Patient-Oriented Eczema Measure Research Articles

One-Year Insights into the GLOBOSTAD Multinational Prospective Observational Study of Patients Receiving Dupilumab for Atopic Dermatitis.

Currently, limited data are available on long-term use of dupilumab to treat atopic dermatitis (AD) in a multinational real-world setting. The aim of this analysis was to report the interim 1-year data for patients with AD enrolled in the GLOBOSTAD registry, including treatment patterns, dupilumab effectiveness and safety, and healthcare burden. GLOBOSTAD is an ongoing, 5-year, multinational, prospective, observational study of adult/adolescent (aged ≥ 12years at baseline) patients with AD who initiated dupilumab in real-world settings according to their local country-specific prescribing guidelines. Outcomes were evaluated at baseline and at 3, 6 and 12months and included Eczema Area and Severity Index (EASI) total score, SCORing Atopic Dermatitis (SCORAD) total score, percent body surface area (BSA) affected, Patient-Oriented Eczema Measure (POEM), Dermatology Life Quality Index (DLQI) total score for adults or Children's Dermatology Life Quality Index (CDLQI) total score for adolescents and pruritus Numeric Rating Scale (NRS) total score. At the interim 1-year cut-off (March 2023), 955 patients were enrolled in GLOBOSTAD, and follow-up data were obtained from 903 patients. After dupilumab initiation, mean improvements in effectiveness outcome measures from baseline to month 3 were EASI from 25.1 to 6.1, SCORAD 59.3 to 25.3, POEM 19.7 to 8.7, DLQI 13.7 to 5.3, CDLQI 12.2 to 2.7 and pruritus NRS 6.3 to 2.5, with each measure exceeding the minimal clinically important difference. These positive changes in effectiveness outcomes were maintained or further improved through 12months since treatment initiation. AD-related hospitalizations and emergency room or urgent care facility visits decreased from 11.1% to 1.7% from baseline to month 12. In a multinational real-world setting, dupilumab demonstrated rapid, robust and sustained effectiveness in patients with moderate-to-severe AD across multiple disease domains, including AD signs, symptoms, quality of life and emergency/urgent care visits. Safety was consistent with the known dupilumab safety profile. ClinicalTrials.gov Identifier NCT03992417.

Time of Day of Biological Treatment Administration and Outcomes in Atopic Dermatitis: Results from a Preliminary Retrospective Study.

Background: Growing evidence on chronotherapy supports administering treatments according to endogenous biological rhythms. Objectives: To evaluate whether the administration time of dupilumab affects its effectiveness in patients with atopic dermatitis (AD), by virtue of the circadian oscillations of immune system activity. Methods: This retrospective study included all adult patients with AD treated with dupilumab from January 2020 to January 2024 at our unit. Data recorded at baseline (T0) and at the 16-week-treatment visit (T16) included itch severity, sleep disturbance, Eczema Area and Severity Index, Patient-Oriented Eczema Measure, Dermatology Life Quality Index, and immunoglobulin E levels. Therapeutic response was compared between two groups, based on injection time, that is, between 12:00 a.m. and 12:00 p.m. versus between 12:00 p.m. and 12:00 a.m. Results: Fifty-three patients were included, of whom 21 took dupilumab between 12:00 a.m. and 12:00 p.m. and 32 between 12:00 p.m. and 12:00 a.m. All clinical parameters improved from T0 to T16, without significant differences between groups. However, there was a greater improvement in these parameters in subjects taking dupilumab between 12:00 a.m. and 12:00 p.m., compared with the others. Conclusions: These preliminary results suggest a difference in therapeutic response to dupilumab based on the administration time, leading to potential optimization of its efficacy. Further studies on larger samples are needed.

Efficacy and safety of lebrikizumab for the treatment of moderate-to-severe atopic dermatitis: a systematic review and meta-analysis.

Lebrikizumab, an IL-13 immunomodulator, has shown recommendable effectiveness and safety in clinical studies for the treatment of moderate-to-severe atopic dermatitis (AD) in adolescents and adults. To evaluate the efficacy and safety of lebrikizumab in the treatment of moderate-to-severe AD through a meta-analysis. PubMed, Embase, Web of Science, Medline, and ClinicalTrials.gov databases were searched up to 8 August 2023. Randomized clinical trials of lebrikizumab treatment for moderate-to-severe AD were included by screening titles, abstracts, and papers. Five studies involving 1,551 patients with AD were identified. Pooled analysis revealed significant improvements in the Eczema Area and Severity Index (EASI) score (SMD = -0.527; 95% CI = [-0.617, -0.436]), Investigator's Global Assessment (IGA) score (RR = 2.122; 95% CI = [1.803, 2.496]), Body Surface Area (BSA) score (SMD = -0.608; 95% CI = [-1.099, -0.118]), SCORing Atopic Dermatitis (SCORAD) score (SMD = -0.441; 95% CI = [-0.633, -0.250]). Moreover, Pruritus Numeric Rating Scale (P-NRS) score, Patient-oriented Eczema Measure (POEM) scores, Sleep-loss score and Dermatology Life Quality Index (DLQI) scores showed similar results. Adverse events (AEs) (RR = 0.984; 95% CI = [0.907, 1.068]) for lebrikizumab showed no statistically significant difference compared to placebo, with similar results for serious adverse events (SAEs) (RR = 0.748; 95% CI = [0.410, 1.364]). This meta-analysis reveals that lebrikizumab has higher efficacy and safety in the treatment of moderate-to-severe AD, with the 250mg Q2W dosage regimen appearing to be more advantageous.

Achievement of No-to-minimal Itch and Sleep Improvement with Tapinarof Cream 1% Once Daily in Two Pivotal Phase 3 Trials in Adults and Children Down to 2 Years of Age with Atopic Dermatitis

Introduction: Itch frequently causes sleep disturbance in patients with atopic dermatitis (AD). The gold-standard Peak Pruritus Numerical Rating Scale (PP-NRS) improvement from baseline is 4 points; however, more stringent outcomes include achieving no-to-minimal itch (PP-NRS ≤1). Tapinarof cream 1% once daily (QD) demonstrated superior efficacy, including itch reduction, versus vehicle and was well tolerated in adults and children down to 2 years of age with AD in the ADORING 1 and 2 pivotal phase 3 trials. Here we present highly stringent itch outcomes and sleep improvement with tapinarof from these trials. Methods: In ADORING 1 and 2, patients with a Validated Investigator Global Assessment for Atopic Dermatitis™ score ≥3 (moderate or severe), Eczema Area and Severity Index score ≥6, and body surface area involvement of 5–35% were randomized to tapinarof cream or vehicle QD for 8 weeks. Stringent PP-NRS assessments were analyzed post hoc and included achieving no‑to‑minimal itch (PP-NRS ≤1) or PP-NRS score <2. Mean weekly PP-NRS scores were assessed on an 11-point scale (0 indicates “no itch” and 10 is “worst imaginable itch”). The Patient Oriented Eczema Measure (POEM) question 2 evaluated sleep disturbance on a 5-point scale (0 indicates “no days” and 4 is “every day”); outcomes were pooled and stratified by age. Results: 407 and 406 patients were randomized in ADORING 1 and 2. Mean baseline scores were similar across ADORING 1 and 2 treatment groups: PP-NRS, 6.7 and 6.8; pooled POEM sleep disturbance scores, 2.0 (aged ≥12 years) and 2.4 (<12 years), respectively. Statistically significant achievement of no-to-minimal itch (PP-NRS ≤1), PP-NRS <2, and improvement in sleep were achieved with tapinarof versus vehicle as early as Week 1, the first assessment, and continued through Week 8. Stringent itch outcomes were achieved with tapinarof versus vehicle at Week 8: no-to-minimal itch, 31.4% versus 17.4% (P=0.0072) and 33.0% versus 14.0% (P=0.0003); and PP-NRS <2, 48.1% versus 28.4% (P=0.0006) and 46.8% versus 19.6% (P<0.0001) in ADORING 1 and 2, respectively. Sleep scores improved with tapinarof versus vehicle at Week 8: –1.4 versus –0.8 (≥12 years); –1.7 versus –1.0 (<12 years; both P<0.0001). Conclusion: Tapinarof cream 1% QD demonstrated early, significant, and meaningful achievement of no-to-minimal itch and improvement of sleep in adults and children down to 2 years of age with AD.

Ruxolitinib Cream Monotherapy Improved Symptoms and Quality of Life in Adults and Adolescents with Mild-to-Moderate Atopic Dermatitis: Patient-Reported Outcomes from Two Phase III Studies.

Atopic dermatitis (AD) is associated with itch, skin pain, sleep disturbances, and diminished quality of life (QoL). Ruxolitinib (Janus kinase [JAK] 1/JAK2 inhibitor) cream demonstrated efficacy and safety in adults and adolescents with mild-to-moderate AD in two phase III studies (TRuE-AD1/TRuE-AD2). In TRuE-AD1/TRuE-AD2, significant improvements in itch were observed as early as 12 h following application of ruxolitinib cream. The aim of this paper was to assess additional patient-reported outcomes (PROs) in the vehicle-controlled (VC) and long-term safety (LTS) periods of TRuE-AD1/TRuE-AD2. In the TRuE-AD studies, patients aged ≥12 years with AD were randomized 2:2:1 to apply twice-daily 1.5% ruxolitinib cream, 0.75% ruxolitinib cream, or vehicle cream continuously for 8weeks (VC period). During the LTS period, patients applied the same ruxolitinib cream strength, but on an as-needed basis; patients who initially applied vehicle were re-randomized to apply 0.75% or 1.5% ruxolitinib cream. Pooled data from both study periods were analyzed. PRO assessments included symptoms (itch [Patient-Oriented Eczema Measure, POEM], skin pain [numerical rating scale], and sleep [POEM and Patient-Reported Outcomes Measurement Information System]) and assessments of disease-specific QoL (Dermatology Life Quality Index [DLQI] and the children's version [CDLQI]). A total of 1208 and 1031 patients from the VC and LTS periods, respectively, were included in the analysis. Significant improvements in skin pain were observed within 12h among patients who applied ruxolitinib cream versus vehicle; improvements continued throughout the VC period. Improvements in patient-reported symptoms (including sleep) were observed within 2 weeks (first assessment) of ruxolitinib cream application. At Week 2, significant improvements in symptom burden and overall QoL were observed with ruxolitinib cream (0.75%/1.5%) versus vehicle in POEM (-8.9/-9.8 vs -2.2; both p<0.0001), DLQI (mean changes from baseline, -5.8/-6.1 vs -1.2; both p<0.0001), and CDLQI (-4.3/-5.3 vs -1.3; both p<0.0001). Further symptom burden and QoL improvements were reported during the VC period and were maintained through the end of the LTS period (Week 52). Consistent with the previously reported itch response data, ruxolitinib cream improved skin pain within 12 h of application. Ruxolitinib cream improved patient-reported AD symptom burden and overall QoL by Week 2. Improvements continued or were maintained for 52 weeks. (Graphical abstract and plain language summary available). ClinicalTrials.gov identifiers, NCT03745638 and NCT03745651 (both studies were registered on November 19, 2018).

Unveiling the Impact of Moderate and Severe Atopic Dermatitis: Insights on Burden, Clinical Characteristics, and Healthcare Resource Utilization in Adult Greek Patients from the APOLO Cross-Sectional Study.

Background: Moderate to severe (M2S) atopic dermatitis (AD) is a chronic condition impacting individuals, society, and healthcare systems. Considering the changing M2S-AD treatment landscape, this study assesses the M2S-AD burden in patients reaching referral centers in Greece. Methods: This was a multicenter, cross-sectional study. Patients aged 12 years or older with clinically diagnosed M2S-AD were enrolled. Data collected included clinical practice assessments and the following validated patient-reported instruments: Dermatology Life Quality Index (DLQI); EuroQol-5 Dimensions-3 Level scale (EQ-5D-3L); Patient Oriented Eczema Measure (POEM); Peak Pruritus Numerical Rating Scale (PP-NRS); and Work Productivity and Activity Impairment: General Health (WPAI:GH). A pain frequency/intensity/cause questionnaire and a sleep disturbance scale were also used. Results: Outcomes of 184 adults (51.1% female) with M2S-AD based on the Eczema Area and Severity Index (EASI) are presented (n = 117 moderate; n = 67 severe). Among the patients, 14.8% were obese, 59.2% had allergic comorbidities, and 88.0% were receiving AD-specific therapy (systemic: 38.6%). The median age, disease duration, body surface area, and total EASI scores were 38.8 years, 11.8 years, 30.0%, and 16.9, respectively. The median DLQI score was 12.0, with 'symptoms/feelings' being the most affected domain. EQ-5D dimensions 'anxiety/depression' and 'pain/discomfort' were also affected (65.2% and 64.1% reporting problems, respectively). The median POEM score was 17.0. Pain, severe pruritus (PP-NRS ≥ 7), and sleep disturbance were reported by 80.4%, 62.0%, and 88.5%, respectively. The median WPAI:GH 'work productivity loss' and 'activity impairment' scores were 23.8% and 30.0%, respectively. Conclusions: Both moderate and severe AD patients reaching Greek specialized centers experience significant symptom burden and impairments in quality of life, sleep, work, and daily activities.

The Eczema Bathing Study: Weekly versus daily bathing for people with eczema? Protocol of an online, randomised controlled trial

Background A priority setting partnership for eczema (syn atopic eczema, atopic dermatitis) has identified that bathing frequency is a key area of patient interest. However, there are nolarge, high-quality randomised controlled trials (RCTs) investigating this. The Rapid Eczema Trials project is a novel programme of research that aims to deliver multiple online RCTs, using a citizen science approach. This project involves working with members of the public to co-design and conduct studies that answer questions of importance to them. The first trial to be conducted through this project is assessing the impact of bathing frequency on eczema. Methods This is an online, two-arm, parallel-group superiority RCT with internal pilot phase. People aged ≥1 year with eczemaliving in the United Kingdom are eligible. Exclusion criteria are: people with other types of eczema such as venous eczema, hand eczema and contact eczema; recently started a new eczema treatment; taking part in another eczema trial; Patient Oriented Eczema Measure (POEM) ≤2; planning to swim more than twice a week; unable/unwilling to change bathing practices. Participants are allocated 1:1 to either the weekly bathing group (bathe 1 or 2 times a week) or the daily bathing group (bathe 6 or more times a week) for 4 weeks. The primary outcome is POEM, assessed weekly over 4 weeks. Secondary outcomes include skin specific quality of life, eczema control, itch severity, use of usual eczema treatments, proportion who achieve an improvement in POEM of ≥3 points, global change in eczema and safety outcomes. A sample of participants will also be invited to a semi-structured interview to discuss their experience. The primary comparative analysis will be according to randomised allocation regardless of actual frequency of bathing. The trial will be reported in accordance with CONSORT guidelines. The study has received ethical approval by the London - Surrey Research Ethics Committee (2 Redman Place, London, E20 1JQ, United Kingdom) on 11/10/2023 ( approval number: 23/PR/0899). Trial registration ISRCTN12016473, 22/11/2023, https://doi.org/10.1186/ISRCTN12016473

Mental health among parents and their children with eczema in Hong Kong.

This cross-sectional survey research investigated mental health symptoms and quality of life among Chinese parents and their children with eczema at a paediatric dermatology clinic in Hong Kong from November 2018 to October 2020. Health-related quality of life, eczema severity, and mental health among children with eczema, as well as their parents' mental health, were studied using the Children's Dermatology Life Quality Index (CDLQI), Infants' Dermatitis Quality of Life Index (IDQOL), Nottingham Eczema Severity Score (NESS), Patient-Oriented Eczema Measure (POEM), and the Chinese version of the 21-item Depression, Anxiety, and Stress Scales (DASS-21). In total, 432 children and 380 parents were recruited. Eczema severity (NESS and POEM) and health-related quality of life (CDLQI) were significantly positively associated with parental and child depression, anxiety, and stress levels according to the DASS-21, regardless of sex (children: r=0.28- 0.72, P<0.001 to 0.007; parents: r=0.20-0.52, P<0.001 to 0.034). Maternal depression was marginally positively associated with increased anxiety in boys with eczema (r=0.311; P=0.045). Younger parents had higher risk of developing more anxiety and stress compared with the older parents (adjusted odds ratio [aOR]=-0.342, P=0.014 and aOR=-0.395, P=0.019, respectively). Depression level of parents with primary to secondary education was 58% higher than their counterparts with post-secondary education or above (aOR=-1.579; P=0.007). Depression, anxiety, and stress among children with eczema and their parents were associated with eczema severity and impaired quality of life in those children. These findings regarding impaired mental health in children with eczema and their parents highlight the need to include mental well-being and psychosocial outcomes in future studies and clinical practice.

Practicality, Validity, and Responsiveness of Using the Proxy Version of the Child Health Utility–9 Dimensions With Children Aged 2 to 5 Years

ObjectivesThis study aimed to assess the practicality, validity, and responsiveness of the proxy Child Health Utility–9 Dimensions (CHU9D) in children aged 2 to 5 years. MethodsWe used data from the Barrier Enhancement for Eczema Prevention trial, a UK randomized controlled trial testing whether daily emollients in infancy could prevent eczema in high-risk infants. The main parent/carer completed the proxy CHU9D using developers’ additional guidance for completion in those younger than 5 years and the Patient-Oriented Eczema Measure (POEM) at ages 2, 3, 4, and 5 years. Practicality was assessed by completion rates. Construct validity assessed whether CHU9D could discriminate between those with/without eczema and between eczema severity levels on POEM. Responsiveness was determined by ability to discriminate between 3 groups: (1) those whose POEM score deteriorated ≥3 points, (2) those whose change was not clinically important (−2.9 to 2.9 points), and (3) those whose POEM score improved ≥3 points. Analysis was conducted in Stata 17. ResultsOf 1394 children participating in the Barrier Enhancement for Eczema Prevention trial, study questionnaires were completed by 1212 (87%), 981 (70%), 990 (71%), and 976 (70%) at 2, 3, 4, and 5 years. Of these the CHU9D was completed by 1066 (88.0%), 685 (69.8%), 925 (93.4%), and 923 (94.6%), respectively. Mean utility at all time points was approximately 0.934 (range 0.443-1). For construct validity, very small differences in the CHU9D between known groups were observed (P < .01). A total of 801 participants had responsiveness data: 13% deteriorated, 72% had nonclinically important change, and 15% improved. Mean utility change (standardized response mean) for these groups was −0.0198 (0.21), 0.0041 (0.05), and 0.0175 (0.21) showing small change and small responsiveness. ConclusionsProxy CHU9D in 2- to 5-year-old children shows potential but further research is needed.

Real-world treatment outcomes of systemic treatments for moderate-to-severe atopic dermatitis in children aged less than 12 years: 2-year results from PEDISTAD

The arrival of biologics and small-molecule therapies (eg Janus kinase inhibitors) changed atopic dermatitis treatment, but older systemic treatments continue to be prescribed. To provide real-world effectiveness, safety, and adherence data for dupilumab, cyclosporine, and methotrexate. PEDIatric STudy in Atopic Dermatitis (NCT03687359) is a real-world, prospective, observational, 10-year study of children (<12years) with inadequately controlled moderate-to-severe atopic dermatitis. We report 2-year interim results. Median treatment durations were 8.1, 13.0, and 10.7months for dupilumab (n=144), methotrexate (n=114), and cyclosporine (n=121), respectively. Dupilumab had numerically greater within-group improvements than methotrexate and cyclosporine in Eczema Area and Severity Index (-12.4∗ vs -5.7∗ and -3.3); body surface area affected (-19.9%∗ vs -11.8%∗ and -8.8%∗); itching (night-time: -2.1∗ vs -0.4 and+0.1; daytime: -1.5∗ vs +0.1 and+0.2; ≥6years); itching/scratching (-3.6∗ vs -1.4∗ and -0.2; <6years); and Patient-Oriented Eczema Measure (-7.0∗ vs -4.7∗ and -1.5) (∗P<.05 within-group improvements from baseline). Dupilumab had less discontinuations (8.3% vs 28.9% and 43.0%) and adverse event(s) (18.1% vs 29.8% and 31.4%). No randomization, placebo, or specified dosages. Dupilumab was associated with numerically greater outcomes and higher adherence than cyclosporine or methotrexate.

Improvement Across Dimensions of Disease with Lebrikizumab Use in Atopic Dermatitis: Two Phase 3, Randomized, Double-Blind, Placebo-Controlled Monotherapy Trials (ADvocate1 and ADvocate2).

Atopic dermatitis is a complex, chronic, inflammatory skin disease thatrequires long-term control of symptoms like itch and sleep loss and improvement in quality of life, in addition to reduction of clinical signs. Lebrikizumab is a selective interleukin-13 inhibitor approved in the European Union, United Kingdom, United Arab Emirates, Canada, and Japan for treatment of moderate-to-severe atopic dermatitis in adults and adolescents. Here, we assess the magnitude of changes across signs and symptoms of atopic dermatitis with lebrikizumab monotherapy over the 16-week induction period in two phase 3 studies, ADvocate1 and ADvocate2. Eligible adults (aged≥18years) and adolescents (aged 12 to<18years and weighing≥40kg) with moderate-to-severe atopic dermatitis were randomized to receive either 250mg of lebrikizumab or placebo subcutaneously every two weeks. Least squares mean percentage change from baseline through week 16 was compared between lebrikizumab and placebo using mixed model repeated measure analysis for the following endpoints: Eczema Area and Severity Index (EASI), Pruritus Numeric Rating Scale (NRS), Sleep-Loss Scale, Patient-Oriented Eczema Measure (POEM), and Dermatology Life Quality Index (DLQI). In both trials, significant (P<0.05) improvements were observed for lebrikizumab treatment compared with placebo at each 2-week timepoint for EASI, Pruritus NRS, Sleep-Loss Scale, and POEM, and at each 4-week timepoint for DLQI, through week 16. Statistically significant (P<0.001) improvements were observed at 16weeks for lebrikizumab treatment versus placebo in ADvocate1/ADvocate2 for EASI (71.9%/75.0% vs. 35.6%/43.3%), Pruritus NRS (53.3%/46.3% vs. 21.4%/18.0%), Sleep-Loss Scale (57.7%/55.6% vs. 23.9%/25.5%), POEM (54.4%/45.8% vs. 18.8%/16.9%), and DLQI (64.2%/60.5% vs. 28.5%/32.2%). Patient photos show improvements in skin appearance when disease measures improve. Lebrikizumab monotherapy resulted in significant and fast improvements in multiple dimensions of disease (clinical signs, symptoms, and quality of life) over 16weeks in patients with moderate-to-severe atopic dermatitis. ClinicalTrials.gov identifiers, NCT04146363; NCT04178967.

Efficacy and safety of dupilumab in the treatment of moderate to severe atopic dermatitis

Objective: To analyse the efficacy and safety of dupilumab in the treatment of moderate to severe atopic dermatitis (AD). Methods: The clinical data of moderate to severe AD patients who received dupilumab therapy in the Department of Dermatology, Xiangya Hospital, Central South University from August 2020 to November 2022 were retrospectively analyzed. The efficacy was evaluated by Eczema Area and Severity Index (EASI), SCORing Atopic Dermatitis (SCORAD), Numerical Rating Scale (NRS), Patient Oriented Eczema Measure (POEM), and Dermatology Quality of Life Index (DLQI) before treatment and 2, 4, 16 and 24 weeks after treatment. Adverse events that occurred during treatment were recorded. Repeated Measures ANOVA and Generalized Estimating Equations were used to compare changes in scores and changes in laboratory indices at different time points before and after treatment. Results: The age of 259 patients was (35.4±25.9) years, the duration of AD was 4.00 (2.00, 9.00) years, and 64.1% (166 patients) were men patients. The scores of EASI, SCORAD, POEM, DLQI and NRS at 2, 4, 16 and 24 weeks after treatment with dupilumab were significantly lower than those before treatment (all P<0.001). The proportions of EASI50, EASI75, and EASI90 were 91.0% (101/111), 71.2% (79/111), and 40.5% (45/111) at 16 weeks, and 95.0% (76/80), 80.0% (64/80) and 45.0% (36/80) at 24 weeks, respectively. Basal total IgE levels (P=0.005) and EOS counts (P<0.001) at Week 24 were significantly lower than those before treatment. Adverse events occurred in 54 patients (20.9%), mainly manifested as intractable erythema of the face and neck (5.0%, 13 patients) and conjunctivitis (1.9%, 5 patients). Conclusions: Dupilumab can effectively improve the rash area, rash severity and itchiness of moderate to severe atopic dermatitis, improve the quality of life of patients, and reduce the incidence of adverse effects.

Generational differences in perceived severity of atopic dermatitis.

Atopic dermatitis (AD) is a chronic inflammatory dermatosis that affects all age groups. The impact of AD on patients' lives could differ across generations. Understanding the differences in objective and subjective severity of AD between generations may support more personalized care for the AD patients. Thus, this study aimed to compare the clinical severity and subjective impact of AD between generation Z (GZ) and the millennial generation (MG). We carried out a cross-sectional observational study in patients diagnosed with moderate to severe AD born between 1993-2001 (GZ) and 1978-1992 (MG) who attended an AD specialist care unit for the first time. We collected severity indices evaluated by the dermatologist, such as the Eczema Area and Severity Index (EASI) or the Investigator Global Assessment (IGA), and severity scales that included patient assessment, such as the SCORing Atopic Dermatitis (SCORAD) or the Patient-Oriented Eczema Measure (POEM). A total of 73 patients were included, of which 56.2% (41/73) were women. 52.86% (37/73) of the patients belonged to the MG, and 43.8% (33/73) belonged to GZ. Patients belonging to GZ presented lower severity of their AD compared to the MG (EASI: 9.75 ± 11.68 vs. 16.63 ± 14.66; P < 0.05). However, their perception of disease severity was similar to the MG (SCORAD: 43.54 ± 28.99 vs. 32.98 ± 21.91; P = 0.96; POEM: 13.21 ± 8.98 vs. 15.48 ± 6.69; P = 0.14). GZ presents a higher subjective perception of severity than millennials. Understanding these generational disparities contributes to creating more effective treatment strategies and provides a more targeted approach to care that addresses each generational group's unique needs and expectations.

A prospective observational cohort study comparing the treatment effectiveness and safety of ciclosporin, dupilumab and methotrexate in adult and paediatric patients with atopic dermatitis: results from the UK-Irish A-STAR register.

The main conventional systemic atopic dermatitis (AD) treatments are methotrexate (MTX) and ciclosporin (CyA). Dupilumab was the first novel systemic agent to enter routine clinical practice. There are no head-to-head randomised controlled trials or real-world studies comparing these agents directly. Network meta-analyses provide indirect comparative efficacy and safety data and have shown strong evidence for dupilumab and CyA. The aim of this study was to compare the real-world clinical effectiveness and safety of CyA, dupilumab and MTX in AD. We compared the effectiveness and safety of these systemic agents in a prospective observational cohort study of adult and paediatric patients recruited into the UK-Irish Atopic eczema Systemic TherApy Register (A-STAR). Treatment effectiveness measures included Eczema Area and Severity Index (EASI), Patient-Oriented Eczema Measure (POEM), Peak Pruritus Numerical Rating Scale (PP-NRS), Dermatology Life Quality Index (DLQI) and children's DLQI (cDLQI). Minimum duration of treatment was 28 days and follow-up was 12 months. Adjusted Cox-regression was used to compare the hazards of achieving EASI-50, EASI-75 and EASI-90 over time, and linear mixed-effects models were used to estimate changes in efficacy scores. Treatment safety was assessed by examining adverse events (AEs) at follow-up visits. 488 patients (n=311 adults and n=177 children/adolescents) on dupilumab (n=282), methotrexate (n=149), or CyA (n=57) were included. CyA and MTX were primarily used first line, while dupilumab was mainly a second line systemic as per UK National Institute of Clinical and Care Excellence (NICE) recommendations. EASI-50, EASI-75 and EASI-90 were achieved more rapidly in the dupilumab and CyA groups compared to MTX. After adjustment for previous severity, the reduction in EASI, POEM, PP-NRS and DLQI was greater for patients treated with dupilumab compared to MTX. In severe patients the reduction in EASI, POEM, and PP-NRS was even greater with CyA. The incidence of AEs was similar across groups (734, 654 and 594 per 10,000 person-month on CyA, dupilumab and MTX respectively). This real-world comparison of CyA, dupilumab and MTX in AD suggests that dupilumab is consistently more effective than MTX and that CyA is most effective in very severe disease within one follow-up year.

Systemic Immunomodulatory Treatments for Atopic Dermatitis

There are multiple approved systemic treatments for atopic dermatitis. Lebrikizumab is a newly licensed biologic medication that has been compared to placebo in clinical trials but not to other systemic treatments. To compare reported measures of efficacy and safety of lebrikizumab to other systemic treatments for atopic dermatitis in a living systematic review and network meta-analysis. The Cochrane Central Register of Controlled Trials, MEDLINE, Embase, the Latin American and Caribbean Health Science Information database, the Global Resource of Eczema Trials database, and trial registries were searched from inception through November 3, 2023. Randomized clinical trials evaluating 8 or more weeks of treatment with systemic immunomodulatory medications for moderate to severe atopic dermatitis. Titles, abstracts, and full texts were screened in duplicate. Data were abstracted in duplicate and random-effects bayesian network meta-analyses were performed. Minimal important differences were used to define important differences between medications. Certainty of evidence was assessed using the GRADE approach (Grading of Recommendations Assessment, Development and Evaluation). The updated analysis was completed from December 13, 2023, to February 20, 2024. Efficacy outcomes were the Eczema Area and Severity Index (EASI), the Patient Oriented Eczema Measure (POEM) Dermatology Life Quality Index (DLQI), and Peak Pruritus Numeric Rating Scales (PP-NRS) and were compared using mean difference (MD) with 95% credible intervals (CrI). Safety outcomes were serious adverse events and withdrawal due to adverse events. Other outcomes included the proportion of participants with 50%, 75%, and 90% improvement in EASI (EASI-50, -75, -90) and the proportion with success on the Investigator Global Assessment compared using odds ratios with 95% CrI. The study sample included 97 eligible trials, with a total of 24 679 patients. Lebrikizumab was associated with no important difference in change in EASI (MD, -2.0; 95% CrI, -4.5 to 0.3; moderate certainty), POEM (MD, -1.1; 95% CrI -2.5 to 0.2; moderate certainty), DLQI (MD, -0.2; 95% CrI -2.1 to 1.6; moderate certainty), or PP-NRS (MD, 0.1; 95% CrI -0.4, 0.6; high certainty) compared to dupilumab among adults with atopic dermatitis who were treated for up to 16 weeks. Dupilumab was associated with higher odds of efficacy in binary outcomes compared with lebrikizumab. The relative efficacy of other approved systemic medications was similar to that found by previous updates of this living study, with high-dose upadacitinib and abrocitinib demonstrating numerically highest relative efficacy. For safety outcomes, low event rates limited useful comparisons. In this living systematic review and network meta-analysis, lebrikizumab was similarly effective to dupilumab for the short-term treatment of atopic dermatitis in adults. Clinicians and patients can use these comparative data to inform treatment decisions.

Stable Response and Sustained Improvement of Itch and Sleep Symptoms in Patients with Atopic Dermatitis Treated with Lebrikizumab over 52 Weeks.

Lebrikizumab demonstrated significant improvement versus placebo for measures of skin clearance and patient-reported outcomes at weeks 16 and 52 in patients with moderate-to-severe atopic dermatitis (AD). We report the sustained impact of lebrikizumab monotherapy, over 52 weeks and between visits, on the frequency of itch and sleep loss symptoms, as assessed by Patient-Oriented Eczema Measure (POEM), in patients with moderate-to-severe AD. In ADvocate1 and ADvocate2, Week-16 lebrikizumab responders (EASI75 or IGA 0/1 with ≥ 2-point improvement and without rescue medication) were randomized to lebrikizumab every 2 weeks (Q2W), every 4 weeks (Q4W), or placebo for 36 weeks. This pooled analysis reports improvement from Week 16 to 52 in patients achieving POEM response 0 (no days) or 1 (1-2 days) for Items 1 (itch) and 2 (sleep disturbance) for the lebrikizumab Q2W and Q4W treatment arms. Observed (excluding data collected after treatment discontinuation, rescue medication use, or patient transfer to escape arm) results were reported. At Week 16, for lebrikizumab Q2W and Q4W, 35.9% (n = 37/103) and 39.3% (n = 42/107) of patients responded 0 or 1 to Item 1 of POEM (Itch) and 12.6% (n = 13/103) and 12.1% (n = 13/107) responded 0. A total of 66.0% (n = 68/103) and 72.6% (n = 77/106) of patients responded 0 or 1 to Item 2 of POEM (Sleep) and 37.9% (n = 39/103) and 44.3% (n = 47/106) responded 0, respectively. By Week 52, for lebrikizumab Q2W and Q4W, 44.6% (n = 29/65) and 48.0% (n = 36/75) responded 0 or 1 to Item 1 of POEM (Itch), and 21.5% (n = 14/65) and 18.7% (n = 14/75) of patients responded 0. A total of 83.1% (n = 54/65) and 78.4% (n = 58/74) responded 0 or 1 to Item 2 of POEM (Sleep), and 67.7% (n = 44/65) and 59.5% (n = 44/74) responded 0, respectively. Weekly POEM responses for itch and sleep disturbance remained stable between doses and visits, and continued to improve from Week 16 through 52, in lebrikizumab-treated patients, demonstrating consistent improvement over time for key AD symptoms. ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967).

A Systematic Review and Meta-analysis of Mobile Health Applications and Telemonitoring in Atopic Dermatitis Self-Management.

Up to 25% of children and 5.6% of adults in the USA have atopic dermatitis (AD), with substantial impacts on quality of life. Effective control can be challenging despite therapy efforts. The emergence of information and communication technologies (ICT) in AD management prompted this study to assess its impact on self-management. We conducted a meta-analysis to assess outcomes from peer-reviewed clinical trials evaluating the effectiveness of teledermatology, mobile health (mHealth) apps, and electronic devices for managing AD. We searched PubMed, Web of Science, Scopus, and Embase for articles written in English and published until May 2023. Twelve trials with 2424 participants were selected from 811 studies. A meta-analysis of 1038 individuals reported a mean difference (MD) of -1.57 [95% confidence interval (CI): -2.24, -0.91] for the Patient Oriented Eczema Measure (POEM). A meta-analysis of 495 individuals reported a Dermatology Life Quality Index (DLQI) MD of -0.59 [95% CI: -0.95, -0.23]. Despite heterogeneity (I2 = 47% and I2 = 74%), the impact was significant (P ≤ 0.001). SCORing Atopic Dermatitis (SCORAD) showed an insignificant MD of -0.12 (P = 0.91). mHealth applications and telemonitoring show significant improvement in patients' quality of life (DLQI) and self-management (POEM) but no significant impact on AD severity (SCORAD).

Atopic Dermatitis, Sleep, and the COVID-19 Pandemic

Abstract Objective To investigate sleep disorders among children with atopic dermatitis (AD), before and during the coronavirus disease 2019 (COVID-19) pandemic. Materials and Methods The present longitudinal, prospective study included 26 patients with AD, and the Sleep Disturbance Scale for Children (SDSC) questionnaire and questions about sleep hygiene were used. The severity of AD was determined by the Patient-Oriented Eczema Measure (POEM). The first evaluation was conducted before the pandemic (in 2019) and the second, during the pandemic, from September to December 2020. Results Sleep disorder was present in 17 (65.38%) patients in the 1st evaluation, and in 11 (42.30%) in the 2nd (p = 0.04). In the 1st evaluation, disorders of initiating and maintaining sleep (DIMSs) were more frequent in patients with moderate-to-severe AD (83.33%). During the pandemic, 6 patients (23.07%) reported improvement in sleep quality. Conclusion Sleep quality was negatively influenced by the severity of AD. During the COVID-19 pandemic, there was improvement in sleep quality, despite the absence of changes in disease severity.

Impact of Atopic Dermatitis on Adult Women's Lives: A Survey of 1,009 French Women.

Atopic dermatitis (AD) is one of the most common inflammatory diseases, and has a higher prevalence among females in adulthood. The aim of this observational, cross-sectional, survey-based study was to evaluate the impact of AD on the daily lives of adult women patients. A scientific committee composed exclusively of women constructed a specific questionnaire in partnership with the French Eczema Association. Severity of AD was evaluated with the Patient-Oriented Eczema Measure (POEM). A sample of 1,009 adult women (mean age ± standard deviation: 41.8 ± 14.2 years) with AD was identified from a representative sample of the French population (82% response rate 1,230 women surveyed). According to the POEM, 50.64% (n = 511) of subjects were identified as having mild AD, 39.35% (n = 397) moderate AD, and 10.01% (n = 101) severe AD. Overall, 67.7% (n = 682) reported that their eczema involved a visible area (face, neck or hands), and 19.6% (n = 198) a sensual area (breasts/chest, genital area or buttocks). Of the 720 women with menstrual cycles, exacerbations of AD were reported to occur mostly before (50.6%) and during (48.3%) menstruation. A small proportion of women, 7.3% (n = 74), reported being afraid of becoming pregnant because of their eczema. If AD involvement was in a visible area it had a greater impact on romantic relationships, sexual relationships and occupation. If AD involvement was in a sensual area it had a greater influence on romantic relationships and sexuality. Particular attention should be given to patients with localization of AD on the face, neck or hands, as they have a higher risk of social exclusion. Moreover, these results should encourage health professionals to ask patients with AD about the possible involvement of sensual areas.

Targeted Combined Endpoint Improvement in Patient and Disease Domains in Atopic Dermatitis: A Treat-to-Target Analysis of Adults with Moderate-to-Severe Atopic Dermatitis Treated with Upadacitinib.

A treat-to-target approach was recently developed to guide systemic treatment for adults with atopic dermatitis (AD). Recommendations outlined criteria for a 3-month initial acceptable treatment target and a 6-month optimal target, evaluated using global assessment of patient-reported disease severity, as well as Eczema Area and Severity Index, itch assessed on an 11-point numerical rating scale, Dermatology Life Quality Index, or Patient-Oriented Eczema Measure. Achievement of these targets with once-daily upadacitinib (15 mg and 30 mg) monotherapy was evaluated using integrated adult data from the Measure Up 1 and 2 phase 3 studies. Among the 852 patients treated with upadacitinib 15 mg or 30 mg, the 3-month initial acceptable target was achieved by >80%, >78%, and ≥87% of patients, and the 6-month optimal target was achieved by ≥53%, >61%, and >73% of patients at weeks 2, 16, and 52, respectively. Achievement of all 6 individual criteria for each of the target goals also increased over time. These findings suggest that upadacitinib 15 mg and 30 mg may help improve standards of care in patients with moderate-to-severe AD by achieving 6-month target goals at 16weeks and as early as 2 weeks for most patients.