Introduction: Psychodermatology studies the connection between skin and mental health and is especially relevant in older adults, where visible skin changes and aging often reflect psychological well-being. This is an understudied area in dermatology.
Methods: This narrative review examined literature on the current concepts and management strategies of geriatric psychodermatology. Research databases such as MEDLINE, PubMed, Springer, Google Scholar, and others were investigated, with a total of 131 papers identified. No publication date limits were included.
Results: There is a complex and fascinating relationship between the skin and the brain often referred to as the "skin-brain axis." Common psychodermatologic disorders in the elderly include obsessive-compulsive and related disorders, delusional infestation, and psychogenic pruritus, and these are often difficult to diagnose and manage in the elderly. We also summarize secondary dermatoses from anxiety, depression, stress, and dementia in the elderly. Comprehensive geriatric assessment extends beyond physical health and includes dermatologic, psychiatric, cognitive, and psychosocial domains. Comprehensive care requires collaboration among dermatology, psychiatry, and geriatrics, often incorporating both pharmacologic and non-pharmacologic approaches. We also describe dermatologic signs of elder abuse, dementia complicating psychodermatoses, and review treatment strategies of these conditions.
Conclusion: Psychocutaneous dermatology is a relevant and understudied area that dermatologists should familiarize themselves with. Multidisciplinary care including pharmacologic and non-pharmacologic strategies are often required for the management of these patients.
{"title":"Geriatric Psychodermatology: Current Concepts and Therapeutic Strategies.","authors":"Alaya Kiser, Tamara Korkomaz, Brianna Ong, Anagha Bangalore Kumar, Katlein França","doi":"10.1007/s13555-025-01638-1","DOIUrl":"https://doi.org/10.1007/s13555-025-01638-1","url":null,"abstract":"<p><strong>Introduction: </strong>Psychodermatology studies the connection between skin and mental health and is especially relevant in older adults, where visible skin changes and aging often reflect psychological well-being. This is an understudied area in dermatology.</p><p><strong>Methods: </strong>This narrative review examined literature on the current concepts and management strategies of geriatric psychodermatology. Research databases such as MEDLINE, PubMed, Springer, Google Scholar, and others were investigated, with a total of 131 papers identified. No publication date limits were included.</p><p><strong>Results: </strong>There is a complex and fascinating relationship between the skin and the brain often referred to as the \"skin-brain axis.\" Common psychodermatologic disorders in the elderly include obsessive-compulsive and related disorders, delusional infestation, and psychogenic pruritus, and these are often difficult to diagnose and manage in the elderly. We also summarize secondary dermatoses from anxiety, depression, stress, and dementia in the elderly. Comprehensive geriatric assessment extends beyond physical health and includes dermatologic, psychiatric, cognitive, and psychosocial domains. Comprehensive care requires collaboration among dermatology, psychiatry, and geriatrics, often incorporating both pharmacologic and non-pharmacologic approaches. We also describe dermatologic signs of elder abuse, dementia complicating psychodermatoses, and review treatment strategies of these conditions.</p><p><strong>Conclusion: </strong>Psychocutaneous dermatology is a relevant and understudied area that dermatologists should familiarize themselves with. Multidisciplinary care including pharmacologic and non-pharmacologic strategies are often required for the management of these patients.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145988771","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-16DOI: 10.1007/s13555-025-01635-4
Andrew Blauvelt, Angela Williams, Kimberly M Deininger, Shanshan Qin, Lauren Nelson, Lori McLeod
Introduction: Atopic dermatitis (AD) is a chronic, inflammatory skin disease with a hallmark symptom of pruritus. We developed Worst Pruritus Numeric Rating Scale (NRS)-a single-item, patient-reported outcome measure-to assess itch severity in clinical trial populations of adults with moderate-to-severe AD. The objective of this study was to evaluate the psychometric properties of Worst Pruritus NRS and determine its appropriateness for use in clinical trials assessing the efficacy of treatments among adults with moderate-to-severe AD.
Methods: We used data from a subset of 267 participants in a phase 2 clinical trial of rocatinlimab (NCT03703102; N = 274) to confirm reliability, validity, and ability to detect change in Worst Pruritus NRS. We estimated and confirmed a meaningful within-patient change (MWPC) threshold using anchor- and distribution-based methods.
Results: All intraclass correlation coefficients (ICCs) were ≥ 0.86, providing robust evidence for test-retest reliability. Evidence supported construct validity, including known-groups validity (all P < 0.0001). There were moderate, positive correlations between scores on Worst Pruritus NRS and supportive measures at week 16, including Dermatology Life Quality Index (DLQI) question 1 (itch item) (r = 0.78), DLQI (r = 0.66), Eczema Area and Severity Index (EASI) (r = 0.50), Investigator's Global Assessment (IGA) (r = 0.46), Body Surface Area of Involvement (BSA) (r = 0.40), and SCORing Atopic Dermatitis (SCORAD) itch item (r = 0.97). On average, patients with better DLQI question 1 scores, EASI, and IGA classifications achieved better (i.e., lower) scores on Worst Pruritus NRS at week 16 (P < 0.0001). Ability to detect change was supported with moderate-to-strong and positive correlations between Worst Pruritus NRS change scores and changes in supporting measures. MWPC estimates confirmed the commonly applied 4-point threshold value and a range of 3 to 4 points as indicative of meaningful within-patient change.
Conclusions: Worst Pruritus NRS is a reliable and valid patient-reported outcome measure to assess itch severity in clinical trial settings among adults with moderate-to-severe AD.
简介:特应性皮炎(AD)是一种慢性炎症性皮肤病,其标志性症状为瘙痒。我们开发了最严重瘙痒数值评定量表(NRS),这是一种单项的、患者报告的结果测量方法,用于评估中度至重度AD成人临床试验人群的瘙痒严重程度。本研究的目的是评估最严重瘙痒NRS的心理测量特性,并确定其是否适合用于评估成人中重度AD治疗效果的临床试验。方法:我们使用来自267名受试者的2期临床试验数据(NCT03703102; N = 274)来确认可靠性、有效性和检测最严重瘙痒症NRS变化的能力。我们使用基于锚点和分布的方法估计并确认了有意义的患者内变化(MWPC)阈值。结果:所有类内相关系数(ICCs)均≥0.86,为重测信度提供了有力证据。证据支持结构效度,包括已知组效度(所有P)结论:最严重瘙痒NRS是一种可靠和有效的患者报告的结果测量,用于评估临床试验中中度至重度AD成人患者的瘙痒严重程度。
{"title":"Psychometric Evaluation of Worst Pruritus Numeric Rating Scale in Adults With Moderate-to-Severe Atopic Dermatitis.","authors":"Andrew Blauvelt, Angela Williams, Kimberly M Deininger, Shanshan Qin, Lauren Nelson, Lori McLeod","doi":"10.1007/s13555-025-01635-4","DOIUrl":"https://doi.org/10.1007/s13555-025-01635-4","url":null,"abstract":"<p><strong>Introduction: </strong>Atopic dermatitis (AD) is a chronic, inflammatory skin disease with a hallmark symptom of pruritus. We developed Worst Pruritus Numeric Rating Scale (NRS)-a single-item, patient-reported outcome measure-to assess itch severity in clinical trial populations of adults with moderate-to-severe AD. The objective of this study was to evaluate the psychometric properties of Worst Pruritus NRS and determine its appropriateness for use in clinical trials assessing the efficacy of treatments among adults with moderate-to-severe AD.</p><p><strong>Methods: </strong>We used data from a subset of 267 participants in a phase 2 clinical trial of rocatinlimab (NCT03703102; N = 274) to confirm reliability, validity, and ability to detect change in Worst Pruritus NRS. We estimated and confirmed a meaningful within-patient change (MWPC) threshold using anchor- and distribution-based methods.</p><p><strong>Results: </strong>All intraclass correlation coefficients (ICCs) were ≥ 0.86, providing robust evidence for test-retest reliability. Evidence supported construct validity, including known-groups validity (all P < 0.0001). There were moderate, positive correlations between scores on Worst Pruritus NRS and supportive measures at week 16, including Dermatology Life Quality Index (DLQI) question 1 (itch item) (r = 0.78), DLQI (r = 0.66), Eczema Area and Severity Index (EASI) (r = 0.50), Investigator's Global Assessment (IGA) (r = 0.46), Body Surface Area of Involvement (BSA) (r = 0.40), and SCORing Atopic Dermatitis (SCORAD) itch item (r = 0.97). On average, patients with better DLQI question 1 scores, EASI, and IGA classifications achieved better (i.e., lower) scores on Worst Pruritus NRS at week 16 (P < 0.0001). Ability to detect change was supported with moderate-to-strong and positive correlations between Worst Pruritus NRS change scores and changes in supporting measures. MWPC estimates confirmed the commonly applied 4-point threshold value and a range of 3 to 4 points as indicative of meaningful within-patient change.</p><p><strong>Conclusions: </strong>Worst Pruritus NRS is a reliable and valid patient-reported outcome measure to assess itch severity in clinical trial settings among adults with moderate-to-severe AD.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145988720","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-15DOI: 10.1007/s13555-025-01650-5
Mahmoud A Rageh, Wael M Seoudy, Mohamed F Abozeid, Abeer Mohamed Elkholy, Alaa E A Moubasher, Amany Mohammad Abdel-Latif, Dalia Abdel Aziz Attallah, Essamelden M Mohamed, Hanan Abdelrady Assaf, Hanan Sabry, Mohamed Mahmoud Nasr, Mohamed Saad Hegazy, Nahla Hunter, Nehal Zuelfakkar, Nermeen Ibrahim Bedair, Noha Ezzat Mohammed, Sameh F Abdelkodous, Yasser Mostafa Gohary, Sara M Mohy
Introduction: Dermocosmetics are widely used to complement dermatologic care, yet context-specific guidance remains limited for populations with Fitzpatrick skin types III-V. We convened a national expert panel to generate transparent, reproducible recommendations across ten common clinical scenarios.
Methods: Egyptian dermatologists participated in round 1 (national survey, n = 601) and round 2 (expert panel, n = 16), both with anonymous ratings and inter-round feedback, using the RAND/UCLA appropriateness method (median bands 1-3/4-6/7-9; disagreement index (DI) = interpercentile range (IPR)/IPR adjusted for symmetry (IPRAS); DI > 1.0 = disagreement). Per-item outputs included median, P30, P70, IPR (30-70), asymmetry Index (AI), IPRAS, DI, and final category (appropriate/uncertain/inappropriate). We additionally benchmarked classifications against prior consensus, guidelines, and key evidence frameworks.
Results: Across ten vignettes and 30 ingredients (30 ingredients × 10 scenarios = 300 items; multiple raters per item in round 1), 158 (52.7%) items were appropriate (median ≥ 7; DI ≤ 1.0), 135 (45.0%) were uncertain, and 7 (2.3%) were inappropriate. Photoprotection had the highest appropriateness across scenarios (broad-spectrum/tinted SPF), with a small number of DI-flagged uncertain exceptions. Hydration/barrier agents (e.g., hyaluronic acid, peptides, ceramides) were appropriate in stress-aging, post-laser, and post-procedure care. Pigment modulators (tranexamic acid, arbutin, niacinamide, vitamin C, glabridin) were appropriate in melasma/post-inflammatory hyperpigmentation and chronic sun-induced pigmentation. Classical retinoids were inappropriate for postpartum/breastfeeding and immediate post-procedure; lower-irritancy retinoid esters were context-dependent. Botanicals showed inconsistent support. Panel disagreement (DI > 1.0) declined from 38.3% in round 1 to 15.7% (47/300) in round 2. Patterns largely aligned with prior consensus; visible-light-mitigating photoprotection and timing-specific retinoid use were emphasized for darker phototypes.
Conclusion: We provide a transparent, regionally relevant framework for dermocosmetic ingredient selection. Sun protection and barrier support are foundational; pigment modulators are scenario-specific; retinoids require selective use; botanicals remain adjunctive.
{"title":"Egyptian National Consensus on Dermocosmetic Ingredient Selection Across Common Dermatology Scenarios: A RAND/UCLA Appropriateness Study.","authors":"Mahmoud A Rageh, Wael M Seoudy, Mohamed F Abozeid, Abeer Mohamed Elkholy, Alaa E A Moubasher, Amany Mohammad Abdel-Latif, Dalia Abdel Aziz Attallah, Essamelden M Mohamed, Hanan Abdelrady Assaf, Hanan Sabry, Mohamed Mahmoud Nasr, Mohamed Saad Hegazy, Nahla Hunter, Nehal Zuelfakkar, Nermeen Ibrahim Bedair, Noha Ezzat Mohammed, Sameh F Abdelkodous, Yasser Mostafa Gohary, Sara M Mohy","doi":"10.1007/s13555-025-01650-5","DOIUrl":"https://doi.org/10.1007/s13555-025-01650-5","url":null,"abstract":"<p><strong>Introduction: </strong>Dermocosmetics are widely used to complement dermatologic care, yet context-specific guidance remains limited for populations with Fitzpatrick skin types III-V. We convened a national expert panel to generate transparent, reproducible recommendations across ten common clinical scenarios.</p><p><strong>Methods: </strong>Egyptian dermatologists participated in round 1 (national survey, n = 601) and round 2 (expert panel, n = 16), both with anonymous ratings and inter-round feedback, using the RAND/UCLA appropriateness method (median bands 1-3/4-6/7-9; disagreement index (DI) = interpercentile range (IPR)/IPR adjusted for symmetry (IPRAS); DI > 1.0 = disagreement). Per-item outputs included median, P30, P70, IPR (30-70), asymmetry Index (AI), IPRAS, DI, and final category (appropriate/uncertain/inappropriate). We additionally benchmarked classifications against prior consensus, guidelines, and key evidence frameworks.</p><p><strong>Results: </strong>Across ten vignettes and 30 ingredients (30 ingredients × 10 scenarios = 300 items; multiple raters per item in round 1), 158 (52.7%) items were appropriate (median ≥ 7; DI ≤ 1.0), 135 (45.0%) were uncertain, and 7 (2.3%) were inappropriate. Photoprotection had the highest appropriateness across scenarios (broad-spectrum/tinted SPF), with a small number of DI-flagged uncertain exceptions. Hydration/barrier agents (e.g., hyaluronic acid, peptides, ceramides) were appropriate in stress-aging, post-laser, and post-procedure care. Pigment modulators (tranexamic acid, arbutin, niacinamide, vitamin C, glabridin) were appropriate in melasma/post-inflammatory hyperpigmentation and chronic sun-induced pigmentation. Classical retinoids were inappropriate for postpartum/breastfeeding and immediate post-procedure; lower-irritancy retinoid esters were context-dependent. Botanicals showed inconsistent support. Panel disagreement (DI > 1.0) declined from 38.3% in round 1 to 15.7% (47/300) in round 2. Patterns largely aligned with prior consensus; visible-light-mitigating photoprotection and timing-specific retinoid use were emphasized for darker phototypes.</p><p><strong>Conclusion: </strong>We provide a transparent, regionally relevant framework for dermocosmetic ingredient selection. Sun protection and barrier support are foundational; pigment modulators are scenario-specific; retinoids require selective use; botanicals remain adjunctive.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145984588","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-15DOI: 10.1007/s13555-025-01631-8
Matthias Augustin, Stephan J Rustenbach, Ralph von Kiedrowski, Hamid Amouzadeh, Kathy Tran, Myriam Cordey, Ulrich Mrowietz
Introduction: The German national psoriasis registry PsoBest collects long-term data on the effectiveness, safety, and tolerability of systemic treatments for psoriatic disease. Here, we describe patient characteristics and the safety and effectiveness of apremilast for the treatment of psoriatic disease in Germany based on data from PsoBest.
Methods: This was a descriptive analysis of observational data collected from PsoBest using cross-sectional (baseline characteristics) and longitudinal (outcomes, safety) designs. PsoBest recruits patients with moderate to severe plaque psoriasis or psoriatic arthritis who initiate a new systemic psoriasis treatment. Adverse events (AEs) and sociodemographic descriptors were reported for patients exposed to apremilast during the study period (safety cohort). Clinical and patient-reported outcomes were collected 3, 6, and 12 months after the initiation of apremilast monotherapy (outcomes cohort).
Results: From January 15, 2015 to June 30, 2020, 595 registry patients were exposed to apremilast; 417 were treated with apremilast monotherapy. Patients taking apremilast had a higher mean age and higher proportions of comorbidities such as cardiovascular or metabolic disease compared with those taking other nonbiologic systemic or biologic drugs. The most common nonserious AEs were drug ineffectiveness (14.1%), diarrhea (9.4%), nausea (7.1%), and headache (6.1%). The highest incidence rates of nonserious and serious AEs of special interest were for infections and infestations per system organ class (8.03/100 patient-years) and malignant or unspecified tumors (2.50/100 patient-years), respectively. Improvements in Dermatology Life Quality Index, patient-defined treatment benefits (Patient Benefit Index), body surface area, and Psoriasis Area and Severity Index were observed after 3, 6, and 12 months of apremilast treatment.
Conclusions: Patients in routine care treated with apremilast in the German PsoBest registry experienced treatment benefits and improved skin, psoriasis severity, and quality of life. Safety was consistent with the established safety profile. Apremilast is safe and effective for treating moderate to severe psoriatic disease.
{"title":"Outcomes in Patients with Psoriasis Following Apremilast Treatment: Results from the German Psoriasis Registry PsoBest.","authors":"Matthias Augustin, Stephan J Rustenbach, Ralph von Kiedrowski, Hamid Amouzadeh, Kathy Tran, Myriam Cordey, Ulrich Mrowietz","doi":"10.1007/s13555-025-01631-8","DOIUrl":"https://doi.org/10.1007/s13555-025-01631-8","url":null,"abstract":"<p><strong>Introduction: </strong>The German national psoriasis registry PsoBest collects long-term data on the effectiveness, safety, and tolerability of systemic treatments for psoriatic disease. Here, we describe patient characteristics and the safety and effectiveness of apremilast for the treatment of psoriatic disease in Germany based on data from PsoBest.</p><p><strong>Methods: </strong>This was a descriptive analysis of observational data collected from PsoBest using cross-sectional (baseline characteristics) and longitudinal (outcomes, safety) designs. PsoBest recruits patients with moderate to severe plaque psoriasis or psoriatic arthritis who initiate a new systemic psoriasis treatment. Adverse events (AEs) and sociodemographic descriptors were reported for patients exposed to apremilast during the study period (safety cohort). Clinical and patient-reported outcomes were collected 3, 6, and 12 months after the initiation of apremilast monotherapy (outcomes cohort).</p><p><strong>Results: </strong>From January 15, 2015 to June 30, 2020, 595 registry patients were exposed to apremilast; 417 were treated with apremilast monotherapy. Patients taking apremilast had a higher mean age and higher proportions of comorbidities such as cardiovascular or metabolic disease compared with those taking other nonbiologic systemic or biologic drugs. The most common nonserious AEs were drug ineffectiveness (14.1%), diarrhea (9.4%), nausea (7.1%), and headache (6.1%). The highest incidence rates of nonserious and serious AEs of special interest were for infections and infestations per system organ class (8.03/100 patient-years) and malignant or unspecified tumors (2.50/100 patient-years), respectively. Improvements in Dermatology Life Quality Index, patient-defined treatment benefits (Patient Benefit Index), body surface area, and Psoriasis Area and Severity Index were observed after 3, 6, and 12 months of apremilast treatment.</p><p><strong>Conclusions: </strong>Patients in routine care treated with apremilast in the German PsoBest registry experienced treatment benefits and improved skin, psoriasis severity, and quality of life. Safety was consistent with the established safety profile. Apremilast is safe and effective for treating moderate to severe psoriatic disease.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145984599","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-14DOI: 10.1007/s13555-025-01640-7
Bartłomiej Kwiek, Julia Sieczych, Katarzyna Łukowska, Marcin Ambroziak
Chronic spontaneous urticaria (CSU) is a mast cell-driven disease that affects approximately 1% of the population. Second-generation non-sedating H1-antihistamines (H1AH) are considered the first-line treatment; however, a substantial proportion of patients remain refractory and require alternative therapeutic approaches, including anti-IgE antibodies or other agents that inhibit mast cell activation and degranulation. Glucagon-like peptide 1 receptor agonists (GLP-1RAs) are widely used for the treatment of type 2 diabetes mellitus and obesity and are known to reduce cardiovascular risk as well as comorbidities such as kidney disease and depression. In addition, GLP-1RAs have been reported to improve several autoimmune and autoinflammatory disorders, including dermatoses such as psoriasis, hidradenitis suppurativa, and atopic dermatitis. Several mechanisms have been proposed to explain the immunomodulatory effects of GLP-1RAs, including their influence on cytokine networks and immune cells, particularly mast cells. We report two female patients, aged 44 and 45 years, with long-standing CSU inadequately controlled on high-dose H1AH, who were initially prescreened for participation in a clinical trial with barzolvolimab. Before trial enrollment, both initiated GLP-1RA therapy (semaglutide or tirzepatide) for metabolic indications. Remarkably, both patients achieved complete resolution of CSU within 3 weeks of GLP-1RA initiation, with remission persisting for over 6 months. These observations suggest a potential immunometabolic mechanism linking GLP-1 signaling and mast cell activation, highlighting a novel therapeutic avenue for antihistamine-resistant CSU.
{"title":"Improvement of Chronic Spontaneous Urticaria After Glucagon-Like Peptide 1 Receptor Agonist Therapy: Report of Two Cases.","authors":"Bartłomiej Kwiek, Julia Sieczych, Katarzyna Łukowska, Marcin Ambroziak","doi":"10.1007/s13555-025-01640-7","DOIUrl":"https://doi.org/10.1007/s13555-025-01640-7","url":null,"abstract":"<p><p>Chronic spontaneous urticaria (CSU) is a mast cell-driven disease that affects approximately 1% of the population. Second-generation non-sedating H<sub>1</sub>-antihistamines (H1AH) are considered the first-line treatment; however, a substantial proportion of patients remain refractory and require alternative therapeutic approaches, including anti-IgE antibodies or other agents that inhibit mast cell activation and degranulation. Glucagon-like peptide 1 receptor agonists (GLP-1RAs) are widely used for the treatment of type 2 diabetes mellitus and obesity and are known to reduce cardiovascular risk as well as comorbidities such as kidney disease and depression. In addition, GLP-1RAs have been reported to improve several autoimmune and autoinflammatory disorders, including dermatoses such as psoriasis, hidradenitis suppurativa, and atopic dermatitis. Several mechanisms have been proposed to explain the immunomodulatory effects of GLP-1RAs, including their influence on cytokine networks and immune cells, particularly mast cells. We report two female patients, aged 44 and 45 years, with long-standing CSU inadequately controlled on high-dose H1AH, who were initially prescreened for participation in a clinical trial with barzolvolimab. Before trial enrollment, both initiated GLP-1RA therapy (semaglutide or tirzepatide) for metabolic indications. Remarkably, both patients achieved complete resolution of CSU within 3 weeks of GLP-1RA initiation, with remission persisting for over 6 months. These observations suggest a potential immunometabolic mechanism linking GLP-1 signaling and mast cell activation, highlighting a novel therapeutic avenue for antihistamine-resistant CSU.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-01-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145970699","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-14DOI: 10.1007/s13555-025-01641-6
Tanya Boghosian, Hannah Mendez, Mira Sayegh, Alejandro Rabionet, Jacob Beer, Antonella Tosti
Introduction: Sleep disturbance is increasingly recognized as a modifier of dermatologic disease, yet its role in hair loss remains underexplored. Hair loss disorders, including alopecia areata (AA), androgenetic alopecia (AGA), telogen effluvium (TE), and scarring alopecias, carry substantial psychosocial burden and involve neuroendocrine and immune pathways sensitive to sleep quality.
Objective: To systematically evaluate associations between sleep disturbances and hair loss across major hair loss subtypes, define shared and subtype-specific mechanisms, and highlight insights relevant to counseling, symptom monitoring, and dermatologic management.
Methods: A Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA)-guided systematic review of PubMed and Scopus identified 291 studies examining sleep disturbances in hair loss. After duplicate removal and screening by two independent reviewers, 29 studies were included. Extracted data included study design, level of evidence, hair loss subtype, sleep measures, mechanisms, and psychosocial correlates.
Results: Overall evidence quality was low to moderate (1 level II, 11 level III, 14 level IV, and 3 level V), with cross-sectional studies predominating (n = 15). AA was most represented (n = 14), followed by AGA (n = 11), TE (n = 3), lichen planopilaris (LPP) (n = 1), and traction alopecia (n = 1). Sleep disturbance was consistently elevated across AA, AGA, TE, and LPP populations, commonly assessed by the PSQI. Mechanistic themes varied by subtype: cytokine activation, hypothalamic-pituitary-adrenal axis dysregulation, and altered clock-genes in AA; circadian misalignment, obstructive sleep apnea-related hypoxia, and hormonal imbalance in AGA; neurogenic inflammation and substance-P pathways in TE; and chronic pruritus and pain in LPP. Psychosocial distress amplified sleep disruption in most subtypes.
Conclusions: Across hair loss disorders, sleep disturbance emerges as a biologically plausible and clinically relevant contributor to disease burden. Although most evidence is observational, converging mechanistic and psychosocial data support a bidirectional relationship between sleep quality and hair loss. Incorporating brief sleep assessments into hair loss care and considering sleep-targeted interventions may improve disease stability and patient well-being. Longitudinal and mechanistic studies are needed to clarify causality and identify therapeutic targets.
{"title":"The Intersection of Sleep and Hair Loss: A Systematic Review.","authors":"Tanya Boghosian, Hannah Mendez, Mira Sayegh, Alejandro Rabionet, Jacob Beer, Antonella Tosti","doi":"10.1007/s13555-025-01641-6","DOIUrl":"https://doi.org/10.1007/s13555-025-01641-6","url":null,"abstract":"<p><strong>Introduction: </strong>Sleep disturbance is increasingly recognized as a modifier of dermatologic disease, yet its role in hair loss remains underexplored. Hair loss disorders, including alopecia areata (AA), androgenetic alopecia (AGA), telogen effluvium (TE), and scarring alopecias, carry substantial psychosocial burden and involve neuroendocrine and immune pathways sensitive to sleep quality.</p><p><strong>Objective: </strong>To systematically evaluate associations between sleep disturbances and hair loss across major hair loss subtypes, define shared and subtype-specific mechanisms, and highlight insights relevant to counseling, symptom monitoring, and dermatologic management.</p><p><strong>Methods: </strong>A Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA)-guided systematic review of PubMed and Scopus identified 291 studies examining sleep disturbances in hair loss. After duplicate removal and screening by two independent reviewers, 29 studies were included. Extracted data included study design, level of evidence, hair loss subtype, sleep measures, mechanisms, and psychosocial correlates.</p><p><strong>Results: </strong>Overall evidence quality was low to moderate (1 level II, 11 level III, 14 level IV, and 3 level V), with cross-sectional studies predominating (n = 15). AA was most represented (n = 14), followed by AGA (n = 11), TE (n = 3), lichen planopilaris (LPP) (n = 1), and traction alopecia (n = 1). Sleep disturbance was consistently elevated across AA, AGA, TE, and LPP populations, commonly assessed by the PSQI. Mechanistic themes varied by subtype: cytokine activation, hypothalamic-pituitary-adrenal axis dysregulation, and altered clock-genes in AA; circadian misalignment, obstructive sleep apnea-related hypoxia, and hormonal imbalance in AGA; neurogenic inflammation and substance-P pathways in TE; and chronic pruritus and pain in LPP. Psychosocial distress amplified sleep disruption in most subtypes.</p><p><strong>Conclusions: </strong>Across hair loss disorders, sleep disturbance emerges as a biologically plausible and clinically relevant contributor to disease burden. Although most evidence is observational, converging mechanistic and psychosocial data support a bidirectional relationship between sleep quality and hair loss. Incorporating brief sleep assessments into hair loss care and considering sleep-targeted interventions may improve disease stability and patient well-being. Longitudinal and mechanistic studies are needed to clarify causality and identify therapeutic targets.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-01-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145970734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-12DOI: 10.1007/s13555-025-01630-9
Nikolaos Stavropoulos, Daniel Myszkowski, Dennis Braß, Vasileios Dervenis, Effimia Poungoura, Eggert Stockfleth
Introduction: Atopic dermatitis (AD) is a chronic, relapsing inflammatory disease, significantly impacting a patient's quality of life. To date, a substantial proportion of patients present an insufficient response to available treatment options. Lebrikizumab, a monoclonal antibody targeting interleukin 13, has shown a promising clinical benefit in phase 3 trials, however, real-world data on the effectiveness and safety of lebrikizumab for atopic dermatitis (AD) are limited and mostly restricted to Asian populations. Aim of this study was to evaluate the real-world effectiveness and safety of lebrikizumab in patients with AD.
Methods: This retrospective study included 35 patients from a largely homogenous Central European population with moderate to severe Atopic Dermatitis treated with lebrikizumab at the Dermatology Department of the St. Josef-Hospital in Bochum between December 2023 and April 2025. Eczema area and severity index (EASI), SCORing Atopic Dermatitis (SCORAD), peak-pruritus (PP)-numerical rating scale (NRS) and dermatology life quality index (DLQI) were assessed during the treatment.
Results: Lebrikizumab reduced all clinical indices by week 4, with improvements maintained through week 16. At week 24, the achievement rates for EASI-50 (50% reduction in EASI), EASI-75 (75% reduction in EASI) and EASI-90 (90% reduction in EASI) were 100%, 75% and 75%, respectively, and the SCORAD-50 (50% reduction in SCORAD) response rate was 64.2%. The proportions of patients achieving a ≥ 4-point reduction in the PP-NRS and in the DLQI at week 24 were 55.8% and 91.6%, respectively. No new safety signals were observed.
Conclusion: Lebrikizumab demonstrated favorable real-world effectiveness and safety over 24 weeks in patients with moderate-to-severe AD, supporting its use in routine clinical practice.
特应性皮炎(AD)是一种慢性、复发性炎症性疾病,严重影响患者的生活质量。迄今为止,相当大比例的患者对现有的治疗方案反应不足。Lebrikizumab是一种靶向白细胞介素13的单克隆抗体,在3期试验中显示出有希望的临床益处,然而,关于Lebrikizumab治疗特应性皮炎(AD)的有效性和安全性的实际数据有限,而且主要局限于亚洲人群。本研究的目的是评估lebrikizumab在AD患者中的实际有效性和安全性。方法:这项回顾性研究包括35例来自中欧大部分同质人群的中度至重度特应性皮炎患者,这些患者于2023年12月至2025年4月在波hum St. josef医院皮肤科接受lebrikizumab治疗。评估治疗期间湿疹面积及严重程度指数(EASI)、特应性皮炎评分(SCORAD)、瘙痒峰(PP)-数值评定量表(NRS)和皮肤病生活质量指数(DLQI)。结果:Lebrikizumab在第4周降低了所有临床指标,并在第16周保持改善。在第24周,EASI-50 (EASI降低50%)、EASI-75 (EASI降低75%)和EASI-90 (EASI降低90%)的完成率分别为100%、75%和75%,SCORAD-50 (SCORAD降低50%)的有效率为64.2%。在第24周,PP-NRS和DLQI降低≥4点的患者比例分别为55.8%和91.6%。没有观察到新的安全信号。结论:Lebrikizumab在中重度AD患者24周内显示出良好的实际有效性和安全性,支持其在常规临床实践中的使用。
{"title":"Retrospective Analysis of Lebrikizumab in the Management of Atopic Dermatitis: Insights from Real-World Practice.","authors":"Nikolaos Stavropoulos, Daniel Myszkowski, Dennis Braß, Vasileios Dervenis, Effimia Poungoura, Eggert Stockfleth","doi":"10.1007/s13555-025-01630-9","DOIUrl":"https://doi.org/10.1007/s13555-025-01630-9","url":null,"abstract":"<p><strong>Introduction: </strong> Atopic dermatitis (AD) is a chronic, relapsing inflammatory disease, significantly impacting a patient's quality of life. To date, a substantial proportion of patients present an insufficient response to available treatment options. Lebrikizumab, a monoclonal antibody targeting interleukin 13, has shown a promising clinical benefit in phase 3 trials, however, real-world data on the effectiveness and safety of lebrikizumab for atopic dermatitis (AD) are limited and mostly restricted to Asian populations. Aim of this study was to evaluate the real-world effectiveness and safety of lebrikizumab in patients with AD.</p><p><strong>Methods: </strong> This retrospective study included 35 patients from a largely homogenous Central European population with moderate to severe Atopic Dermatitis treated with lebrikizumab at the Dermatology Department of the St. Josef-Hospital in Bochum between December 2023 and April 2025. Eczema area and severity index (EASI), SCORing Atopic Dermatitis (SCORAD), peak-pruritus (PP)-numerical rating scale (NRS) and dermatology life quality index (DLQI) were assessed during the treatment.</p><p><strong>Results: </strong>Lebrikizumab reduced all clinical indices by week 4, with improvements maintained through week 16. At week 24, the achievement rates for EASI-50 (50% reduction in EASI), EASI-75 (75% reduction in EASI) and EASI-90 (90% reduction in EASI) were 100%, 75% and 75%, respectively, and the SCORAD-50 (50% reduction in SCORAD) response rate was 64.2%. The proportions of patients achieving a ≥ 4-point reduction in the PP-NRS and in the DLQI at week 24 were 55.8% and 91.6%, respectively. No new safety signals were observed.</p><p><strong>Conclusion: </strong> Lebrikizumab demonstrated favorable real-world effectiveness and safety over 24 weeks in patients with moderate-to-severe AD, supporting its use in routine clinical practice.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145959046","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-11DOI: 10.1007/s13555-025-01645-2
Stephanie T de Leon, Diandra A Zabala, Noldtawat Viriyaskultorn, Panyapat Buranaporn, Woramate Bhorntarakcharoen, Thrit Hutachoke, Thanyaporn Leesanguankul, Teerapat Wannawittayapa, Wetch Tantrapongsathorn, Sariya Sittiwanaruk, Rungsima Wanitphakdeedecha
Introduction: Combined platelet-rich plasma and hyaluronic acid (PRP-HA) offers a promising nonsurgical technique for tissue regeneration through synergistic efficacy and longevity effects. This study aims to investigate PRP-HA's efficacy and safety for neck rejuvenation.
Methods: This 32-week prospective trial enrolled 30 Thai participants with mild-to-moderate neck aging. Treatment consisted of three monthly intradermal PRP-HA injections to the anterior neck surface, with follow-ups at 2 weeks, and 1, 2, 3, and 6 months posttreatment completion. Assessment included skin firmness, elasticity, biometric parameters, pain scores, and adverse effects.
Results: Of 29 completing participants, neck skin firmness improved 54% from baseline at 3-month posttreatment completion, increasing to 65% at 6 months (p < 0.0001). While gross elasticity initially improved at 1 month posttreatment (p = 0.0217); it subsequently declined. The 6-month follow-up showed substantial reductions in melanin and erythema (p < 0.01). Sustained improvements were observed in hydration through study completion (p < 0.01). Sebum levels decreased significantly after the first two treatments and at 3 months posttreatment (p < 0.05). No significant changes appeared in skin texture, wrinkles, and brightness. Most participants reported 51-75% improvement after the third treatment, maintaining through 6 months. No severe adverse effects were reported.
Conclusions: PRP-HA demonstrates safe and effective improvements in neck skin firmness, hydration, and pigment and sebum regulation, with benefits lasting 6 months after three treatment sessions. However, variable effects on elasticity and modest results on wrinkles, texture, and brightness warrant further controlled trials to further elucidate and confirm its rejuvenative properties on the neck.
Trial registration: This trial is registered under the Thai Clinical Trials Registry (TCTR20230212003).
{"title":"Efficacy and Safety of Platelet-Rich Plasma and Hyaluronic Acid Combination Treatment for Neck Rejuvenation in Thailand: A Prospective Study.","authors":"Stephanie T de Leon, Diandra A Zabala, Noldtawat Viriyaskultorn, Panyapat Buranaporn, Woramate Bhorntarakcharoen, Thrit Hutachoke, Thanyaporn Leesanguankul, Teerapat Wannawittayapa, Wetch Tantrapongsathorn, Sariya Sittiwanaruk, Rungsima Wanitphakdeedecha","doi":"10.1007/s13555-025-01645-2","DOIUrl":"https://doi.org/10.1007/s13555-025-01645-2","url":null,"abstract":"<p><strong>Introduction: </strong>Combined platelet-rich plasma and hyaluronic acid (PRP-HA) offers a promising nonsurgical technique for tissue regeneration through synergistic efficacy and longevity effects. This study aims to investigate PRP-HA's efficacy and safety for neck rejuvenation.</p><p><strong>Methods: </strong>This 32-week prospective trial enrolled 30 Thai participants with mild-to-moderate neck aging. Treatment consisted of three monthly intradermal PRP-HA injections to the anterior neck surface, with follow-ups at 2 weeks, and 1, 2, 3, and 6 months posttreatment completion. Assessment included skin firmness, elasticity, biometric parameters, pain scores, and adverse effects.</p><p><strong>Results: </strong>Of 29 completing participants, neck skin firmness improved 54% from baseline at 3-month posttreatment completion, increasing to 65% at 6 months (p < 0.0001). While gross elasticity initially improved at 1 month posttreatment (p = 0.0217); it subsequently declined. The 6-month follow-up showed substantial reductions in melanin and erythema (p < 0.01). Sustained improvements were observed in hydration through study completion (p < 0.01). Sebum levels decreased significantly after the first two treatments and at 3 months posttreatment (p < 0.05). No significant changes appeared in skin texture, wrinkles, and brightness. Most participants reported 51-75% improvement after the third treatment, maintaining through 6 months. No severe adverse effects were reported.</p><p><strong>Conclusions: </strong>PRP-HA demonstrates safe and effective improvements in neck skin firmness, hydration, and pigment and sebum regulation, with benefits lasting 6 months after three treatment sessions. However, variable effects on elasticity and modest results on wrinkles, texture, and brightness warrant further controlled trials to further elucidate and confirm its rejuvenative properties on the neck.</p><p><strong>Trial registration: </strong>This trial is registered under the Thai Clinical Trials Registry (TCTR20230212003).</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145951616","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-10DOI: 10.1007/s13555-025-01643-4
Grisha S Mateev, Zdravka V Demerdjieva, Rumyana K Yankova, Klimentina D Gospodinova, Boryana E Ilieva, Razvigor B Darlenski
Introduction: Treatment adherence is crucial for managing chronic diseases, including plaque psoriasis. In Bulgaria, patients with plaque psoriasis can receive treatment with reimbursed biologics, such as guselkumab, if they meet National Health Insurance Fund (NHIF) requirements. These requirements include stringent disease criteria and a complex administrative process. The objective of this analysis is to assess the proportion of patients adhering to the guselkumab administration schedule, as specified in the summary of product characteristics (SmPC), after the first continuation of the NHIF treatment approval period (approximately 48 weeks).
Methods: This was a prospective, multicenter, single-country, noninterventional study. The primary endpoint was the proportion of patients adhering to the guselkumab administration schedule as outlined in the SmPC after the first continuation of the NHIF treatment approval period. Secondary endpoints included evaluating guselkumab's safety and efficacy, as well as patient profile.
Results: This study included 39 female and 61 male patients with plaque psoriasis, with a mean age of 51.5 years. Overall, 95% of enrolled patients adhered to the guselkumab dosing regimen (i.e., received all seven doses) at 50 weeks after study initiation. Treatment with guselkumab led to a rapid and sustained reduction in Psoriasis Area and Severity Index (PASI) scores, with 84.4% of patients achieving PASI 90 and 42.7% reaching PASI 100 by the final visit. Significant improvements were also observed in absolute PASI, body surface area (BSA), and Dermatology Life Quality Index (DLQI) scores, indicating marked disease control and enhanced quality of life across the study period. There were ten adverse events during the study, and no new safety signals for guselkumab were identified.
Conclusions: Bulgarian patients treated with guselkumab adhered well to treatment in this study, with an adherence rate comparable to that observed in randomized clinical trials and higher than the drug survival rates reported in real-world studies. This may be owing, in part, to the existing patient support programs specific to Bulgaria. Treatment with guselkumab in real-life clinical practice in Bulgaria was well tolerated and effective in reducing signs and symptoms of plaque psoriasis, consistent with the overall efficacy and safety profile demonstrated in randomized controlled trials.
{"title":"Guselkumab Treatment ADHEREnce in BulGaria of Patients with Psoriasis-ADHERE-BG Study.","authors":"Grisha S Mateev, Zdravka V Demerdjieva, Rumyana K Yankova, Klimentina D Gospodinova, Boryana E Ilieva, Razvigor B Darlenski","doi":"10.1007/s13555-025-01643-4","DOIUrl":"https://doi.org/10.1007/s13555-025-01643-4","url":null,"abstract":"<p><strong>Introduction: </strong>Treatment adherence is crucial for managing chronic diseases, including plaque psoriasis. In Bulgaria, patients with plaque psoriasis can receive treatment with reimbursed biologics, such as guselkumab, if they meet National Health Insurance Fund (NHIF) requirements. These requirements include stringent disease criteria and a complex administrative process. The objective of this analysis is to assess the proportion of patients adhering to the guselkumab administration schedule, as specified in the summary of product characteristics (SmPC), after the first continuation of the NHIF treatment approval period (approximately 48 weeks).</p><p><strong>Methods: </strong>This was a prospective, multicenter, single-country, noninterventional study. The primary endpoint was the proportion of patients adhering to the guselkumab administration schedule as outlined in the SmPC after the first continuation of the NHIF treatment approval period. Secondary endpoints included evaluating guselkumab's safety and efficacy, as well as patient profile.</p><p><strong>Results: </strong>This study included 39 female and 61 male patients with plaque psoriasis, with a mean age of 51.5 years. Overall, 95% of enrolled patients adhered to the guselkumab dosing regimen (i.e., received all seven doses) at 50 weeks after study initiation. Treatment with guselkumab led to a rapid and sustained reduction in Psoriasis Area and Severity Index (PASI) scores, with 84.4% of patients achieving PASI 90 and 42.7% reaching PASI 100 by the final visit. Significant improvements were also observed in absolute PASI, body surface area (BSA), and Dermatology Life Quality Index (DLQI) scores, indicating marked disease control and enhanced quality of life across the study period. There were ten adverse events during the study, and no new safety signals for guselkumab were identified.</p><p><strong>Conclusions: </strong>Bulgarian patients treated with guselkumab adhered well to treatment in this study, with an adherence rate comparable to that observed in randomized clinical trials and higher than the drug survival rates reported in real-world studies. This may be owing, in part, to the existing patient support programs specific to Bulgaria. Treatment with guselkumab in real-life clinical practice in Bulgaria was well tolerated and effective in reducing signs and symptoms of plaque psoriasis, consistent with the overall efficacy and safety profile demonstrated in randomized controlled trials.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145948516","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-09DOI: 10.1007/s13555-025-01634-5
Andrew Blauvelt, Kimberly M Deininger, Joshua Porter, Alexis Sohn, Shanshan Qin, Lori McLeod, Angela J Rylands, Lauren Nelson
Introduction: Atopic dermatitis (AD) is a chronic inflammatory skin condition often associated with skin pain and sleep disturbance. The AD Skin Pain Numeric Rating Scale (SP-NRS) and Sleep Disturbance NRS (SD-NRS) are single-item patient-reported outcome measures developed to assess AD-related skin pain and sleep disturbance severity, respectively, in AD clinical trials.
Methods: We used data from three randomized, double-blinded, placebo-controlled clinical trials of rocatinlimab in adults (aged ≥ 18 years) (ROCKET-IGNITE and ROCKET-SHUTTLE) and adolescents (aged ≥ 12 to < 18 years) (ROCKET-ASTRO) with moderate-to-severe AD to assess the reliability, validity, and responsiveness of the AD SP-NRS and SD-NRS. Clinical outcome assessments (COAs) supported the psychometric evaluation, and we estimated meaningful change thresholds for the AD SP-NRS and SD-NRS using anchor-based methods, which we confirmed with distribution-based methods. We included data from both the treatment arm and placebo in our analyses, and we analyzed results from adult and adolescent populations separately.
Results: This psychometric analysis sample used 262 adults (ROCKET-IGNITE, n = 145; ROCKET-SHUTTLE, n = 117) and 109 adolescents (ROCKET-ASTRO, n = 109), subsets from the initial data cuts of the respective clinical trials, in the psychometric analysis sample. Both AD SP-NRS and SD-NRS scores demonstrated high test-retest reliability for both adults and adolescents (intraclass correlation coefficients ≥ 0.80) and moderate-to-strong (|r| ≥ 0.30) positive correlations with most supporting COAs. Anchor-based meaningful within-patient change threshold ranges derived for AD SP-NRS and SD-NRS scores supported both 3-point and 4-point improvement thresholds for characterizing clinically meaningful changes.
Conclusions: The AD SP-NRS and SD-NRS are reliable, valid, and responsive measures for assessing moderate-to-severe AD in adults and adolescents in clinical trials. The meaningful change thresholds identified in this study can be used in future clinical trials to interpret treatment effects.
特应性皮炎(AD)是一种慢性炎症性皮肤病,常伴有皮肤疼痛和睡眠障碍。AD皮肤疼痛数值评定量表(SP-NRS)和睡眠障碍数值评定量表(SD-NRS)是在AD临床试验中分别用于评估AD相关皮肤疼痛和睡眠障碍严重程度的单项患者报告结果测量。方法:我们使用rocatinlimab在成人(≥18岁)(ROCKET-IGNITE和ROCKET-SHUTTLE)和青少年(≥12岁)中进行的三个随机、双盲、安慰剂对照临床试验的数据。结果:该心理测量分析样本使用262名成人(ROCKET-IGNITE, n = 145; ROCKET-SHUTTLE, n = 117)和109名青少年(ROCKET-ASTRO, n = 109),这些亚群来自各自临床试验的初始数据cut,在心理测量分析样本中。AD SP-NRS和SD-NRS评分在成人和青少年中均表现出较高的重测信度(类内相关系数≥0.80),并且与大多数支持coa呈中至强(|或|≥0.30)正相关。基于锚定的AD SP-NRS和SD-NRS评分的患者内有意义的变化阈值范围支持3分和4分改善阈值来表征临床有意义的变化。结论:在临床试验中,AD SP-NRS和SD-NRS是评估成人和青少年中重度AD的可靠、有效和反应灵敏的方法。本研究确定的有意义的变化阈值可用于未来的临床试验来解释治疗效果。
{"title":"Psychometric Evaluation of Skin Pain and Sleep Disturbance Numeric Rating Scales in Moderate-to-Severe Atopic Dermatitis.","authors":"Andrew Blauvelt, Kimberly M Deininger, Joshua Porter, Alexis Sohn, Shanshan Qin, Lori McLeod, Angela J Rylands, Lauren Nelson","doi":"10.1007/s13555-025-01634-5","DOIUrl":"https://doi.org/10.1007/s13555-025-01634-5","url":null,"abstract":"<p><strong>Introduction: </strong>Atopic dermatitis (AD) is a chronic inflammatory skin condition often associated with skin pain and sleep disturbance. The AD Skin Pain Numeric Rating Scale (SP-NRS) and Sleep Disturbance NRS (SD-NRS) are single-item patient-reported outcome measures developed to assess AD-related skin pain and sleep disturbance severity, respectively, in AD clinical trials.</p><p><strong>Methods: </strong>We used data from three randomized, double-blinded, placebo-controlled clinical trials of rocatinlimab in adults (aged ≥ 18 years) (ROCKET-IGNITE and ROCKET-SHUTTLE) and adolescents (aged ≥ 12 to < 18 years) (ROCKET-ASTRO) with moderate-to-severe AD to assess the reliability, validity, and responsiveness of the AD SP-NRS and SD-NRS. Clinical outcome assessments (COAs) supported the psychometric evaluation, and we estimated meaningful change thresholds for the AD SP-NRS and SD-NRS using anchor-based methods, which we confirmed with distribution-based methods. We included data from both the treatment arm and placebo in our analyses, and we analyzed results from adult and adolescent populations separately.</p><p><strong>Results: </strong>This psychometric analysis sample used 262 adults (ROCKET-IGNITE, n = 145; ROCKET-SHUTTLE, n = 117) and 109 adolescents (ROCKET-ASTRO, n = 109), subsets from the initial data cuts of the respective clinical trials, in the psychometric analysis sample. Both AD SP-NRS and SD-NRS scores demonstrated high test-retest reliability for both adults and adolescents (intraclass correlation coefficients ≥ 0.80) and moderate-to-strong (|r| ≥ 0.30) positive correlations with most supporting COAs. Anchor-based meaningful within-patient change threshold ranges derived for AD SP-NRS and SD-NRS scores supported both 3-point and 4-point improvement thresholds for characterizing clinically meaningful changes.</p><p><strong>Conclusions: </strong>The AD SP-NRS and SD-NRS are reliable, valid, and responsive measures for assessing moderate-to-severe AD in adults and adolescents in clinical trials. The meaningful change thresholds identified in this study can be used in future clinical trials to interpret treatment effects.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145942798","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}