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Risk Prediction Models for Sentinel Node Positivity in Melanoma: A Systematic Review and Meta-Analysis.
IF 11.5 1区 医学
JAMA dermatology Pub Date : 2025-03-12 DOI: 10.1001/jamadermatol.2025.0113
Bryan Ma, Maharshi Gandhi, Sonia Czyz, Jocelyn Jia, Brian Rankin, Selena Osman, Eva Lindell Jonsson, Lynne Robertson, Laurie Parsons, Claire Temple-Oberle
{"title":"Risk Prediction Models for Sentinel Node Positivity in Melanoma: A Systematic Review and Meta-Analysis.","authors":"Bryan Ma, Maharshi Gandhi, Sonia Czyz, Jocelyn Jia, Brian Rankin, Selena Osman, Eva Lindell Jonsson, Lynne Robertson, Laurie Parsons, Claire Temple-Oberle","doi":"10.1001/jamadermatol.2025.0113","DOIUrl":"10.1001/jamadermatol.2025.0113","url":null,"abstract":"<p><strong>Importance: </strong>There is a need to identify the best performing risk prediction model for sentinel lymph node biopsy (SLNB) positivity in melanoma.</p><p><strong>Objective: </strong>To comprehensively review the characteristics and discriminative performance of existing risk prediction models for SLNB positivity in melanoma.</p><p><strong>Data sources: </strong>Embase and MEDLINE were searched from inception to May 1, 2024, for English language articles.</p><p><strong>Study selection: </strong>All studies that either developed or validated a risk prediction model (defined as any calculator that combined more than 1 variable to provide a patient estimate for probability of melanoma SLNB positivity) with a corresponding measure of model discrimination were considered for inclusion by 2 reviewers, with disagreements adjudicated by a third reviewer.</p><p><strong>Data extraction and synthesis: </strong>Data were extracted in duplicate according to Data Extraction for Systematic Reviews of Prediction Modeling Studies, Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis, and Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guidelines. Effects were pooled using random-effects meta-analysis.</p><p><strong>Main outcome and measures: </strong>The primary outcome was the mean pooled C statistic. Heterogeneity was assessed using the I2 statistic.</p><p><strong>Results: </strong>In total, 23 articles describing the development of 21 different risk prediction models for SLNB positivity, 20 external validations of 8 different risk prediction models, and 9 models that included sufficient information to obtain individualized patient risk estimates in routine preprocedural clinical practice were identified. Among all risk prediction models, the pooled weighted C statistic was 0.78 (95% CI, 0.74-0.81) with significant heterogeneity (I2 = 97.4%) that was not explained in meta-regression. The Memorial Sloan Kettering Cancer Center and Melanoma Institute of Australia models were most frequently externally validated with both having strong and comparable discriminative performance (pooled weighted C statistic, 0.73; 95% CI, 0.69-0.78 vs pooled weighted C statistic, 0.70; 95% CI, 0.66-0.74). Discrimination was not significantly different between models that included gene expression profiles (pooled C statistic, 0.83; 95% CI, 0.76-0.90) and those that only used clinicopathologic features (pooled C statistic, 0.77; 95% CI, 0.73-0.81) (P = .11).</p><p><strong>Conclusions and relevance: </strong>This systematic review and meta-analysis found several risk prediction models that have been externally validated with strong discriminative performance. Further research is needed to evaluate the associations of their implementation with preprocedural care.</p>","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.5,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11904803/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143604879","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
Human Papillomavirus Vaccination and Actinic Keratosis Burden: The VAXAK Randomized Clinical Trial.
IF 11.5 1区 医学
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
{"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":"&lt;p&gt;&lt;strong&gt;Importance: &lt;/strong&gt;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).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To investigate the effect of HPV vaccination on burden of disease in immunocompetent patients with high numbers of AK.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design, setting, and participants: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Interventions: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcomes and measures: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions and relevance: &lt;/strong&gt;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
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
{"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":"<p><strong>Importance: </strong>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.</p><p><strong>Objective: </strong>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.</p><p><strong>Design, setting, and participants: </strong>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.</p><p><strong>Exposures: </strong>Quintiles of ranked neighborhood deprivation measured by the nationwide ADI.</p><p><strong>Main outcomes and measures: </strong>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).</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions and relevance: </strong>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.</p>","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
JAMA dermatology Pub Date : 2025-03-05 DOI: 10.1001/jamadermatol.2025.0049
Ivo Abraham, Karen MacDonald
{"title":"The Evolving Landscape of Biologics-Biosimilars, Biobetters, and Bioparallels.","authors":"Ivo Abraham, Karen MacDonald","doi":"10.1001/jamadermatol.2025.0049","DOIUrl":"https://doi.org/10.1001/jamadermatol.2025.0049","url":null,"abstract":"","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":"143556905","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}
引用次数: 0
Effectiveness of Adalimumab Biosimilars and Originator for Psoriasis.
IF 11.5 1区 医学
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
{"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":"&lt;p&gt;&lt;strong&gt;Importance: &lt;/strong&gt;The uncertainties about the real-world effectiveness of adalimumab biosimilars limit their widespread adoption for psoriasis.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To compare the effectiveness of adalimumab biosimilars Amjevita and Imraldi with Humira for psoriasis.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design, setting, and participants: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Exposures: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcomes and measures: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;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
JAMA dermatology Pub Date : 2025-03-05 DOI: 10.1001/jamadermatol.2025.0019
Sherry Ershadi, John S Barbieri
{"title":"At-Home LED Devices for the Treatment of Acne Vulgaris: A Systematic Review and Meta-Analysis.","authors":"Sherry Ershadi, John S Barbieri","doi":"10.1001/jamadermatol.2025.0019","DOIUrl":"10.1001/jamadermatol.2025.0019","url":null,"abstract":"","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/PMC11883593/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143556790","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
Long-Term Efficacy and Safety of Rituximab in Patients With Pemphigus Foliaceus Compared With Pemphigus Vulgaris.
IF 11.5 1区 医学
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
{"title":"Long-Term Efficacy and Safety of Rituximab in Patients With Pemphigus Foliaceus Compared With Pemphigus Vulgaris.","authors":"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","doi":"10.1001/jamadermatol.2024.6654","DOIUrl":"10.1001/jamadermatol.2024.6654","url":null,"abstract":"","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/PMC11883594/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143556892","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
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
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
{"title":"Efficacy, Safety, and Tolerability of Oral DFD-29, a Low-Dose Formulation of Minocycline, in Rosacea: Two Phase 3 Randomized Clinical Trials.","authors":"Neal Bhatia, James Del Rosso, Linda Stein Gold, Edward Lain, Zoe Diana Draelos, Srinivas Sidgiddi","doi":"10.1001/jamadermatol.2024.6542","DOIUrl":"10.1001/jamadermatol.2024.6542","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;A low-dose modified formulation of minocycline hydrochloride, DFD-29, is under evaluation for treating papulopustular rosacea (PPR).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To determine the efficacy and safety of DFD-29, 40 mg, compared with doxycycline, 40 mg, and placebo for treating PPR.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design, setting, and participants: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Interventions: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcomes and measures: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;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 &lt; .001; MVOR-2: TD, 34.1%; 95% CI, 21.3-46.8; P &lt; .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 &lt; .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 &lt; .001; MVOR-2: TD, -6.8; 95% CI, -8.9 to -4.8; P &lt; .001) and doxycycline (MVOR-1: TD, -4.7; 95% CI, -6.7 to -2.8; P &lt; .001; MVOR-2: TD, -3.5; 95% CI, -5.4 to -1.6; P &lt; .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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions and relevance: &lt;/strong&gt;In this study, DFD-29 was superior in efficacy to both doxycycline and placebo and demonstrated a favorable risk-benef","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/PMC11883608/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143556888","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
Subungual Amelanotic Melanoma.
IF 11.5 1区 医学
JAMA dermatology Pub Date : 2025-03-05 DOI: 10.1001/jamadermatol.2024.6167
Xing Fang, Tianjing Gao, Yu Fu
{"title":"Subungual Amelanotic Melanoma.","authors":"Xing Fang, Tianjing Gao, Yu Fu","doi":"10.1001/jamadermatol.2024.6167","DOIUrl":"https://doi.org/10.1001/jamadermatol.2024.6167","url":null,"abstract":"","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":"143556894","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}
引用次数: 0
Circular Necrotic Yellow-Red Plaque on the Chest.
IF 11.5 1区 医学
JAMA dermatology Pub Date : 2025-03-05 DOI: 10.1001/jamadermatol.2025.0028
Tian-Yi Zhang, Yue-Ping Zeng
{"title":"Circular Necrotic Yellow-Red Plaque on the Chest.","authors":"Tian-Yi Zhang, Yue-Ping Zeng","doi":"10.1001/jamadermatol.2025.0028","DOIUrl":"https://doi.org/10.1001/jamadermatol.2025.0028","url":null,"abstract":"","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":"143556801","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}
引用次数: 0
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