Background Given its public health impact, there is need for broad and representative data on the humanistic burden of atopic dermatitis (AD). Objective To establish the humanistic burden of AD in US ...adults. Methods Data were from the 2013 US National Health and Wellness Survey; AD self-reports were propensity-matched with non-AD controls and with psoriasis controls. Bivariate analyses were conducted on burden outcomes between the AD and control groups. Results Demographics and baseline characteristics were comparable between matched groups. Subjects with AD (n = 349) versus non-AD controls (n = 698) had significantly higher rates of anxiety, depression, and sleep disorders (29.8%, 31.2%, and 33.2% vs 16.1%, 17.3%, and 19.2%, respectively all P < .001); a lower Short Form-36 v2 mental component summary score (44.5 vs 48.0, respectively P < .001); a lower physical component summary score (47.6 vs 49.5, respectively P = .004), and lower health utilities (0.67 vs 0.72, respectively P < .001) in addition to a higher work absenteeism rate (9.9% vs 3.6%, respectively P < .001) and activity impairment rate (33.6% vs 25.2%, respectively P < .001). Subjects with AD and psoriasis controls (n = 260 each) showed similar impairment in health-related quality of life and productivity. Limitations Data were self-reported. Conclusion AD is associated with a substantial humanistic burden that is similar in magnitude to that of psoriasis, which is also recognized for its debilitating symptoms, indicating the need for more effective treatments for AD.
Summary Background Dupilumab, a fully human anti-interleukin-4 receptor α monoclonal antibody, inhibits interleukin-4 and interleukin-13 signalling, key drivers of type-2-mediated inflammation. ...Adults with uncontrolled persistent asthma who are receiving medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist require additional treatment options as add-on therapy. We aimed to assess the efficacy and safety of dupilumab as add-on therapy in patients with uncontrolled persistent asthma on medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist, irrespective of baseline eosinophil count. Methods We did this randomised, double-blind, placebo-controlled, parallel-group, pivotal phase 2b clinical trial at 174 study sites across 16 countries or regions. Adults (aged ≥18 years) with an asthma diagnosis for 12 months or more based on the Global Initiative for Asthma 2009 Guidelines receiving treatment with medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist were eligible for participation. Patients were randomly assigned (1:1:1:1:1) to receive subcutaneous dupilumab 200 mg or 300 mg every 2 weeks or every 4 weeks, or placebo, over a 24-week period. The primary endpoint was change from baseline at week 12 in forced expiratory volume in 1 s (FEV1 in L) in patients with baseline blood eosinophil counts of at least 300 eosinophils per μL assessed in the intention-to-treat population. Safety outcomes were assessed in all patients that received at least one dose or part of a dose of study drug. This trial is registered at ClinicalTrials.gov , number NCT01854047 , and with the EU Clinical Trials Register, EudraCT number 2013-000856-16. Findings 769 patients (158 in the placebo group and 611 in the dupilumab groups) received at least one dose of study drug. In the subgroup with at least 300 eosinophils per μL, the greatest increases (200 mg every 2 weeks, p=0·0008; 300 mg every 2 weeks, p=0·0063) in FEV1 compared with placebo were observed at week 12 with doses every 2 weeks in the 300 mg group (mean change 0·39 L SE 0·05; mean difference 0·21 95% CI 0·06–0·36; p=0·0063) and in the 200 mg group (mean change 0·43 L SE 0·05; mean difference 0·26 0·11–0·40; p=0·0008) compared with placebo (0·18 L SE 0·05). Similar significant increases were observed in the overall population and in the fewer than 300 eosinophils per μL subgroup (overall population: 200 mg every 2 weeks, p<0·0001; 300 mg every 2 weeks, p<0·0001; <300 eosinophils per μL: 200 mg every 2 weeks, p=0·0034; 300 mg every 2 weeks, p=0·0086), and were maintained to week 24. Likewise, dupilumab every 2 weeks produced the greatest reductions in annualised rates of exacerbation in the overall population (70–70·5%), the subgroup with at least 300 eosinophils per μL (71·2–80·7%), and the subgroup with fewer than 300 eosinophils per μL (59·9–67·6%). The most common adverse events with dupilumab compared with placebo were upper respiratory tract infections (33–41% vs 35%) and injection-site reactions (13–26% vs 13%). Interpretation Dupilumab increased lung function and reduced severe exacerbations in patients with uncontrolled persistent asthma irrespective of baseline eosinophil count and had a favourable safety profile, and hence in addition to inhaled corticosteroids plus long-acting β2 -agonist therapy could improve the lives of patients with uncontrolled persistent asthma compared with standard therapy alone. Funding Sanofi-Genzyme and Regeneron Pharmaceuticals.
Background The adult burden of atopic dermatitis (AD) is poorly characterized. Objective We sought to characterize AD burden in adults with moderate to severe disease from the patient's perspective. ...Methods Patient-reported outcomes collected at screening in a phase 2b clinical trial of dupilumab included pruritus numeric rating scale, 5-Dimension Pruritus Scale, subjective components of SCORing AD, Patient-Oriented Eczema Measure, Hospital Anxiety and Depression Scale, Dermatology Life Quality Index, and 5-Dimension EuroQol. Results Most of the 380 patients had been living with AD for nearly all their lives, whereas approximately 40% were given a diagnosis as adults; 40.3% had asthma and 60.5% had other allergic conditions. Despite 48.2% of patients using systemic therapies in the past year, patients reported problems with itch frequency (85% of patients), duration (41.5% reported itching ≥18 h/d), and severity (6.5 of 10 on numeric rating scale); 55% reported AD-related sleep disturbances 5 d/wk or more. Hospital Anxiety and Depression Scale scores suggesting clinically relevant anxiety or depression were reported by 21.8% of patients. Quality of life was impaired on Dermatology Life Quality Index and 5-dimension EuroQol. Limitations This study had limited generalizability; conclusions may not reflect those with mild AD or not participating in a clinical trial. Conclusions Adults with moderate to severe AD report multidimensional burden including disease activity, patient-reported symptoms, comorbidities, and quality-of-life impact.
Background Moderate to severe atopic dermatitis (AD) is associated with substantial patient burden despite current therapies. Objective We sought to evaluate dupilumab treatment on patient-reported ...outcomes in adults with moderate to severe AD. Methods Adults (N = 380) with moderate to severe AD inadequately controlled by topical medications were randomized to 16 weeks of double-blind, subcutaneous treatment with dupilumab 100 mg every 4 weeks, 200 mg every 2 weeks, 300 mg every 2 weeks, 300 mg once weekly, or placebo. Patient-reported outcomes included pruritus numeric rating scale; patient-reported sleep item on Scoring AD scale; Patient-Oriented Eczema Measure; Hospital Anxiety and Depression Scale; Dermatology Life Quality Index; and 5-dimension 3-level EuroQol. Results Dupilumab reduced peak itch at 16 weeks relative to placebo by 1.1 to 3.2 points on numeric rating scale ( P < .0001 all doses, except 100 mg every 4 weeks P < .05); improved sleep and health-related quality of life on Dermatology Life Quality Index and 5-dimension 3-level EuroQol ( P < .05 all doses, except 100 mg every 4 weeks); and reduced anxiety and depression symptoms ( P < .05 all doses). Dupilumab's effects appeared early and achieved clinically relevant improvements without significant safety concerns. Limitations There are potential cultural differences affecting patient-reported outcome responses. Outcomes were secondary or exploratory end points. Conclusion Dupilumab produced early and sustained patient-reported and clinically relevant improvements in sleep, mental health, and health-related quality of life; the two 300-mg dose regimens resulted in greatest benefits.
There are gaps in our understanding of the epidemiology of atopic dermatitis (AD) in adults.
To evaluate the prevalence and severity of AD in adults from countries/regions within Asia, Eurasia, Latin ...America, Middle East, and Russia.
This international, web-based survey was performed in Argentina, Brazil, China, Colombia, Egypt, Hong Kong, Israel, Malaysia, Mexico, Russia, Kingdom of Saudi Arabia (KSA), Singapore, Taiwan, Thailand, Turkey, and United Arab Emirates. Questionnaires were sent to adult members of online respondent panels for determination of AD and assessment of severity. A diagnosis of AD required respondents to meet the modified United Kingdom (UK) Working Party criteria and to self-report they had a physician diagnosis of AD. Severity of AD was determined using Patient-Oriented Scoring of Atopic Dermatitis (PO-SCORAD), Patient-Oriented Eczema Measure (POEM), and Patient Global Assessment (PGA).
Among respondents by country/region the prevalence of AD ranged from 3.4% in Israel to 33.7% in Thailand. The prevalence was generally higher in females versus males. Severity varied by scale, although regardless of scale the proportion of respondents with mild and moderate disease was higher than severe disease. PGA consistently resulted in the lowest proportion of severe AD (range 2.4% China – 10.8% Turkey) relative to PO-SCORAD (range 13.4% China – 41.6% KSA) and POEM (range 5.1% China – 16.6% Israel).
This survey highlights the importance of AD in adults, with high prevalence and high morbidity among respondents and emphasizes that AD is not just a disease of childhood—there is disease persistence and chronicity in adults.
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