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BackgroundThe validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) is a standardized severity assessment for use in clinical trials and registries for atopic dermatitis (AD).ObjectivesTo investigate the reliability, validity, responsiveness and within-patient meaningful change of the vIGA-AD.MethodsData were analysed from adult patients with moderate-to-severe AD in the BREEZE-AD1 (N = 624 patients; NCT03334396), BREEZE-AD2 (N = 615; NCT03334422) and BREEZE-AD5 (N = 440; NCT03435081) phase III baricitinib clinical studies.ResultsAcross studies, test-retest reliability for stable patients showed moderate-to-good agreement [range of Kappa values for Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD), 0·516-0·639; for Eczema Area and Severity Index (EASI), 0·658-0·778]. Moderate-to-large correlations between vIGA-AD and EASI or body surface area (range at baseline, 0·497-0·736; Week 16, 0·716-0·893) supported convergent validity. Known-groups validity was demonstrated vs. EASI and PGI-S-AD (vIGA-AD for severe vs. moderate EASI categories at baseline, P

Background Despite previous attempts to classify atopic dermatitis (AD) into subtypes (e.g. extrinsic vs. intrinsic), there is a need to better understand specific phenotypes in adulthood. Objectives To identify, using machine learning (ML), adult AD phenotypes. Methods We used unsupervised cluster analysis to identify AD phenotypes by analysing different responses to predetermined variables (age of disease onset, severity, itch and skin pain intensity, flare frequency, anatomical location, presence and/or severity of current comorbidities) in adults with AD from the Danish Skin Cohort. Results The unsupervised cluster analysis resulted in five clusters where AD severity most clearly differed. We classified them as 'mild', 'mild-to-moderate', 'moderate', 'severe' and 'very severe'. The severity of multiple predetermined patient-reported outcomes was positively associated with AD, including an increased number of flare-ups and increased flare-up duration and disease severity. However, an increased severity of rhinitis and mental health burden was also found for the mild-to-moderate phenotype. Conclusions ML confirmed the use of disease severity for the categorization of phenotypes, and our cluster analysis provided novel detailed information about how flare patterns and duration are associated with AD disease severity. [ABSTRACT FROM AUTHOR]

This article presents a Danish nationwide cohort study on the long-term drug survival of biologics in the treatment of hidradenitis suppurativa (HS), a chronic inflammatory skin disease. The study analyzed data from 452 patients who were treated with various biologics between 2005 and 2021. The results showed that the median drug survival time for adalimumab was approximately 8 months, with bio-naïve patients having a significantly longer drug survival time compared to non-naïve patients. The study also reported real-life drug survival data on secukinumab in HS. The findings suggest the need for further research into more effective biologics for HS. [Extracted from the article]

Introduction/Background Atopic dermatitis (AD) is a chronic, inflammatory disease that can affect multiple regions of the body, but can be particularly burdensome on exposed areas of skin, such as the head and neck (H&N).Tralokinumab, a high-affinity monoclonal antibody that specifically neutralizes interleukin-13, is approved in multiple countries for adults with moderate-to-severe AD. Phase 3 trials showed tralokinumab provided significant improvements in AD severity and was well-tolerated up to 52 weeks of treatment. The ongoing open-label, 5-year extension trial, ECZTEND (NCT03587805), assesses the safety and efficacy of tralokinumab after the completion of parent trials (PT). Objective To assess tralokinumab efficacy in the H&N region. Methods This post hoc analysis included adult patients with moderate-to-severe AD initially randomized to tralokinumab 300mg Q2W in the phase 3 PTs ECZTRA 1 (NCT03131648) or ECZTRA 2 (NCT03160885). Patients on active tralokinumab treatment were followed for up to 52 weeks in PTs and for up to 152 weeks in ECZTEND as of data cutoff April 30, 2022. Patients re-randomized to placebo at Week (Wk) 16 were not included beyond that timepoint. For this analysis, overall EASI and H&N regional EASI (H&N EASI) were evaluated. H&N EASI (0-7.2) was calculated based on the severity of erythema, induration/papulation, excoriation, lichenification and area of involvement. All data were analyzed and presented as observed. Results At baseline, 87.8% (1047/1192) of patients had H&N involvement (H&N EASI>1), and 49.9% (591/1192) of patients exhibited severe AD (IGA 4). Baseline median H&N EASI for the pooled PTs was 3.0 (IQR 1.8; 4.5). In the pooled PTs, 48.2% (542/1125) and 71.2% (558/784) of patients achieved H&N EASI≤1, at Wk16 and Wk52, respectively. After 3 years additional treatment (Wk152 in ECZTEND), the proportion of patients with H&N EASI≤1 was 87.2% (232/266) and the median H&N EASI was 0.2 (IQR 0.0; 0.5). In the subgroup of patients (n=301) with severe AD (IGA 4) and high H&N involvement (H&N EASI≥4), median H&N EASI improved from 5.4 at baseline to 2.4 and 0.8 at Wk16 and Wk52, respectively, and 0.4 at Wk152. Improvements in H&N region were comparable to overall EASI improvement. Conclusions Tralokinumab provided sustained improvements in the H&N regions in patients with moderate-to-severe AD for up to 4 years. Sustained improvements were also seen in patients with severe disease and substantial H&N involvement at baseline. [ABSTRACT FROM AUTHOR]

A study published in the British Journal of Dermatology provides insight into the prevalence of ichthyoses in Denmark. Ichthyosis is a group of genetic skin disorders characterized by dry and scaly skin. The study found that the prevalence of ichthyoses in Denmark is 1.6 per 10,000 people, with ichthyosis vulgaris being the most common type. The prevalence varied by age and sex, with higher rates in younger age groups and a higher prevalence in women over 50 years old. However, the study may underestimate the true prevalence and further research is needed. [Extracted from the article]

Background Sufficient data on access to systemic treatment for patients with psoriasis living in Latin America (LA) including Brazil and Chile are lacking. Understanding the availability and limiting factors of access to treatments can help to improve patient care and decrease long-term healthcare costs. Objectives In association with the Global Psoriasis Atlas, this cross-sectional survey study analysed the availability and insurance reimbursement of systemic treatments for adult patients with psoriasis in Brazil and Chile. Methods A multicentre, cross-sectional Global Healthcare Study on Psoriasis was performed in Brazil and Chile in 2020. For each eligible adult patient with psoriasis, doctors and nurses completed a 48-item questionnaire about clinical aspects of psoriasis including the Psoriasis Area Severity Index (PASI), body surface area (BSA) score and the Dermatology Life Quality Index (DLQI), as well as the availability of systemic treatments and insurance reimbursement status. Between-country differences were compared with Wilcoxon rank sum tests for continuous variables, and a χ2-test or Fisher's exact test, where appropriate, for categorical variables. The median and interquartile range (IQR) was calculated for non-normal distributed data. Results A total of 1424 patients with psoriasis from 43 centres [27 centres in Brazil (n = 826) and 16 in Chile (n = 598)], were included with a mean (SD) age of 49.1 (16.3) and 49.2 (15.1) years, respectively. Unstratified analyses revealed that patients with psoriasis in Chile had more severe disease than those in Brazil [PASI 11.6 vs. 8.4 (P < 0.001) and BSA 14.7 vs. 12.0 (P = 0.003), respectively]. For patients with moderate-to-severe psoriasis, defined as PASI and/or BSA ≥ 10, systemic nonbiologic drugs were available (81.2% in Brazil and 65.3% in Chile, P ≤ 0.001), but only 37.0% of patients in Brazil and 27.3% in Chile received biologics (P = 0.01). Lack of availability and/or lack of insurance reimbursement for biologic drugs for patients with moderate-to-severe psoriasis was reported for 22.2% (50 of 225) in Brazil and 67.9% (148 of 218) in Chile (P < 0.001). Patients with no access to biologic therapies due to lack of availability/insurance reimbursement had a median PASI of 9.15 (IQR 3.00–14.25) in Brazil and 12.0 (IQR 5.00–19.00) in Chile (P = 0.007), as well as a median BSA of 7.0 (IQR 3.00–15.00) and 12.0 (IQR 5.00–22.50) (P = 0.002), and median DLQI of 11.0 (6.00–15.00) and 21.0 (6.50–25.00) (P = 0.007), respectively. Conclusions Chilean patients had significantly more severe psoriasis compared with Brazilian patients in our study. While nonbiologic treatments for moderate-to-severe psoriasis were available in both LA countries, there is a high need for improvement in access to more effective psoriasis treatments including biologics. Our results highlight a significant gap between treatment recommendations in international psoriasis guidelines and real-world situations in Brazil and Chile. [ABSTRACT FROM AUTHOR]

Background Children with atopic dermatitis (AD) may have disturbed sleep, affected self-esteem and decreased quality of life, likely interfering with performance in school. Objectives To examine the association between hospital-managed paediatric AD, school performance and cognitive function. Methods In this cross-sectional study we linked data from the Danish national registers and identified three populations between 2001 and 2019. Population 1 comprised children with graduation grades registered from lower secondary school, population 2 comprised adolescents with registration of an upper secondary graduation mean, and population 3 comprised male conscripts with registration of an IQ test score. AD was defined as a hospital diagnostic code (inpatient or outpatient) prior to the exam or conscription date, and was stratified according to severity, activity and atopic comorbidity. Outcomes included graduation mean from lower and upper secondary school, special educational assistance in primary and lower secondary school, and IQ at conscription. Results In total, 770 611 (12 137 with AD), 394 193 (6261 with AD) and 366 182 (4539 with AD) children and adolescents were included in populations 1 (lower secondary graduation), 2 (upper secondary graduation) and 3 (conscription), respectively. In lower secondary school, children with severe AD had significantly lower overall, written and oral graduation grade means compared with children with mild AD: respectively, difference −0.29 [95% confidence interval (CI) −0.45 to −0.13, P < 0.001], difference −0.26 (95% CI −0.42 to −0.10, P = 0.0016) and difference −0.30 (95% CI −0.49 to −0.11, P = 0.0018). In upper secondary school, adolescents with AD performed similarly to their peers without AD. Young men with AD scored significantly lower IQ test means at conscription examination than male conscripts without AD: difference −0.60 (95% CI −0.87 to −0.32, P < 0.001). Conclusions AD, in particular when severe, is associated with lower school performance in childhood and IQ in young men, which can interfere with academic achievements in life. Optimization of treatment of children with AD and specific educational support to children with severe AD could be needed. [ABSTRACT FROM AUTHOR]

Atopic dermatitis (AD) is a chronic, inflammatory skin disease characterized by intense itch and eczematous skin lesions that can impact individuals at any age across any area of the body. There is a need for safe treatments for AD that provide rapid itch relief and skin clearance and that are suitable for long-term use. Upadacitinib is a selective, reversible oral Janus kinase 1 (JAK1) inhibitor, which is approved in multiple countries for the treatment of adolescents and adults with moderate-to-severe AD. The current analysis assessed the long-term safety for up to 4 years of upadacitinib 15 and 30 mg in adolescents and adults with moderate-to-severe AD, using integrated data from three ongoing global pivotal phase 3 studies. The Measure Up 1, Measure Up 2, and AD Up studies are ongoing pivotal phase 3, randomized, placebo-controlled, multicenter studies evaluating the safety and efficacy of upadacitinib 15 mg and upadacitinib 30 mg in adolescents and adults with moderate-to-severe AD. Patients were randomized 1 : 1 : 1 to receive oral upadacitinib 15 mg, upadacitinib 30 mg or placebo once daily alone (Measure Up 1 and Measure Up 2) or with concomitant topical corticosteroids (AD Up). At Week 16, patients receiving upadacitinib 15 or 30 mg during the double-blinded period continued their assigned treatment in the blinded extension (BE) period, whereas patients receiving placebo were re-randomized 1 : 1 to receive either upadacitinib 15 or 30 mg in the BE period (upadacitinib treatment for up to 260 weeks). A total of 2693 adults and adolescents (upadacitinib 15 mg, 1340; upadacitinib 30 mg, 1353) who received at least one dose of upadacitinib were included in the integrated analysis. Treatment-emergent adverse events of special interest (AESI) were analysed as exposure-adjusted rates per 100 patient-years (PY) for the entire treatment period to adjust for potentially different durations of follow-up. Upadacitinib was well tolerated by both adults and adolescents. For all patients, rates of AESIs were similar at the 1-year analysis and up to 4-year analysis for upadacitinib (15 mg/30 mg) for: serious infections, 2.3 and 2.2/2.8 and 2.8; opportunistic infections, 1.6 and 1.8/1.9 and 2.4; active tuberculosis, <0.1/<0.1 at both time points; herpes zoster, 3.5 and 3.1/5.2 and 5.8; nonmelanoma skin cancer (NMSC), 0.3 and 0.4/0.4 and 0.3; malignancy excluding NMSC, 0.1 and 0.4/0.5 and 0.3; and adverse events leading to death, 0 and 0/<0.1 and <0.1. Rates of adjudicated major adverse cardiovascular events (MACE) were 0.1 and <0.1/<0.1 and <0.1, and for venous thromboembolic events (VTE) were <0.1 for both doses at the 1-year analysis and up to 4-year analysis. Rates of gastrointestinal perforations were 0 for both doses at both timepoint analyses. Rates of serious infections remain low (<3.0 E/100 PY). Based on the integrated analysis of long-term safety data for up to 4 years, rates of AESIs remained low throughout a longer duration of treatment with upadacitinib 15 or 30 mg among adults and adolescents with moderate-to-severe AD. No new safety risks were observed. Findings of the current safety analysis continue to support a favorable benefit-risk profile of upadacitinib in the treatment of adults and adolescents with moderate-to-severe AD for up to 4 years of treatment. [ABSTRACT FROM AUTHOR]

Introduction Atopic dermatitis (AD) is a chronic, inflammatory disease that can affect multiple regions of the body, but can be particularly burdensome on exposed areas of skin, such as the head and neck (H&N). Tralokinumab, a high-affinity monoclonal antibody that specifically neutralizes interleukin-13, is approved in multiple countries for adults with moderate-to-severe AD. Phase 3 trials showed tralokinumab provided significant improvements in AD severity and was well-tolerated up to 52 weeks of treatment. The ongoing open-label, 5-year extension trial, ECZTEND (NCT03587805), assesses the safety and efficacy of tralokinumab after the completion of parent trials (PT). Objective To assess tralokinumab efficacy in the head and neck region. Methods: This post hoc analysis included adult patients with moderate-to-severe AD initially randomized to tralokinumab 300mg Q2W in the phase 3 PTs ECZTRA 1 (NCT03131648) or ECZTRA 2 (NCT03160885). Patients on active tralokinumab treatment were followed for up to 52 weeks in PTs and for up to 152 weeks in ECZTEND as of data cutoff April 30, 2022. Patients re-randomized to placebo at Week (Wk) 16 were not included beyond that timepoint. For this analysis, overall EASI and H&N regional EASI (H&N EASI) were evaluated. H&N EASI (0-7.2) was calculated based on the severity of erythema, induration/papulation, excoriation, lichenification and area of involvement. All data were analyzed and presented as observed. Results: At baseline, 87.8% (1047/1192) of patients had H&N involvement (H&N EASI>1), and 49.9% (591/1192) of patients exhibited severe AD (IGA 4). Baseline median H&N EASI for the pooled PTs was 3.0 (IQR 1.8; 4.5). In the pooled PTs, 48.2% (542/1125) and 71.2% (558/784) of patients achieved H&N EASI=1, at Wk16 and Wk52, respectively. After 3 years additional treatment (Wk152 in ECZTEND), the proportion of patients with H&N EASI=1 was 87.2% (232/266) and the median H&N EASI was 0.2 (IQR 0.0; 0.5). In the subgroup of patients (n=301) with severe AD (IGA 4) and high H&N involvement (H&N EASI=4), median H&N EASI improved from 5.4 at baseline to 2.4 and 0.8 at Wk16 and Wk52, respectively, and 0.4 at Wk152. Improvements in H&N region were comparable to overall EASI improvement. Conclusions: Tralokinumab provided sustained improvements in the H&N regions in patients with moderate-to-severe AD for up to 4 years. Sustained improvements were also seen in patients with severe disease and substantial H&N involvement at baseline. [ABSTRACT FROM AUTHOR]

Introduction/Background Atopic dermatitis (AD) is an inflammatory skin disease associated with atopic comorbidities, including asthma, food allergy, hay fever, and allergic conjunctivitis. Tralokinumab, a high-affinity monoclonal antibody that specifically targets IL-13, is indicated for the treatment of moderate-to-severe AD. Objectives: To assess the impact of atopic comorbidities on the efficacy and safety of tralokinumab vs. placebo for moderateto-severe AD in patients age ≥12 years. Methods: This post-hoc analysis presents data from the adult trials ECZTRA 1 and 2 (NCT03131648 and NCT03160885 pooled; 300 mg tralokinumab every 2 weeks [Q2W] vs. placebo) and ECZTRA 3 (NCT03363854; 300 mg tralokinumab Q2W vs. placebo, both plus TCS as needed), and the ECZTRA 6 adolescent trial (NCT03526861; pooled 150 mg and 300 mg tralokinumab Q2W vs. placebo). Tralokinumab-treated patients received a loading dose. Proportion of patients achieving IGA 0/1 and EASI-75 at Week 16 according to patient-reported current or past atopic comorbidity are presented as observed regardless of rescue medication use; missing data were imputed as non-responders. Results: In total 2,223 patients were included across four trials. Among patients in ECZTRA 1 and 2, 50.5% reported history of asthma, 38.5% food allergy, 53.8% hay fever, and 33.5% allergic conjunctivitis, while 19.8% reported no atopic comorbidities and 79.3% reported ≥1 atopic comorbidity. Proportions of patients in ECZTRA 3 and 6 reporting history of atopic comorbidities were largely similar, although more adolescent patients reported food allergy. In all subgroups at Week 16, higher proportions of patients receiving tralokinumab vs. placebo achieved EASI-75. In ECZTRA 1 and 2, response rates among patients in each subgroup were asthma: 35.3% vs. 12.8%, food allergy: 33.2% vs. 14.7%, hay fever: 36.8% vs. 16.5%, allergic conjunctivitis: 34.8% vs. 12.7%, none: 34.6% vs. 20.5%; and ≥1 atopic comorbidity: 35.5% vs. 15.2% (P<0.05 for all). A similar pattern of response was observed in ECZTRA 3 and 6, and for IGA 0/1 across trials. EASI-75 response rates for tralokinumab-treated patients were consistent across patients with different numbers of atopic comorbidities. Safety across subgroups was consistent with the safety profile of tralokinumab observed overall in adults and adolescents. Conclusions: 16 weeks of tralokinumab treatment improved AD signs and symptoms in adult and adolescent patients with and without atopic comorbidities, regardless of type or number of atopic comorbidities. The safety profile of tralokinumab was consistent between patients with and without atopic comorbidities. [ABSTRACT FROM AUTHOR]

Skin pain is a common and bothersome symptom of atopic dermatitis (AD) that is associated with a substantial burden. To assess the efficacy of abrocitinib vs. dupilumab on skin pain in patients with moderate-to-severe AD. Data from patients aged ≥18 years who received oral abrocitinib 200 mg once daily (QD) or subcutaneous dupilumab 300 mg once every 2 weeks in combination with topical therapy in the phase 3 trials JADE COMPARE (NCT03720470) and JADE DARE (NCT04345367) were analysed. Data from patients who received abrocitinib 100 mg QD or placebo in the JADE COMPARE trial were also included in this analysis. Patients rated their skin pain using the Skin Pain Numerical Rating Scale (NRS) item of the Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) instrument ['How painful was your skin over the past 24 h?' on a scale from 0 (not painful) to 10 (extremely painful) ] in JADE COMPARE or the Skin Pain Numerical Rating Scale [SP-NRS, which queried patients for the severity of their 'worst skin pain' in the past 24 h on a scale from 0 (no skin pain) to 10 (worst skin pain imaginable)] in JADE DARE. Least squares mean (LSM) changes from baseline and proportions of patients who achieved a ≥4-point improvement from baseline in PSAAD skin pain score or SP-NRS were assessed through Week 16 (JADE COMPARE) or Week 26 (JADE DARE). The JADE COMPARE analysis (Skin Pain NRS item of the PSAAD) was performed post hoc, whereas the JADE DARE analysis (SP-NRS) was prespecified. At Week 2 of JADE COMPARE, LSM change from baseline in PSAAD skin pain score was greater with abrocitinib 200 mg [−2.8 (95% CI, −3.1, −2.5)] than with abrocitinib 100 mg [−2.1 (−2.3, −1.8)], dupilumab [−2.0 (−2.3, −1.8)], or placebo [−1.3 (−1.6, −0,9)]; improvements were sustained through Week 16 of treatment with abrocitinib 200 mg [−4.1 (−4.4, −3.8)], abrocitinib 100 mg [−3.3 (−3.6, −3.0)] and dupilumab [−4.0 (−4.2, −3.7)] compared with placebo [−1.8 (−2.2, −1.4)]. In JADE DARE, LSM change from baseline in SP-NRS was significantly greater with abrocitinib 200 mg vs. dupilumab at Week 2 [−3.7 (−3.9, −3.4) vs. −2.6 (−2.8, −2.3); P < 0.0001] and week 12 [−4.5 (−4.7, −4.2) vs. −4.0 (−4.3, −3.8); P = 0.0116]; no significant differences were observed between the treatment arms at Week 16 [−4.4 (−4.7, −4.2) vs. −4.2 (−4.4, −4.0); P = 0.16], Week 20 [−4.8 (−5.0, −4.5) vs. −4.5 (−4.7 vs. −4.2); P = 0.06] or Week 26 [−4.5 (−4.8, −4.3)] vs. −4.3 (−4.6, −4.1); P = 0.27]. The proportions of patients who achieved a ≥4-point improvement in PSAAD skin pain score at week 2 of JADE COMPARE were greater with abrocitinib 200 mg (43%) than with abrocitinib 100 mg (23%), dupilumab (24%) or placebo (14%). At Week 16, these proportions increased to 76% (abrocitinib 200 mg), 57% (abrocitinib 100 mg) and 70% (dupilumab) compared with placebo (29%). In JADE DARE, the proportions of patients who achieved a ≥4-point improvement in SP-NRS were significantly greater with abrocitinib 200 mg vs. dupilumab at Week 2 (58% vs. 36%; P < 0.0001) and Week 12 (71% vs. 61%; P = 0.0098) but not at subsequent timepoints. Similar to previous findings on the effect of abrocitinib on itch, these results suggest that abrocitinib 200 mg provides greater early skin pain relief in patients with moderate-to-severe AD compared with dupilumab, but the difference between the treatments diminishes with time. At earlier time points, skin pain improvement with abrocitinib 100 mg was similar to that with dupilumab. [ABSTRACT FROM AUTHOR]

Atopic dermatitis (AD) is a chronic, inflammatory disease characterized by sensitive and dry skin, eczematous lesions and intense pruritus. Patients with moderate-to-severe AD often require systemic treatments if their symptoms are insufficiently controlled with topical treatments or phototherapy. While numerous systemic therapies are currently available for moderate-to-severe AD, more data evaluating patient satisfaction with various characteristics of these treatments are needed to help guide physicians and their patients with joint treatment decision-making. This study aims to investigate patient satisfaction with AD treatments according to the degree and speed of itch improvement and the degree of skin clearance. A cross-sectional, web-based survey was used to evaluate patient preferences for characteristics associated with systemic AD therapies. Respondents were required to have a physician-confirmed diagnosis of AD (currently moderate or severe), to be aged ≥18 years, to be a US resident, and to read and understand English. Assessments included worst itch experienced in the past 24 h (using a scale from 0 to 10, with 0 defined as no itch and 10 defined as the worst imaginable itch), time to noticeable itch reduction following initiation of their current treatment (1–6 days, 7–13 days or ≥14 days) and the amount of body surface area still affected by AD (≤2%, 3–10% or >10%; patient-assessed). Patient satisfaction with itch improvement, speed of itch improvement and skin clearance with their current treatment was also assessed and classified into three categories: satisfied, dissatisfied or neither. P values were determined by Chi-square tests (or Fisher's exact test where appropriate). Of the 213 individuals recruited by physicians to participate in the survey, 200 respondents fulfilled the eligibility criteria, consented to participate and completed surveys. A total of 186 respondents indicated that they were currently receiving treatment for their AD; treatments included over-the-counter creams, ointments or medicines (26.9%, n = 50), prescription creams (72.0%, n = 134), oral corticosteroids (16.7%, n = 31) or dupilumab (11.3%, n = 21). Treatment satisfaction differed based on the patient's itch level within the past 24 h (P < 0.001): 85.2% (n = 23) of the 27 patients reporting the lowest levels of itch (0–1) indicated they were satisfied with their current treatment, whereas only 7.1% (n = 1) of the 14 patients reporting the worst levels of itch (8–10) were satisfied with their current treatment. Among the 73 respondents who experienced the fastest itch reduction (within 1–6 days), 65.8% (n = 48) were satisfied with their treatment. For the 36 respondents experiencing itch reduction ≥14 days post treatment, 13.9% (n = 5) were satisfied with their treatment (P < 0.001). Of the 75 respondents with the highest degree of skin clearance (≤2% of body surface area still affected), 65.3% (n = 49) were satisfied with their treatment. Among the 21 respondents with the lowest degree of skin clearance (>10% of body surface area still affected), 14.3% (n = 3) were satisfied with their treatment (P < 0.001). Safety was not evaluated, which may limit the findings in this analysis. In patients with moderate-to-severe AD, the majority of respondents experiencing the lowest levels of itch, the fastest onset of itch improvement and the highest degree of skin clearance also reported satisfaction with their current treatment. These findings underscore the stringent thresholds for both the degree and speed of symptom improvement required to achieve patient satisfaction. This highlights patients' desire for treatments offering both rapid and extensive itch reduction and skin clearance and may help broaden physicians' understanding of patient preferences and inform treatment decisions. [ABSTRACT FROM AUTHOR]

Previous analyses based on short-term, phase 2 studies reported that baseline biomarkers do not correlate with clinical outcomes following dupilumab treatment in patients with atopic dermatitis (AD). This new analysis based on 16-week, phase 3 studies reports whether pretreatment levels of common serum biomarkers can predict treatment response to dupilumab in adults with moderate-to-severe AD. LIBERTY AD SOLO 1 and 2 (NCT02277743 and NCT02277769), two randomized, double-blind studies, included patients ≥18 years-old with moderate-to-severe AD treated with dupilumab 300 mg every 2 weeks or placebo for 16 weeks. Correlation between change in Eczema Area and Severity Index (EASI) and log of baseline IgE, CC chemokine ligand 17 [CCL17; previously referred to as thymus and activation-regulated chemokine (TARC)] and lactate dehydrogenase (LDH) at baseline was assessed using Spearman's correlation coefficient (ρ). At Week 16, change in EASI showed little correlation with baseline total IgE [Spearman's correlation coefficient (ρ) = –0.14, n = 370 for dupilumab; ρ = –0.03, n = 202 for placebo], baseline CCL17 (ρ = –0.28, n = 369 for dupilumab; ρ = –0.05, n = 201 for placebo) or baseline LDH (ρ = –0.30, n = 370 for dupilumab; ρ = –0.08, n = 202 for placebo). Overall safety was consistent with the known dupilumab safety profile. Baseline levels of total IgE, CCL17 and LDH do not predict treatment response to dupilumab, as measured by EASI, in adults with moderate-to-severe AD. [ABSTRACT FROM AUTHOR]

Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by eczematous morphology and intense pruritus. Previous clinical trials have demonstrated that upadacitinib (UPA) was superior to placebo (PBO) in the treatment of moderate-to-severe AD. Here, we analyse the efficacy and safety of UPA across 52 weeks in adolescent and adult subgroups from three phase 3 studies. Patients were randomized to UPA 15 mg (UPA15), UPA 30 mg (UPA30) or PBO orally once daily, either alone or with concomitant topical corticosteroids. After 16 weeks, patients in the PBO group were randomized to the UPA15 or UPA30 groups. For both adolescent and adult subgroups at 52 weeks, the proportion of responders in the UPA15 and UPA30 groups was: ≥70% and 83% for EASI75, ≥31% and 47% for vIGA-AD 0/1 and ≥37% and 61% for Worst Pruritus Numeric Rating Scale improvement ≥4. Children's Dermatology Life Quality Index (CDLQI) 0/1 was achieved by ≥15% (UPA15) and ≥28% (UPA30) of adolescents aged 12 to <16 years; DLQI 0/1 was achieved by ≥18% (UPA15) and ≥38% (UPA30) of adolescents aged 16 to <18 years and ≥30% (UPA15) and ≥45% (UPA30) of adults. Hospital Anxiety and Depression Scale (HADS-A and HADS-D) <8 was achieved in ≥28% of adolescents and ≥45% of adults for both treatment groups. Rates of serious adverse events (AEs) and serious AEs leading to discontinuation at week 52 were similar for both adolescents and adults. UPA15 and UPA30 responses in moderate-to-severe AD across 52 weeks were similar between adolescents and adults, with acceptable safety outcomes in both populations. [ABSTRACT FROM AUTHOR]

Lebrikizumab 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. ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967) are identically designed phase 3, randomized, double-blinded, placebo-controlled trials evaluating lebrikizumab for the treatment of moderate-to-severe atopic dermatitis (AD). At Week 16 of both studies, lebrikizumab 250 mg every 2 weeks (Q2W) showed statistically significant improvements in measures of skin clearance and patient reported outcomes. Patients treated with lebrikizumab achieved clinically meaningful improvements in the signs and symptoms of AD with fewer AD flares across multiple definitions than patients treated with placebo. In patients who met the protocol-defined criteria for response to lebrikizumab at Week 16, most patients treated with lebrikizumab Q2W and lebrikizumab every 4 weeks (Q4W) maintained an Investigator's Global Assessment (IGA) 0/1 response (71% and 77%, respectively) and a 75% improvement in the Eczema and Severity Index from baseline (EASI 75; 78% and 82%, respectively) up to Week 52. The objective of this analysis is to determine the proportion and the individual efficacy trajectory of lebrikizumab-treated patients who exhibited a stable response with no or minimal fluctuations of efficacy from Week 16 to Week 52 in Week 16 responders. Patients who responded to lebrikizumab at the end of the 16-week induction period were rerandomized 2 : 2 : 1 to receive lebrikizumab Q2W, lebrikizumab Q4W or placebo Q2W (withdrawal) for 36 additional weeks. Week 16 responders were defined as those achieving an EASI 75 or IGA 0/1 with a ≥2-point improvement and without rescue medication use. We defined no or minimal fluctuations as maintaining EASI 75 for at least 80% of the 10 study visits from Week 16 to Week 52. Separately, we analysed EASI 90 with the same criteria. We also analysed the proportion of patients who achieved each endpoint at all 10 maintenance period study visits. ADvocate2 analyses were performed on a modified population, excluding 17 patients who entered the maintenance period (from a single study site) and whose eligibility could not be confirmed. Therefore, analyses were performed on the modified pooled population of ADvocate1 and ADvocate2 patients. All analyses were performed post hoc. If patients used rescue medication, discontinued treatment or transferred to the escape arm, data collected at or after the event was imputed as nonresponse. In ADvocate1 and ADvocate2, 291 patients met the criteria for response at Week 16 (EASI 75 or IGA 0/1 with a ≥2-point improvement and without rescue medication use) and were rerandomized to receive lebrikizumab Q2W (n = 113), lebrikizumab Q4W, (n = 118) or withdrawal (n = 60) from Week 16 to Week 52. The proportions of patients who maintained EASI 75 for at least 80% of the maintenance period were 71% (lebrikizumab Q2W), 71% (lebrikizumab Q4W) and 60% (withdrawal). The proportions of patients who maintained EASI 75 at all study visits were 53% (lebrikizumab Q2W), 55% (lebrikizumab Q4W) and 38% (withdrawal). The proportions of patients to achieve and maintain the more stringent response of EASI 90 for at least 80% of study visits were 45% (lebrikizumab Q2W), 51% (lebrikizumab Q4W) and 35% (withdrawal). In ADvocate1 and ADvocate2, approximately 7 out of 10 of patients who continued treatment with lebrikizumab maintained at least an EASI 75 response with no or minimal fluctuations. These individual patient data show that most patients treated with monotherapy lebrikizumab Q2W and Q4W maintain a stable response with no or minimal fluctuations of efficacy up to Week 52. [ABSTRACT FROM AUTHOR]

Missing data occur in clinical trials and have the potential to lead to biased results. Subsequently, the analytical methods for handling the missing data are important to evaluate. In atopic dermatitis (AD) trials, missing data are not handled consistently across studies. Lebrikizumab 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. In ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967), two randomized, double-blinded, placebo-controlled Phase 3 trials evaluating the efficacy and safety of lebrikizumab monotherapy in adolescent and adult patients with moderate-to-severe AD, a combined nonresponder/multiple imputation (NRI/MI) approach, was applied on the primary and key secondary endpoints. This study aims to illustrate the NRI/MI method using individual patient examples and to present Week 16 study results from ADvocate1 and ADvocate2 with NRI/MI and single imputation methods, NRI and last-observation carried forward (LOCF). In the combined NRI/MI method, data from patients after initiating rescue medication or discontinuing treatment due to lack of efficacy were imputed with NRI, and missing data for other reasons were imputed with MI, which uses a statistical model based on all available patient data to impute missing values. The MI method considers each patient's trajectory and leverages information from other patients within the same treatment arm to impute the missing data. With NRI alone, the cause leading to the missing data is not considered and missing data for any reason are imputed as nonresponse. With LOCF, missing data are replaced with the last available measurement; LOCF assumes that the patient response would be stable over time and does not consider the reason for missing data. We determined the amount of missing data in ADvocate1 and ADvocate2, and we assessed patient-level imputed IGA scores to illustrate NRI/MI, NRI and LOCF. With these missing data handling methods, we evaluated the percentage of patients achieving the co-primary endpoints of ADvocate1 and ADvocate2: an Investigator's Global Assessment score of 0 or 1 [IGA (0,1); clear or almost clear] with ≥2-point improvement from baseline or 75% improvement in Eczema Area and Severity Index (EASI 75) at Week 16. With the NRI/MI method, most missing data at Week 16 were imputed with NRI (ADvocate1: 73%, ADvocate2: 82%) compared with MI (ADvocate1: 27%, ADvocate2: 18%). Example imputed IGA scores based on patient-level data will be presented to demonstrate the missing data handling methods. For NRI/MI, NRI and LOCF, respectively, the percentage of patients achieving IGA 0,1 were 12.7%, 11.3% and 12.8% for placebo in ADvocate1 and 10.8%, 9.6% and 11.0% for placebo in ADvocate2; 43.1%, 41.0% and 42.4% for lebrikizumab in ADvocate1 and 33.2%, 31.3% and 33.5% for lebrikizumab in ADvocate2. The percentage of patients achieving EASI 75 were 16.2%, 14.2% and 16.3% for placebo in ADvocate1 and 18.1%, 17.1% and 19.2% for placebo in ADvocate2; 58.8%, 56.5% and 60.1% for lebrikizumab in ADvocate1 and 52.1%, 50.2% and 55.5% for lebrikizumab in ADvocate2. When using the NRI/MI method, we determined most missing data in ADvocate1 and ADvocate2 were handled with NRI. This analysis suggests that the NRI/MI method may provide a realistic estimation of response rate in ADvocate1 and ADvocate2. [ABSTRACT FROM AUTHOR]

The landscape of targeted systemic treatments for moderate-to-severe atopic dermatitis (AD) continues to expand. With limited head-to-head randomized controlled trials conducted in AD, a network meta-analysis (NMA) helps inform treatment decisions by providing indirect comparisons across therapies. This study aims to update an NMA presented in Silverberg et al. (2022), assessing the comparative efficacy of targeted systemic treatments without concomitant topical corticosteroids in moderate-to-severe AD by including the latest Phase 3 monotherapy data for lebrikizumab. Data from the two most recently published Phase 3 monotherapy trials for lebrikizumab in moderate-to-severe AD [ADvocate1 (NCT04146363); ADvocate2 (NCT04178967)] were included in the analyses along with other eligible Phase 3 or 4 randomized placebo-controlled trials for abrocitinib, baricitinib, dupilumab, tralokinumab and upadacitinib identified through a systemic literature review in Silverberg et al. (2022). Prespecified efficacy outcomes included ≥90% and ≥75% improvement in Eczema Area and Severity Index (EASI 90, EASI 75) from baseline, ≥4-point improvement in Pruritus Numerical Rating Scale from baseline (ΔNRS ≥4) and Investigator Global Assessment (IGA) score of 0 or 1 (clear or almost clear) with a ≥2-point reduction from baseline (IGA 0/1), at the primary endpoint timepoint for each study (Week 12 for abrocitinib, Week 16 for all other therapies). Bayesian NMA was performed with fixed-effect, random-effect and baseline risk-adjusted models; fit statistics and diagnostics were assessed. The odds ratio (OR), number needed to treat (NNT), placebo-unadjusted absolute response rate (ARR) and Surface Under the Cumulative RAnking curve (SUCRA) scores were estimated. Statistical significance was assessed by OR 95% credible intervals excluding 1. The updated NMA analysed 13 unique placebo-controlled trials involving 7105 patients in 32 arms across six targeted therapies. Fit statistics and diagnostics supported fixed-effect models for all outcomes analysed. All targeted therapies had significantly greater response rates compared with placebo across all outcomes. For EASI 90, upadacitinib 30 mg had the most favorable response estimates (ARR = 58.3%, OR = 23.1, NNT = 1.9, SUCRA = 98.5%), followed by abrocitinib 200 mg (ARR = 45.2%, OR = 13.5, NNT = 2.5, SUCRA = 84.3%), upadacitinib 15 mg (ARR = 43.7%, OR = 12.8, NNT = 2.6, SUCRA = 82.0%), dupilumab 300 mg (ARR = 27.3%, OR = 6.2, NNT = 4.7, SUCRA = 52.8%), abrocitinib 100 mg (ARR = 26.8%, OR = 6.0, NNT = 4.8, SUCRA = 48.4%), baricitinib 4 mg (ARR = 25.0%, OR = 5.5, NNT = 5.2, SUCRA = 45.5%) and lebrikizumab 250 mg (ARR = 23.6%, OR = 5.1, NNT = 5.6, SUCRA = 40.0%). A similar rank order was observed for EASI 75 [upadacitinib 30 mg (ARR = 72.3%, OR = 19.1, NNT = 1.7, SUCRA = 98.5%), abrocitinib 200 mg (ARR = 64.6%, OR = 13.3, NNT = 1.9, SUCRA = 87.3%), upadacitinib 15 mg (ARR = 59.8%, OR = 10.9, NNT = 2.1, SUCRA = 80.2%), dupilumab 300 mg (ARR = 45.3%, OR = 6.0, NNT = 3.0, SUCRA = 55.4%), abrocitinib 100 mg (ARR = 44.9%, OR = 5.9, NNT = 3.1, SUCRA = 53.5%) and lebrikizumab 250 mg (ARR = 44.7%, OR = 5.9, NNT = 3.1, SUCRA = 53.9%)]. For ΔNRS ≥4, upadacitinib 30 mg also had the most favorable response (ARR = 56.1%, OR = 12.9, NNT = 2.1, SUCRA = 99.0%), followed by abrocitinib 200 mg (ARR = 45.4%, OR = 8.3, NNT = 2.8, SUCRA = 83.6%), upadacitinib 15 mg (ARR = 42.9%, OR = 7.6, NNT = 3.0, SUCRA = 79.2%), dupilumab 300 mg (ARR = 33.9%, OR = 5.2, NNT = 4.0, SUCRA = 54.2%), lebrikizumab 250 mg (ARR = 33.9%, OR = 5.1, NNT = 4.1, SUCRA = 54.1%) and abrocitinib 100 mg (ARR = 31.5%, OR = 4.6, NNT = 4.5, SUCRA = 46.1%). For IGA 0/1, upadacitinib 30 mg (ARR = 61.8%, OR = 19.4, NNT = 1.9, SUCRA = 99.9%) and upadacitinib 15 mg (ARR = 48.1%, OR = 11.1, NNT = 2.5, SUCRA = 86.9%) had the most favorable estimates, followed by abrocitinib 200 mg (ARR = 39.3%, OR = 7.7, NNT = 3.2, SUCRA = 75.5%), dupilumab 300 mg (ARR = 32.4%, OR = 5.7, NNT = 4.1, SUCRA = 62.1%) and lebrikizumab 250 mg (ARR = 28.0%, OR = 4.7, NNT = 5.0, SUCRA = 49.1%). Baricitinib 2 mg and tralokinumab 300 mg were generally ranked lower across outcomes. Among targeted treatments for moderate-to-severe AD used without concomitant topical corticosteroids for 12–16 weeks, upadacitinib 30 mg remains the most efficacious therapy in this NMA, generally followed by abrocitinib 200 mg, upadacitinib 15 mg, dupilumab 300 mg and lebrikizumab 250 mg or abrocitinib 100 mg. [ABSTRACT FROM AUTHOR]

Lebrikizumab (LEB) is a monoclonal antibody that binds with high affinity to interleukin (IL)-13, thereby blocking the downstream effects of IL-13 with high potency. To report integrated safety information in adult and adolescent patients with moderate-to-severe atopic dermatitis treated with LEB, from an integrated safety analysis of eight clinical Phase 2 and 3 trials. These data include adult and adolescent patients who received at least one dose of study drug from a total of eight atopic dermatitis clinical trials: ADvocate1, ADvocate2, ADhere, ADore, ADjoin (ongoing), ARBAN, TREBLE and a Phase 2b study. Treatment duration ranged from a single dose to 100 weeks. This analysis includes all placebo-controlled Week 0- to 16-safety data in patients treated with LEB 250 mg every 2 weeks (LEBQ2W, n = 783) compared with placebo (n = 404) known as ALL PC Weeks 0–16, and all patients who received at least one dose of LEB (n = 1720) known as ALL LEB. Conjunctivitis cluster is defined by MedDRA-preferred terms of conjunctivitis, allergic conjunctivitis, bacterial conjunctivitis, viral conjunctivitis and giant papillary conjunctivitis. Exposure adjusted incidence rates (IR) are provided as per 100 patient-years. In ALL PC Weeks 0–16 analysis, the frequency of treatment-emergent adverse events (TEAE) was 49.2% in LEBQ2W (n = 384) compared with 53.1% in placebo (n = 215). The majority of TEAEs reported were mild or moderate in severity with 2.3% (n = 18) reported as severe in LEBQ2W and 4.4% (n = 18) in placebo. Serious adverse events (SAEs) were reported by 1.3% (n = 10) in LEBQ2W and 1.9% (n = 8) in placebo. No deaths reported in LEBQ2W and one death in placebo. The most frequently reported TEAE in LEBQ2W was conjunctivitis and in placebo was atopic dermatitis. Conjunctivitis cluster was reported by 8.5% (n = 67) in LEBQ2W and 2.5% (n = 10) in placebo. All conjunctivitis cluster events were mild or moderate. Injection site reactions (ISRs) were reported by 2.6% (n = 20) in LEBQ2W and 1.5% (n = 6) in placebo. Adverse events leading to discontinuation were reported by 2.3% (n = 18) in LEBQ2W and 1.4% (n = 6) in placebo. In ALL LEB, the frequency of TEAEs was 64.3% (n = 1106, IR: 137.9), with the majority being mild or moderate in severity. Severe TEAEs were reported by 5.3% (n = 91). The incidence rates of TEAE did not increase with duration of treatment exposure. The SAEs were reported by 3.3% (n = 56, IR: 3.5). Three (0.2%) deaths occurred in ALL LEB. Conjunctivitis cluster was reported by 10.6% (n = 183, IR:12.2) with the majority being mild or moderate in severity and 0.3% (n = 6) being reported as severe. The ISRs were reported by 3.1% (n = 53, IR: 3.3). Adverse events leading to discontinuation were reported by 4.2% (n = 73, IR: 4.5). The overall safety profile for lebrikizumab consisted of AEs that were mostly nonserious, mild or moderate in severity, and did not lead to treatment discontinuation. Safety profile was similar in both adults and adolescents. [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]

Lebrikizumab demonstrated robust efficacy during the first 16 weeks of treatment in ADvocate1 and ADvocate2. This study aims to describe the 52-week results of lebrikizumab-treated patients who did not meet the protocol-defined criteria for response at 16 weeks of treatment. During the induction period, patients were randomized 2 : 1 to lebrikizumab 250 mg or placebo every 2 weeks (Q2W) for 16 weeks. Protocol-defined criteria for response were characterized as achieving a 75% Eczema Area and Severity Index (EASI75) or an Investigator's Global Assessment of 0 or 1 (IGA 0,1) with a ≥2-point improvement and without rescue medication use. At Week 16, patients from the lebrikizumab treatment arm, who did not reach the criteria for response, were assigned to the Escape arm (n = 215). These patients continued to receive lebrikizumab 250 mg Q2W for an additional 36 weeks. Endpoints and measurements included at week 52 were EASI75, EASI90, IGA (0,1) and pruritus. Pruritus was assessed using an 11-point Pruritus Numeric Rating Scale (NRS). Data are presented as observed results with no imputation for missing data. Pooled results for patients who did not respond to lebrikizumab and entered the escape arm show 36.1% achieved IGA (0,1) with 2-point improvement at Week 52. In the same population, 75.5% achieved EASI75, 44.2% achieved EASI90 and 66.4% reported 4-point improvement in Pruritus NRS. These results suggest that patients, who do not achieve protocol-defined response at 16 weeks of treatment, can be slow responders and derive benefit from continuing long-term therapy with lebrikizumab. [ABSTRACT FROM AUTHOR]

Lebrikizumab (LEB) is a novel, high affinity monoclonal antibody that selectively binds to interleukin (IL)-13. Lebrikizumab has been shown to provide robust improvements in signs and symptoms in adolescent and adult patients with moderate-to-severe AD across three phase 3 clinical trials (ADvocate1, ADvocate2 and ADhere). However, little is known about the efficacy of LEB in difficult to treat regions such as the face and hands. This study aims to report efficacy of LEB in improving facial and hand dermatitis. ADvocate1 and ADvocate2 assessed LEB 250 mg every 2 weeks (LEBQ2W) vs. placebo for 16 weeks in monotherapy. ADhere compared low-to-mid potency topical corticosteroids (TCS) in addition to LEB Q2W vs. TCS and placebo for 16 weeks. In all trials, clinicians assessed for the presence or absence of facial and hand dermatitis. If present at baseline, at Week 16, clinicians assessed the change from baseline on a scale of cleared, improved, no change or worsened. Patients with improved or cleared dermatitis are described. In ADvocate1 at baseline, facial dermatitis was identified in 71.4% (202/283) of LEBQ2W patients and 80.9% (114/141) of placebo. At Week 16, 61.9% (125/202; P < 0.001) of LEBQ2W were improved or cleared vs. 31.6% (36/114) of placebo. At baseline, hand dermatitis was identified in 72.1% (204/283) of LEBQ2W patients vs. 73.0% (103/141) of placebo. At Week 16, 67.2% (137/204; P < 0.001) of LEBQ2W were improved or cleared vs. 29.1% (30/103) of placebo. In ADvocate2 at baseline, facial dermatitis was identified in 73.7% (207/281) of LEBQ2W patients and 78.8% (115/146) of placebo. At Week 16, 57.5% (119/207; P < 0.001) of LEBQ2W were improved or cleared vs. 21.7% (25/115) of placebo. At baseline, hand dermatitis was identified in 73.3% (206/281) of LEBQ2W patients and 72.6% (106/146) of placebo. At Week 16, 61.7% (127/206; P < 0.001) of LEBQ2W were improved or cleared vs. 18.9% (20/106) of placebo. In ADhere at baseline, facial dermatitis was identified in 72.4% (105/145) of LEBQ2W patients and 59.1% (39/66) of placebo. At Week 16, 68.6% (72/105; P = 0.02) of LEBQ2W were improved or cleared vs. 46.2% (18/39) of placebo. At baseline, hand dermatitis was identified in 71.0% (103/145) of LEBQ2W patients and 66.7% (44/66) of placebo. At Week 16, 72.8% (75/103; P = 0.001) of LEBQ2W were improved or cleared vs. 43.2% (19/44) of placebo. Lebrikizumab treatment is efficacious in improving and clearing hand and face dermatitis in most patients at Week 16. [ABSTRACT FROM AUTHOR]

Competing Interests: Conflicts of interest J.P.T. has received grants, consulting fees, speaker honoraria, payment for expert testimony and/or participated on a data safety monitoring board for Pfizer, LEO Pharma, Astana, AbbVie, Arena, Union, Coloplast, Regeneron, Sanofi-Genzyme, Eli Lilly and Company and OM85. J.S. has received consulting fees from AbbVie, LEO Pharma, Eli Lilly and Company, Novartis, Sanofi-Genzyme, Pierre Fabre and Pfizer. B.B., K.J.M., F.D. and E.H. are employees of and shareholders in Eli Lilly and Company. G.E. has received grants, consulting fees and speaker honoraria for Janssen, GlaxoSmithKline, Gebro Pharma and Laboratorios Rovi, and has received payments for clinical trials from Eli Lilly and Company.