JAMA dermatology最新文献

英文中文

Human Papillomavirus Vaccination and Actinic Keratosis Burden: The VAXAK Randomized Clinical Trial.

IF 11.5 1区医学 Q1 DERMATOLOGY

JAMA dermatology

Pub Date : 2025-03-06 DOI: 10.1001/jamadermatol.2025.0531

Emily Wenande, Anna Hastrup, Stine Wiegell, Peter A Philipsen, Niels Bech Thomsen, Shadmehr Demehri, Susanne K Kjaer, Merete Haedersdal

Importance: The substantial morbidity and socioeconomic costs associated with actinic keratosis (AK) management represent major public health concerns. Anecdotal evidence suggests that human papillomavirus (HPV) vaccination may offer therapeutic and preventive effects against AK and keratinocyte carcinomas (KCs).Objective: To investigate the effect of HPV vaccination on burden of disease in immunocompetent patients with high numbers of AK.Design, setting, and participants: The VAXAK trial was a parallel-design, double-blind, randomized sham-controlled clinical trial with 12 months' follow-up. This single-center trial was conducted at the Department of Dermatology, Bispebjerg University Hospital in Copenhagen, Denmark, between May 2021 and June 2024. Eligible participants were immunocompetent adults with 15 or more clinical AK lesions in a 50 cm2 to 100 cm2 test area on the head, trunk, or extremities.Interventions: Participants were randomized 1:1 to blinded, 9-valent alphapapillomavirus vaccine or sham vaccine (isotonic sodium chloride solution), each administered intramuscularly at 0, 2, and 6 months. Thick AKs (Olsen grade II-III) received cryotherapy at months 6 and 9; test areas were otherwise untreated during the study.Main outcomes and measures: The preselected primary outcome was the percentage reduction in baseline AKs assessed 2, 6, 9, and 12 months after first vaccination. Secondary outcomes included total AK number, thick lesions, new AKs, and rate of incident KCs over 12 months.Results: Participants were selected by consecutive sampling of 163 screened patients following exclusion of 93 individuals due to ineligibility or patients opting out. Among 70 enrolled participants (median [IQR] age, 75.50 [69.00-79.00] years; 47 [67%] male), 69 completed the study. Median (IQR) AK reductions were higher in the HPV-vaccinated vs sham group, shown consistently over the study period (month 2: 35% [25%-44%] vs 25% [18%-33%]; P = .03; month 6: 47% [33%-53%] vs 29% [16%-44%]; P = .01; month 9: 58% [37%-63%] vs 42% [33%-56%]; P = .09; month 12: 58% [47%-69%] vs 47% [32%-65%]; P = .05). Total AK numbers were correspondingly lower in the HPV-vaccinated group (median [IQR] at month 6: 14.00 [11.00-16.00] vs 17.00 [12.00-23.00]; P = .01; month 12: 10.00 [6.00-24.00] vs 16.00 [8.50-21.00]; P = .02). Coincidingly, fewer thick AKs were observed in the HPV-vaccinated group (median [IQR] at month 6: 5.00 [3.00-7.00] vs 6.50 [3.75-10.00]; P = .02; month 12: 3.00 [2.00-5.00] vs 5.00 [2.50-8.50]; P = .049). In contrast, no significant differences in rates of new AKs (1-2 AK[s] per month) or KC numbers overall or per participant were identified during the 12-month trial.Conclusions and relevance: In this randomized clinical trial, standard alphapapillomavirus vaccination was found to reduce AK burden

{"title":"Human Papillomavirus Vaccination and Actinic Keratosis Burden: The VAXAK Randomized Clinical Trial.","authors":"Emily Wenande, Anna Hastrup, Stine Wiegell, Peter A Philipsen, Niels Bech Thomsen, Shadmehr Demehri, Susanne K Kjaer, Merete Haedersdal","doi":"10.1001/jamadermatol.2025.0531","DOIUrl":"10.1001/jamadermatol.2025.0531","url":null,"abstract":"Importance: The substantial morbidity and socioeconomic costs associated with actinic keratosis (AK) management represent major public health concerns. Anecdotal evidence suggests that human papillomavirus (HPV) vaccination may offer therapeutic and preventive effects against AK and keratinocyte carcinomas (KCs).Objective: To investigate the effect of HPV vaccination on burden of disease in immunocompetent patients with high numbers of AK.Design, setting, and participants: The VAXAK trial was a parallel-design, double-blind, randomized sham-controlled clinical trial with 12 months' follow-up. This single-center trial was conducted at the Department of Dermatology, Bispebjerg University Hospital in Copenhagen, Denmark, between May 2021 and June 2024. Eligible participants were immunocompetent adults with 15 or more clinical AK lesions in a 50 cm2 to 100 cm2 test area on the head, trunk, or extremities.Interventions: Participants were randomized 1:1 to blinded, 9-valent alphapapillomavirus vaccine or sham vaccine (isotonic sodium chloride solution), each administered intramuscularly at 0, 2, and 6 months. Thick AKs (Olsen grade II-III) received cryotherapy at months 6 and 9; test areas were otherwise untreated during the study.Main outcomes and measures: The preselected primary outcome was the percentage reduction in baseline AKs assessed 2, 6, 9, and 12 months after first vaccination. Secondary outcomes included total AK number, thick lesions, new AKs, and rate of incident KCs over 12 months.Results: Participants were selected by consecutive sampling of 163 screened patients following exclusion of 93 individuals due to ineligibility or patients opting out. Among 70 enrolled participants (median [IQR] age, 75.50 [69.00-79.00] years; 47 [67%] male), 69 completed the study. Median (IQR) AK reductions were higher in the HPV-vaccinated vs sham group, shown consistently over the study period (month 2: 35% [25%-44%] vs 25% [18%-33%]; P = .03; month 6: 47% [33%-53%] vs 29% [16%-44%]; P = .01; month 9: 58% [37%-63%] vs 42% [33%-56%]; P = .09; month 12: 58% [47%-69%] vs 47% [32%-65%]; P = .05). Total AK numbers were correspondingly lower in the HPV-vaccinated group (median [IQR] at month 6: 14.00 [11.00-16.00] vs 17.00 [12.00-23.00]; P = .01; month 12: 10.00 [6.00-24.00] vs 16.00 [8.50-21.00]; P = .02). Coincidingly, fewer thick AKs were observed in the HPV-vaccinated group (median [IQR] at month 6: 5.00 [3.00-7.00] vs 6.50 [3.75-10.00]; P = .02; month 12: 3.00 [2.00-5.00] vs 5.00 [2.50-8.50]; P = .049). In contrast, no significant differences in rates of new AKs (1-2 AK[s] per month) or KC numbers overall or per participant were identified during the 12-month trial.Conclusions and relevance: In this randomized clinical trial, standard alphapapillomavirus vaccination was found to reduce AK burden","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.5,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11886873/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143566572","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Area Deprivation Index and Melanoma Thickness in Veterans.

IF 11.5 1区医学 Q1 DERMATOLOGY

JAMA dermatology

Pub Date : 2025-03-06 DOI: 10.1001/jamadermatol.2025.0311

Alejandra K Moncayo, Jacqueline M Ferguson, Mathew P Dizon, Linden Huhmann, Daniel Y Kim, Nhan Do, Mary T Brophy, Thomas F Osborne, Allyson C Spence, Nathanael R Fillmore, Susan M Swetter, Rebecca I Hartman

Importance: The US Veterans Health Administration (VHA) provides comprehensive medical care for enrolled veterans. Differences in melanoma diagnosis, associated with individual-level factors, have been previously published. The area deprivation index (ADI) ranks a neighborhood's level of deprivation and can inform whether the characteristics of a patient's area of residence can contribute to delayed diagnosis, measured by melanoma thickness.

Objective: To evaluate if neighborhood deprivation is associated with thicker (greater than 2 mm) cutaneous melanoma diagnosis after controlling for individual-level characteristics in the US veteran population.

Design, setting, and participants: This national cohort study used data from the US Veterans Eligibility Trends and Statistics database, the Veterans Affairs Cancer Registry, and veterans' electronic health care records. Veterans enrolled at the VHA who were diagnosed with melanoma from October 1, 2013, to December 31, 2019, were included. Data analysis conducted from September 2023 to July 2024.

Exposures: Quintiles of ranked neighborhood deprivation measured by the nationwide ADI.

Main outcomes and measures: Generalized Poisson models were used to calculate the risk of a thick cutaneous melanoma diagnosis, defined by the American Joint Committee on Cancer Staging Manual eighth edition staging as a Breslow thickness greater than 2 mm (ie, T3 to T4 disease).

Results: Of 7249 veterans with a melanoma diagnosis included in the study, 6988 (96.4%) were male, and the mean (SD) age was 68.9 (12.2) years. A total of 856 (11.8%) lived in the least deprived neighborhoods (quintile 1: ADI of 1-20) and 1205 (16.6%) lived in the most deprived neighborhoods (quintile 5: ADI of 81-100) nationwide. The risk of thicker melanoma at diagnosis increased with measured deprivation in the neighborhood. There was a 33% increased risk of thicker melanoma (greater than 2 mm) in veterans in quintile 5 compared with those in quintile 1 of ADI (adjusted risk ratio, 1.33; 95% CI, 1.05-1.68).

Conclusions and relevance: In this national cohort study of US veterans with melanoma, neighborhood-level deprivation at time of diagnosis was independently associated with thicker melanoma at diagnosis after controlling for individual-level factors and tumor characteristics. These findings underscore the significant association between neighborhood deprivation and melanoma diagnosis.

{"title":"Area Deprivation Index and Melanoma Thickness in Veterans.","authors":"Alejandra K Moncayo, Jacqueline M Ferguson, Mathew P Dizon, Linden Huhmann, Daniel Y Kim, Nhan Do, Mary T Brophy, Thomas F Osborne, Allyson C Spence, Nathanael R Fillmore, Susan M Swetter, Rebecca I Hartman","doi":"10.1001/jamadermatol.2025.0311","DOIUrl":"10.1001/jamadermatol.2025.0311","url":null,"abstract":"Importance: The US Veterans Health Administration (VHA) provides comprehensive medical care for enrolled veterans. Differences in melanoma diagnosis, associated with individual-level factors, have been previously published. The area deprivation index (ADI) ranks a neighborhood's level of deprivation and can inform whether the characteristics of a patient's area of residence can contribute to delayed diagnosis, measured by melanoma thickness.Objective: To evaluate if neighborhood deprivation is associated with thicker (greater than 2 mm) cutaneous melanoma diagnosis after controlling for individual-level characteristics in the US veteran population.Design, setting, and participants: This national cohort study used data from the US Veterans Eligibility Trends and Statistics database, the Veterans Affairs Cancer Registry, and veterans' electronic health care records. Veterans enrolled at the VHA who were diagnosed with melanoma from October 1, 2013, to December 31, 2019, were included. Data analysis conducted from September 2023 to July 2024.Exposures: Quintiles of ranked neighborhood deprivation measured by the nationwide ADI.Main outcomes and measures: Generalized Poisson models were used to calculate the risk of a thick cutaneous melanoma diagnosis, defined by the American Joint Committee on Cancer Staging Manual eighth edition staging as a Breslow thickness greater than 2 mm (ie, T3 to T4 disease).Results: Of 7249 veterans with a melanoma diagnosis included in the study, 6988 (96.4%) were male, and the mean (SD) age was 68.9 (12.2) years. A total of 856 (11.8%) lived in the least deprived neighborhoods (quintile 1: ADI of 1-20) and 1205 (16.6%) lived in the most deprived neighborhoods (quintile 5: ADI of 81-100) nationwide. The risk of thicker melanoma at diagnosis increased with measured deprivation in the neighborhood. There was a 33% increased risk of thicker melanoma (greater than 2 mm) in veterans in quintile 5 compared with those in quintile 1 of ADI (adjusted risk ratio, 1.33; 95% CI, 1.05-1.68).Conclusions and relevance: In this national cohort study of US veterans with melanoma, neighborhood-level deprivation at time of diagnosis was independently associated with thicker melanoma at diagnosis after controlling for individual-level factors and tumor characteristics. These findings underscore the significant association between neighborhood deprivation and melanoma diagnosis.","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.5,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11886871/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143566474","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The Evolving Landscape of Biologics-Biosimilars, Biobetters, and Bioparallels.

IF 11.5 1区医学 Q1 DERMATOLOGY

JAMA dermatology

Pub Date : 2025-03-05 DOI: 10.1001/jamadermatol.2025.0049

Ivo Abraham, Karen MacDonald

引用次数: 0

Effectiveness of Adalimumab Biosimilars and Originator for Psoriasis.

IF 11.5 1区医学 Q1 DERMATOLOGY

JAMA dermatology

Pub Date : 2025-03-05 DOI: 10.1001/jamadermatol.2025.0055

Duc Binh Phan, Anthony P Bewley, Philip Laws, Teena Mackenzie, Catherine H Smith, Christopher E M Griffiths, Mark Lunt, Richard B Warren, Zenas Z N Yiu

Importance: The uncertainties about the real-world effectiveness of adalimumab biosimilars limit their widespread adoption for psoriasis.Objective: To compare the effectiveness of adalimumab biosimilars Amjevita and Imraldi with Humira for psoriasis.Design, setting, and participants: An emulation of 2 targeted pragmatic clinical trials was conducted using data from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR), a prospective pharmacovigilance registry tracking individuals receiving biologic and conventional systemic treatments for psoriasis in the UK and the Republic of Ireland. Data from patients with psoriasis using adalimumab registered to BADBIR were included. Data were collected from September 2007 to January 2023, and data were analyzed from January to September 2023.Exposures: The effectiveness of initiating Amjevita and Imraldi were compared with initiating Humira among adalimumab-naive patients, and the effectiveness of switching from Humira to either Amjevita or Imraldi were compared with continuing Humira among patients who had been using Humira consistently for more than 2 years.Main outcomes and measures: The study outcomes were absolute Psoriasis Area and Severity Index (PASI) score of 2 or less and PASI score of 4 or less at 12 months after the index date. Inverse propensity treatment weighting was used to analyze receiving either biosimilars or Humira to account for confounding. Multiple imputations were used to account for missing PASI data at 12 months and inverse probability of censoring weighting to account for censorship due to deviation from the treatments under investigation. Logistic regression models were fitted to compare the outcomes between study cohorts.Results: Of 11 400 included patients, 6924 (60.7%) were male, and the mean (SD) age was 45.3 (12.5) years. A total of 6133 patients were identified in the new user analysis (5416 starting Humira, 382 starting Amjevita, and 335 starting Imraldi) and 5267 patients in the switcher analysis (3808 continuing Humira, 847 switching to Amjevita, and 612 switching to Imraldi). Amjevita and Imraldi new users had no significantly different probability of achieving a PASI score of 2 or less (Amjevita: adjusted odds ratio [aOR], 0.98; 95% CI, 0.78-1.25; Imraldi: aOR, 0.83; 95% CI, 0.64-1.07) and a PASI score of 4 or less (Amjevita: aOR, 1.07; 95% CI, 0.84-1.37; Imraldi: aOR, 0.91; 95% CI, 0.69-1.20) compared with Humira new users. Patients who switched to Amjevita and Imraldi also had no statistically significant differences in achieving a PASI score of 2 or less (Amjevita: aOR, 1.19; 95% CI, 0.94-1.51; Imraldi: aOR, 0.92; 95% CI, 0.72-1.18) and a PASI score of 4 or less (Amjevita: aOR, 1.32; 95% CI, 0.96-1.84; Imraldi: aOR, 1.00; 95% CI, 0.70-1.41) compared with those who continued Humira.<st

{"title":"Effectiveness of Adalimumab Biosimilars and Originator for Psoriasis.","authors":"Duc Binh Phan, Anthony P Bewley, Philip Laws, Teena Mackenzie, Catherine H Smith, Christopher E M Griffiths, Mark Lunt, Richard B Warren, Zenas Z N Yiu","doi":"10.1001/jamadermatol.2025.0055","DOIUrl":"10.1001/jamadermatol.2025.0055","url":null,"abstract":"Importance: The uncertainties about the real-world effectiveness of adalimumab biosimilars limit their widespread adoption for psoriasis.Objective: To compare the effectiveness of adalimumab biosimilars Amjevita and Imraldi with Humira for psoriasis.Design, setting, and participants: An emulation of 2 targeted pragmatic clinical trials was conducted using data from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR), a prospective pharmacovigilance registry tracking individuals receiving biologic and conventional systemic treatments for psoriasis in the UK and the Republic of Ireland. Data from patients with psoriasis using adalimumab registered to BADBIR were included. Data were collected from September 2007 to January 2023, and data were analyzed from January to September 2023.Exposures: The effectiveness of initiating Amjevita and Imraldi were compared with initiating Humira among adalimumab-naive patients, and the effectiveness of switching from Humira to either Amjevita or Imraldi were compared with continuing Humira among patients who had been using Humira consistently for more than 2 years.Main outcomes and measures: The study outcomes were absolute Psoriasis Area and Severity Index (PASI) score of 2 or less and PASI score of 4 or less at 12 months after the index date. Inverse propensity treatment weighting was used to analyze receiving either biosimilars or Humira to account for confounding. Multiple imputations were used to account for missing PASI data at 12 months and inverse probability of censoring weighting to account for censorship due to deviation from the treatments under investigation. Logistic regression models were fitted to compare the outcomes between study cohorts.Results: Of 11 400 included patients, 6924 (60.7%) were male, and the mean (SD) age was 45.3 (12.5) years. A total of 6133 patients were identified in the new user analysis (5416 starting Humira, 382 starting Amjevita, and 335 starting Imraldi) and 5267 patients in the switcher analysis (3808 continuing Humira, 847 switching to Amjevita, and 612 switching to Imraldi). Amjevita and Imraldi new users had no significantly different probability of achieving a PASI score of 2 or less (Amjevita: adjusted odds ratio [aOR], 0.98; 95% CI, 0.78-1.25; Imraldi: aOR, 0.83; 95% CI, 0.64-1.07) and a PASI score of 4 or less (Amjevita: aOR, 1.07; 95% CI, 0.84-1.37; Imraldi: aOR, 0.91; 95% CI, 0.69-1.20) compared with Humira new users. Patients who switched to Amjevita and Imraldi also had no statistically significant differences in achieving a PASI score of 2 or less (Amjevita: aOR, 1.19; 95% CI, 0.94-1.51; Imraldi: aOR, 0.92; 95% CI, 0.72-1.18) and a PASI score of 4 or less (Amjevita: aOR, 1.32; 95% CI, 0.96-1.84; Imraldi: aOR, 1.00; 95% CI, 0.70-1.41) compared with those who continued Humira.<st","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.5,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11883583/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143556822","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

At-Home LED Devices for the Treatment of Acne Vulgaris: A Systematic Review and Meta-Analysis.

IF 11.5 1区医学 Q1 DERMATOLOGY

JAMA dermatology

Pub Date : 2025-03-05 DOI: 10.1001/jamadermatol.2025.0019

Sherry Ershadi, John S Barbieri

引用次数: 0

Long-Term Efficacy and Safety of Rituximab in Patients With Pemphigus Foliaceus Compared With Pemphigus Vulgaris.

IF 11.5 1区医学 Q1 DERMATOLOGY

JAMA dermatology

Pub Date : 2025-03-05 DOI: 10.1001/jamadermatol.2024.6654

Billal Tedbirt, Estelle Houivet, Maud Maho-Vaillant, Marie-Laure Golinski, Sébastien Calbo, Catherine Prost-Squarcioni, Bruno Labeille, Catherine Picard-Dahan, Guillaume Chaby, Marie-Aleth Richard, Emmanuelle Tancrède-Bohin, Sophie Duvert-Lehembre, Emmanuel Delaporte, Philippe Bernard, Frédéric Caux, Marina Alexandre, Philippe Musette, Saskia Ingen-Housz-Oro, Pierre Vabres, Gaëlle Quereux, Alain Dupuy, Sébastien Debarbieux, Martine Avenel-Audran, Michel D'Incan, Christophe Bédane, Nathalie Bénéton, Denis Jullien, Nicolas Dupin, Laurent Misery, Laurent Machet, Marie Beylot-Barry, Olivier Dereure, Bruno Sassolas, Nadège Cordel, Géraldine Jeudy, Jacques Benichou, Vivien Hébert, Pascal Joly

引用次数: 0

Subungual Amelanotic Melanoma.

IF 11.5 1区医学 Q1 DERMATOLOGY

JAMA dermatology

Pub Date : 2025-03-05 DOI: 10.1001/jamadermatol.2024.6167

Xing Fang, Tianjing Gao, Yu Fu

引用次数: 0

Efficacy, Safety, and Tolerability of Oral DFD-29, a Low-Dose Formulation of Minocycline, in Rosacea: Two Phase 3 Randomized Clinical Trials.

IF 11.5 1区医学 Q1 DERMATOLOGY

JAMA dermatology

Pub Date : 2025-03-05 DOI: 10.1001/jamadermatol.2024.6542

Neal Bhatia, James Del Rosso, Linda Stein Gold, Edward Lain, Zoe Diana Draelos, Srinivas Sidgiddi

Introduction: A low-dose modified formulation of minocycline hydrochloride, DFD-29, is under evaluation for treating papulopustular rosacea (PPR).Objective: To determine the efficacy and safety of DFD-29, 40 mg, compared with doxycycline, 40 mg, and placebo for treating PPR.Design, setting, and participants: This study included data from 2 double-blind, placebo-controlled, phase 3 randomized clinical trials (MVOR-1 and MVOR-2) conducted between March 2022 and May 2023 at 61 centers in the US and Germany. Healthy adults 18 years and older with moderate to severe PPR were included.Interventions: Participants were randomized 3:3:2 to oral DFD-29 (minocycline hydrochloride capsules), 40 mg; doxycycline, 40 mg; or placebo once daily for 16 weeks.Main outcomes and measures: The coprimary efficacy outcomes were (1) proportion of participants with Investigator's Global Assessment (IGA) treatment success with DFD-29 vs placebo and (2) total inflammatory lesion count reductions with DFD-29 vs placebo. Secondary outcomes included comparisons between DFD-29 and doxycycline in coprimary outcomes and between DFD-29 and placebo in erythema reduction.Results: Of 653 participants enrolled, 323 were randomized in MVOR-1 (247 [76.5%] women; mean [SD] age, 47.2 [13.7] years) and 330 were randomized in MVOR-2 (249 [75.5%] women; mean [SD] age, 51.6 [14.0] years). DFD-29 demonstrated superior efficacy in IGA success rates compared with placebo (MVOR-1: treatment difference [TD], 32.9%; 95% CI, 19.6-46.2; P < .001; MVOR-2: TD, 34.1%; 95% CI, 21.3-46.8; P < .001) and compared with doxycycline (MVOR-1: TD, 18.0%; 95% CI, 5.0-31.1; P = .01; MVOR-2: TD, 28.3%; 95% CI, 17.4-39.3; P < .001). DFD-29 also showed superior efficacy in least-squares mean reductions in total inflammatory lesions vs placebo (MVOR-1: TD, -9.2; 95% CI, -11.5 to -6.9; P < .001; MVOR-2: TD, -6.8; 95% CI, -8.9 to -4.8; P < .001) and doxycycline (MVOR-1: TD, -4.7; 95% CI, -6.7 to -2.8; P < .001; MVOR-2: TD, -3.5; 95% CI, -5.4 to -1.6; P < .001). Adverse events with DFD-29, doxycycline, and placebo were reported in 32 of 121 (26.4%), 25 of 116 (21.6%), and 27 of 76 (35.5%), respectively, in MVOR-1 and 51 of 122 (41.8%), 40 of 121 (33.1%), and 30 of 82 (36.6%), respectively, in MVOR-2. The most common adverse events with DFD-29, doxycycline, and placebo were nasopharyngitis, reported in 4 of 121 (3.3%), 2 of 116 (1.7%), and 3 of 76 (3.9%), respectively, in MVOR-1 and 13 of 122 (10.7%), 10 of 121 (8.3%), and 13 of 82 (15.9%), respectively, in MVOR-2, and COVID-19, reported in 4 of 121 (3.3%), 3 of 116 (2.6%), and 4 of 76 (5.3%) in MVOR-1 and 7 of 122 (5.7%), 8 of 121 (6.6%), and 5 of 82 (6.1%) in MVOR-2.Conclusions and relevance: In this study, DFD-29 was superior in efficacy to both doxycycline and placebo and demonstrated a favorable risk-benef

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引用次数: 0

Circular Necrotic Yellow-Red Plaque on the Chest.

IF 11.5 1区医学 Q1 DERMATOLOGY

JAMA dermatology

Pub Date : 2025-03-05 DOI: 10.1001/jamadermatol.2025.0028

Tian-Yi Zhang, Yue-Ping Zeng

引用次数: 0

Alopecia Areata-Specific Patient-Reported Outcome Measures: A Systematic Review.

IF 11.5 1区医学 Q1 DERMATOLOGY

JAMA dermatology

Pub Date : 2025-03-05 DOI: 10.1001/jamadermatol.2024.6660

Emadodin Darchini-Maragheh, Anthony Moussa, Nicole Yoong, Laita Bokhari, Leslie Jones, Rodney Sinclair

Importance: Alopecia areata (AA) has a high prevalence worldwide and causes considerable morbidity in patients. Patient-reported outcomes (PROs) have become an important component of clinical outcome assessment. The quality of existing AA-specific PRO measures (PROMs) has not been evaluated to date.

Objective: To identify and critically appraise the quality of the measurement properties of existing AA-specific PROMs and provide evidence-based recommendations on the most valid PROMs.

Evidence review: Using the predefined eligibility criteria, a systematic search was undertaken using 3 databases to screen the literature for available AA-specific PROMs after 2000. Original developmental studies and related validation studies that reported at least 1 measurement property of the primary PROM were retrieved. The Consensus Based Standards for the Selection of Health Measurement Instruments guidelines were used to examine the quality of the psychometric properties of retrieved PROMs. The quality of evidence was graded using the Grading of Recommendations Assessment, Development and Evaluation approach. Data were analyzed from April to July 2024.

Findings: A total of 15 articles were identified, including 8 developmental studies (describing 11 PROMs) and 7 validation studies. Three PROMs (Scale of Alopecia Areata Distress, Alopecia Areata Quality of Life Index, and Alopecia Areata Patients' Quality of Life) were AA-specific health-related quality-of-life instruments. Five instruments were single-item symptom-based PROMs (PRO measures for eyebrow, eyelash, nail appearance, and eye irritation, and Scalp Hair Assessment PRO). Three PROMs (Alopecia Areata Patient Priority Outcomes [AAPPO], Alopecia Areata Severity Self-Assessment, and Alopecia Areata Symptom Impact Scale) were based on both constructs. All PROMs were developed based on adult individuals. Seven PROMs (Scale of Alopecia Areata Distress, AAPPO, and all 5 symptom-based PROMs) featured very good development design. Content validity was the most frequently reported measurement property, rated to be sufficient for 8 PROMs. Internal consistency was reported for 5 PROMs with sufficient quality. AAPPO was the only PROM with high-quality evidence of sufficient structural validity and internal consistency. AAPPO was also the only PROM assessed for test-retest reliability, which was judged to be sufficient. No study reported measurement error.

Conclusions and relevance: This systematic review shows that there is still an unmet need for high-quality validation studies on the internal structure of AA-specific PROMs. Recommendations have been provided to help improve the rigor of the validation of AA-specific PROMs. Use of standards in psychometric testing of instruments could enhance the quality of instruments.

{"title":"Alopecia Areata-Specific Patient-Reported Outcome Measures: A Systematic Review.","authors":"Emadodin Darchini-Maragheh, Anthony Moussa, Nicole Yoong, Laita Bokhari, Leslie Jones, Rodney Sinclair","doi":"10.1001/jamadermatol.2024.6660","DOIUrl":"https://doi.org/10.1001/jamadermatol.2024.6660","url":null,"abstract":"Importance: Alopecia areata (AA) has a high prevalence worldwide and causes considerable morbidity in patients. Patient-reported outcomes (PROs) have become an important component of clinical outcome assessment. The quality of existing AA-specific PRO measures (PROMs) has not been evaluated to date.Objective: To identify and critically appraise the quality of the measurement properties of existing AA-specific PROMs and provide evidence-based recommendations on the most valid PROMs.Evidence review: Using the predefined eligibility criteria, a systematic search was undertaken using 3 databases to screen the literature for available AA-specific PROMs after 2000. Original developmental studies and related validation studies that reported at least 1 measurement property of the primary PROM were retrieved. The Consensus Based Standards for the Selection of Health Measurement Instruments guidelines were used to examine the quality of the psychometric properties of retrieved PROMs. The quality of evidence was graded using the Grading of Recommendations Assessment, Development and Evaluation approach. Data were analyzed from April to July 2024.Findings: A total of 15 articles were identified, including 8 developmental studies (describing 11 PROMs) and 7 validation studies. Three PROMs (Scale of Alopecia Areata Distress, Alopecia Areata Quality of Life Index, and Alopecia Areata Patients' Quality of Life) were AA-specific health-related quality-of-life instruments. Five instruments were single-item symptom-based PROMs (PRO measures for eyebrow, eyelash, nail appearance, and eye irritation, and Scalp Hair Assessment PRO). Three PROMs (Alopecia Areata Patient Priority Outcomes [AAPPO], Alopecia Areata Severity Self-Assessment, and Alopecia Areata Symptom Impact Scale) were based on both constructs. All PROMs were developed based on adult individuals. Seven PROMs (Scale of Alopecia Areata Distress, AAPPO, and all 5 symptom-based PROMs) featured very good development design. Content validity was the most frequently reported measurement property, rated to be sufficient for 8 PROMs. Internal consistency was reported for 5 PROMs with sufficient quality. AAPPO was the only PROM with high-quality evidence of sufficient structural validity and internal consistency. AAPPO was also the only PROM assessed for test-retest reliability, which was judged to be sufficient. No study reported measurement error.Conclusions and relevance: This systematic review shows that there is still an unmet need for high-quality validation studies on the internal structure of AA-specific PROMs. Recommendations have been provided to help improve the rigor of the validation of AA-specific PROMs. Use of standards in psychometric testing of instruments could enhance the quality of instruments.","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.5,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143556853","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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