Dermatology and Therapy最新文献

{"title":"Tildrakizumab Treatment Patterns in Adults With Moderate-to-Severe Plaque Psoriasis: A Retrospective Analysis From the Canadian Patient Support Program.","authors":"Vimal H Prajapati, Nicole Bellefontaine, Devi Gopalan, Rommel Mangaser, Pak Chan, Maxwell B Sauder","doi":"10.1007/s13555-025-01434-x","DOIUrl":"10.1007/s13555-025-01434-x","url":null,"abstract":"<p><strong>Introduction: </strong>Tildrakizumab is an anti-interleukin-23 p19 monoclonal antibody approved in several countries to treat adult patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Limited data are available on tildrakizumab treatment patterns in clinical practice. The Canadian tildrakizumab patient support program (PSP), which provides personalized reimbursement, financial aid, and injection training support for disease management, was used in this study to evaluate real-world persistence and adherence to tildrakizumab.</p><p><strong>Methods: </strong>This retrospective, observational study used data collected in the Canadian tildrakizumab PSP database between August 4, 2021, and August 1, 2023. Adult (≥18 years) patients with moderate-to-severe plaque psoriasis who enrolled in the PSP and received ≥6 months of treatment with tildrakizumab before August 1, 2023, were included. Data up to Week 52 following treatment initiation were analyzed. Persistence was defined as the number of days until treatment discontinuation. Adherence was measured as the proportion of days covered (PDC) from treatment initiation to treatment discontinuation or study cutoff, with PDC ≥80% indicating high adherence.</p><p><strong>Results: </strong>The study included 813 patients with a mean ± standard deviation (SD) age of 49.6 ± 15.9 years; 55.0% (447/813) were male, and 92.7% (754/813) were biologic-naïve when initiating tildrakizumab. Patients received tildrakizumab treatment for a mean ± SD of 329.6 ± 55.0 days. After 1 year, 88.0% of patients were persistent on treatment. Adherence was also high, with mean ± SD PDC being 97.5% ± 8.9% and 93.5% of patients having PDC ≥80%. Eighty-five patients discontinued treatment, primarily because of switching to other therapies. Common adverse outcomes included treatment misuse (18.9%), disease flare (8.2%), and treatment discontinuation (7.4%).</p><p><strong>Conclusion: </strong>Persistence and adherence to tildrakizumab were high through 52 weeks of treatment among patients with moderate-to-severe plaque psoriasis enrolled in the Canadian PSP.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2047-2059"},"PeriodicalIF":3.5,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12256372/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144179954","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real‑World Experience of 1 Year of Tralokinumab Treatment in Adult Patients with Atopic Dermatitis: A Single-Center Retrospective Study.","authors":"Adrian O Rodriguez, Caid Sterling Smith","doi":"10.1007/s13555-025-01445-8","DOIUrl":"10.1007/s13555-025-01445-8","url":null,"abstract":"<p><strong>Introduction: </strong>Atopic dermatitis (AD) is a chronic inflammatory disease requiring long-term management. Biologic therapies have emerged as systemic treatment options for AD, and real-world evidence (RWE) of their use is needed to inform optimal treatment decisions.</p><p><strong>Methods: </strong>A retrospective, single-center case series was conducted including 37 adults with AD who were systemic-naive or inadequately responded to previous AD treatment and had a visit around 1 year after tralokinumab initiation prior to May 2024. Patient demographics, disease characteristics, and treatment history were collected. Outcomes of tralokinumab treatment, including investigator's global assessment (IGA) score, body surface area (BSA), and adverse events (AEs), were extracted from a 2-month visit (defined as 1-3 months) and a 1-year visit (defined as ≥ 10 months) after tralokinumab initiation.</p><p><strong>Results: </strong>Thirty-seven patients (median age, 58.0 years; 49% male) on tralokinumab for approximately 1 year or longer were included. At baseline, most patients (97% [33/34]) had moderate-to-severe AD (IGA 3 or 4), and median (interquartile range [IQR]) BSA was 10.0% (5.0%; 18.8%); 19% (7/37) of patients were biologic-experienced, having been previously on dupilumab. Most patients (95% [35/37]) transitioned to tralokinumab due to inadequate response to previous treatment. The proportion of patients with IGA score 0 or 1 increased from 0% (0/34) at baseline to 85% (22/26) after 2 months and 93% (28/30) at 1 year of tralokinumab treatment. Median (IQR) BSA improved to 0.5% (0.0%; 1.0%) and 0.0% (0.0%; 1.0%) at the 2-month and 1-year visits, respectively. Similar improvements were observed regardless of Fitzpatrick skin type or previous treatment history. No AEs were reported through 1 year of follow-up.</p><p><strong>Conclusions: </strong>This large case series provides RWE building on tralokinumab clinical trial data and highlights the potential rapid and long-term response in patients with AD irrespective of their Fitzpatrick skin type or treatment history, including patients previously treated with dupilumab.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2307-2315"},"PeriodicalIF":3.5,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12256368/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144207976","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Two-Year Efficacy and Safety of Lebrikizumab in Patients with Moderate-to-Severe Atopic Dermatitis: A Long-Term Extension (ADjoin).","authors":"Emma Guttman-Yassky, Stephan Weidinger, Eric L Simpson, Melinda Gooderham, Alan D Irvine, Lynda Spelman, Jonathan I Silverberg, Hany ElMaraghy, Louise DeLuca-Carter, Maria Lucia Buziqui Piruzeli, Chaoran Hu, Fan Emily Yang, Evangeline Pierce, Laia Bardolet, Diamant Thaçi","doi":"10.1007/s13555-025-01452-9","DOIUrl":"10.1007/s13555-025-01452-9","url":null,"abstract":"<p><strong>Introduction: </strong>The efficacy and safety of lebrikizumab, a high-affinity monoclonal antibody targeting interleukin-13, were investigated in patients with moderate-to-severe atopic dermatitis (AD) up to 52 weeks in phase 3 trials. This analysis evaluates safety and maintenance of response through 104 weeks of lebrikizumab treatment in patients with moderate-to-severe AD who achieved clinical response with lebrikizumab at week 16.</p><p><strong>Methods: </strong>ADjoin is a 100-week phase 3 long-term extension study. Adult and adolescent patients with moderate-to-severe AD were enrolled into parent studies ADvocate1, ADvocate2, and ADhere. ADvocate1&2 week 16 lebrikizumab clinical responders (patients who achieved Investigator's Global Assessment [IGA] [0, 1] or Eczema Area and Severity Index [EASI] 75 without rescue) were re-randomized 2:2:1 to lebrikizumab 250 mg Q2W, Q4W, or placebo (lebrikizumab withdrawal). Patients who completed week 52 of ADvocate1&2 could enroll into ADjoin. ADhere week 16 lebrikizumab clinical responders could enroll into ADjoin and were randomized 2:1 to lebrikizumab 250 mg Q2W or Q4W. Analyses were performed on patients who received 104 weeks of lebrikizumab treatment in parent and extension studies combined. Efficacy analyses are reported as observed from week 16 for patients who were re-randomized to lebrikizumab Q2W or Q4W. Safety assessments included monitoring adverse events.</p><p><strong>Results: </strong>IGA (0, 1) was maintained by 86.4% (Q2W) and 76.4% (Q4W) patients from ADvocate1&2 and 83.9% (Q2W) and 78.6% (Q4W) patients from ADhere at week 104. EASI 75 was maintained by 95.6% (Q2W) and 96.3% (Q4W) ADvocate1&2 patients and 95.1% (Q2W) and 96.0% (Q4W) ADhere patients at week 104. Pruritus NRS ≥ 4-point improvement was maintained by 100% (Q2W) and 89.7% (Q4W) ADvocate1&2 patients at week 104 and 81.8% (Q2W) and 90.0% (Q4W) ADhere patients at week 68. During ADjoin, adverse events were reported by 62.2% of patients from ADvocate1&2 and ADhere who received lebrikizumab Q2W or Q4W, with the majority being mild (31.5%) or moderate (27.0%) in severity, and 2.2% leading to discontinuation due to adverse event.</p><p><strong>Conclusions: </strong>Skin and itch outcomes were maintained over 2 years of continuous lebrikizumab 250 mg treatment. The safety profile of lebrikizumab in ADjoin is consistent with previous lebrikizumab studies in patients with moderate-to-severe AD.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT04392154.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2217-2232"},"PeriodicalIF":3.5,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12256369/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144474240","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Determination of Risk Factors Influencing Psoriatic Arthritis Screening and Evaluation Questionnaire Scores in Palmoplantar Pustulosis: Post Hoc Analysis of EPPPIK Study.","authors":"Byung Soo Kim, Seong Jin Jo, Dong Hyun Kim, Hee Joo Kim, Chul Hwan Bang, Bong Seok Shin, Joo-Heung Lee, Ju Hee Lee, Sung Eun Chang, Kyung-Eun Jung, Youngdoe Kim, Jihye An, Sang Woong Youn, Chul Jong Park","doi":"10.1007/s13555-025-01460-9","DOIUrl":"10.1007/s13555-025-01460-9","url":null,"abstract":"<p><strong>Introduction: </strong>Palmoplantar pustulosis (PPP) is a chronic inflammatory skin condition characterized by pustules on the palms and soles. Patients with PPP may be at an increased risk of developing psoriatic arthritis (PsA). The Psoriatic Arthritis Screening and Evaluation (PASE) questionnaire is a tool designed to screen for PsA in at-risk populations. The objective of this study was to identify potential risk factors influencing PASE scores in patients with PPP.</p><p><strong>Methods: </strong>The EPPPIK study was a cross-sectional, multicenter, noninterventional study conducted at 20 sites in Korea, in which patients (≥ 19 years of age) with a confirmed PPP diagnosis were reviewed. In a post hoc analysis of EPPPIK data, PASE outcomes were evaluated for two groups of patients with PPP stratified on the basis of a cutoff score of 37 points.</p><p><strong>Results: </strong>In total, 375 patients with PPP (mean age, 51.3 years; 38.9% male) were included. At enrollment, 175 (46.7%) patients had a PASE score ≥ 37, and 200 (53.3%) patients had a PASE score < 37. Significant differences between the groups were demonstrated for sex, age of menarche, presence of arthritis or psoriatic arthropathy, Physician's Global Assessment score, Palmo-Plantar Pustulosis Area and Severity Index (PPPASI) score, and hand PPPASI score (p ≤ 0.05). Quality-of-life (QoL) measurements and patient-reported outcomes were significantly worse in patients with PASE ≥ 37 (p ≤ 0.05). Multivariable linear regression analysis revealed that a PASE score ≥ 37 was positively associated with female sex (β = 7.19; p < 0.001) and high hand PPPASI score (β = 0.22; p = 0.0243).</p><p><strong>Conclusions: </strong>In patients with PPP, PASE score ≥ 37 correlated with increased presence of any arthritis or psoriatic arthropathy, more severe PPP, worse QoL outcomes, female sex, and higher hand PPPASI scores. Therefore, PASE may serve as a useful tool for initial screening and appropriate treatment selection, management, and ongoing monitoring of patients with PPP.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2233-2246"},"PeriodicalIF":3.5,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12256390/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144474238","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Transforming Aesthetic Dermatology: The Role of Artificial Intelligence in Skin Health.","authors":"Xiang Chen, Zhaokang Zhou, Hui Ding, Huiying Zheng, Yiping Ge","doi":"10.1007/s13555-025-01459-2","DOIUrl":"10.1007/s13555-025-01459-2","url":null,"abstract":"<p><p>Artificial intelligence (AI) has profoundly impacted various medical fields, including dermatology, which is to a large extent an image-based discipline. Initially applied in general dermatology, AI has expanded into aesthetic dermatology, where it assists in integrating objective approaches with the aesthetic judgment of dermatologists. This review explores the role of AI in aesthetic dermatology, focusing on skin condition assessment, diagnosis, treatment optimization, and patient education, as well as the challenges and future directions in this evolving field.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"1999-2013"},"PeriodicalIF":3.5,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12256394/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144368672","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of a Photolyase-Based Medical Device on Actinic Keratosis in Phototypes III-IV Patients: Real-Life Clinical Setting.","authors":"Fernando Bulla, Susana Mejía, Sebastian Gil-Quiñones, Sara Cataño, Susana Sierra","doi":"10.1007/s13555-025-01455-6","DOIUrl":"10.1007/s13555-025-01455-6","url":null,"abstract":"<p><strong>Introduction: </strong>Actinic keratoses (AK) are premalignant skin lesions that occur in chronically photo-exposed body areas. Topical sunscreens prevent but do not reverse ultraviolet radiation (UVR)-induced damage to deoxyribonucleic acid (DNA). Eryfotona is a sunscreen product that combines high solar protection factors with light-driven DNA repair enzymes known as photolyases. This photolyase-based medical device has been shown to reduce the absolute number of AK; however, a more comprehensive assessment of AK lesions is ideal for determining its actual effect in everyday practice. The purpose of the study is to evaluate the photoprotective effect of Eryfotona sunscreen on individual AK lesions, assessing changes in their clinical and dermoscopic presentation in a real-life clinical setting and the impact on the health-related quality of life.</p><p><strong>Methods: </strong>This was an observational, prospective, real-life study of adult patients with skin phototypes III or IV and actinic keratosis (AK) lesions on the face and scalp. Patients were treated with sunscreen containing photolyase twice daily for 6 months, with follow-up visits at 3 and 6 months. The clinical evaluation included the actinic keratosis and severity index (AKASI), the absolute number and individual dimensions of AK lesions, and the Olsen clinical classification scheme. The dermoscopic evaluation included the Zalaudek classification and assessment of lesion pigmentation. The AK Quality of Life (AKQoL) questionnaire was administered to patients during each follow-up. A repeated measures analysis of variance was performed to compare quantitative outcomes, and Fisher's exact tests were used for categorical variables.</p><p><strong>Results: </strong>A total of 45 patients with 205 AK lesions were included; 25 patients completed both follow-ups. Clinically, there was a significant improvement from an AKASI score of 2.55 at baseline to 1.90 at 6 months (p = 0.000), and a significant difference was also observed in the dimensions of individual AK lesions and the Olsen classification between the three evaluation times (p = 0.000). Dermoscopic assessment, as classified by the Zalaudek classification, showed significant improvement throughout the three evaluations (p = 0.000). In total, 53 lesions disappeared, corresponding to 26.36% of the lesions.</p><p><strong>Conclusions: </strong>Eryfotona provided effective and safe photoprotection and treatment of actinic keratosis on the face and scalp in patients with phototypes III and IV in the real-life clinical setting, showing promising effects on higher-grade lesions.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2131-2145"},"PeriodicalIF":3.5,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12256378/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144301336","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Impact of Psoriasis on Sleep Quality: Examining the Relationship Between Psoriasis, Sleep, and Mental Health.","authors":"Andrea Leung, Kathryn Haran, Georgia Marquez-Grap, Kristen Chang, Chandler E Johnson, Allison Kranyak, Tina Bhutani, Wilson Liao","doi":"10.1007/s13555-025-01449-4","DOIUrl":"10.1007/s13555-025-01449-4","url":null,"abstract":"<p><strong>Introduction: </strong>Psoriasis is a chronic immune-mediated skin disease with known physical and mental health comorbidities, such as cardiovascular disease, depression, and anxiety. Psoriasis also has a significant impact on quality of life and sleep due to factors like itch and pain. This study aims to assess the relationship between sleep quality, mental health, and psoriasis, and specifically investigate the impact of poor sleep quality on mental health outcomes within participants with psoriasis.</p><p><strong>Methods: </strong>In this cross-sectional study, we enrolled 556 participants into two cohorts: 487 participants were enrolled into the psoriasis cohort, and 69 were enrolled into the healthy control cohort. The demographics, disease severity, family history, sleep quality (PROMIS 8a, PROMIS 8b, and Insomnia Severity Index), and mental health (Patient Health Questionnaire-8 and Generalized Anxiety Disorder-7) of participants were assessed. Descriptive analysis and logistic regression models were employed to examine sleep and mental health, adjusting for potential confounders like demographics and comorbidities.</p><p><strong>Results: </strong>A comparison of patients with psoriasis and healthy controls revealed worsened sleep and mental health outcomes in patients with psoriasis. Among participants with psoriasis, greater sleep impairment (Patient-Reported Outcomes Measurement Information System (PROMIS) 8a), sleep disturbance (PROMIS 8b), and insomnia were significantly associated with anxiety (ORa 1.22; 95% confidence interval (CI) 1.16, 1.30; ORa 1.26; 95% CI 1.16, 1.80; ORa 5.13; 95% CI 2.91, 9.33; respectively) and depression (ORa 1.42; 95% CI 1.32, 1.56; ORa 1.16; 95% CI 1.08, 1.26; ORa 7.04; 95% CI 4.01, 12.77; respectively).</p><p><strong>Conclusion: </strong>These findings underscore the importance of recognizing how psoriasis can impact mental health and sleep. Building a collaborative relationship between patients with psoriasis and their providers is essential to improve overall sleep and life quality.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2247-2254"},"PeriodicalIF":3.5,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12256367/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144474239","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Clinical Experience of Tralokinumab in a Tertiary Centre: An Alternative for Patients with Conjunctivitis on Dupilumab?","authors":"Neenu Sebastian, Omar Chircop, Tim H Clayton, Firas C Kreeshan, Hamish J A Hunter, Richard B Warren","doi":"10.1007/s13555-025-01446-7","DOIUrl":"10.1007/s13555-025-01446-7","url":null,"abstract":"<p><strong>Introduction: </strong>Tralokinumab, a human IgG4 monoclonal antibody that inhibits the IL-13 pathway, is approved for the treatment of atopic dermatitis. However, real-world data are lacking and are needed to inform its efficacy and safety in broader populations.</p><p><strong>Methods: </strong>This retrospective study reviewed the Eczema Area and Severity Index (EASI) and Dermatology Life Quality Index (DLQI) at baseline and 16-20 weeks of 39 consecutive patients who received subcutaneous tralokinumab at the label dose in a tertiary centre.</p><p><strong>Results: </strong>Twenty-nine out of 39 patients had an EASI score recorded after 16-20 weeks. At 16-20 weeks, 65.5% (19/29) of patients achieved EASI 50, 37.9% (11/29) achieved EASI 75, and 27.8% (9/29) achieved EASI 90. DLQI was reduced by an average of - 10.4 points at 16-20 weeks. No serious adverse events were reported. Ocular adverse events were reported in 25.6% (10/39) of the cohort but did not lead to treatment discontinuation. Six out of seven patients that previously experienced conjunctivitis with dupilumab had no recurrence with tralokinumab.</p><p><strong>Conclusion: </strong>Our study supports using tralokinumab in atopic dermatitis with similar real-world efficacy to that shown in clinical trials. Tralokinumab offers an alternative for patients failing dupilumab because of conjunctivitis.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2275-2279"},"PeriodicalIF":3.5,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12256365/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144181303","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Rapid Itch Improvement and Skin Clearance with Upadacitinib Versus Placebo (Measure Up 1 and Measure Up 2) and Versus Dupilumab (Heads Up): Results from Three Phase 3 Clinical Trials in Patients with Moderate-to-Severe Atopic Dermatitis.","authors":"Eric L Simpson, Jonathan I Silverberg, Vimal H Prajapati, Kilian Eyerich, Norito Katoh, Mark Boguniewicz, Emma Guttman-Yassky, E James Song, Wan-Ju Lee, Henrique D Teixeira, Tianshuang Wu, Cristina Sancho Sanchez, Namita Vigna, Brian M Calimlim, Marjolein de Bruin-Weller","doi":"10.1007/s13555-025-01443-w","DOIUrl":"10.1007/s13555-025-01443-w","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;Achievement of stringent outcomes (e.g., ≥ 90% improvement from baseline in Eczema Area and Severity Index [EASI 90] or minimal-to-no itch on the Worst Pruritus Numerical Rating Scale [WP-NRS 0/1]) is associated with a substantial improvement in quality of life among patients with atopic dermatitis (AD). Using stringent outcomes, we evaluated the efficacy of upadacitinib vs placebo and vs dupilumab on rapid itch improvement and skin clearance in patients with moderate-to-severe AD in three phase 3 clinical trials.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Patients received orally administered upadacitinib 15 mg (UPA15), 30 mg (UPA30), or placebo once daily for 16 weeks in Measure Up 1 and Measure Up 2 and orally administered UPA30 once daily or subcutaneously administered 300 mg dupilumab every 2 weeks (after a 600 mg loading dose) for 24 weeks in Heads Up. Key outcomes included the proportion of patients achieving WP-NRS 0/1, WP-NRS 0, EASI 90, and EASI 100, as well as the proportion of patients achieving composite outcomes (EASI 90 and WP-NRS 0/1; EASI 100 and WP-NRS 0). Patients assessed WP-NRS daily for the first 16 weeks and at scheduled visits thereafter, and investigators assessed EASI at scheduled visits.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A greater proportion of patients receiving upadacitinib vs placebo and vs dupilumab achieved WP-NRS 0/1 at week 16 (nominal p &lt; 0.001 vs placebo) and week 24 (nominal p &lt; 0.001 vs dupilumab), with differences as early as the day after treatment initiation (day 2; nominal p &lt; 0.05 vs placebo and vs dupilumab), as well as WP-NRS 0 at week 16 (nominal p &lt; 0.001 vs placebo) and week 24 (nominal p &lt; 0.001 vs dupilumab), with differences as early as day 8 (nominal p &lt; 0.01 vs placebo; nominal p &lt; 0.001 vs dupilumab). A greater proportion of patients receiving upadacitinib vs placebo and vs dupilumab achieved EASI 90 at week 16 (p &lt; 0.001 vs dupilumab), with differences as early as week 1 (nominal p &lt; 0.01 vs placebo; nominal p &lt; 0.05 vs dupilumab), as well as EASI 100 at week 16 (p &lt; 0.001 vs placebo) and week 24 (nominal p &lt; 0.001 vs dupilumab), with differences as early as week 4 (nominal p &lt; 0.001 vs placebo and vs dupilumab). A greater proportion of patients also achieved EASI 90 and WP-NRS 0/1 by week 2 (UPA15: 2.7%, UPA30: 6.7% vs placebo: 0%, nominal p &lt; 0.001; UPA30: 7.1% vs dupilumab: 1.2%, nominal p &lt; 0.001) and EASI 100 and WP-NRS 0 by week 4 (UPA15: 1.6%, UPA30: 3.9% vs placebo: 0.2%, nominal p ≤ 0.01; UPA30: 4.7% vs dupilumab: 0.6%, nominal p &lt; 0.01) through all evaluated time points.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Patients with moderate-to-severe AD treated with upadacitinib rapidly achieved stringent itch improvement and skin clearance targets compared with those receiving placebo or dupilumab, with responses sustained through weeks 16 (Measure Up 1 and Measure Up 2) and 24 (Heads Up).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Clinical trial registration: &lt;/strong&gt;ClinicalTrials.gov; NCT03569293 ","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2061-2076"},"PeriodicalIF":3.5,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12256373/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144207974","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient-Reported Outcomes by Baseline Body Surface Area Involvement Among Individuals Initiating Biologic Therapy: Results from the CorEvitas Psoriasis Registry.","authors":"April W Armstrong, Steven R Feldman, Timothy Fitzgerald, Theodore Alkousakis, Adam Sima, Alvin Li, Hyung-Joo Kang, Sandra I Main, Saakshi Khattri, Linda Stein Gold","doi":"10.1007/s13555-025-01456-5","DOIUrl":"10.1007/s13555-025-01456-5","url":null,"abstract":"<p><strong>Introduction: </strong>Psoriasis body surface area (BSA) of 10% or more has been a major criterion for determining systemic therapy eligibility. However, patients with BSA < 10% and even ≤ 3% may have high disease burden and difficulties accessing biologics. To assess psoriasis burden among patients with BSA ≤ 10%, this study characterized patient-reported outcomes (PROs) across BSA categories among systemic treatment-naïve patients initiating biologic therapy.</p><p><strong>Methods: </strong>Patients from the CorEvitas Psoriasis Registry initiating biologics between April 2015 and September 2023 were categorized according to low (< 3%), medium (3-10%), or high (> 10%) BSA involvement. Measures assessed at initiation of biologic therapy included health-related quality of life, itch, pain, fatigue, psoriatic arthritis, psoriasis disease characteristics, and medical history. Overlap between BSA groups for each outcome was calculated via non-parametric Mann-Whitney statistic transformation (range 0.0-1.0; 0.5 indicates complete similarity [i.e., for a comparison between low and high BSA groups, overlap of 0.5 means there is 50% probability that a randomly selected patient with low BSA would have the same or greater PRO burden as one with high BSA]; 0 or 1 indicates complete dissimilarity) to determine whether each measure differed in randomly selected patients with low or medium versus high BSA.</p><p><strong>Results: </strong>Of 1640 patients who initiated biologics, 7.0% had low BSA, 46.9% had medium BSA, and 46.2% had high BSA involvement. PRO overlap statistics ranged from 0.52 to 0.59 and from 0.60 to 0.70 for randomly selected patients with high versus medium and low BSA, respectively, indicating patients with high and medium BSA are likely to have similar levels of disease burden, and patients with high BSA are slightly more likely to have higher disease burden than those with low BSA. Near complete overlap (range 0.44-0.58) was observed for psoriasis disease characteristics and medical history in the low versus high and medium BSA groups.</p><p><strong>Conclusion: </strong>Observed overlap in PROs across BSA categories shows that patients with low BSA can experience similarly poor quality of life and high symptom burden to those with higher BSA. These findings support the appropriateness of considering biologic therapies for patients with low BSA and indicators of high disease burden.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT02707341.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2117-2130"},"PeriodicalIF":3.5,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12256371/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144265601","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}