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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]

Real-world data on the effectiveness of systemic therapy in atopic dermatitis (AD) are limited. Adult patients with AD in the CorEvitas AD registry (2020–2021) who received systemic therapies for 4–12 months prior to enrollment were included based on disease severity: body surface area (BSA) 0%–9% and BSA ≥10%. Demographics, clinical characteristics, and outcomes were assessed using descriptive statistics. Pairwise effect sizes (ES) were used to compare BSA groups. The study included 308 patients (BSA 0%–9%: 246 [80%]; BSA ≥10%: 62 [20%]). Despite systemic therapy, both BSA groups reported the use of additional topical therapy and the presence of lesions at difficult locations. Moderate-to-severe AD (vIGA-AD®) was reported by 11% (BSA 0%–9%) and 66% (BSA ≥10%; ES = 0.56) of patients. Mean disease severity scores: total BSA (2% and 22%; ES = 3.59), EASI (1.1 and 11.1; ES = 2.60), and SCORAD (12.1 and 38.0; ES = 1.99). Mean scores for PROs: DLQI (3.7 and 7.5; ES = 0.75), and peak pruritus (2.2 and 4.5; ES = 0.81). Inadequate control of AD was seen in 27% and 53% of patients (ES = 0.23). Patients with AD experience a high disease burden despite systemic treatment for 4–12 months. This study provides potential evidence of suboptimal treatment and the need for additional effective treatment options for AD. This real-world study assessed clinical characteristics and overall disease burden in adult patients with atopic dermatitis (AD) who were receiving systemic therapy for 4–12 months. Patients reported greater involvement of back and anterior trunk, and lesions at difficult locations. Irrespective of body surface area involvement, patients continued to experience inadequate control of AD, varied disease severity, and impact on quality of life. The study provides potential evidence of suboptimal treatment and the need for effective treatment options for the management of AD. Besides clinical outcomes, treating dermatologists and dermatology practitioners should include patient-reported outcomes in routine clinical care to determine the best treatment options for their patients. [ABSTRACT FROM AUTHOR]

This post hoc analysis assessed association between scalp hair regrowth and improvements in health-related quality of life (HRQoL) and psychological burden in patients with severe alopecia areata (AA). Data were pooled from two phase-3 trials (N = 1200). Patients randomized to once-daily placebo, baricitinib 2-mg, or 4-mg were analyzed independently of treatment allocation, and categorized according to scalp hair regrowth (at Week 36): meaningful regrowth (Severity of Alopecia Tool (SALT) score ≤20); intermediate regrowth (≥30% SALT improvement [SALT30] at any post-baseline visit to Week 36, but SALT score > 20 at Week 36); no/minimal regrowth (never achieved SALT30). Skindex-16 for AA score change-from-baseline and proportion of patients with baseline Hospital Anxiety and Depression Scale (HADS) scores ≥8 that shifted to <8 (normal) were assessed. Patients with meaningful regrowth achieved greater improvements in all Skindex-16 AA domains versus no/minimal regrowth. More patients with meaningful versus no/minimal regrowth shifted from HADS ≥8 to <8 (anxiety:46.8% versus 26.4%; depression:52.3% versus 24.0%). Improvements occurred with intermediate regrowth but to a lesser extent versus meaningful regrowth. Patients with severe AA and scalp hair regrowth at Week 36 experienced greater improvements in HRQoL and anxiety and depression versus patients with no/minimal regrowth. The highest benefit was observed in patients with meaningful regrowth (SALT score ≤20).ClinicalTrials.gov listing: NCT03570749 and NCT03899259 [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]

Dupilumab is a treatment option for moderate-to-severe atopic dermatitis (AD). Not all patients treated with dupilumab achieve and maintain clinically meaningful responses; some experience adverse events and some discontinue dupilumab for other reasons. For these patients, prospective data are needed to better understand the efficacy of systemic medications administered after discontinuation of dupilumab. Lebrikizumab (LEB) is a 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. ADhere (NCT04250337) is a randomized, double-blind phase 3 trial evaluating the efficacy of lebrikizumab in combination with topical corticosteroids (TCS) over 16 weeks in adults and adolescents with moderate-to-severe AD. The results of this study, previously reported, showed statistically and clinically meaningful improvements in the signs and symptoms of AD in patients treated with LEB plus TCS vs. placebo (PBO) plus TCS. Of the patients randomized to LEB plus TCS, 20 reported prior dupilumab exposure. This study aims to evaluate the efficacy of LEB plus low to mid-potency TCS for the treatment of moderate-to-severe AD in the subpopulation of ADhere patients with prior exposure to dupilumab. At baseline, eligible patients in ADhere were randomized 2 : 1 to LEB 250 mg plus TCS or PBO plus TCS. Patients with prior exposure to dupilumab were permitted, with at least 8 weeks of washout prior to entering the study. Reported medical history was used to identify patients with prior exposure to dupilumab. Efficacy was measured through Investigator's Global Assessment (IGA), Eczema Area and Severity Index (EASI) and Pruritus Numeric Rating Scale (NRS). ADhere analyses were performed on a modified population, excluding 17 patients (from a single study site) whose eligibility could not be confirmed. All analyses are descriptive summaries using post hoc, as-observed analyses. The Pruritus NRS analysis only includes patients with baseline values ≥4. Observed results exclude data collected after use of rescue medication or treatment discontinuation. In ADhere, 211 patients were randomized 2 : 1 to LEB plus TCS (n = 145) or PBO plus TCS (n = 66). Of the patients randomized to LEB plus TCS, 20 reported prior dupilumab exposure. Of these 20 patients, the reason for dupilumab discontinuation was loss of response or inadequate response (10 patients), subject decision (four patients) or intolerance to medication (one patient). The final five patients discontinued due to affordability, treatment availability or unspecified reasons. In patients treated with LEB plus TCS, baseline disease characteristics were comparable between the overall LEB-treated population (n = 145) and the subpopulation with prior dupilumab exposure (n = 20). Of the 20 patients with prior dupilumab exposure, 13 patients presented with an IGA of three and seven patients presented with an IGA of 4. The mean [standard deviation (SD)] body surface area reported at baseline was 37.3 (15.7). The mean (SD) baseline scores for EASI and Pruritus NRS were 25.9 (8.1) and 7.8 (1.9), respectively. The mean (SD) duration since AD onset was longer in patients with prior dupilumab experience vs. the overall LEB-treated population 27.0 (22.5) vs. 21.0 (17.4) years, respectively]. In patients treated with LEB plus TCS, two of the 20 with prior dupilumab exposure were excluded due to use of rescue medication or treatment discontinuation. The IGA 0/1 with 2-point improvement was achieved by 6/18 patients, EASI 75 was achieved by 13/18 patients and Pruritus NRS 4-point improvement was achieved by 8/15 patients at Week 16. One patient reported rescue medication use. The results of this subpopulation analysis suggest that patients with prior dupilumab exposure can benefit from lebrikizumab treatment in combination with TCS. Additional data are needed to confirm this finding due to the small number of patients in the subpopulation. [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]

Background: Itch and sleep disturbance due to itch are burdensome symptoms associated with atopic dermatitis (AD). Rapid onset of action is important for AD treatments to improve quality of life and relieve suffering. Objectives: This subanalysis evaluated how quickly baricitinib 1-mg and 2-mg reduced itch and associated sleep disturbance during the first 7 days after treatment initiation in a phase 3, double-blind, placebo-controlled trial. Methods: Adult patients with AD were randomized 1:1:1 to placebo (N = 147), baricitinib 1 mg (N = 147) or baricitinib 2 mg (N = 146). Patients kept daily diaries, completing the Itch Numeric Rating Scale (NRS) (itch severity from 0 = no itch to 10 = worst itch imaginable) and the Atopic Dermatitis Sleep Scale (ADSS) to measure sleep disturbance (number of nighttime awakenings because of itch). Mixed model repeated measures analysis was used to analyze change from day 1 to day 7 values. Results: Patients receiving either dose of baricitinib had a 9.9% decrease in itch NRS scores from baseline to Day 2 vs 1.5% decrease for placebo (significant between-group least squares mean [LSM] difference: 8.3; 95% CI −12.66 to −3.89; P =.0002). Baricitinib 2 mg reduced nighttime awakenings due to itch (ADSS item 2) at day 2 by 25.2% vs 3.9% in the placebo group (between-group LSM difference: −21.4, P =.0025). Baricitinib 2 mg continued to demonstrate a statistically significant difference from placebo in sleep symptoms at day 7 (LSM difference −23.9; P =.001). Conclusions: Baricitinib 2-mg provided relief from itching and sleep disturbance in patients with AD, beginning the day after taking first dose. Clinical trials at www.clinicaltrials.gov: BREEZE-AD5 (NCT03435081) [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]

Lebrikizumab (LEB) is a novel, high-affinity monoclonal anti - body that selectively binds to interleukin (IL)-13. To evaluate the efficacy and safety of LEB monotherapy in patients with moderate-to-severe atopic dermatitis (AD) in two identical phase 3 trials ADvocate1 (ADv1) and ADvocate2 (ADv2). Patients who responded to LEB 250 mg every 2 weeks (LEB Q2W) at the end of the 16-week induction period were re-randomized in a 2 : 2 :1 ratio to receive LEB Q2W, LEB 250 mg every 4 weeks (LEB Q4W) or placebo (LEB withdrawal) for an additional 36 weeks. Response, at week 16, was defined as achieving an IGA (0, 1) with a ≥2-point improvement or EASI75 and no use of rescue medication. Efficacy outcomes reported at week 52 included IGA (0, 1), EASI 75, ≥4-point reduction in Pruritis Numeric Rating Scale (NRS), EASI 90 and DLQI ≥4-point. Safety analysis was conducted on all patients who received ≥1 dose of LEB. Patients maintained IGA (0, 1) in LEB Q2W (ADv1, 75.8%; ADv2, 64.6%), LEB Q4W (ADv1, 74.2%; ADv2, 80.6%) and LEB withdrawal (ADv1, 46.5%; ADv2, 49.8%). Maintenance of EASI75 was, in LEB Q2W (ADv1, 79.2%; ADv2, 77.4%), LEB Q4W (ADv1, 79.2%; ADv2, 84.7%) and LEB withdrawal (ADv1, 61.3%; ADv2, 72.0%). For Pruritus NRS ≥4-point improvement from baseline, patients-maintained improvement in the LEB Q2W (ADv1, 81.2%; ADv2, 90.3%), LEB Q4W (ADv1, 80.4%; ADv2, 88.1%) and LEB withdrawal (ADv1, 65.4%; ADv2, 67.6%). Maintenance of EASI90 was, in LEB Q2W (ADv1, 66.1%; ADv2, 61.5%), LEB Q4W (ADv1, 66.6%; ADv2, 67.4%) and LEB withdrawal (ADv1, 45.5%; ADv2, 36.9%). DLQI ≥4-point improvement from baseline was LEB Q2W (ADv1, 64.0%; ADv2, 59.0%), LEB Q4W (ADv1, 62.7%; ADv2, 73.0%) and LEB withdrawal (ADv1, 57.7%; ADv2, 45.5%). TEAEs were reported by 58.1% (ADv1) and 67.8% (ADv2) LEB-treated patients at week 52. Serious adverse events were reported by 3.3% of ADv1 patients and 2.7% of ADv2 patients. In ADv1 and ADv2, 2.3% and 3.9% of patients reported an adverse event leading to treatment discontinuation, respectively. Both LEB Q2W and LEB Q4W maintained improvement in all reported outcomes for the treatment of moderate-to-severe AD through 52 weeks. The safety profile was consistent with previously published data. [ABSTRACT FROM AUTHOR]

Background: Atopic dermatitis (AD) has a negative impact on patients&rsquo; quality of life (QoL)., Objective: To report the impact of specific AD lesion locations on QoL in adult patients with AD using real-world data., Methods: The Adelphi US Disease Specific Programme was conducted between January&ndash;April 2018. Physicians documented patient demographics/characteristics, AD lesion locations, and body surface area; patients completed questionnaires reporting the impact of lesion locations on QoL., Results: AD severity was moderate in 51.6% of patients and severe in 6.0%. Lesions were commonly identified in more than one location. All AD lesion locations impacted QoL. Visible areas were most bothersome, including head/neck (68%), hands/fingers (58%), front (30%), upper extremities (22%), and lower extremities (16%), with statistically significant associations for a number of Dermatology Life Quality Index (DLQI) items. Itch, soreness, pain, and stinging are also associated with a number of body areas but in particular with those that are most visible/accessible. Lesions on the head/neck and hands/fingers (58%) demonstrated an increased impact on the anxiety and depression dimension of the EuroQol 5-Dimension tool., Conclusions: In patients with AD, quality of life was most affected in patients with lesions in visible areas, including head/neck, hands/fingers, and upper extremities, with statistically significant associations for a number of DLQI domains. Physicians should be aware of the burden of AD lesions on QoL and consider having conversations with patients to better understand the impact of these lesions. Prior presentation: 28th Annual European Academy of Dermatology and Venereology Congress; 9&ndash;13 October 2019, Madrid, Spain. Poster number P0233.J Drugs Dermatol. 2020;19(10): 943-948. doi:10.36849/JDD.2020.5422.