Search

In this post-hoc analysis, IGA clear or almost clear at week 6 was metby more patients treated with roflumilast than patients treated with vehicle (roflumilast 0.3%, 27.2%; roflumilast 0.15%, 22.3%; vehicle, 6.3%; nominal I P i <= 0.026). Https://doi.org/10.1093/bjd/ljad060 DearEditor, Psoriatic lesions can occur on difficult-to-treat areas such as the face or intertriginous regions.[1] While topical corticosteroids may be effective for treating psoriasis, risk of local skin, ocular and systemic side-effects require cautious use, especially in these locations.[2],[3] Topical vitamin D analogues are less effective than corticosteroids and may be associated with local side-effects and should not be applied to facial skin.[[2], [4]] Thus, patients with psoriasis need a topical treatment that is effective and can be used safely on a wide range of anatomical areas without restrictions on treatment duration or site of application. [Extracted from the article]

Introduction & Objectives: Upadacitinib (UPA) 15 and 30 mg once daily is approved for moderate to severe atopic dermatitis (AD) in several jurisdictions, including the European Union, Japan, Canada, and the United States, with indication/posology differences. Clinical studies have documented the safety and efficacy of UPA; however, real-world data on UPA are limited. The AD-VISE study objective is to characterize the real-world utilization patterns and effectiveness of UPA 15 and 30 mg in adults and adolescents with AD in clinical practice. Materials & Methods: AD-VISE is an ongoing observational, prospective, multicountry study to assess the use of UPA in routine clinical practice for 2 years. Adult and adolescent patients (pts) receiving UPA for AD are being enrolled. Primary effectiveness outcome measures included validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) 0/1 at month 4. Other outcome measures included Eczema Area and Severity Index (EASI), Worst Pruritus Numeric Rating Scale (WP-NRS), and Dermatology Life Quality Index (DLQI). This interim analysis (data cutoff February 27, 2023) reports baseline data and 2- and 4-month effectiveness data. Effectiveness analyses included pts that were enrolled at least 4 months by the data cutoff date or discontinued from the study; non-responder imputation with multiple imputation (NRI-MI) was used. Results: Baseline analyses included 267 pts, of whom 21 (7.9%) were adolescents; effectiveness analyses included 209 patients (NRI-MI). Overall, 155 (58.1%) pts started on UPA 15 mg and 112 (41.9%) started on UPA 30 mg. Most pts in this analysis were from Canada (56.2%), followed by Russia (10.9%) and Australia (8.6%). Mean (SD) UPA exposure was 218.8 (±117.6) days; 5.6% of pts discontinued UPA and 3.7% discontinued the study. The most common reason for starting on UPA 15 mg was attempting lowest possible effective dose (42.9%) and on 30 mg, high disease burden/severity of skin symptoms (35.2%). More pts starting UPA 30 mg vs 15 mg were between 18 to <65 years old (96.4% vs 76.1%), male (61.6% vs 51.0%), had severe AD (vIGA-AD score 4: 53.6% vs 46.3%), had prurigo nodules (30.6% vs 18.4%), asthma (45.5% vs 24.5%), and prior biologic systemic therapy use (16.1% vs 10.3%). More than half of the pts (51.2%) achieved vIGA-AD 0/1 at month 2, and this proportion increased to 61.3% at month 4. Similarly, rate of achieving EASI 90 (month 2: 46.9%; month 4: 57.2%) and DLQI 0/1 (month 2: 35.1%; month 4: 41.3%) increased, whereas rates were maintained for =4-point WP-NRS improvement (month 2: 68.1%; month 4: 69.3%). Similar results were observed with other endpoints. Conclusion: Initial findings from the AD-VISE study, the largest study to report multicountry real-world data on UPA treatment patterns and effectiveness in AD, suggest that most pts achieved clear/almost clear skin and clinically meaningful itch improvement by month 4. Because this is a real-world observational study, it was expected that physicians start with UPA dose per local label. The main reason for starting UPA 30 mg was high disease burden/severity of skin symptoms, whereas 15 mg was started to attempt the lowest possible effective dose. More pts starting UPA 30 mg vs 15 mg were adults, male, and had prior biologic systemic therapy use. [ABSTRACT FROM AUTHOR]

Atopic dermatitis (AD) may be more common than previously thought in adults aged ≥60 years, a population underrepresented in clinical trials. Rigorous demonstration of efficacy and safety in older adults is clinically important due to distinct disease presentations in this group, age-related immune shifts, changes in drug metabolism and risks associated with a heightened burden of medical comorbidities and polypharmacy. Treatment options providing efficacy with acceptable safety profiles are of particular importance. Here, we report the efficacy and safety of dupilumab for the treatment of moderate-to-severe AD in patients aged ≥60 years. Data were pooled from four randomized, placebo-controlled dupilumab trials in patients with moderate-to-severe AD (LIBERTY AD SOLO 1 & 2 [NCT02277743, NCT02277769], LIBERTY AD CAFÉ [NCT02755649] and LIBERTY AD CHRONOS [NCT02260986]). Patients aged ≥60 years (N =183) received dupilumab 300 mg weekly (qw), every 2 weeks (q2w) or a placebo. Topical corticosteroids (TCSs) were permitted in LIBERTY AD CAFÉ and LIBERTY AD CHRONOS. Reported efficacy measures include the percentage of patients achieving a 75% reduction in Eczema Area and Severity Index (EASI-75), mean change in Peak Pruritus Numerical Rating Scale (PP-NRS) scores, and mean change in Dermatology Life Quality Index (DLQI). Safety data are also presented. Among patients aged ≥60 years, significant increases in EASI-75 responses were observed in patients treated with dupilumab 300 mg qw (61.6%) and 300 mg q2w (63.0%) vs. placebo (14.3%; P<0.0001 for both) at week 16. Least squares (LS) mean change (± standard error [SE]) in PP-NRS scores was significantly greater in patients treated with dupilumab 300 mg qw (−1.6 [0.2]) and 300 mg q2w (−1.7 [0.3]) vs. placebo (−0.9 [0.3]; P<0.05 for both) at week 2. Improvements continued to week 16 in patients treated with dupilumab 300 mg qw (−4.0 [0.3]) and 300 mg q2w (−3.8 [0.3]) vs. placebo (−1.7 [0.3]; P<0.0001 for both). Similarly, significant improvement (LS mean change [±SE]) in DLQI was seen in patients treated with dupilumab 300 mg qw (−5.0 [0.6]) and 300 mg q2w (−6.0 [0.7]) vs. placebo (−2.8 [0.6]; P<0.01 vs. qw and P<0.001 vs. q2w) at week 2; improvements continued to week 16 in patients treated with dupilumab 300 mg qw (−8.0 [0.6]) and 300 mg q2w (−9.65 [0.7]) vs. placebo (−3.3 [0.7]; P<0.0001 for both). 52 (72.2%) patients in the 300 mg qw treatment group, 32 (58.2%) patients in the 300 mg q2w treatment group, and 40 (71.4%) patients in the placebo group experienced ≥1 TEAE. The two most common treatment-emergent adverse events (TEAEs) were injection-site reactions (13.9%) and nasopharyngitis (9.7%) during 300 mg qw dupilumab treatment; dermatitis atopic (20.0%) and nasopharyngitis (5.5%) during 300 mg q2w dupilumab treatment; and dermatitis atopic (30.4%) and upper respiratory tract infection (7.1%) during placebo treatment. 3 (4.2%) patients during 300 mg qw dupilumab treatment and 2 (3.6%) patients during 300 mg q2w dupilumab treatment discontinued treatment permanently as a result of TEAEs. Dupilumab efficacy and safety profiles in patients aged ≥60 years were generally consistent with that seen in patients aged <60 years with atopic dermatitis, and have been previously reported. Dupilumab, with or without TCS, improves AD signs, symptoms and quality of life with a consistent and acceptable safety profile in patients aged ≥60 years with moderate-to-severe AD. [ABSTRACT FROM AUTHOR]

Chronic itch (pruritus) is a defining characteristic of atopic dermatitis (AD) and is a significant contributor to poor quality of life in patients. A Pruritus/Peak Pruritus Numerical Rating Scale (NRS) score of 0/1 could be considered a complete or near-complete itch response. This study aims to report Pruritus NRS and Overall Disease Severity (ODS) score of 0/1 over time in patients older than 12 years with moderate-to-severe AD initiating dupilumab treatment in real-world practice. Patients aged ≥12 years with moderate-to-severe AD, initiating real-world dupilumab treatment for AD per approved prescribing information in the USA and Canada, were eligible for entry into PROSE (NCT03428646). Enrolled patients received their first dose of dupilumab at the baseline visit; there were no restrictions on post-baseline dupilumab dosing changes, or concomitant medication use; patients were encouraged to stay in the study if they discontinued dupilumab. Data presented are from an interim analysis (data cut taken as of November 2022); only ≥36 months of patient experience in PROSE at the time of interim analysis is reported. No formal hypothesis testing was performed; descriptive statistics are presented. Among 857 patients [mean (SD) age 40.1 (17.9) years and 42% male], mean (SD) duration of dupilumab treatment was 23.1 (13.7) months. At Month 36, 185 patients (21.6%) had discontinued from the study; the main reason was withdrawal of consent by the patient (76 patients, 8.9%). The proportion of patients with available observations reporting a Pruritus NRS score of 0/1 increased from baseline (2.7%) to Month 3 (28.1%) and continued to increase up to Month 36 (56.3%). Similarly, the proportion of patients with a clinician-reported ODS score of 0/1 also increased from baseline (2.2%) to Month 3 (39.8%) and up to Month 36 (65.1%). Safety was consistent with the known dupilumab safety profile. In this interim analysis of PROSE, a majority of patients reported a complete/near-complete pruritus response and overall disease severity response over a 36-month period. [ABSTRACT FROM AUTHOR]