tbuckley/cabot-search huggingface dataset:
594 - United States prevalence of atopic dermatitis in adults and pediatrics by race and ethnicity
Authors: Andrew Alexis, Dave Nelson, Candrice Heath, Russel Burge, Beth Mitchell, Andrea Cohee, Evangeline Pierce, Amber Reck Atwater, Raj Chovatiya
Journal: British Journal of Dermatology (2024)

Abstract 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&amp;lt;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.
678 - Patient-reported outcomes for GSK1070806, an anti-IL-18 monoclonal antibody: a phase 1b, randomised, double-blind, parallel-group placebo-controlled study of patients with atopic dermatitis
Authors: Parima Ghafoori, Lea Fortunato, Dharm S Patel, Joanne Ellis, Gabriel Wong, John B Kelly, Helen Birch, Wen-Hung Chen, Iain Uings
Journal: British Journal of Dermatology (2024)

Abstract Introduction/Background Administration of GSK1070806, an anti–IL-18 monoclonal antibody, in patients with atopic dermatitis (AD) resulted in significant clinical improvements versus placebo after 12 weeks. Objectives Assessment of patient-reported outcomes (PROs) for patients with AD receiving GSK1070806. Methods In this multicentre, randomised, double-blind, parallel-group study (NCT04975438), adults (≥18 years) with confirmed AD diagnosis for ≥6 months and moderate-to-severe disease (Eczema Area and Severity Index ≥16; Investigator’s Global Assessment score ≥3) received 2 mg/kg GSK1070806 or placebo (single one-hour intravenous infusion). PRO measures included Peak Pruritis Numerical Rating Scale (PP-NRS), Dermatology Life Quality Index (DLQI), Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS-SD 8b), Brief Fatigue Inventory Item 3 (BFI-Item 3), and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). PROs were assessed at baseline and either daily (PP-NRS and BFI-Item 3) or a combination of weekly (up to Week 4) and biweekly (after Week 4) (PROMIS-SD, DLQI and FACIT-F) for up to 24 weeks. Changes from baseline (CFB) in PP-NRS and DLQI scores at Week 12 were analysed using a Bayesian repeated measures model with all other PROs analysed descriptively. Results Of 34 enrolled patients (53% female, mean [standard deviation] age 44.8 [16.9] years), 23 received GSK1070806 and 11 received placebo. Posterior median of difference (95% credible interval) CFB at Week 12 in PP-NRS were -4.6 (-5.5, -3.7; GSK1070806) and -0.5 (-1.7, 0.7; placebo), and for DLQI were -6.1 (-8.8, -3.4; GSK1070806) and -0.01 (-4.3, 4.1; placebo). Observed mean PROMIS-SD 8b, BFI-Item 3 and FACIT-F scores also indicated improvements among patients who received GSK1070806 versus placebo. Conclusions Patients with moderate-to-severe AD who received GSK1070806 experienced positive improvements across all PROs versus placebo. These results provide further evidence of GSK1070806 benefit in patients with moderate-to-severe AD.
704 - Effectiveness of atopic dermatitis patient education programs – a systematic review and meta-analysis
Authors: Luis F Andrade, Parsa Abdi, Kayla D Mashoudy, Amritpal Kooner, Ashley Egler, Rebecca Urbonas, Aaron Smith, Gil Yosipovitch
Journal: British Journal of Dermatology (2024)

Abstract Background Patient education in atopic dermatitis (AD) has worked in parallel to the gold standard of pharmacological treatment as a foundational component of therapeutic regimens. In addition to improving patient education, past investigations of educational interventions have demonstrated profound reductions in disease severity for patients living with AD. However, prior meta-analytical work has focused mostly on specific patient groups (e.g pediatric education), and there is limited data on the impact of said educational interventions across different AD severity scales, adult populations, and virtual platforms. Objective In this study, we conducted a systematic review of the literature to determine the effectiveness of online programming in AD education compared to in-person interventions. Methods A comprehensive search was conducted in accordance with the Cochrane Handbook for Systematic Reviews of Interventions 2019. Studies were retrieved based on articles published up to 04 April 2023. Adherence to the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) Statement guided the reportage process for this systematic review and meta-analysis. The primary outcome of our meta-analysis was the effect of various educational modalities on atopic dermatitis severity as measured by multiple scales across the studies, the most common including SCORAD, Dermatology Life Quality Index (DLQI), Patient Oriented Eczema Measure (POEM), and Eczema Area and Severity Index (EASI). Results Our study found significant differences in various disease severity and patient-reported indexes for those enrolled in educational experimental compared to control including SCORAD (standard mean difference [SMD] = 0.65, 95% Confidence Intervals (CI): 0.45–0.86), P &amp;lt; 0.00001), QOL (SMD= 0.36 ,95% CI: 0.18–0.54, P = 0.0002), POEM (SMD = 0.28, 95% CI: 0.07–0.49, P = 0.009), and EASI (SMD = 0.80, 95% CI: 0.54–1.06, P &amp;lt; 0.00001). Conclusion Our pooled analyses showed that targeted educational programs are an effective method of improving quality of life and reducing disease severity in AD. Moreover, virtual interventions can be employed as constructive tools for reducing barriers of access to patient education. Future research on educational interventions should utilize various methodologies to encourage individual learning preferences with a focus on adult cohorts.
649 - Safety of tralokinumab for the treatment of atopic dermatitis in patients with up to 4.5 years of treatment: an updated integrated analysis of eight clinical trials
Authors: Kristian Reich, Richard G Langley, Juan Francisco Silvestre, Delphine Staumont-Salle, Antonio Costanzo, Andrew Pink, Amy Paller, Norito Katoh, Andreas Wollenberg, Richard B Warren, Christian Bjerregård Øland, Ann-Marie Tindberg, Le Gjerum, Eric Simpson
Journal: British Journal of Dermatology (2024)

Abstract Introduction/Background Clinical trials of up to 52 weeks showed that tralokinumab, a monoclonal antibody that specifically neutralizes interleukin-13, was efficacious and well-tolerated as monotherapy and combination with TCS. Objectives Here, we evaluate the long-term safety of tralokinumab in an integrated analysis of seven phase 3 parent trials (PTs) (NCT03131648, NCT03160885, NCT03363854, NCT03562377, NCT03526861, NCT03761537, NCT04587453), and the ongoing, up to 5-year extension study (ECZTEND; NCT03587805). Methods Two datasets were analyzed: placebo-controlled (initial 16-week period of the PTs), and all-tralokinumab combining PTs with ECZTEND including patients from first dose until end of tralokinumab exposure or data cut-off (April 30th, 2022). In the all-tralokinumab dataset, periods on placebo were disregarded. Treatment-emergent adverse events (AEs) were recorded. AEs of special interest (AESIs) were predefined. Proportions of patients with events and incidence rates (IR) per 100 patient-years of exposure (PYE) were calculated. PYE was defined as time until first event or exposure end, whichever came first, and incidence was defined as first event. Results 2693 patients (≥12 years) received tralokinumab for up to 238.5 weeks (≈4.5 years) with a median exposure time of 76.5 weeks in the all-tralokinumab dataset. Median age at baseline was 33.0 years (min-max; 12-92). 10.4% of patients were 12-17 years. 2307 patients experienced an AE (IR=202.0), most (97.3%) of which were mild-to-moderate. Serious AEs (SAEs) were reported in 226 patients (IR=4.5); SAEs were considered possibly or probably related by the investigator in 50 patients (IR=0.9). No preferred term level SAEs were reported with an IR≥0.1. Discontinuation of treatment due to AEs was low (IR=2.8). AEs leading to drug withdrawal with an IR&amp;gt;0.1 were dermatitis atopic (IR=0.5) and injection site reaction (ISR) (IR=0.2). Frequently reported AEs in the all-tralokinumab dataset were consistent with the placebo-controlled dataset, including nasopharyngitis (IR=18.4), upper respiratory tract infection (IR=6.9), conjunctivitis (IR=5.0), ISR (IR=3.6), conjunctivitis allergic (IR=2.7), and injection site pain (IR=1.5). AESIs, including eye disorders, skin infections requiring systemic treatment, eczema herpeticum, and malignancies, were observed in the all-tralokinumab dataset at rates similar to or lower than the placebo-controlled dataset. Conclusion Long-term use of tralokinumab, for up to 4.5 years, was well-tolerated, and the pattern of AEs was consistent with the initial placebo-controlled treatment period with no new safety signals identified.
638 - Long-term safety and efficacy of roflumilast cream 0.15% in adults and children aged ≥6 years with mild to moderate atopic dermatitis: a 52-week, phase 3, open-label extension trial
Authors: Eric L Simpson, Lawrence F Eichenfield, Kim A Papp, Seth Forman, Adelaide A Hebert, Mercedes E Gonzalez, Melinda Gooderham, H Chih-ho Hong, Vimal H Prajapati, Emma Guttman, Jonathan Silverberg, Melissa Seal, David Krupa, Patrick Burnett, Scott Synder, David H Chu, Robert C Higham, David R Berk
Journal: British Journal of Dermatology (2024)

Abstract Background Roflumilast, a highly potent phosphodiesterase-4 inhibitor, is being investigated as a non-steroidal, once-daily cream for atopic dermatitis (AD). Methods INTEGUMENT-OLE (NCT04804605) was an open-label 52-week safety trial. Patients (N=658) with mild to moderate AD who completed a 4-week randomized vehicle-controlled phase 3 trial of roflumilast cream continued or switched to once-daily roflumilast cream 0.15% in this open-label extension trial. Starting at Week 4, patients achieving Validated Investigator Global Assessment for AD (vIGA-AD) score of 0 (Clear) switched to twice-weekly (BIW) maintenance dosing. The primary endpoint was safety; secondary endpoints included vIGA-AD, Worst Itch-Numeric Rating Scale (WI-NRS), and Eczema Area and Severity Index (EASI). “Disease control” was defined as duration of vIGA-AD=0/1 on BIW dosing following achievement of vIGA-AD=0. Results With cumulative treatment up to 56 weeks, 36.7% of patients reported treatment-emergent adverse events (AEs); most were mild to moderate in severity. Overall, 4.7% of patients had AEs deemed treatment-related and 3.0% discontinued due to AEs. The most common AEs (&amp;gt;2%) were COVID-19, upper respiratory tract infection, nasopharyngitis, and headache. At Week 52, 55.7%, 61.1%, and 53.6% of patients achieved vIGA-AD=0/1 (Clear/Almost Clear), ≥75% reduction in EASI, and ≥4-point reduction in WI-NRS (among patients aged ≥12 years with baseline WI-NRS ≥4), respectively. Of the 130 (19.8%) patients who achieved disease control, 50% maintained “disease control” for at least 281 days. Conclusion Treatment with roflumilast cream 0.15% demonstrated long-term safety in patients with AD consistent with parent trials and durable efficacy through 52 weeks, including patients who switched to BIW dosing.
619 - Lebrikizumab improves signs and symptoms of moderate-to-severe atopic dermatitis in patients not adequately controlled or non-eligible for cyclosporine: a placebo-controlled, randomized phase 3 clinical study (ADvantage)
Authors: Richard B Warren, Marjolein de Bruin-Weller, Athanasios Tsianakas, Abdallah Khemis, Jacek C Szepietowski, H Chih-Ho Hong, Clara Armengol, Meritxell Falqués, Helena Agell, Eric Massana, Esther Garcia Gil, Stephan Weidinger
Journal: British Journal of Dermatology (2024)

Abstract Introduction Lebrikizumab (LEB), a novel monoclonal antibody with high affinity and slow off-rate to interleukin-13, is efficacious and safe in adults and adolescents with moderate-to-severe atopic dermatitis (AD). Efficacy of cyclosporine A (CsA), used for severe AD, may not be optimal in some AD patients and its safety limits long-term use. Objectives We report 16-week efficacy and safety of LEB + low-/mid-potency topical corticosteroids (TCS) in patients with moderate-to-severe AD, not adequately controlled/non-eligible for CsA, in the phase 3 ADvantage study. Methods ADvantage had a 16-week, randomized, double-blind, PBO-controlled, parallel-group period followed by a 36-week open-label maintenance period. Eligibility: adults and adolescents (age ≥12 - &amp;lt;18 years), Eczema Area and Severity Index (EASI) ≥16, Investigator’s Global Assessment (IGA) ≥3, ≥10% body surface area of AD involvement, and patients not adequately controlled or non-eligible for CsA. Randomization: 2:1 to LEB 250 mg with a loading dose of LEB 500 mg at baseline and week-2, or PBO every two weeks (Q2W). All patients received concomitant mid-potency TCS through week-16; dosage tapered once lesions were controlled and stopped after 7 days. Primary endpoint: percentage of patients achieving 75% reduction in EASI (EASI 75) at week-16. Secondary endpoints: percentage of patients achieving EASI 90, IGA 0/1, and ≥4-point improvement in pruritus Numeric Rating Scale (NRS) at week-16. Safety endpoints: treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and TEAEs causing discontinuation. Results 312/331 patients (212 LEB+TCS and 100 PBO+TCS) completed the 16-week period. At week 16, significantly higher proportion of LEB+TCS vs PBO+TCS patients achieved EASI 75 (68.4% vs 40.8%, p&amp;lt;0.001) and EASI 90 (42.9% vs 20.8%, nominal p&amp;lt;0.001); higher percentage of patients achieved IGA 0/1 (42.0% vs 24.5%, nominal p&amp;lt;0.01) and ≥4-point improvement in pruritus NRS (49.9% vs 29.7%, nominal p&amp;lt;0.05). TEAEs: 61.8% LEB+TCS vs 53.2% PBO+TCS, with nasopharyngitis and conjunctivitis being the most common TEAEs. SAEs and TEAEs causing discontinuation were low and similar in both groups. Conclusions At week 16, LEB 250 mg Q2W + TCS significantly improved AD signs and symptoms in adults and adolescents with moderate-to-severe AD and history of inadequate response to CsA, or for whom CsA was not advisable.
672 - Nemolizumab monotherapy improves itch, sleep disturbance, and skin lesions in patients with moderate-to-severe prurigo nodularis: Pooled analyses from OLYMPIA 1 and OLYMPIA 2 phase 3 studies
Authors: Gil Yosipovitch, Sonja Ständer, Martin Metz, Andrew E Pink, Jonathan I Silverberg, Howard Sofen, Faiz Ahmed, Aliene Noda, Zarif K Jabbar Lopez, Christophe Piketty, Shawn G Kwatra
Journal: British Journal of Dermatology (2024)

Abstract Introduction Nemolizumab demonstrated clinically and statistically significant improvements in itch, sleep disturbance, and skin lesions in adults with moderate-to-severe prurigo nodularis (PN) in two phase 3 pivotal studies (OLYMPIA 1 [NCT04501666]1 and OLYMPIA 2 [NCT04501679]2). Objectives To report pooled efficacy and safety from two phase 3 studies of nemolizumab in the treatment of PN. Materials &amp; Methods A pooled analysis of two phase 3 pivotal studies in adults with moderate-to-severe PN, randomized (2:1) to receive either nemolizumab (initial 60 mg subcutaneous dose followed by 30 mg or 60 mg [depending on a baseline weight below or ≥90 kg, respectively]) or matching placebo every 4 weeks (Q4W). Results Nemolizumab significantly improved all pre-specified efficacy endpoints vs placebo. At Week 16, a ≥4-point improvement from baseline in weekly average Peak Pruritus Numerical Rating Scale (PP-NRS) was achieved in 57.4% of nemolizumab- vs 18.7% placebo-treated patients (P&amp;lt;0.0001), an Investigator’s Global Assessment score of 0/1 [clear/almost clear skin] with ≥2-point reduction from baseline was achieved in 31.9% of nemolizumab- vs 9.1% of placebo-treated patients (P&amp;lt;0.0001) at Week 16, itch-free/nearly itch-free state (defined as PP-NRS&amp;lt;2) was achieved in 34.6% of nemolizumab- vs 5.9% of placebo-treated patients (P&amp;lt;0.0001) and a ≥4-point improvement from baseline in weekly average Sleep Disturbance NRS was achieved in 50.9% of nemolizumab- vs 16.0% of placebo-treated patients (P&amp;lt;0.0001). Treatment-emergent adverse events (TEAEs) were reported in 66.5% of patients (nemolizumab) and 59.1% (placebo). Of these patients, the majority in each treatment group experienced that were considered mild or moderate in severity. Conclusion Nemolizumab monotherapy administered Q4W was well-tolerated and led to rapid and sustained clinically meaningful improvements in itch intensity and sleep disturbance along with improvement in skin lesions. Pooled results were consistent with those observed in individual pivotal phase 3 studies.2,3
710 - Improving pediatric atopic dermatitis care: online intervention in the Deep South
Authors: Thy N Huynh, Manoj Sharma, Summer V Morrissette, Robert T Brodell, Vinayak K Nahar
Journal: British Journal of Dermatology (2024)

Abstract Introduction/Background Atopic dermatitis (AD) affects about 9.6 million children in the United States (US) under the age of 18. Most of these young people have moderate-to-severe AD symptoms, which have a significant negative impact on their own and their families' quality of life. Preventing triggers, repairing the skin's protective layer, and reducing inflammation are the main goals of effective AD treatment. Even though medical experts play a crucial role in teaching parents about managing AD, many caregivers struggle to follow treatment plans, which results in preventable flare-ups. Objectives The purpose of this study was twofold: firstly, to assess the efficacy of an intervention aimed at enhancing healthcare professionals' confidence and practices in managing AD; and secondly, to pinpoint areas for improvement to better assist parents in navigating their children's chronic illness. Methods The study involved the recruitment of 37 healthcare workers from a large university medical center located in the deep South of the United States using email and word-of-mouth. The medical professionals watched a 20-minute YouTube movie, conducted an online pre-test survey, and then completed an online post-test survey. Results The majority of participants (68.6%) identified as female, and the largest racial group was White (59.4%). The participant pool encompassed residents, fellows, or trainees (40.5%), physicians (37.8%), and advanced practice providers (10.8%), with an average age of 39.74 years. The findings indicated an improvement in participants' confidence to prescribe new therapies and educate patients about self-management behaviors for AD. Additionally, more respondents felt capable of offering resources to aid their patients' self-management and mobilizing social support for this purpose. Conclusions In the era of new targeted therapies, this online intervention presents an opportunity to bolster healthcare professionals' confidence and refine their practices in managing AD, potentially yielding enhanced outcomes for children and their families.
653 - Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema: pooled results of the phase 3 DELTA-1 and -2 trials
Authors: Robert Bissonnette, Margitta Worm, Richard B Warren, Tove Agner, Melinda Gooderham, Marie Louise Schuttelaar, Keith Baranowski, Ursula Plohberger, Laura Soerensen, Sibylle Schliemann
Journal: British Journal of Dermatology (2024)

Abstract Introduction/Background Chronic Hand Eczema (CHE) is a frequent inflammatory skin disease associated with pain, pruritus, and significant occupational, functional, social, and psychological burden. Delgocitinib is a topical pan-JAK inhibitor which showed a dose-dependent efficacy in adults with CHE in a Phase 2b trial. Objectives The objectives of this analysis were to study (1) the efficacy of twice-daily applications of delgocitinib cream 20 mg/g, as assessed by Investigator's Global Assessment for CHE treatment success (primary outcome), and the secondary outcomes ≥75%/≥90% improvement in Hand Eczema Severity Index and ≥4-point improvement in the Dermatology Life Quality Index, and (2) the safety of twice-daily applications of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of adults with moderate to severe CHE in a pooled analysis of the DELTA-1 and DELTA-2 trials. Methods In the Phase 3 DELTA-1 (NCT04871711) and DELTA-2 (NCT04872101) trials, adults with moderate to severe CHE were randomized 2:1 to twice-daily delgocitinib cream 20 mg/g or cream vehicle for 16 weeks. The primary endpoint was the Investigator's Global Assessment for CHE (IGA-CHE) treatment success at Week 16, defined as IGA-CHE score of 0/1 (clear/almost clear, i.e., no/barely perceptible erythema and no other signs), with a ≥2-step improvement from baseline. Key secondary endpoints included ≥75%/≥90% improvement in Hand Eczema Severity Index (HECSI-75/90) and ≥4-point improvement in the Dermatology Life Quality Index (DLQI). This DELTA-1 and -2 pooled analysis included 639 patients treated with delgocitinib cream and 321 with cream vehicle. Results At Week 16, a significantly greater proportion of delgocitinib-treated patients, versus cream vehicle, achieved IGA-CHE treatment success (24.3% vs. 8.4%; P&amp;lt;0.001), HECSI-75 (49.4% vs. 20.9%; P&amp;lt;0.001), HECSI-90 (30.3% vs. 10.6%; P&amp;lt;0.001), and DLQI ≥4-point improvement (73.3% vs. 47.8%; P&amp;lt;0.001). Most frequent adverse events (occurring in ≥5% of patients) were COVID-19, nasopharyngitis, and headache with similar rates in both treatment groups. Conclusions In the DELTA-1 and -2 pooled analysis, delgocitinib cream twice-daily confirmed its clinical efficacy in patient- and clinician-reported efficacy outcomes versus cream vehicle in adult CHE patients and suggests an innovative treatment option in this often difficult-to-treat patient population.