The use of nonstandardized and inadequately validated outcome measures in atopic eczema trials is a major obstacle to practising evidence-based dermatology. The Harmonising Outcome Measures for Eczema (HOME) initiative is an international multiprofessional group dedicated to atopic eczema outcomes research. In June 2011, the HOME initiative conducted a consensus study involving 43 individuals from 10 countries, representing different stakeholders (patients, clinicians, methodologists, pharmaceutical industry) to determine core outcome domains for atopic eczema trials, to define quality criteria for atopic eczema outcome measures and to prioritize topics for atopic eczema outcomes research. Delegates were given evidence-based information, followed by structured group discussion and anonymous consensus voting. Consensus was achieved to include clinical signs, symptoms, long-term control of flares and quality of life into the core set of outcome domains for atopic eczema trials. The HOME initiative strongly recommends including and reporting these core outcome domains as primary or secondary endpoints in all future atopic eczema trials. Measures of these core outcome domains need to be valid, sensitive to change and feasible. Prioritized topics of the HOME initiative are the identification/development of the most appropriate instruments for the four core outcome domains. HOME is open to anyone with an interest in atopic eczema outcomes research.
Two single doses of 750 mg mepolizumab did not result in clinical success in patients with AD, despite a significant decrease in peripheral blood eosinophils.
Summary
Conjunctivitis is a common condition that causes the eye to become red, itchy and oozing. It is common in patients with atopic dermatitis (also called eczema), and in other allergic diseases, including asthma. Apart from allergies, conjunctivitis can also be caused by infections, chemicals, irritants, and other diseases. Dupilumab is a prescription medicine approved in the USA for people 12 years and older with moderate‐to‐severe AD uncontrolled by topical (applied to the skin) prescription medicines or who cannot use topical medicines, for adults in other countries whose AD is uncontrolled with existing therapies, and for people 12 years and older for maintenance treatment of moderate‐to‐severe asthma uncontrolled with their current medicines. Dupilumab blocks activity of specific substances that cause these allergic diseases. In most AD studies, more dupilumab‐treated patients had conjunctivitis than patients on placebo (dummy drug). To investigate this effect, the authors assessed rates, risk factors, severity, and outcomes of conjunctivitis in 11 dupilumab studies in AD, asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and eosinophilic esophagitis (EoE). In 5 of 6 AD studies, dupilumab‐treated patients were more likely to get conjunctivitis than placebo‐treated patients. No conjunctivitis was confirmed to be caused by infection, and it does not seem to be allergic in nature. Patients who entered these studies with more severe AD or who previously had conjunctivitis were more likely to get conjunctivitis. In asthma and CRSwNP studies, conjunctivitis rates were less frequent for both dupilumab and placebo than in AD studies, and were similar for dupilumab and placebo. In the EoE study, nobody had conjunctivitis. In all studies, conjunctivitis was mostly mild to moderate; most cases recovered during the treatment period. Causes of conjunctivitis in dupilumab‐treated patients require further study.
AD is a heterogeneous disease both clinically and biologically. Four distinct clusters of patients with AD have been identified that could represent endotypes with unique biological mechanisms. Elucidation of these endotypes warrants further investigation and will require future intervention trials with specific agents, such as biologics.
Introduction: Dupilumab has recently been approved for the treatment of moderate to severe atopic dermatitis (AD) in adults. Daily practice data on dupilumab treatment are scarce. Objective: To study the effect of 16-week treatment with dupilumab on clinical response and serum biomarkers in adult patients with moderate-severe AD in daily practice. Methods: Data were extracted from the BioDay registry, a prospective multicenter registry. Sixteen-week clinical effectiveness of dupilumab was expressed as number of patients achieving EASI-50 (Eczema Area and Severity Index) or EASI-75, as well as patient-reported outcomes measures (Patient-Oriented Eczema Measure, Dermatology Life Quality Index, Numeric Rating Scale pruritus). Twenty-one biomarkers were measured in patients treated with dupilumab without concomitant use of oral immunosuppressive drugs at five different time points (baseline, 4, 8, 12, and 16 weeks). Results: In total, 138 patients treated with dupilumab in daily practice were included. This cohort consisted of patients with very difficult-to-treat AD, including 84 (61%) patients who failed treatment on ≥2 immunosuppressive drugs. At week 16, the mean percent change in EASI score was 73%. The EASI-50 and EASI-75 were achieved by 114 (86%) and 82 (62%) patients after 16 weeks of treatment. The most reported side effect was conjunctivitis, occurring in 47 (34%) patients. During dupilumab | 117 ARIËNS et Al.
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