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INTRODUCTION: Atopic dermatitis (AD) is a chronic inflammatory skin disease for which signs and symptoms have a negative impact on a patients quality of life (QoL) and mental health. Here, we assess the impact of lebrikizumab on QoL and mental health after 16 weeks of treatment in patients with moderate-to-severe AD. METHODS: Data were analyzed over 16 weeks from two separate phase 3, randomized, placebo-controlled, monotherapy trials (ADvocate1 and ADvocate2). Patient-reported outcomes were assessed using the following measures: Dermatology Life Quality Index (DLQI), EQ-5D-5L visual analogue scale (VAS), EQ-5D-5L index scores (UK and US), Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety, and PROMIS Depression. RESULTS: Treatment with lebrikizumab 250 mg every 2 weeks in two studies led to statistically significant improvements (based on nominal p values) versus placebo in DLQI since week 4 (the first timepoint assessed) for the following measures: change from baseline in DLQI total score (ADvocate1 - 7.8 vs - 2.8; ADvocate2 - 7.3 vs - 3.9), proportion of patients with DLQI ≥ 4-point improvement (ADvocate1 69.5% vs 36.2%; ADvocate2 60.5% vs 42.6%), DLQI total score ≤ 5 (ADvocate1 36.7% vs 8.8%; ADvocate2 29.6% vs 10.8%), and DLQI (0, 1) (ADvocate1 12.3% vs 1.7%; ADvocate2 9.2% vs 1.7%). Improvements in DLQI measures, EQ-5D-5L index scores (UK and US), and EQ-5D-5L VAS were sustained through week 16. Additionally, lebrikizumab improved PROMIS Anxiety and PROMIS Depression scores, and improvements were higher in patients with at least a mild score (≥ 55) versus placebo for PROMIS Anxiety (ADvocate1 - 7.43 vs - 1.51; ADvocate2 - 4.95 vs - 0.82) and PROMIS Depression (ADvocate1 - 7.42 vs - 2.46; ADvocate2 - 4.28 vs - 2.00). CONCLUSIONS: Treatment with monotherapy 250 mg lebrikizumab for 16 weeks provided clinically meaningful improvements in outcomes related to QoL and mental health for patients with moderate-to-severe AD. Lebrikizumab-treated patients reported improvements in DLQI as early as week 4, the first measure since baseline. TRIAL REGISTRATION: ClinicalTrials.gov Registration NCT04146363 (ADvocate1) and NCT04178967 (ADvocate2).

Background: The Severity of Alopecia Tool (SALT) is a standardized method for quantifying scalp hair loss in alopecia areata (AA). SALT scores can be used to guide treatment decisions and are widely used as eligibility criteria and endpoints for clinical trials in AA. However, clinicians may be unfamiliar with assessing and envisioning SALT scores in practice. Objectives: To aid clinicians in the determination and application of SALT scores in a clinical setting, this manuscript seeks to contextualize SALT scores using patient images from a clinical trial of adults with severe AA. Methods: Images from 722 patients enrolled in BRAVE-AA1, a phase 2/3 study of baricitinib in adults with severe AA (SALT score ≥50; ≥50% scalp hair loss), were obtained at baseline and Weeks 12, 36, and 52 and compiled into a repository. Photographs were selected to represent SALT scores across the full range of disease (SALT scores 0–100) and to demonstrate the progression of SALT scores during the course of treatment. Results: Images of six patients depict the range of SALT scores (0–100). Photographs are of male and female patients of different ages (21–69) and races (Asian, Black, White) with varying extent, density, and patterns of hair loss. Images of two additional patients demonstrate the use of SALT to monitor treatment progress, showing distinct patterns and timing of clinical response over 52 weeks of therapy. Conclusions: The SALT is widely used in clinical trials for AA, but clinicians may lack familiarity. Presented patient images show SALT scores commonly used as eligibility criteria and endpoints in clinical trials, which may be useful in identifying patients eligible for systemic treatment and in visualizing therapeutic response.

Background: Sleep loss is a key factor contributing to disease burden in people with atopic dermatitis (AD). Mitigating itch to improve sleep is an important outcome of AD treatment. This study explored the content validity and measurement properties of the Sleep-Loss Scale, a single-item rating scale for assessing itch interference with sleep in clinical trials of AD treatments. Methods: Concept elicitation and cognitive debriefing interviews were conducted with 21 adults and adolescents (12–17 years of age) with moderate-to-severe AD to develop a conceptual model of patient experience in AD and explore the content validity of the scale. Data collected from adults with moderate-to-severe AD enrolled in a phase 2b study (NCT03443024) were used to assess Sleep-Loss Scale's psychometric performance, including reliability, construct validity, and ability to detect change. Meaningful within-patient change (MWPC) thresholds were also determined using anchor-based methods. Results: Qualitative findings from concept elicitation highlighted the importance of sleep-loss related to itch in AD. Debriefing analysis of the Sleep-Loss Scale indicated that the scale was relevant, appropriate, and interpreted as intended. Trial data supported good reliability, construct validity and ability to detect improvement. MWPC was defined as a 1-point improvement using trial data, a finding supported by qualitative data. Conclusions: The Sleep-Loss Scale provides a valid and reliable patient-reported measure of the impact of itch on sleep in patients with AD, and can detect change, indicating it is fit-for-purpose to evaluate the efficacy of AD treatments in moderate-to-severe patients. Key summary points: • The Sleep-Loss Scale is a novel rating scale for assessing the impact of itch on sleep in atopic dermatitis (AD). • A mixed-methods approach was used to explore the content validity and psychometric properties of the Sleep-Loss Scale. • Qualitative results supported sleep loss as a common experience in AD and indicated that the Sleep-Loss Scale was relevant, appropriate, and interpreted as intended. • Quantitative results demonstrated the Sleep-Loss Scale is valid, reliable, and able to detect change. • The Sleep-Loss Scale was found to be fit-for-purpose for use in clinical trials of AD treatments among moderate-to-severe patients. [ABSTRACT FROM AUTHOR]

Introduction/Background Atopic dermatitis (AD) has different clinical presentations, pathophysiology, comorbidity frequencies, and genetic profiles in adult-onset vs childhood-onset disease. Based on these differences, it is plausible that treatment response would also be different between adult- and childhood-onset AD. Lebrikizumab, a novel, high affinity monoclonal antibody, selectively targeting IL-13 with high affinity and slow dissociation rate, has been approved in the EU, UK, and Japan and is under investigation in the US and elsewhere for the treatment of moderate-to-severe AD. Objectives To evaluate the Week-16 efficacy of lebrikizumab monotherapy by age of AD onset in adults and adolescents with moderate-to-severe AD from ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967), identically-designed, randomized, double-blind, placebo-controlled phase 3 trials. Methods In ADvocate1 and ADvocate2, eligible patients were randomly allocated 2:1 to receive lebrikizumab 250 mg or placebo every 2 weeks. The date of AD onset was collected, and age of onset was calculated accordingly. Patients were stratified by age of AD-onset as ≤2, >2-to-<18, and ≥18 years. Efficacy was assessed at Week 16 with the proportion of patients with Investigator's Global Assessment score of 0 or 1 with ≥2-point improvement (IGA 0,1; the trials' primary endpoint); ≥75% (EASI 75) and ≥90% (EASI 90) improvement in the Eczema Area and Severity Index from baseline; ≥4-point Pruritus Numeric Rating Scale (NRS) improvement from baseline (with baseline score ≥4), and percentage change in total EASI from baseline. Data from patients who received topical or systemic rescue medication or discontinued treatment due to lack of efficacy were imputed as nonresponders or set to baseline values. Data from patients who discontinued treatment for other reasons were set to missing and analyzed by multiple imputation. This was a post-hoc analysis conducted on the modified, pooled intent-to-treat population. Treatment-by-age subgroup interaction was assessed with logistic regression. Binary outcomes were analyzed by the Cochran-Mantel-Haenszel method, and continuous outcomes were analyzed with ANCOVA. Results At baseline, the numbers of patients treated with lebrikizumab and placebo, respectively, were 215 and 117 in the ≤2 years AD-onset subgroup, 178 and 103 in the >2-to-<18 years subgroup, and 171 and 67 in the ≥18 years subgroup. At baseline, the percentages of patients with ≥1 atopic comorbidity were 81% in the ≤2 years subgroup, 74% in the >2-to-<18 years subgroup, and 58% in the ≥18 years subgroup. At Week 16, treatment-by-age subgroup interactions were not significant at the 0.10 level for IGA 0,1; EASI 75; EASI 90; and Pruritus NRS 4-pt improvement. Within each subgroup, a higher proportion of lebrikizumab-treated compared with placebo-treated patients (p<0.001) achieved IGA 0,1 responses (≤2 years: 41% vs. 12%; >2-to-<18 years: 35% vs. 12%; ≥18 years: 38% vs. 12%), EASI 75 responses (≤2 years: 57% vs. 17%; >2-to-<18 years: 51% vs. 16%; ≥18 years: 58% vs. 20%), and EASI 90 responses (≤2 years: 38% vs. 10%; >2-to-<18 years: 32% vs. 9%; ≥18 years: 33% vs. 8%). Additionally, the least-squares mean percentage change from baseline in total EASI score for lebrikizumab and placebo, respectively, was -65% and -26% in the ≤2 years subgroup, -60% and -26% in the >2-to-<18 years subgroup, and -63% and -30% in the ≥18 years subgroup (p<0.001 for lebrikizumab vs. placebo in all subgroups). The proportion of lebrikizumab-treated patients who reported ≥4-point improvement in Pruritus NRS from baseline (baseline ≥4) was greater compared with placebo-treated patients ([N]; ≤2 years: 43% [201] vs. 11% [108]; >2-to-<18 years: 41% [161] vs. 14% [96]; ≥18 years: 45% [154] vs. 12% [60]; p<0.001). Conclusions Regardless of age of AD onset, lebrikizumab was associated with significant improvements in AD signs and symptoms compared with placebo over 16 weeks of treatment. [ABSTRACT FROM AUTHOR]

Introduction The decision to initiate systemic therapy (ST) in patients with atopic dermatitis (AD) is complex, with no criteria that are globally agreed upon. To aid dermatology providers in this decision-making, the "When to Start Systemic Therapy Checklist" was developed. The checklist comprises three components: (A) clinical severity, (B) subjective burden, and (C) lack of treatment response, each with several criteria. Systemic therapy is indicated when at least one criterion in each component is fulfilled. Objectives To corroborate the validity of this checklist, we evaluated the agreement between the decision to initiate ST using the checklist, against the reference, CorEvitas AD Registry patients prescribed a ST. Methods Adults with moderate-to-severe AD from the prospective, longitudinal CorEvitas AD registry were included in this descriptive analysis (July 2020 – August 2023). Patients were included if they were initiating ST at enrollment (ST group) or not initiating ST at enrollment (non-ST group) but had vIGA-AD® ≥3 and Eczema Area Severity Index ≥12. The checklist criteria were compared against registry outcome measures; when a criterion did not match a measure, either a proxy measure was selected or that part of the questionnaire was excluded. Overall percentage agreement (accord between checklist criteria and ST initiation status [reference standard]) with corresponding 95% confidence intervals (CIs) was calculated. Results In the ST group (n=1488), 97.0% of patients met at least one criterion from section A, 94.1% from section B, and 92.1% for either section A or B. In the non-ST group (n=208), 100% of patients met at least one criterion from section A, 92.3% from section B, and 92.3% from either section A or B. Among patients in the ST group who met at least one criterion each from section A and B, overall percentage agreement was 81.7% (95% CI: 79.8%, 83.5%). Section C, which addresses "lack of treatment response" could not be evaluated due to the absence of relevant data in the registry. Conclusions Nearly all patients initiating ST met at least one criterion from both section A and B of the "When to Start Systemic Therapy Checklist", demonstrating a strong alignment between the checklist sections A and B and disease burden of AD patients in the registry. Subsequent research is needed to assess section C due to registry limitations. Future analyses should examine why some patients with high disease burden and severity remain untreated with systemics. [ABSTRACT FROM AUTHOR]

The article discusses the results of two phase III clinical trials, ADvocate1 and ADvocate2, which examined the efficacy and safety of lebrikizumab monotherapy in patients with moderate-to-severe atopic dermatitis (AD). The trials found that lebrikizumab significantly improved patient-reported itch and reduced sleep loss due to itch. The improvements in itch and sleep loss were observed as early as the first few days of treatment and were consistent with previous studies on lebrikizumab. The study was funded by Dermira, a subsidiary of Eli Lilly and Company, and medical writing assistance was provided by ProScribe–Envision Pharma Group. [Extracted from the article]

Introduction/Background There is evidence of disparities in healthcare utilization for patients with atopic dermatitis (AD), but research exploring differences in patient treatment satisfaction and patient perception of interactions with their AD healthcare provider (HCP) by race and ethnicity is limited. Objectives The primary study objectives were to understand racial and ethnic differences in adult patients with AD for treatment use, treatment satisfaction, and patient perceptions on HCP interactions. Methods Adult patients living with self-reported AD in the United States (US) were recruited through the National Eczema Association (NEA) and the AmeriSpeak panel, a national sample of US adults. Sampling targets were used to achieve condition-based population proportions across multiple racial and ethnic categories. Patients completed an 80- to 110-item electronic one-time survey including questions on overall AD severity over the last month, current AD treatment, current AD treatment satisfaction, AD provider type, and perceptions of their interactions with HCPs. Data are reported using descriptive statistics. Results Overall, 260 patients (NEA n=18; AmeriSpeak n=242) completed the survey (mean age 40.6 years; 66.2% female; 55.0% White, 23.5% Black/African American, 11.5% Asian, and 10.0% American Indian/Alaskan Native, Native Hawaiian or Other Pacific Islander, or multiple-races (i.e. other races (OtR)); 13.5% Hispanic/Latino). Nearly half (49.6%) reported severity as mild, 43.1% moderate, and 7.3% severe. Overall, 63.8% of patients were using over-the-counter ointments/creams/lotions/gels for their AD, while 62.6% were using prescription creams/lotions. 28.2% reported being dissatisfied/very dissatisfied with their current treatment regimen, with treatment dissatisfaction was highest among Black/African American patients (36.2%) and lowest among OtR patients (21.7%). Additionally, 22.6% of patients reported that in the past year they or a household member had been unable to get medicine or any healthcare (medical, dental, mental health, vision); this was reported by 32.2% Black/African American, 21.1% White, 19.2% OtR, 13.3% Asian, 20.0% Hispanic/Latino, and 23.0% Non-Hispanic/Non-Latino. 49.2% indicated that a dermatologist was the provider they primarily saw for medications to treat their AD. This was followed by primary care providers (33.1%), those who did not see a provider for their AD (10.4%), and allergists (4.2%). Of those who indicated they saw a provider for their AD, 39.1% of patients report their HCP listened to their AD concerns 'somewhat' or 'a little bit'; Asian (61.6%), White (38.9%), Black/African American (32.7%), and OtR (30.4%). 43.3% of Hispanic/Latino and 38.5% of Non-Hispanic/Non-Latino patients reported their HCP listened 'somewhat' or 'a little bit.' Only 1.3% of all patients reported their HCPs did not listen to their concerns 'at all.' When asked how much they thought their AD HCP understood their perspective on their AD, 42.4% of all patients chose 'somewhat' or 'a little bit.' This was reported by 46.2% Asian patients, 44.4% White patients, 41.7% OtR patients, 36.4% Black/African American patients, 53.1% Hispanic/Latino patients, and 40.7% Non-Hispanic/Non-Latino patients. Additionally, 42.1% of all patients reported they 'somewhat' or 'a little bit' trust that their HCP effectively treats their AD. This was reported by 50.0% Asian patients, 45.3% White patients, 34.6% Black/African American patients, 33.3% OtR patients, 43.8% Hispanic/Latino patients, and 41.8% Non-Hispanic/Non-Latino patients. Overall, 3% of patients reported they did not trust their HCP to effectively treat their AD 'at all' and 1.3% reported their HCPs did not understand their perspective 'at all.' Conclusions Nearly a quarter of patients living with AD reported not being able to access medicine or healthcare in the past year. Although there were differences in the percentages reported by race and ethnicity, some patients indicated there were gaps with regards to the patient-physician relationship around not feeling completely listened to, understood, or trusting HCPs treating AD. These findings may help inform clinical practice considerations in AD. [ABSTRACT FROM AUTHOR]

Introduction/Background Lebrikizumab is a novel, high-affinity monoclonal antibody, selectively targeting IL-13 with a slow dissociation rate. The efficacy and safety of lebrikizumab to treat moderate-to-severe atopic dermatitis (AD) have been established in phase 3 studies, including subset analyses by race and ethnicity. ADmirable (NCT05372419) is the first phase 3b, open-label, 24-week study to evaluate the efficacy and safety of lebrikizumab in adult and adolescent patients with moderate-to-severe AD and skin of color (SOC). Objectives To present the baseline demographics, clinical characteristics, and 16-week efficacy from an interim analysis of ADmirable. Methods Patients who enrolled by June 29, 2023, and completed 16 weeks of lebrikizumab treatment or discontinued treatment on or prior to Week 16 were included in this analysis. At baseline and Week 2, patients received a 500-mg lebrikizumab loading dose followed by 250 mg every 2 weeks through Week 16. Key eligibility criteria included: ≥12 years of age (≥40 kg for adolescents), self-reported race other than White, Fitzpatrick Phototype IV-VI, chronic AD present for ≥1 year, history of inadequate response to topical medications, naïve to biologics indicated for AD treatment, baseline Eczema Area and Severity Index (EASI) ≥16, Investigator's Global Assessment (IGA) ≥3, and ≥10% body surface area (BSA) of AD involvement. Baseline demographics and clinical characteristics were collected during screening. Efficacy endpoints included the proportion of patients achieving ≥75%/≥90% reduction in EASI (EASI 75/90); IGA of 0,1 with ≥2-point improvement from baseline (IGA 0,1) and ≥3-point and ≥4-point Pruritus Numeric Rating Scale (NRS) improvement from baseline; mean percentage change in EASI and Pruritus NRS; and changes in post-inflammatory hyperpigmented (PIH) lesions as measured by PDCA-Derm™, a new scale comparing PIH lesions with unaffected, adjacent normal skin. Serious adverse events (SAEs) were also assessed. Additional innovative objective measures of pigment and erythema were utilized in this trial. Discrete variables are described using frequencies and percentages, and continuous variables are described with summary statistics. All data are as observed. Results The analysis included 50 enrolled patients. Forty patients (80%) were Black/African-American, 7 (14%) were Asian, and 3 (6%) were American Indian/Alaska Native; 11 (22%) were Hispanic/Latino and 39 (78%) were not Hispanic/Latino; 8 (16%) patients were adolescents and 23 (46%) patients were female. The proportions of patients with Fitzpatrick Phototype IV, V, and VI were 42%, 22%, and 36%, respectively. At baseline, mean (SD) age was 42.2 (19.7) years; and disease duration was 19.3 (15.8) years. Mean (SD) baseline BMI was 30.2 (7.7) kg/m2. Mean (SD) BSA affected was 41.7% (20.8) and 64% of patients presented with IGA=3. At baseline, mean (SD) EASI and Pruritus NRS were 28.1 (12.4) and 7.2 (2.2), respectively, and 27 patients (54%) had at least one PIH lesion. Clinical characteristics included AD with prurigo nodules (16%), follicular/perifollicular accentuation of AD (14%), allergic shiners (12%), pityriasis alba (10%), and AD with nummular features (10%). 40 patients completed the Week-16 visit. At Week 16, the proportions of patients achieving the following outcomes were: EASI 75: 68%; EASI 90: 46%; IGA 0,1: 39%; ≥3-Point Pruritus NRS improvement: 66%; and ≥4-point Pruritus NRS improvement: 56%. At Week 16, the mean percentage change from baseline (improvement) was -79.1% for EASI and -53.9% for Pruritus NRS. At Week 16, 12 of 21 patients with baseline hyperpigmented lesions had improved PDCA-Derm™ and 6 of the 21 lesions achieved normal skin tone. No SAEs were observed. Conclusions In this interim analysis of the first Phase 3b clinical trial of lebrikizumab for patients with moderate-to-severe AD and SOC, lebrikizumab improved AD signs and symptoms as measured with objective and subjective tools and scales, and no SAEs were observed. [ABSTRACT FROM AUTHOR]

Introduction/Background Lebrikizumab (LEB) is a novel monoclonal antibody that binds with high affinity and slow off-rate to interleukin (IL)-13, thereby blocking the downstream effects of IL-13 with high potency. ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967) are identically designed Phase 3 trials that evaluated LEB as a monotherapy treatment for moderate-to-severe atopic dermatitis (AD). Many patients who met the protocol-defined response criteria at Week 16, defined as achieving ≥75% improvement in the Eczema Area and Severity Index (EASI 75) or an Investigator's Global Assessment of 0 or 1 (IGA 0/1) without use of rescue therapy, maintained a deep response up to Week 521. Deep response was defined as maintaining an IGA 0 (clear skin), a 100% improvement in the Eczema Area and Severity Index (EASI 100), or a Pruritus Numeric Rating Scale score of 0 or 1 (Pruritus NRS 0/1). Patients completing Week 52 were given the option to roll over into a long-term extension (LTE) study, ADjoin (NCT04392154), allowing the opportunity to analyze deep response for a longer period of time. This analysis supports the evolution of AD treatment goals toward maintaining higher efficacy thresholds for a longer duration. Objectives To present the long-term maintenance of LEB's depth of response for up to 104 weeks of treatment (52 weeks in the ADvocate studies and 52 weeks in the ADjoin study). Methods Patients entering ADjoin from ADvocate1 and ADvocate2 continued taking the same LEB dose as the parent study. Patients receiving placebo (LEB withdrawal) during the maintenance period of ADvocate1 and ADvocate2 transitioned to receive LEB every 2 weeks (Q2W) during ADjoin (data not included in this analysis). The proportion of patients achieving IGA and EASI responses were calculated from the LEB-treated patients who were IGA 0/1 or EASI 75 responders, respectively, at Week 16 in ADvocate1 and ADvocate2. The proportion of patients achieving a Pruritus NRS 0/1 response were calculated from the LEB patients who were per protocol responders at Week 16 of ADvocate1 and ADvocate2. Each patient's absolute Pruritus NRS score was calculated by averaging daily scores from the previous seven days with at least one nonmissing value. The weekly score was then rounded to the nearest integer. Consistent with common reporting practices for LTE studies, this post hoc analysis reports observed data which were analyzed regardless of rescue medication use or treatment discontinuation. Results From Week 52 to Week 104, the proportion of IGA 0 responders was maintained and slightly increased in patients treated with LEB Q2W (50.8% [N=59] to 52.3% [N=44]) and LEB every 4 weeks (Q4W; 43.5% [N=69] to 45.5% [N=55]). Greater improvements over the second year of treatment were seen in the proportion of EASI 100 responders treated with LEB Q2W (36.4% [N=88] to 39.7% [N=68]) and LEB Q4W (30.7% [N=101] to 41.3% [N=80]) as well as the proportion of Pruritus NRS 0/1 responders treated with LEB Q2W (46.3% [N=80] to 57.4% [N=61]) and Q4W (47.9% [N=94] to 55.4% [N=65]). Although rescue medication was allowed during ADjoin, a relatively low proportion of patients received ≥1 topical rescue medication in the LEB Q2W (9.8%) and LEB Q4W (15.2%) treatment arms. Conclusions These 2-year results demonstrate an extended maintenance of deep response in patients treated with LEB Q2W and LEB Q4W after responding to 16 weeks of LEB Q2W. Approximately 50% and 40% of LEB-treated patients sustained total skin clearance (IGA 0 and EASI 100, respectively) and more than 55% of LEB-treated patients reported no or minimal itch (Pruritus NRS 0/1). Maintenance treatment with LEB Q2W and LEB Q4W allows patients and providers to elevate their expected treatment goals in AD beyond EASI 75 and IGA 0/1 response. [ABSTRACT FROM AUTHOR]

Introduction Historically, atopic dermatitis (AD) was believed to affect primarily children. However, a recent meta-analysis of 17 studies reporting age of AD onset as >16 years found that the pooled proportion of adult-onset AD was 26.1%, and that AD onset can occur at all ages. Lebrikizumab (LEB) is a high-affinity monoclonal antibody which targets IL-13, the key cytokine implicated in AD. Objectives This analysis investigated the efficacy and safety of lebrikizumab in adults ≥60 years with moderate-to-severe AD. Methods Data for patients aged ≥60 years from two Phase 3 trials, ADvocate1 and ADvocate2, were pooled. A total of 98 patients ≥ 60 years participated in the ADvocate trials (N=28 placebo (PBO), N=70 LEB). Patients were treated with lebrikizumab 250mg every 2 weeks or PBO, for 16 Weeks. Baseline demographics and characteristics were recorded. Efficacy was assessed in the pooled modified intent to treat population at Week 16 with Investigator's Global Assessment (IGA) (0,1) with ≥2-point improvement, ≥75% improvement in Eczema Area and Severity Index (EASI 75), EASI percentage change from baseline (CFB), and Pruritus Numeric Rating Scale (NRS) ≥4-point improvement. Categorical outcomes were evaluated by Cochran Mantel Haenszel tests to compare treatment groups. Continuous outcomes were analyzed using the analysis of covariance model. Data collected after use of rescue medication or discontinuation due to lack of efficacy were imputed with non-responder imputation (NRI) for categorical endpoints, or baseline values for continuous endpoints. Data collected after discontinuation for other reasons were set to missing and missing data were imputed with multiple imputation. Safety was also assessed in the integrated modified safety population. Results The baseline mean age was 67.2 years (standard deviation [SD] 6.7, range 60-93) in LEB- treated patients and 69 years ([6.2], range 60-85) in PBO. The LEB-treated population was 62.9% male (n=44/70) vs PBO 46.4% (n=13/28). Race was comparable between groups. At baseline 67.1% LEB (n=47/70) and 57.1% PBO (n=16/28) patients had IGA 3, while 32.9% LEB (n=23/70) and 42.9% PBO (n=12/28) had IGA 4. Other baseline characteristics were comparable: EASI: LEB 26.1, [10.6] vs PBO 27.1, [8.1]; BSA: LEB 38.3, [19.8] vs. PBO 40.9, [18.1]; and Pruritus NRS: LEB 7.5, [2.0] vs PBO 7.4, [1.7]. At Week 16, IGA (0,1) was achieved by 34.5% LEB-treated patients vs 11% PBO (P=0.022). EASI 75 was achieved by 48.9% and 16.3% of LEB- and PBO-treated patients, respectively (P=0.004). Pruritus NRS with ≥4-point improvement was reported by 45.5% and 12.2% of LEB vs PBO, respectively (P=0.004). The mean percent CFB EASI was LEB -58.5% (SE 8.5) and PBO -29.4% (SE 11.1) (P=0.002). Safety results in the older adult population were consistent with the overall modified safety population. Conclusions At Week 16, efficacy and patient reported outcome endpoints were met in the older adult population. These results indicate that lebrikizumab is an effective treatment for moderate-to-severe AD in the adult population ≥60 years of age and has a consistent safety profile. [ABSTRACT FROM AUTHOR]

Background/Purpose To address issues regarding health disparities and differential access to health care in diverse racial and ethnic populations, many of whom are part of underserved communities, current and robust data on atopic dermatitis (AD) prevalence by race/ethnicity are needed. Whereas data on pediatric prevalence of atopic dermatitis in diverse race/ethnicity populations have been reported, there are limited epidemiologic data on adult populations with AD. Methods Analyses were conducted using cross-sectional data from the 2021 National Health Interview Survey. Weighted overall frequencies of subject reports of diagnosed AD or eczema were estimated by race/ethnicity. Adjusted odds ratios were estimated to compare prevalence rates between subgroups. Corresponding population denominators for use in estimating prevalence rates were obtained from the US Census Bureau (2020 Census Demographic Profile). Prevalence is reported as percentage (standard error). Pediatric data was also analyzed for the presentation. Results Overall US prevalence of AD in adults ages 18-64 was 7.6% (0.2) and age 65+ was 6.1% (0.3), with a weighted US estimate of 15.3 and 3.2 million respectively. Race/ethnicity prevalence rates for all adults were Black/African American 8.5% (0.6), White 7.7% (0.2), Asian 6.5% (0.7), American Indian/Alaskan Native 4.9% (2.1), and Hispanic 4.8% (0.4). The odds ratio for Hispanic vs Non-Hispanic White was 0.6 (95%CI 0.5-0.7; p<0.0001). Conclusions Total US prevalence of AD in all adults is approximately 18 million. Hispanic adults have a lower prevalence AD than all other adult groups. Additional studies are needed to understand sociodemographic variations in AD prevalence. [ABSTRACT FROM AUTHOR]

Introduction/Background The efficacy of monotherapy lebrikizumab to treat moderate-to-severe atopic dermatitis (AD) has been established in phase 3 studies. Disease characteristics and efficacy outcomes may vary among racial and ethnic subgroups. Objectives: To report the week 16 efficacy results of lebrikizumab-treated patients by racial and ethnic subgroups from ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967). Methods: Eligible patients were randomized 2:1 to receive lebrikizumab or placebo every 2 weeks. Other AD treatments during this induction period were prohibited. The week 16 efficacy endpoints reported here include Investigator's Global Assessment 0 or 1 with =2-point improvement from baseline (IGA 0/1), =75% improvement in the Eczema Area and Severity Index from baseline (EASI 75), =90% improvement in EASI from baseline (EASI 90), and =4-point Pruritus Numeric Rating Scale (NRS) improvement from baseline. Race and ethnicity were self-reported. Data were collected globally. Data were pooled from ADvocate1 (Intent to Treat [ITT]) and ADvocate2 (modified ITT). Subsequent data from patients who received topical or systemic rescue medication or discontinued treatment due to lack of efficacy were imputed as nonresponders. Subsequent data from patients who discontinued treatment for other reasons were set to missing. Missing data were handled with multiple imputation. Logistic regression tested the interaction between the treatment by subgroup. P>0.1 indicated consistent treatment effect of lebrikizumab versus placebo across subgroups. For each outcome, the Cochran-Mantel-Haenszel method evaluated treatment effect within each subgroup after adjusting for stratification factors. Results: Most patients (818/851 [96.1%]) were Asian (192 [22.6%]), Black/African American (84 [9.9%]), or White (542 [63.7%]). Due to the low proportion of patients identifying as another racial category (33/851 [3.9%]) including American Indian or Alaska Native, Native Hawaiian or other Pacific Islander, multiple, other, and not reported, only results of Asian, Black/African American, and White subgroups are reported. In patients with completed ethnicity data (N=839), 10.8% (91/839) identified as Hispanic/Latino and 89.2% (748/839) identified as not Hispanic/Latino. At baseline, Asian patients reported a numerically earlier mean age of AD onset (8.3 years) compared to White (16.5 years) and Black/African American (16.9 years) patients. A numerically greater proportion of Asian patients presented with severe (IGA 4) disease at baseline (49.5%) and prior use of systemic treatment for AD (75.5%) compared with White (35.1% and 51.1%, respectively) and Black/African American (33.3% and 36.9%, respectively) patients. At week 16, no significant treatment differences were observed for the proportion of patients achieving or reporting IGA 0/1, EASI 75, EASI 90, or ≥4-point Pruritus NRS improvement across racial or ethnic subgroups (p>0.1). In Asian patients, a higher proportion treated with lebrikizumab vs placebo (p<0.001) achieved or reported IGA 0/1 (25.1%, 4.1%), EASI 75 (45.5%, 8.5%), EASI 90 (26.5%, 4.3%), and Pruritus NRS ≥4-point improvement (36.4%, 5.7%). In Black/African American patients, a greater proportion treated with lebrikizumab versus placebo achieved or reported IGA 0/1 (33.2%, 13.2%) EASI 75 (51.7%, 18.8%), EASI 90 (26.9%, 13.2%), and ≥4-point Pruritus NRS improvement (41.7%, 17.4%). No statistical comparisons were performed due to limited sample size. In White patients treated with lebrikizumab, statistical significance was observed versus placebo (p<0.001) for IGA 0/1 (43.3%, 14.1%), EASI 75 (59.7%, 20.4%), EASI 90 (38.3%, 10.9%), and Pruritus NRS ≥4-point improvement (45.9%, 14.8%). Significant and similar differences with lebrikizumab-treatment versus placebo were observed among IGA 0/1, EASI 75, and ≥4-point Pruritus NRS improvement in Hispanic/Latino (p<0.05) and non-Hispanic/Latino (p<0.001) patients. The proportion of lebrikizumab-treated patients achieving EASI 90 versus placebo was numerically greater in Hispanic/Latino patients (p=0.057) but only reached statistical significance in non-Hispanic/Latino patients (p<0.001). Conclusions: In ADvocate1 and ADvocate2, lebrikizumab was effective across racial and ethnic subgroups for the treatment of moderate-to-severe AD after 16 weeks of monotherapy treatment. [ABSTRACT FROM AUTHOR]

Introduction/Background Atopic dermatitis (AD) is a chronic disease affecting children and adults and requires long-term treatment. Moderate-to-severe AD causes itching, which considerably impacts sleep. Interleukin (IL)-13 is the key cytokine in the skin of patients with AD. Lebrikizumab (LEB) is a novel monoclonal antibody that binds with high affinity and slow off-rate to IL-13, thereby blocking the downstream effects of IL-13 with high potency. LEB has demonstrated efficacy and maintained improvement in measures of itch and sleep over 52 weeks in previous phase 3 trials. ADhere (NCT04250337) was a 16-week, randomized, double-blinded, placebo-controlled, phase 3 clinical trial, where patients were treated with LEB and topical corticosteroids (TCS) vs placebo and TCS. LEB responders from ADhere at week 16 were defined as having Investigator's Global Assessment response of 0 or 1 or reporting 75% improvement from ADhere baseline in Eczema Area and Severity Index who did not use rescue medications. ADhere LEB responders were rerandomized 2:1 into ADjoin (NCT04392154) for blinded treatment with LEB 250 mg every 2 weeks (Q2W) or every 4 weeks (Q4W), respectively, with TCS use as needed, for an additional 100 weeks with itch and sleep data being collected for the first 52 weeks. Objectives: The objectives of the study are to report the impact of LEB on itch and sleep improvements over a longer period (68 weeks) in ADhere week 16 LEB responders with moderate-to-severe AD who entered a long-term extension study, ADjoin. Methods: Itch was reported using the Pruritus Numeric Rating Scale (NRS), a patient-reported, single-item, daily, 11-point scale, where the minimal clinically important difference (MCID) is 3 points. Sleep loss due to itch was reported using the Sleep-Loss Scale, a patient-reported, single-item, 5-point scale, where the MCID is 1 point. We report =3-point improvement in Pruritus NRS among patients with baseline score at least 3, percent change from ADhere baseline (PCFB) in Pruritus NRS, Pruritus NRS (0,1), =1-point improvement in Sleep-Loss Scale score among patients with baseline score at least 1, =2-point improvement in Sleep-Loss Scale score among patients with baseline score at least 2 and PCFB in Sleep-Loss Scale score. All outcomes were reported at week 52 of ADjoin study, after a total of 68 weeks of LEB treatment. As observed analyses used all data collected. Results: At week 68, most patients reported maintaining ≥3-point improvement in Pruritus NRS treated with LEB Q2W (80.6%, 29/36) and LEB Q4W (88.9%, 16/18). Patients treated with LEB Q2W and LEB Q4W reported maintaining 65.3% and 59.4% improvement in Pruritus NRS at week 68 compared to ADhere baseline, respectively. At week 68, 45.9% (17/37) patients in LEB Q2W group and 31.6% (6/19) in LEB Q4W group reached Pruritus NRS of 0 or 1. At week 68, most patients reported maintaining ≥1-point improvement in Sleep-Loss Scale score treated with LEB Q2W (96.9%, 31/32) and LEB Q4W (85.7%, 12/14). Similarly, most patients reported maintaining ≥2-point improvement in Sleep-Loss Scale score treated with LEB Q2W (60.9%, 14/23) and LEB Q4W (75.0%, 6/8). Patients treated with LEB Q2W and Q4W reported maintaining 84.1% and 58.8% improvement in Sleep-Loss Scale score at week 68, respectively, compared to ADhere baseline. Conclusions: LEB + TCS maintained itch and sleep improvement at 68 weeks in patients with moderate-to-severe atopic dermatitis. [ABSTRACT FROM AUTHOR]

Introduction Lebrikizumab is a novel monoclonal antibody that binds with high affinity and slow off-rate to IL-13, thereby blocking the downstream effects of IL-13 with high potency. The efficacy and safety of lebrikizumab have been investigated in a number of Phase 3 trials including: ADvocate1 (NCT04146363), ADvocate2 (NCT04178967), ADhere (NCT04250337), and ADjoin (NCT04392154). Lebrikizumab (with or without TCS) was efficacious in providing clinically meaningful improvements in the signs and symptoms of AD through Week(W) 52 in adult and adolescent patients with moderate-to-severe AD. Objectives: We report the efficacy and safety of lebrikizumab (LEB) in the long-term extension study ADjoin (NCT04392154) following 104 weeks of continuous LEB treatment with and without TCS use. Methods: Patients in ADvocate1&2 who achieved either EASI 75 or IGA 0/1 (without rescue) at W16 were re-randomized 2:2:1 to LEB250mg Q2W, LEB250mg Q4W, or placebo (LEB withdrawal). Patients who completed W52 of ADvocate1&2 were able to enroll in ADjoin. Patients in ADhere who achieved either EASI 75 or IGA 0/1 (without rescue) at W16 were able to enroll into ADjoin and randomized 2:1 to LEB250mg Q2W or LEB250mg Q4W. Data are reported for patients originating from ADvocate1&2 and ADhere who received LEB250mg Q2W or Q4W in ADjoin. Efficacy outcomes were assessed based on all collected data (as observed analysis) up to 104W of LEB treatment. Safety was reported from ADjoin enrollment up to the data cut-off April 14, 2023. Results: At W104, IGA 0/1 was maintained by 38/44 (86.4%; Q2W) and 42/55 (76.4%; Q4W) patients from ADvocate1&2 and 26/31 (83.9%; Q2W) and 11/14 (78.6%; Q4W) patients from ADhere. EASI 75 was maintained by 65/68 (95.6%; Q2W) and 77/80 (96.3% Q4W) ADvocate1&2 patients and 39/41 (95.1%; Q2W) and 24/25 (96.0%; Q4W) ADhere patients at W104. In patients who achieved EASI 75 at W16, EASI 90 was achieved by 56/68 (82.4%; Q2W) and 66/80 (82.5%; Q4W) ADvocate1&2 patients and 35/41 (85.4%; Q2W) and 18/25 (72.0%; Q4W) ADhere patients at 104W.During ADjoin, 166/267 (62.2%) patients from the subpopulations of ADvocate1&2 and ADhere who received LEB Q2W or Q4W in ADjoin reported adverse events (AEs), most of which were mild (31.5%, n=84) or moderate (27.0%, n=72) in severity. Serious AEs were reported by 10 (3.8%) patients. There was one death in the ADhere Q2W arm. Six (2.3%) patients reported AEs leading to treatment discontinuation. The safety profile of LEB in ADjoin is consistent with that observed during ADvocate1&2 and ADhere. Conclusions: Efficacy outcomes were maintained long-term, over 2 years of continuous LEB treatment, in both LEB250mg Q2W and Q4W arms. The safety profile of LEB in ADjoin is consistent with previous LEB studies in patients with moderate-to-severe AD. [ABSTRACT FROM AUTHOR]

Introduction Lebrikizumab (LEB) is a monoclonal antibody (Ab) that has shown efficacy and safety in patients with moderate-tosevere atopic dermatitis (AD) in Phase 2/3 trials. LEB targets IL-13 and inhibits signaling of the IL-4Ra/IL-13Ra1 complex. The potential immunomodulator effect of LEB necessitates investigating its impact on immune responses. Objectives: To report the seroresponses to the Tdap (Diphtheria/Tetanus Toxoids/Pertussis) and MCV (Meningococcal (Groups A, C, Y, and W-135)) vaccines in LEB-treated and placebo (PBO)-treated adult patients (aged 18-15 years) with moderate-to-severe AD; and to compare the efficacy of LEB vs PBO in the treatment of AD. Methods: ADopt-VA was a US Phase 3, 16-week (W) randomized, double-blind, placebo-controlled study to assess LEB impact on vaccine immune responses in adult patients with moderate-to-severe AD. The primary endpoint was the immune response to 2 vaccines, the Tdap and MCV. LEB was given as a 500 mg loading dose at baseline and W2, followed by 250 mg LEB Q2W. At W12, both vaccines (Tdap and MCV) were administered to all patients, LEB group N=107, Placebo (PBO) group N=81. Immune responses were determined by Ab level differences between W12 and W16. Secondary efficacy endpoints at W16 were Investigator Global Assessment (IGA) and Eczema Area and Severity Index (EASI 75) scores. Results: For Tdap, 73.6% of LEB patients had a positive Ab response vs 73.4% for PBO, 90% CI, 0.3 (-10.2, 11.2). For MCV, LEB patients had an 86.9% positive Ab response vs 75.0% for PBO, 90% CI, 12.2 (2.5, 22.0). IGA (0,1) was achieved by 40.6% of LEB patients vs 18.9% receiving PBO (p=<0.001); EASI 75 was achieved by 58.0% and 32.7% (p<0.001), respectively. The safety profile was consistent with previous LEB trials. Conclusions: These data show that LEB does not negatively impact immune responses for Tdap or MCV vaccines in adults with moderate-to-severe AD. [ABSTRACT FROM AUTHOR]