the treatment plan should take into account all symptoms manifesting in the individual patient. The first available pharmacologic treatment to address the redness associated with rosacea is topical brimonidine. In the United States, brimonidine topical gel 0.33% is indicated for persistent facial erythema of rosacea; approval was based on clinically significant efficacy and good safety data from large-scale clinical trials. Use of brimonidine in routine clinical practice has yielded new insights that elaborate on the findings from clinical trials. For example, real-world use has shown that a percentage of patients (in our experience, approximately 10 to 20%) treated with brimonidine experience a worsening of erythema that has been called "rebound." Our routine use of this agent for >1 year has yielded strategies to set patient expectations, optimize treatment initiation, and minimize potential problems; this article details those strategies. Because we believe that the term "rebound" has been used to describe several physiologically distinct events, we have also proposed more specific terminology for such events.

Introduction: Acne is a chronic inflammatory disease. Key to a patient's success on fixed-dose adapalene-benzoyl peroxide (BPO) gel is ensuring adherence. Use of a pump system to deliver a pre-measured amount of gel with each pressure enables application of a more consistent dose vs. the tube, which should improve adherence. In the present study, we evaluate patient preference for two different containers for dispensing adapalene-BPO gel., Methods: In this 15-day, open-label study, 300 subjects were asked to treat their acne using fixed-dose adapalene 0.1%-BPO 2.5% gel dispensed in either a tube or a pump once-daily for up to 7 days. At week 1, subjects switched to the alternative packaging design for the same timeframe. At the end of the treatment period, subjects were asked to complete a subject preference survey., Results: Among subjects completing the survey (n = 291), 79.0% (n = 230) preferred the pump for dispensing adapalene-BPO gel and 21.0% (n = 61) preferred the tube (p < 0.001). The top three characteristics of the pump were that it was easy to use (89.0%; n = 259/291), clean (73.2%; n = 213/291) and convenient (69.4%; n = 202/291). When asked to rate their experience with using the pump, 91.8% (n = 267/291; p < 0.001) of subjects reported being satisfied on a self-assessment scale. The majority of subjects stated they would tell their doctor about their preference for the pump next time adapalene-BPO gel was prescribed (76.6%; n = 223/291; p < 0.001) and would prefer the pump if both containers cost the same amount (80.1%; n = 233/291; p < 0.001)., Conclusion: Patients prefer using a pump instead of a tube to dispense adapalene-BPO gel. This delivery mechanism helps to ensure consistent application and thus may improve patient adherence to the prescribed acne treatment regimen.