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In several randomized controlled trials, dupilumab demonstrated a robust efficacy and safety profile in patients with moderate-to-severe atopic dermatitis (AD). The ongoing GLOBOSTAD study (NCT03992417) characterizes patients treated with dupilumab, their AD treatment patterns, effectiveness, and safety of dupilumab in the real world. Here, we present comprehensive data on patients enrolled in France. This 5-year, multinational, prospective, observational study enrolled patients aged ≥ 12 years with moderate-to-severe AD. Patients received dupilumab based on country-specific prescribing information. In France, dupilumab is indicated for adults/adolescents with no response to ciclosporin/topical treatments, respectively [1]. Assessments were performed at baseline (BL)/3 months(M; ± 1 M)/6M(± 2 M)/12M(± 2 M). Data are reported as observed for enrollment/safety (n = 94; data cutoff: March 2023) and follow-up (n = 88) populations. Of the 94 patients, 5.3% were aged 12–17 years, 76.6% were 18–39, 14.9% were 40–64, 3.2% were ≥ 65, with mean (standard deviation, SD) age of 30.7(13.0), and 50% female patients. Ciclosporin and topical corticosteroid/calcineurin inhibitors use was reported in 19.1% and 46.8%/9.6% patients, respectively, 12 M before enrollment. 88/59/68 patients completed ≥ 1 follow-up assessment at 3 M/6 M/12 M, respectively. Mean (SD) Eczema Area and Severity Index (> 21 = severe; ≤ 7 = mild/no disease) scores at BL/3 M/12 M were 15.4(10.6)/4.1(4.9)/4.0(7.5). Similarly, SCORing Atopic Dermatitis (> 50 = severe; ≤ 25 = mild/no disease) scores were 51.0(16.5)/23.3(14.6)/17.8(14.2); pruritus Numerical Rating Scale (0–10) scores were 6.1(2.2)/3.1(2.5)/1.7(2.2); and Dermatology Life Quality Index (0–30) scores were 12.8(6.2)/6.0(6.2)/3.5(3.8). Adverse events considered related to dupilumab were reported in 37.2% patients and led to permanent discontinuation in 2.1%. In the year prior to enrollment, ciclosporin use was reported in few, and topical treatment use in about half of the patients. On dupilumab initiation, AD clinical scores rapidly improved and were sustained until end of observation period. Safety data were consistent with previous studies. [ABSTRACT FROM AUTHOR]

Sleep disturbances are part of a symptom triad, along with itch and pain, that patients with atopic dermatitis (AD) report as being frequent and burdensome.1 The effects of dupilumab on sleep were evaluated in adults with chronic AD in five randomized, double-blind, placebo-controlled clinical trials ( I N i = 2632). 2a), sleep disturbances were reported to be less frequent among dupilumab-treated patients vs. placebo-treated patients; in particular, 58.6-63.4% of dupilumab-treated patients vs. 40.5% of placebo-treated patients reported no days of sleep disturbances. [Extracted from the article]

Summary: Background: Dupilumab, a human monoclonal antibody, blocks the shared receptor unit for interleukin‐4 and interleukin‐13. International phase II and III studies have evaluated the efficacy and safety of dupilumab in adults with moderate‐to‐severe atopic dermatitis (AD), but the effects of dupilumab in Japanese patients have not been reported. Objectives: To evaluate the efficacy and safety of dupilumab in Japanese patients with moderate‐to‐severe AD. Methods: We analysed the efficacy and safety of dupilumab in the Japanese cohorts of a 16‐week, phase IIb dose‐finding trial (AD‐1021; NCT01859988); a 16‐week, phase III, placebo‐controlled monotherapy trial (LIBERTY AD SOLO 1; NCT02277743) and a 52‐week, phase III, placebo‐controlled study of dupilumab with topical corticosteroids (LIBERTY AD CHRONOS; NCT02260986). Results: Twenty‐seven, 106 and 117 Japanese patients were enrolled in AD‐1021, SOLO 1 and CHRONOS, respectively. Baseline disease severity was numerically higher in the Japanese cohort than in the overall study population. Generally, dupilumab significantly improved signs and symptoms of AD, including pruritus and patient quality of life, compared with placebo in the Japanese cohort, consistent with the overall study population. The combined safety profile of dupilumab in the Japanese cohort was similar to that in the total study populations; dupilumab was associated with an increased incidence of injection‐site reactions and conjunctivitis compared with placebo. Dupilumab was associated with rapid reduction in thymus and activation‐regulated chemokine and gradual IgE reductions. Conclusions: Dupilumab alone or with topical corticosteroids improved signs and symptoms of AD, had an acceptable safety profile, and suppressed biomarkers of type 2 inflammation compared with placebo in Japanese adult patients with moderate‐to‐severe AD. What's already known about this topic? Differences in atopic dermatitis (AD) pathology have been reported between Asian and Western populations, in which distinct helper T‐cell activation profiles have been observed.International clinical studies in adults with moderate‐to‐severe AD have evaluated the efficacy and safety of dupilumab, which blocks interleukin‐4 and interleukin‐13, key molecules in type 2 inflammation.The effects of dupilumab in Japanese patients specifically have not yet been reported. What does this study add? Dupilumab alone or with topical corticosteroids improved signs and symptoms of AD and had an acceptable safety profile compared with placebo in Japanese patients with moderate‐to‐severe AD.The effects were comparable with those observed in the overall study population.Reported immunological differences in AD pathology in Asian patients may be secondary to type 2 immune activation. Plain language summary available online Respond to this article [ABSTRACT FROM AUTHOR]

Summary: Background: Dupilumab [a monoclonal antibody blocking the shared receptor subunit for interleukin (IL)‐4 and IL‐13] is approved for patients aged ≥ 12 years with inadequately controlled, moderate‐to‐severe atopic dermatitis (AD). Dupilumab trials of up to 52 weeks demonstrated efficacy and a favourable safety profile in patients with moderate‐to‐severe AD inadequately controlled with topical medications. Objectives: To further characterize the safety of dupilumab by evaluating clinical laboratory findings from three randomized, double‐blinded, placebo‐controlled phase III trials (LIBERTY AD SOLO 1 & 2 and LIBERTY AD CHRONOS). Methods: Patients were randomized 1 : 1 : 1 (SOLO 1 & 2) or 3 : 1 : 3 (CHRONOS) for 16 and 52 weeks, respectively, to dupilumab weekly, every 2 weeks or placebo. CHRONOS patients received a standardized concomitant topical corticosteroid regimen. Laboratory outcomes were summarized descriptively in 1376 patients from SOLO 1 & 2 and 740 from CHRONOS. Results: Treatment groups had similar results in baseline laboratory parameters. Platelets and neutrophils showed mild decreases from baseline in dupilumab vs. placebo groups. Some dupilumab‐treated patients had small transient increases in eosinophils. Grade 3 eosinophilia was reported in < 1% of dupilumab‐treated and placebo‐treated patients; no adverse events were associated with eosinophilia. Lactate dehydrogenase levels decreased from baseline during dupilumab treatment in all trials. No clinically meaningful changes were observed between treatment groups in other haematology, chemistry or urinalysis parameters. Conclusions: There were no clinically important changes in routine laboratory parameters that could be attributed to dupilumab. This study supports the use of dupilumab as a systemic treatment for moderate‐to‐severe AD that does not require laboratory monitoring. What's already known about this topic? Long‐term treatment of atopic dermatitis (AD) with conventional immunosuppressive agents is limited by the risk of significant side‐effects and a need for repeated tests to monitor haematological and/or organ (e.g. liver, kidney) toxicities.Dupilumab [a monoclonal antibody blocking the shared receptor subunit for interleukin (IL)‐4 and IL‐13] is approved for the treatment of patients with inadequately controlled, moderate‐to‐severe AD.In 16‐week and 52‐week studies, dupilumab demonstrated a positive risk/benefit profile in moderate‐to‐severe AD. What does this study add? This study is the first comprehensive analysis of dupilumab laboratory safety data of the 16‐week SOLO 1 & 2 (pooled N = 1376) and 52‐week CHRONOS (N = 740) trials, demonstrating an absence of clinically important changes in haematology, serum chemistry and urinalysis parameters in patients with moderate‐to‐severe AD treated with dupilumab.Our data support the use of dupilumab as a systemic treatment for the long‐term management of moderate‐to‐severe AD without routine laboratory monitoring in clinical practice. Respond to this article [ABSTRACT FROM AUTHOR]

Summary: Background: Dupilumab (monoclonal antibody inhibiting IL‐4/IL‐13 signalling) is approved for use in adolescents aged ≥ 12 years with inadequately controlled moderate‐to‐severe atopic dermatitis (AD). Dupilumab significantly improved AD signs/symptoms in a 16‐week, randomised, placebo‐controlled phase III trial in adolescents (NCT03054428). Objectives: To characterize the pharmacokinetics of dupilumab, and long‐term safety and efficacy in adolescents. Methods: This was a global, multicentre, phase IIa, open‐label, ascending‐dose, sequential cohort study with a phase III open‐label extension (OLE) in adolescents with moderate‐to‐severe AD. In the phase IIa study, patients received one dupilumab dose (2 mg kg−1 or 4 mg kg−1) and 8 weeks of pharmacokinetic sampling. Thereafter, patients received the same dose weekly for 4 weeks, with 8‐week safety follow‐up. Patients then enrolled in the OLE, continuing 2 mg kg−1 or 4 mg kg−1 dupilumab weekly. Primary end points were dupilumab concentration–time profile and incidence of treatment‐emergent adverse events (TEAEs). Secondary outcomes included Eczema Area and Severity Index (EASI). Results: Forty adolescents received dupilumab in the phase IIa study; 36 enrolled in the OLE. Dupilumab showed nonlinear, target‐mediated pharmacokinetics. Mean ± SD trough dupilumab concentrations in serum at week 48 (OLE) were 74 ± 19 mg L−1 and 161 ± 60 mg L−1 for 2 mg kg−1 and 4 mg kg−1, respectively. Dupilumab was well tolerated over 52 weeks; the most common TEAEs were nasopharyngitis (week 52: 41% [2 mg kg−1], 47% [4 mg kg−1]) and AD exacerbation (29%, 42%). After one dupilumab dose in the phase IIa study, EASI improved from baseline to week 2 [mean ± SD reduction −34% ± 20% (2 mg kg−1) and −51% ± 29% (4 mg kg−1)]. With continuing treatment, EASI scores improved further [week 52: −85% ± 12% (2 mg kg−1) and −84% ± 20% (4 mg kg−1)]. Conclusions: In adolescents with moderate‐to‐severe AD, dupilumab's pharmacokinetic profile was similar to that in adults. These 52‐week safety and efficacy data support long‐term use of dupilumab in this patient population. What's already known about this topic? Adolescents with moderate‐to‐severe atopic dermatitis (AD) have high unmet medical need, with significant disease burden and limited treatment options.Dupilumab (monoclonal antibody against interleukin‐4 receptor α) is approved for the treatment of adolescents with moderate‐to‐severe AD who are inadequately responsive to standard of care (U.S.A.) or candidates for systemic therapy (European Union).A 16‐week, randomized, placebo‐controlled phase III trial in adolescents demonstrated significant improvements in AD signs/symptoms with an acceptable safety profile. What does this study add? These studies demonstrate the long‐term safety and efficacy of dupilumab in adolescents with moderate‐to‐severe AD for up to 52 weeks of treatment, thus extending and reinforcing the findings from the 16‐week dupilumab phase III trial.The data from these studies also support the use of dupilumab in combination with current standard of care (topical corticosteroids), which was not evaluated in the 16‐week phase III monotherapy trial. Linked Comment: Sibbald. Br J Dermatol 2020; 182:12–13. Plain language summary available online [ABSTRACT FROM AUTHOR]

Summary: Background: Moderate‐to‐severe atopic dermatitis (AD) is a chronic disease characterized by intense, persistent and debilitating itch, resulting in sleep deprivation, signs of anxiety and depression, impaired quality of life and reduced productivity. The Peak Pruritus Numerical Rating Scale (NRS) was developed and validated as a single‐item, patient‐reported outcome (PRO) of itch severity. Objectives: To describe the content validity and psychometric assessment (test–retest reliability, construct validity, known‐groups validity, sensitivity to change) of the Peak Pruritus NRS, and to derive empirically a responder definition to identify adults with a meaningful change in itch. Methods: Content validity was assessed through in‐depth patient interviews. Psychometric assessments used data from phase IIb and phase III dupilumab clinical trials and included test–retest reliability, construct validity, known‐groups validity and sensitivity to change in patients with moderate‐to‐severe AD. Results: Interview participants indicated that the Peak Pruritus NRS was a relevant, clear and comprehensive assessment of itch severity. Peak Pruritus NRS scores showed large, positive correlations with existing PRO measures of itch, and weak or moderate correlations with clinician‐reported measures assessing objective signs of AD. Peak Pruritus NRS score improvements were highly correlated with improvements in other itch PROs, and moderately correlated with improvements in clinician‐reported measures assessing objective signs of AD. The most appropriate threshold for defining a clinically relevant, within‐person response was ≥ 2–4‐point change in the Peak Pruritus NRS. Conclusions: The Peak Pruritus NRS is a well‐defined, reliable, sensitive and valid scale for evaluating worst itch intensity in adults with moderate‐to‐severe AD. What's already known about this topic? Moderate‐to‐severe atopic dermatitis is characterized by persistent and debilitating itch, which can greatly impair quality of life.A validated, brief patient‐reported outcome measure is needed to quantify the intensity of itch accurately and reliably in patients with atopic dermatitis in clinical trials. What does this study add? The Peak Pruritus Numerical Rating Scale (NRS) is a well‐defined, reliable, fit‐for‐purpose measure to evaluate patient‐reported intensity of worst itch in the previous 24 h for adults with moderate‐to‐severe atopic dermatitis.Clinical response is indicated by a ≥ 2–4‐point change from baseline in Peak Pruritus NRS score. What are the clinical implications of this work? This study provides practising clinicians and clinical trialists with a validated patient‐reported outcome measure to assess itch, a hallmark symptom of atopic dermatitis and a crucial marker of treatment benefit. Plain language summary available online Respond to this article [ABSTRACT FROM AUTHOR]

Summary: Background: In the U.S.A., an Investigator's Global Assessment (IGA) score of ≤ 1 (clear or almost clear skin) has been the standard measure in regulatory outcomes for registration clinical trials in atopic dermatitis (AD), including those supporting the recent approval of dupilumab. Objectives: To evaluate the treatment effect of dupilumab in patients with IGA > 1 at the end of treatment, using other validated outcome measures for AD signs, symptoms and quality of life. Methods: LIBERTY AD SOLO 1 and 2 were two 16‐week, randomized, double‐blind trials enrolling adult patients with moderate‐to‐severe AD (IGA ≥ 3) inadequately controlled with topical treatment. We performed a post hoc analysis in patients receiving dupilumab 300 mg every 2 weeks (q2w) or placebo. Outcome measures in patients with IGA > 1 included Eczema Area and Severity Index (EASI), pruritus numerical rating scale (NRS), affected body surface area (BSA), Patient‐Oriented Eczema Measure (POEM) and Dermatology Life Quality Index (DLQI). The trials were registered at ClinicalTrials.gov: NCT02277743 and NCT02277769. Results: At week 16, 278 of 449 dupilumab q2w‐treated patients (median age 36·0 years) and 396 of 443 placebo‐treated patients had IGA > 1. Among patients with IGA > 1 at week 16, dupilumab significantly improved several outcome measures compared with placebo: EASI (−48·9% vs. −11·3%, P < 0·001), pruritus NRS (−35·2% vs. −9·1%, P < 0·001), affected BSA (−23·1% vs. −4·5%, P < 0·001), POEM score ≥ 4‐point improvement (57·4% vs. 21·0%, P < 0·001) and DLQI score ≥ 4‐point improvement (59·3% vs. 24·4%, P < 0·001). Conclusions: In patients with IGA > 1 at week 16, dupilumab induced statistically significant benefits in multiple validated outcome measures compared with placebo. The IGA ≤ 1 end point significantly underestimates clinically relevant dupilumab treatment effects. What's already known about this topic? An Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear skin) is considered the regulatory standard for treatment success in trials of patients with atopic dermatitis in the U.S.A.It is currently unknown whether patients receiving dupilumab treatment for moderate‐to‐severe atopic dermatitis derive clinical and quality‐of‐life benefit even if they have an end‐of‐treatment IGA score > 1. What's does this study add? This post hoc analysis of patients with an end‐of‐treatment IGA score > 1 from two randomized, placebo‐controlled trials showed that after 16 weeks of treatment dupilumab significantly improved their outcome measures compared with placebo, including measures of signs, symptoms and quality of life.These results show that the regulatory IGA ≤ 1 end point used in clinical trials significantly underestimates clinically relevant dupilumab treatment effects, underscoring potential limitations of the IGA scale. Linked Comment: de Bruin‐Weller. Br J Dermatol 2019; 181:12–13. Respond to this article [ABSTRACT FROM AUTHOR]

Linked Article: Waldman et al. Br J Dermatol 2020; 182:251. Bakker et al. Br J Dermatol 2019; 180:1248–9. [ABSTRACT FROM AUTHOR]

Summary: This is the report from the fifth meeting of the Harmonising Outcome Measures for Eczema initiative (HOME V). The meeting was held on 12–14 June 2017 in Nantes, France, with 81 participants. The main aims of the meeting were (i) to achieve consensus over the definition of the core domain of long‐term control and how to measure it and (ii) to prioritize future areas of research for the measurement of the core domain of quality of life (QoL) in children. Moderated whole‐group and small‐group consensus discussions were informed by presentations of qualitative studies, systematic reviews and validation studies. Small‐group allocations were performed a priori to ensure that each group included different stakeholders from a variety of geographical regions. Anonymous whole‐group voting was carried out using handheld electronic voting pads according to predefined consensus rules. It was agreed by consensus that the long‐term control domain should include signs, symptoms, quality of life and a patient global instrument. The group agreed that itch intensity should be measured when assessing long‐term control of eczema in addition to the frequency of itch captured by the symptoms domain. There was no recommendation of an instrument for the core outcome domain of quality of life in children, but existing instruments were assessed for face validity and feasibility, and future work that will facilitate the recommendation of an instrument was agreed upon. [ABSTRACT FROM AUTHOR]

An exploratory population pharmacokinetic model for functional dupilumab was developed. Data from healthy volunteers and patients with atopic dermatitis (AD) receiving intravenous or subcutaneous doses were integrated. The data included 197 participants (2,518 measurements of dupilumab in serum) from six phase I and II studies. The data were analyzed using stochastic approximation expectation-maximization and importance sampling methods. The best structural model was a two-compartment model with parallel linear and Michaelis-Menten elimination from the central compartment. Estimated parameters were: central volume 2.74 L, elimination rate 0.0459 d−1, central-to-peripheral rate 0.0652 d−1, peripheral-to-central rate 0.129 d−1, bioavailability 60.7%, maximal target-mediated elimination rate 0.968 mg/L/d, and Michaelis-Menten constant 0.01 mg/L. Body weight was a significant covariate of the central volume. No gender effect was observed when controlling for weight. No differences between healthy volunteers and patients with AD were found. The model adequately described dupilumab pharmacokinetics for intravenous and subcutaneous routes of administration. [ABSTRACT FROM AUTHOR]

This article is a report of the fourth meeting of the Harmonising Outcome Measures for Eczema ( HOME) initiative held in Malmö, Sweden on 23-24 April 2015 ( HOME IV). The aim of the meeting was to achieve consensus over the preferred outcome instruments for measuring patient-reported symptoms and quality of life for the HOME core outcome set for atopic eczema ( AE). Following presentations, which included data from systematic reviews, consensus discussions were held in a mixture of whole group and small group discussions. Small groups were allocated a priori to ensure representation of different stakeholders and countries. Decisions were voted on using electronic keypads. For the patient-reported symptoms, the group agreed by vote that itch, sleep loss, dryness, redness/inflamed skin and irritated skin were all considered essential aspects of AE symptoms. Many instruments for capturing patient-reported symptoms were discussed [including the Patient-Oriented SCOring Atopic Dermatitis index, Patient-Oriented Eczema Measure ( POEM), Self-Administered Eczema Area and Severity Index, Itch Severity Scale, Atopic Dermatitis Quickscore and the Nottingham Eczema Severity Score] and, by consensus, POEM was selected as the preferred instrument to measure patient-reported symptoms. Further work is needed to determine the reliability and measurement error of POEM. Further work is also required to establish the importance of pain/soreness and the importance of collecting information regarding the intensity of symptoms in addition to their frequency. Much of the discussion on quality of life concerned the Dermatology Life Quality Index and Quality of Life Index for Atopic Dermatitis; however, consensus on a preferred instrument for measuring this domain could not be reached. In summary, POEM is recommended as the HOME core outcome instrument for measuring AE symptoms. [ABSTRACT FROM AUTHOR]

Bullous pemphigoid (BP) is an autoimmune blistering disease that can have a profound negative impact on quality of life. BP most often affects the elderly, a population with a high medical burden and special safety concerns. In this review, we outline the BP disease course, diagnosis, epidemiology and comorbidities, and describe tools commonly used to assess BP disease activity and severity and the impact of BP on health‐related quality of life. We also outline biologic treatments currently under investigation for the treatment of BP and highlight the importance of considering safety when treating elderly patients. [ABSTRACT FROM AUTHOR]

Summary: 特应性皮炎(又称 AD 或湿疹)是一种常见的皮肤病,可引起强烈和持续的瘙痒和皮疹。对于一些中度至重度 AD 患者来说,护肤霜或软膏不合适或不起效。这些患者可能需要口服或注射药物。 其中一些口服或注射治疗可能具有毒性,常常会产生不想要的副作用,特别是在使用时间较长的情况下,因此必须定期对患者进行检测,查看这些治疗是否在损害他们的血液或器官。 Dupilumab 是一种治疗中度至重度 AD 的较新的注射药物。Dupilumab 专门作用于体内导致 AD 的关键分子。在安慰剂对照临床试验中已经在 2000 多名患者身上对 Dupilumab 进行了长达一年的测试。在这些试验中,患者在接受 Dupilumab 或安慰剂(模拟药物)治疗时提供血液和尿液样本进行实验室检测。 本文中,来自德国和美国的作者分析了血细胞、血生化和尿生化在治疗过程中的变化,以检查是否可以在不需要进行定期实验室检测的情况下安全地使用 Dupilumab。 在对患者的血液和尿液进行了许多常规实验室检测后,他们发现,检测结果中没有可能与 Dupilumab 有关的临床重要变化。因此得出结论,使用 Dupilumab 治疗的中度到重度 AD 患者不需要进行定期实验室检测。 本摘要涉及研究: Dupilumab 治疗中重度特应性皮炎的实验室安全性: 三项 III 期试验 (LIBERTY AD SOLO 1、LIBERTY AD SOLO 2 LIBERTY AD CHRONOS)的结果 Linked Article: Wollenberg et al. Br J Dermatol 2020; 182:1120–1135 [ABSTRACT FROM AUTHOR]

Summary: Atopic dermatitis (also known as AD or eczema) is a common skin disease that can cause intense and persistent itching and rashes. Skin creams or ointments are not suitable or effective for some patients with moderate‐to‐severe AD. In these patients, oral (taken by mouth) or injected medications may be required. Some of those oral or injected treatments could be toxic and often have unwanted side effects, especially when used for a longer period of time, so patients must be regularly tested to see whether those treatments are harming their blood or organs. Dupilumab is a newer injectable drug for treating moderate‐to‐severe AD. Dupilumab specifically targets key molecules in the body that cause AD. Dupilumab has been tested for up to one year in more than 2000 patients enroled in placebo‐controlled clinical trials. During those trials, patients provided blood and urine samples for laboratory testing while they were being treated with dupilumab or placebo (dummy drug). In this paper, the authors from Germany and the U.S.A, analysed how blood cells, blood chemistry, and urine chemistry changed during treatment, to check whether dupilumab is safe to use without the need for regular laboratory tests. After performing many routine laboratory tests on patients' blood and urine, they found that there were no clinically important changes in test results that could be linked to dupilumab. They concluded that patients using dupilumab for moderate‐to‐severe AD do not need routine laboratory testing. This is a summary of the study: Laboratory safety of dupilumab in moderate‐to‐severe atopic dermatitis: results from three phase III trials (LIBERTY AD SOLO 1, LIBERTY AD SOLO 2, LIBERTY AD CHRONOS) Linked Article: Wollenberg et al. Br J Dermatol 2020; 182:1120–1135 [ABSTRACT FROM AUTHOR]

Summary: Atopic dermatitis (AD), also known as eczema, is characterized by red, oozy, and dry skin that can become cracked and infected. Intense itching, which can be very troublesome and can cause sleep disturbance, is the main complaint of patients with AD. AD often begins in childhood and affects 1 in 4 teenagers worldwide. For teenagers, the itchiness and appearance of AD skin can significantly reduce quality of life, but there are few effective treatment options for moderate‐to‐severe AD that are suitable for long‐term use. Dupilumab is a new drug that blocks key molecules that cause allergic conditions, such as AD. It has been shown to be effective in treating moderate‐to‐severe AD in adults and to be relatively safe for long‐term use. This study was conducted in multiple centres across Europe and Canada in 40 patients aged 12 to 17 who received treatment with dupilumab for up to a year. The researchers wanted to know whether dupilumab is effective and safe for treating AD with long‐term use in these patients. They also wanted to know how dupilumab is processed by the body in patients with AD in this age group. They found that treatment with dupilumab substantially improves the skin and symptoms of AD, including itching, in these younger patients, without causing any unexpected side effects. They also found that dupilumab is processed the same way in these younger patients as in adults. The improvements were maintained throughout the one year of treatment. The study results support the use of dupilumab in the continuous treatment of adolescents with moderate‐to‐severe AD. This summary relates to the study: Dupilumab in adolescents with uncontrolled moderate‐to‐severe atopic dermatitis: results from a phase IIa open‐label trial and subsequent phase III open‐label extension Linked Article: Cork et al. Br J Dermatol 2020; 182:85–96 [ABSTRACT FROM AUTHOR]

Summary: 特应性皮炎 (AD) 也称为湿疹, 其表现为皮肤发红、渗液和干燥并可能发生开裂和感染。剧烈瘙痒可能非常麻烦, 而且可能导致睡眠障碍, 是 AD 患者的主要主诉。 AD 通常从儿童开始, 而且影响全世界 1/4 的青少年。对于青少年, AD 皮肤的瘙痒和外观可显著降低生活质量,但适合长期使用的中度至重度 AD 有效治疗选择很少。 Dupilumab 是一种新的药物, 其可阻断导致过敏症状(如 AD)的关键分子。研究显示, 该药物对治疗成人中度至重度 AD 是有效的, 而且长期使用相对安全。 这项研究在 40 例年龄 12 至 17 岁的接受 dupilumab 治疗最长一年的患者中进行, 涉及欧洲和加拿大多个中心。研究人员希望了解 dupilumab 是否对治疗 AD 有效以及这类患者长期使用是否安全 。他们还希望了解 dupilumab 在此年龄段 AD 患者中的身体处理方式。 他们发现, dupilumab 治疗在这些年轻患者中显著改善了皮肤和 AD 症状(包括瘙痒), 而且不会造成任何意外的副作用。他们还发现 dupilumab 在这些年轻患者中的处理方式与成人相同。在整个一年治疗期内维持了改善。 研究结果支持使用 dupilumab 持续治疗中度至重度 AD 青少年患者。 This summary relates to the study: dupilumab 用于未控制的中度至重度特应性皮炎青少年患者中:IIA 期开放标签试验和随后的 III 期开放标签扩展研究结果 Linked Article: Cork et al. Br J Dermatol 2020; 182:85–96 [ABSTRACT FROM AUTHOR]

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Summary: Atopic dermatitis (AD) is a chronic skin disease occurring in about 5 to 10% of adults worldwide. It can cause intense and persistent itch. For almost two‐thirds of patients with moderate‐to‐severe AD, the itching lasts at least 12 hours a day, and is severe to unbearable. In clinical trials that are looking at how effective a treatment for AD is, itch intensity must be measured. Given itch is subjective, its intensity is most accurately reported by patients themselves. In this study, investigators from the U.S.A. and Europe developed a scale of itch called the Peak Pruritus Numerical Rating Scale (NRS). The scale measures the worst itch (peak pruritus) during the past 24 hours by asking patients "On a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". To ensure the scale is reliable and valid (i.e., appropriate for assessing itch in AD patients), patients were interviewed about their opinions of the scale. The scale was then implemented in three large clinical trials of adults with moderate‐to‐severe AD. Interviewed patients said that the scale provided a relevant, clear, and comprehensive assessment of itch severity. As hypothesized, scores from the Peak Pruritus NRS showed moderate‐to‐strong correlation with other measures of itch, and weak‐to‐moderate correlation with measures of AD signs (clinical symptoms). The investigators concluded that the Peak Pruritus NRS is a well‐defined, reliable, sensitive, and valid scale for evaluating worst itch intensity in adults with moderate‐to‐severe AD. Linked Article: Yosipovitch et al. Br J Dermatol 2019; 181:761–769 [ABSTRACT FROM AUTHOR]