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Tralokinumab for moderate-to-severe atopic dermatitis: A viable option for dupilumab nonresponders

Olagun-Samuel, Christine T; Akoh, Christine C; Anyanwu, Nnaemeka; Sher, Elizabeth F; Needle, Carli D; Widawsky, Jamie; Cohen, David E; Milam, Emily; Flamm, Alexandra; Oza, Vikash; Karagounis, Theodora K
PMCID:12621550
PMID: 41256336
ISSN: 2666-3287
CID: 5975852

Matching-Adjusted Indirect Comparison of the Efficacy of Delgocitinib Cream and Dupilumab in the Treatment of Moderate to Severe Atopic Hand Eczema

Cohen, David; Bewley, Anthony; Wollenberg, Andreas; Hong, H Chih-Ho; Armstrong, April; Jonsen, Emilie; Maslin, Douglas; Thoning, Henrik; von Eyben, Rie; Chovatiya, Raj
INTRODUCTION/BACKGROUND:A matching-adjusted indirect comparison (MAIC) was performed comparing the efficacy of delgocitinib and dupilumab in patients with atopic hand eczema (AHE), one aetiological subtype of chronic hand eczema (CHE). METHODS:DELTA 1/2 were phase 3 trials in which adults with moderate to severe CHE received delgocitinib cream 20 mg/g or cream vehicle twice daily for 16 weeks. LIBERTY-AD-HAFT was a phase 3 trial in which patients with moderate to severe AD with hand or foot involvement received subcutaneous dupilumab or placebo every 2 weeks for 16 weeks. An anchored MAIC was conducted using individual patient data (IPD) from DELTA 1/2 and aggregate published data from LIBERTY-AD-HAFT, with vehicle and placebo as the common anchor. IPD from patients with AHE as the primary subtype in DELTA 1/2 were weighted to match age, race, sex and baseline Hand Eczema Severity Index (HECSI) score in LIBERTY-AD-HAFT. RESULTS:LIBERTY-AD-HAFT included 133 patients (dupilumab, n = 67, placebo, n = 66) while DELTA 1/2 included 345 patients with AHE; the effective sample size after weighted matching was 201 (delgocitinib, n = 128, cream vehicle, n = 73). Anchor-adjusted odds ratios comparing delgocitinib versus dupilumab at week 16 were 1.1 (95% CI: 0.3, 3.4; p = 0.890) for Investigator's Global Assessment for Chronic Hand Eczema / Hand and Foot Investigator's Global Assessment score 0/1, 1.2 (95% CI: 0.4, 3.2; p = 0.773) for HECSI 75 and 1.3 (95% CI: 0.4, 4.9; p = 0.661) for HECSI 90 while response difference for HECSI percent improvement was 11.7% (95% CI: -9.2%, 32.7%; p = 0.273). CONCLUSIONS:Topical delgocitinib and dupilumab in patients with AHE had comparable efficacy, with all results being numerically in favour of delgocitinib, although not statistically significant. CLINICAL TRIAL REGISTRATION/BACKGROUND:NCT04871711, NCT04872101, NCT04417894.
PMID: 41240207
ISSN: 2193-8210
CID: 5967232

Weapons of War and Dermatology: A Comprehensive Review of Cutaneous Manifestations from Chemical Warfare Agents, Part I-Caustics, Vesicants, and Choking Agents

Nahm, William J; Cohen, David E; Milam, Emily C
PMID: 41101990
ISSN: 2162-5220
CID: 5955162

Weapons of War and Dermatology: A Comprehensive Review of Cutaneous Manifestations From Chemical Warfare Agents, Part II: Nerve Agents, Cyanides, and Riot Control Agents

Nahm, William J; Milam, Emily C; Cohen, David E
PMID: 40833343
ISSN: 2162-5220
CID: 5909072

Beyond Avoidance: Advanced Therapies for Contact Dermatitis

Yin, Lu; Ungar, Benjamin; Guttman-Yassky, Emma; Cohen, David E; Karagounis, Theodora K
Contact dermatitis (CD) is a common and burdensome condition divided into irritant contact dermatitis (ICD) and allergic contact dermatitis (ACD). Treatment relies on accurate diagnosis and identification of the trigger, as definitive treatment is irritant/allergen avoidance. However, avoidance is not always possible, such as if the patient is reacting to a necessary medical device, if the trigger is integral to the patient's occupation, or if avoidance is practically untenable. In these cases, treatment is particularly challenging, especially as the literature on treatments in this clinical scenario is limited. Additionally, CD has a complex pathophysiology that varies according to trigger type, leading to variable treatment efficacy. This article reviews the current literature on treatments for CD with a focus on treatments when trigger avoidance is not feasible.
PMID: 38821440
ISSN: 2213-2201
CID: 5664052

Rosacea Core Domain Set for Clinical Trials and Practice: A Consensus Statement

Dirr, McKenzie A; Ahmed, Areeba; Schlessinger, Daniel I; Haq, Misha; Shi, Victoria; Koza, Eric; Ma, Melissa; Christensen, Rachel E; Ibrahim, Sarah A; Schmitt, Jochen; Johannsen, Lena; Asai, Yuka; Baldwin, Hilary E; Berardesca, Enzo; Berman, Brian; Vieira, Ana Carolina; Chien, Anna L; Cohen, David E; Del Rosso, James Q; Dosal, Jacquelyn; Drake, Lynn A; Feldman, Steven R; Fleischer, Alan B; Friedman, Adam; Graber, Emmy; Harper, Julie C; Helfrich, Yolanda R; Jemec, Gregor B; Johnson, Sandra M; Katta, Rajani; Lio, Peter; Maier, Lisa E; Martin, George; Nagler, Arielle R; Neuhaus, Isaac M; Palamar, Melis; Parish, Lawrence C; Rosen, Theodore; Shumack, Stephen P; Solomon, James A; Tanghetti, Emil A; Webster, Guy F; Weinkle, Allison; Weiss, Jonathan S; Wladis, Edward J; Maher, Ian A; Sobanko, Joseph F; Cartee, Todd V; Cahn, Brian A; Alam, Murad; ,; Kang, Bianca Y; Iyengar, Sanjana; Anvery, Noor; Alpsoy, Erkan; Bewley, Anthony; Dessinioti, Clio; Egeberg, Alexander; Engin, Burhan; Gollnick, Harald P M; Ioannides, Dimitrios; Kim, Hei Sung; Lazaridou, Elizabeth; Li, Ji; Lim, Hester Gail; Micali, Giuseppe; de Oliveira, Clivia Maria Moraes; Noguera-Morel, Lucero; Parodi, Aurora; Reinholz, Markus; Suh, Dae Hun; Sun, Qiuning; van Zuuren, Esther J; Wollina, Uwe; Zhou, Youwen; Zip, Catherine; Poon, Emily; Pearlman, Ross
IMPORTANCE/UNASSIGNED:Inconsistent reporting of outcomes in clinical trials of rosacea is impeding and likely preventing accurate data pooling and meta-analyses. There is a need for standardization of outcomes assessed during intervention trials of rosacea. OBJECTIVE/UNASSIGNED:To develop a rosacea core outcome set (COS) based on key domains that are globally relevant and applicable to all demographic groups to be used as a minimum list of outcomes for reporting by rosacea clinical trials, and when appropriate, in clinical practice. EVIDENCE REVIEW/UNASSIGNED:A systematic literature review of rosacea clinical trials was conducted. Discrete outcomes were extracted and augmented through discussions and focus groups with key stakeholders. The initial list of 192 outcomes was refined to identify 50 unique outcomes that were rated through the Delphi process Round 1 by 88 panelists (63 physicians from 17 countries and 25 patients with rosacea in the US) on 9-point Likert scale. Based on feedback, an additional 11 outcomes were added in Round 2. Outcomes deemed to be critical for inclusion (rated 7-9 by ≥70% of both groups) were discussed in consensus meetings. The outcomes deemed to be most important for inclusion by at least 85% of the participants were incorporated into the final core domain set. FINDINGS/UNASSIGNED:The Delphi process and consensus-building meetings identified a final core set of 8 domains for rosacea clinical trials: ocular signs and symptoms; skin signs of disease; skin symptoms; overall severity; patient satisfaction; quality of life; degree of improvement; and presence and severity of treatment-related adverse events. Recommendations were also made for application in the clinical setting. CONCLUSIONS AND RELEVANCE/UNASSIGNED:This core domain set for rosacea research is now available; its adoption by researchers may improve the usefulness of future trials of rosacea therapies by enabling meta-analyses and other comparisons across studies. This core domain set may also be useful in clinical practice.
PMID: 38656294
ISSN: 2168-6084
CID: 5657602

Safety Assessment of Polysilicone-11 as Used in Cosmetics

Cherian, Priya; Bergfeld, Wilma F; Belsito, Donald V; Cohen, David E; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Peterson, Lisa A; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Fiume, Monice; Heldreth, Bart
The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Polysilicone-11 as used in cosmetic formulations. This ingredient is reported to function as a film former. The Panel considered the available data and concluded that Polysilicone-11 is safe in cosmetics in the present practices of use and concentration described in this safety assessment.
PMID: 38471032
ISSN: 1092-874x
CID: 5643532

Guidelines of care for the management of atopic dermatitis in adults with phototherapy and systemic therapies

Davis, Dawn M R; Drucker, Aaron M; Alikhan, Ali; Bercovitch, Lionel; Cohen, David E; Darr, Jennifer M; Eichenfield, Lawrence F; Frazer-Green, Lindsy; Paller, Amy S; Schwarzenberger, Kathryn; Silverberg, Jonathan I; Singh, Anne Marie; Wu, Peggy A; Sidbury, Robert
BACKGROUND:For people with atopic dermatitis (AD) refractory to topical therapies, treatment with phototherapy and systemic therapies can be considered. Multiple biologic therapies and Janus kinase (JAK)inhibitors have been approved since 2014 to treat AD. These guidelines update the 2014 recommendations for management of AD with phototherapy and systemic therapies. OBJECTIVE:To provide evidence-based recommendations on the use of phototherapy and systemic therapies for AD in adults. METHODS:A multidisciplinary workgroup conducted a systematic review and applied the GRADE approach for assessing the certainty of evidence and formulating and grading recommendations. RESULTS:The workgroup developed 11 recommendations on the management of AD in adults with phototherapy and systemic agents, including biologics, oral JAK inhibitors, and other immunomodulatory medications. LIMITATIONS/CONCLUSIONS:Most randomized controlled trials of phototherapy and systemic therapies for AD are of short duration with subsequent extension studies, limiting comparative long-term efficacy and safety conclusions. CONCLUSIONS:We make strong recommendations for the use of dupilumab, tralokinumab, abrocitinib, baricitinib, and upadacitinib. We make conditional recommendations in favor of using phototherapy, azathioprine, cyclosporine, methotrexate, and mycophenolate, and against the use of systemic corticosteroids.
PMID: 37943240
ISSN: 1097-6787
CID: 5626462

Executive summary: Guidelines of care for the management of atopic dermatitis in adults with phototherapy and systemic therapies

Davis, Dawn M R; Drucker, Aaron M; Alikhan, Ali; Bercovitch, Lionel; Cohen, David E; Darr, Jennifer M; Eichenfield, Lawrence F; Frazer-Green, Lindsy; Paller, Amy S; Schwarzenberger, Kathryn; Silverberg, Jonathan I; Singh, Anne Marie; Wu, Peggy A; Sidbury, Robert
BACKGROUND:The summarized guidelines update the 2014 recommendations for the management of AD with phototherapy and systemic therapies. METHODS:A multidisciplinary workgroup conducted a systematic review and applied the GRADE approach for assessing the certainty of the evidence and formulating and grading recommendations. RESULTS:The workgroup developed 11 recommendations on the management of AD in adults with phototherapy and systemic therapies, including biologics, oral Janus Kinase inhibitors, and other immunomodulatory medications. CONCLUSIONS:The evidence supported strong recommendations for the use of dupilumab, tralokinumab, abrocitinib, baricitinib, and upadacitinib and conditional recommendations in favor of using phototherapy, azathioprine, cyclosporine, methotrexate, and mycophenolate, and against the use of systemic corticosteroids.
PMID: 37943241
ISSN: 1097-6787
CID: 5626472

Axillary Contact Dermatitis: An Update on Potential Allergens and Management

Musicante, Meryl J; Cohen, David E; Milam, Emily C
The differential diagnosis of dermatoses in the axillae is broad. Contact dermatitis-both irritant and allergic-represents common etiologies. Axillary contact dermatitis can develop following exposure to a variety of irritants and/or allergens. Frequently implicated sources include deodorants, antiperspirants, detergents, soaps, and clothing. Fragrance, a ubiquitous ingredient within these products, as well as metals and dyes, are common causes of contact dermatitis. Clinical assessment, bedside diagnostic techniques, histopathology, and patch testing can aid in the diagnosis and help inform management directions.
PMID: 38478935
ISSN: 2326-6929
CID: 5737762