Baricitinib, an oral selective Janus kinase inhibitor, is approved to treat adults with severe alopecia areata (AA).
Objective
To report the week 152 efficacy results from the phase 3 trial BRAVE-AA2 down-titration substudy.
Methods
BRAVE-AA2 enrolled 546 adults with severe AA (Severity of Alopecia Tool [SALT] score ≥50). Baricitinib 4-mg-treated patients achieving a clinical response (SALT score ≤20) at week 52 were rerandomized 1:1 to stay on 4-mg or down-titrate to 2-mg. The last observation carried forward was used to impute missing or censored data.
Results
At week 52, 86/234 (36.8%) baricitinib 4-mg-treated patients were eligible for down-titration; 44 remained on 4-mg while 42 down-titrated to 2-mg. At week 152, 39/44 (88.6%) 4-mg-treated patients had maintained clinical response, compared to 24/41 (58.5%) down-titrated patients. Among down-titrated patients, loss of treatment benefit was less frequent in those with sustained response and SALT score ≤5 at week 52.
Limitations
Method and timing of down-titration were prespecified in the protocol based on week 52 responder status and not on other clinical factors.
Conclusion
More than half of down-titrated patients maintained response. Sustained treatment response and/or near-total regrowth may be associated with a greater likelihood of response maintenance after down-titration.
{"title":"Outcomes of down-titration in patients with severe scalp alopecia areata initially treated with baricitinib 4-mg: Week 152 data from BRAVE-AA2","authors":"Brett King MD, PhD , Manabu Ohyama MD, PhD , Maryanne Senna MD , Jerry Shapiro MD , Yves Dutronc MD , Frederick Durand MD , Chunyuan Liu PhD , Guanglei Yu PhD , Jill Kolodsick PhD , Chiara Chiasserini ScD , Najwa Somani MD , Bianca Maria Piraccini MD, PhD","doi":"10.1016/j.jaad.2024.09.072","DOIUrl":"10.1016/j.jaad.2024.09.072","url":null,"abstract":"<div><h3>Background</h3><div>Baricitinib, an oral selective Janus kinase inhibitor, is approved to treat adults with severe alopecia areata (AA).</div></div><div><h3>Objective</h3><div>To report the week 152 efficacy results from the phase 3 trial BRAVE-AA2 down-titration substudy.</div></div><div><h3>Methods</h3><div>BRAVE-AA2 enrolled 546 adults with severe AA (Severity of Alopecia Tool [SALT] score ≥50). Baricitinib 4-mg-treated patients achieving a clinical response (SALT score ≤20) at week 52 were rerandomized 1:1 to stay on 4-mg or down-titrate to 2-mg. The last observation carried forward was used to impute missing or censored data.</div></div><div><h3>Results</h3><div>At week 52, 86/234 (36.8%) baricitinib 4-mg-treated patients were eligible for down-titration; 44 remained on 4-mg while 42 down-titrated to 2-mg. At week 152, 39/44 (88.6%) 4-mg-treated patients had maintained clinical response, compared to 24/41 (58.5%) down-titrated patients. Among down-titrated patients, loss of treatment benefit was less frequent in those with sustained response and SALT score ≤5 at week 52.</div></div><div><h3>Limitations</h3><div>Method and timing of down-titration were prespecified in the protocol based on week 52 responder status and not on other clinical factors.</div></div><div><h3>Conclusion</h3><div>More than half of down-titrated patients maintained response. Sustained treatment response and/or near-total regrowth may be associated with a greater likelihood of response maintenance after down-titration.</div></div>","PeriodicalId":17198,"journal":{"name":"Journal of the American Academy of Dermatology","volume":"92 2","pages":"Pages 299-306"},"PeriodicalIF":12.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142502822","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}
Pub Date : 2025-02-01DOI: 10.1016/j.jaad.2024.11.024
Warren R. Heymann MD
{"title":"Turning our attention to melanoma risk in Turner syndrome","authors":"Warren R. Heymann MD","doi":"10.1016/j.jaad.2024.11.024","DOIUrl":"10.1016/j.jaad.2024.11.024","url":null,"abstract":"","PeriodicalId":17198,"journal":{"name":"Journal of the American Academy of Dermatology","volume":"92 2","pages":"Pages 240-241"},"PeriodicalIF":12.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142687323","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}
Pub Date : 2025-02-01DOI: 10.1016/j.jaad.2024.08.075
Matthew F. Helm MD, Galen T. Foulke MD
{"title":"Dermatomyositis","authors":"Matthew F. Helm MD, Galen T. Foulke MD","doi":"10.1016/j.jaad.2024.08.075","DOIUrl":"10.1016/j.jaad.2024.08.075","url":null,"abstract":"","PeriodicalId":17198,"journal":{"name":"Journal of the American Academy of Dermatology","volume":"92 2","pages":"Pages 365-375"},"PeriodicalIF":12.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142308020","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}
Pub Date : 2025-02-01DOI: 10.1016/j.jaad.2024.09.057
Joao Renato V. Gontijo MD, MSc , Jacob H. Nelson DO , Kyra Diehl BS , Veselina B. Korcheva MD , Flavia Vasques Bittencourt MD, PhD , Sancy A. Leachman MD, PhD
{"title":"Thin and in situ melanomas of unfavorable prognosis: A retrospective observational analysis of local recurrence, metastasis, and death in early-stage disease","authors":"Joao Renato V. Gontijo MD, MSc , Jacob H. Nelson DO , Kyra Diehl BS , Veselina B. Korcheva MD , Flavia Vasques Bittencourt MD, PhD , Sancy A. Leachman MD, PhD","doi":"10.1016/j.jaad.2024.09.057","DOIUrl":"10.1016/j.jaad.2024.09.057","url":null,"abstract":"","PeriodicalId":17198,"journal":{"name":"Journal of the American Academy of Dermatology","volume":"92 2","pages":"Pages 325-327"},"PeriodicalIF":12.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142400604","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}
Pub Date : 2025-02-01DOI: 10.1016/S0190-9622(24)03299-7
{"title":"JAAD Case Reports Article List","authors":"","doi":"10.1016/S0190-9622(24)03299-7","DOIUrl":"10.1016/S0190-9622(24)03299-7","url":null,"abstract":"","PeriodicalId":17198,"journal":{"name":"Journal of the American Academy of Dermatology","volume":"92 2","pages":"Pages A20-A21"},"PeriodicalIF":12.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143204582","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}
Pub Date : 2025-02-01DOI: 10.1016/j.jaad.2024.01.091
Christine J. Ko MD , Jeffrey R. Gehlhausen MD, PhD , Jeffrey M. Cohen MD , Pat Croskerry MD, PhD
Cognitive bias may lead to diagnostic error in the patient encounter. There are hundreds of different cognitive biases, but certain biases are more likely to affect patient diagnosis and management. As during morbidity and mortality rounds, retrospective evaluation of a given case, with comparison to an optimal diagnosis, can pinpoint errors in judgment and decision-making. The study of cognitive bias also illuminates how we might improve the diagnostic process. In Part 1 of this series, cognitive bias is defined and placed within the background of dual process theory, emotion, heuristics, and the more neutral term judgment and decision-making bias.
{"title":"Cognitive bias in the patient encounter: Part I. Background and significance","authors":"Christine J. Ko MD , Jeffrey R. Gehlhausen MD, PhD , Jeffrey M. Cohen MD , Pat Croskerry MD, PhD","doi":"10.1016/j.jaad.2024.01.091","DOIUrl":"10.1016/j.jaad.2024.01.091","url":null,"abstract":"<div><div>Cognitive bias may lead to diagnostic error in the patient encounter. There are hundreds of different cognitive biases, but certain biases are more likely to affect patient diagnosis and management. As during morbidity and mortality rounds, retrospective evaluation of a given case, with comparison to an optimal diagnosis, can pinpoint errors in judgment and decision-making. The study of cognitive bias also illuminates how we might improve the diagnostic process. In Part 1 of this series, cognitive bias is defined and placed within the background of dual process theory, emotion, heuristics, and the more neutral term judgment and decision-making bias.</div></div>","PeriodicalId":17198,"journal":{"name":"Journal of the American Academy of Dermatology","volume":"92 2","pages":"Pages 213-220"},"PeriodicalIF":12.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140768788","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}
Pub Date : 2025-02-01DOI: 10.1016/j.jaad.2024.08.060
Anna Chen BA , Leore Lavin MA , Alina Markova MD , Mario E. Lacouture MD
{"title":"Clinical presentations of skin of color in oncodermatology","authors":"Anna Chen BA , Leore Lavin MA , Alina Markova MD , Mario E. Lacouture MD","doi":"10.1016/j.jaad.2024.08.060","DOIUrl":"10.1016/j.jaad.2024.08.060","url":null,"abstract":"","PeriodicalId":17198,"journal":{"name":"Journal of the American Academy of Dermatology","volume":"92 2","pages":"Pages 357-364"},"PeriodicalIF":12.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142289914","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}
Pub Date : 2025-02-01DOI: 10.1016/j.jaad.2024.09.046
Amy S. Paller MD , Marjolein de Bruin-Weller MD , Danielle Marcoux MD , Eulalia Baselga MD , Vania Oliveira de Carvalho MD , Ledit R.F. Ardusso MD , Suzanne G.M.A. Pasmans MD , Mirna Toledo-Bahena MD, MSc , Cory Rubin MD , Joel C. Joyce MD , Lara Wine Lee MD, PhD , Bryan Adams PhD , Rajan Gupta PhD , Marius Ardeleanu MD , Annie Zhang MD
Background
The arrival of biologics and small-molecule therapies (eg Janus kinase inhibitors) changed atopic dermatitis treatment, but older systemic treatments continue to be prescribed.
Objective
To provide real-world effectiveness, safety, and adherence data for dupilumab, cyclosporine, and methotrexate.
Methods
PEDIatric STudy in Atopic Dermatitis (NCT03687359) is a real-world, prospective, observational, 10-year study of children (<12 years) with inadequately controlled moderate-to-severe atopic dermatitis. We report 2-year interim results.
Results
Median treatment durations were 8.1, 13.0, and 10.7 months for dupilumab (n = 144), methotrexate (n = 114), and cyclosporine (n = 121), respectively. Dupilumab had numerically greater within-group improvements than methotrexate and cyclosporine in Eczema Area and Severity Index (−12.4∗ vs −5.7∗ and −3.3); body surface area affected (−19.9%∗ vs −11.8%∗ and −8.8%∗); itching (night-time: −2.1∗ vs −0.4 and + 0.1; daytime: −1.5∗ vs +0.1 and + 0.2; ≥6 years); itching/scratching (−3.6∗ vs −1.4∗ and −0.2; <6 years); and Patient-Oriented Eczema Measure (−7.0∗ vs −4.7∗ and −1.5) (∗P < .05 within-group improvements from baseline). Dupilumab had less discontinuations (8.3% vs 28.9% and 43.0%) and adverse event(s) (18.1% vs 29.8% and 31.4%).
Limitations
No randomization, placebo, or specified dosages.
Conclusion
Dupilumab was associated with numerically greater outcomes and higher adherence than cyclosporine or methotrexate.
背景:生物制剂和小分子疗法(如Janus激酶抑制剂)的出现改变了特应性皮炎(AD)的治疗方法,但旧的系统治疗方法仍在使用:目的:提供杜必鲁单抗、环孢素和甲氨蝶呤的实际有效性、安全性和依从性数据:PEDISTAD (NCT03687359)是一项针对儿童的真实世界、前瞻性、观察性、为期10年的研究:杜比鲁单抗(144 例)、甲氨蝶呤(114 例)和环孢素(121 例)的中位治疗时间分别为 8.1、13.0 和 10.7 个月。在湿疹面积和严重程度指数(-12.4* vs -5.7* 和-3.3)、受影响体表面积(-19.9%* vs -11.8%* 和 -8.8%*);瘙痒(夜间:-2.1* vs -0.4 和 +0.1;白天:-1.5* vs +0.1 和 +0.2;≥6 岁);瘙痒/抓挠(-3.6* vs -1.4* 和 -0.2;局限性:结论:杜匹单抗与瘙痒/搔痒(-3.6* vs -1.4* 和-0.2;局限性:无随机分组、安慰剂或指定剂量)相关:结论:与环孢素或甲氨蝶呤相比,杜比鲁单抗具有更高的疗效和更高的依从性。
{"title":"Real-world treatment outcomes of systemic treatments for moderate-to-severe atopic dermatitis in children aged less than 12 years: 2-year results from PEDIatric STudy in Atopic Dermatitis","authors":"Amy S. Paller MD , Marjolein de Bruin-Weller MD , Danielle Marcoux MD , Eulalia Baselga MD , Vania Oliveira de Carvalho MD , Ledit R.F. Ardusso MD , Suzanne G.M.A. Pasmans MD , Mirna Toledo-Bahena MD, MSc , Cory Rubin MD , Joel C. Joyce MD , Lara Wine Lee MD, PhD , Bryan Adams PhD , Rajan Gupta PhD , Marius Ardeleanu MD , Annie Zhang MD","doi":"10.1016/j.jaad.2024.09.046","DOIUrl":"10.1016/j.jaad.2024.09.046","url":null,"abstract":"<div><h3>Background</h3><div>The arrival of biologics and small-molecule therapies (eg Janus kinase inhibitors) changed atopic dermatitis treatment, but older systemic treatments continue to be prescribed.</div></div><div><h3>Objective</h3><div>To provide real-world effectiveness, safety, and adherence data for dupilumab, cyclosporine, and methotrexate.</div></div><div><h3>Methods</h3><div>PEDIatric STudy in Atopic Dermatitis (NCT03687359) is a real-world, prospective, observational, 10-year study of children (<12 years) with inadequately controlled moderate-to-severe atopic dermatitis. We report 2-year interim results.</div></div><div><h3>Results</h3><div>Median treatment durations were 8.1, 13.0, and 10.7 months for dupilumab (<em>n</em> = 144), methotrexate (<em>n</em> = 114), and cyclosporine (<em>n</em> = 121), respectively. Dupilumab had numerically greater within-group improvements than methotrexate and cyclosporine in Eczema Area and Severity Index (−12.4∗ vs −5.7∗ and −3.3); body surface area affected (−19.9%∗ vs −11.8%∗ and −8.8%∗); itching (night-time: −2.1∗ vs −0.4 and + 0.1; daytime: −1.5∗ vs +0.1 and + 0.2; ≥6 years); itching/scratching (−3.6∗ vs −1.4∗ and −0.2; <6 years); and Patient-Oriented Eczema Measure (−7.0∗ vs −4.7∗ and −1.5) (∗<em>P</em> < .05 within-group improvements from baseline). Dupilumab had less discontinuations (8.3% vs 28.9% and 43.0%) and adverse event(s) (18.1% vs 29.8% and 31.4%).</div></div><div><h3>Limitations</h3><div>No randomization, placebo, or specified dosages.</div></div><div><h3>Conclusion</h3><div>Dupilumab was associated with numerically greater outcomes and higher adherence than cyclosporine or methotrexate.</div></div>","PeriodicalId":17198,"journal":{"name":"Journal of the American Academy of Dermatology","volume":"92 2","pages":"Pages 242-251"},"PeriodicalIF":12.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142400601","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}
Pub Date : 2025-02-01DOI: 10.1016/j.jaad.2024.09.055
Gabriella V. Alvarez MD , Kai-Ping Liao MS , Mackenzie R. Wehner MD, MPhil , Megan N. Rogge MD
{"title":"Melanoma risk in Turner syndrome: A case-control study in Surveillance, Epidemiology, and End Results-Medicare","authors":"Gabriella V. Alvarez MD , Kai-Ping Liao MS , Mackenzie R. Wehner MD, MPhil , Megan N. Rogge MD","doi":"10.1016/j.jaad.2024.09.055","DOIUrl":"10.1016/j.jaad.2024.09.055","url":null,"abstract":"","PeriodicalId":17198,"journal":{"name":"Journal of the American Academy of Dermatology","volume":"92 2","pages":"Pages 321-323"},"PeriodicalIF":12.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142406556","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}
{"title":"Exploring suicidal and self-injurious behaviors signal strength of biologics in treating psoriasis or psoriatic arthritis: A 10-year real-world pharmacovigilance analysis using the FDA Adverse Event Reporting System database","authors":"Yu-Fan Cheng MD, PhD , Ming Chen MD, PhD , Xiong-Yu Li BS , Cai-Lan Hou MD, PhD , Zhu Shen MD, PhD","doi":"10.1016/j.jaad.2024.09.058","DOIUrl":"10.1016/j.jaad.2024.09.058","url":null,"abstract":"","PeriodicalId":17198,"journal":{"name":"Journal of the American Academy of Dermatology","volume":"92 2","pages":"Pages 327-329"},"PeriodicalIF":12.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142468636","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}