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This case report highlights the successful treatment of refractory atopic dermatitis (AD) in an immunosuppressed patient using dupilumab, a biologic agent that selectively targets cytokines crucial in the pathogenesis of AD. The patient had a history of failed treatment with numerous topical and systemic immunomodulating agents, including corticosteroids and immunosuppressive drugs for organ transplant. Dupilumab treatment resulted in significant improvement of symptoms, including reduced pruritus, and ultimately achieved disease control. Importantly, the patient experienced no adverse effects apart from one COVID-19 infection over three years of co-administration of dupilumab with immunosuppressive transplant rejection treatment. The safety of dupilumab in immunocompromised and transplant patients has been a concern, but studies have shown its safety and efficacy in these patient populations. This case highlights the potential for dupilumab as a safe and effective treatment option for patients with severe AD who are immunocompromised or have undergone solid organ transplantation.

Background: Actinic keratosis (AK) is one of the most common dermatologic diagnoses. While there are several treatment options, many topical therapies have poor adherence due to duration of treatment and local skin reactions (LSRs). Objective: To review the available literature on the most commonly used patient-administered field-directed therapies for AK and create consensus statements on the role of medication adherence in improving AK outcomes. Methods: A literature search of PubMed was completed for English-language original research articles reporting efficacy, safety, and tolerability data for 5-FU, diclofenac gel, imiquimod cream, and tirbanibulin. Once the articles were selected, they were distributed to a panel consisting of seven dermatologists with extensive expertise in managing AKs. Each panelist reviewed the articles and assigned them a level of evidence based on Strength of Recommendation Taxonomy (SORT) criteria. The panelists then met to review and discuss the studies and created consensus statements on the management of AKs and the importance of medication compliance. A modified Delphi process was used to approve the adoption of each statement. Results: The literature search produced 1,326 articles that met search criteria. After screening these articles for relevance and applying the inclusion criteria, 17 articles were chosen to be reviewed by the panel and assigned a level of evidence based on SORT criteria. The panel then created six consensus statements that received a unanimous vote for adoption. Conclusion: While there are several options for the treatment of AK, there is little consensus on a standard of care. Clearance rates for the most common topical field therapies vary significantly but are also difficult to directly compare due to differences in methodology for measuring and assessing outcomes. Overall, it is clear that an efficacious, tolerable, and convenient treatment for AKs is critical to optimal adherence and management and, given the results of recent studies, tirbanibulin may be the best topical option for meeting these criteria.

Background: Patients' experiences regarding topical actinic keratosis (AK) treatments may optimize clinical outcomes. PROAK study aimed to evaluate patient- and clinician-reported outcomes among adult patients with AK on face or scalp who were prescribed tirbanibulin in real-world clinical practice in the United States. Methods: Key primary endpoint was quality of life (QoL) assessed by Skindex-16. Additional endpoints were tirbanibulin treatment effectiveness and satisfaction (Treatment Satisfaction Questionnaire for Medication and Expert Panel Questionnaire). Results: 290 patients were included in this analysis. At week 8, Skindex-16 scores improved in all domains (mean change from baseline [standard deviation, SD]: -14.3 [27.8] in symptoms, -24.9 [33.0] in emotions, and -9.8 [23.7] in functioning domain). Clinicians and patients reported high global satisfaction with tirbanibulin (mean [SD] scores of 78.8 [20.1] and of 74.5 [23.5]). Overall skin appearance improved from baseline to week 8 (91.0% clinicians; 84.1% patients). In comparison with previous treatments, tirbanibulin had shorter skin reactions duration (89.2% clinicians; 73.9% patients); milder skin reaction severity (91.0% clinicians; 76.6% patients); better daily activities impact (87.4% clinicians; 64.0% patients); and was easier to use (88.3% clinicians; 71.2% patients). Investigator’s Global Assessment (IGA) success (0-1) was achieved by 73.8% of the patients. Skin photodamage severity reduction from baseline to week 8 was significant (77.4% vs. 39.6%; p

Background Given the chronic nature of psoriasis and the loss of response that can be observed with therapies over time, it is important to understand the long-term efficacy of new treatments. Objectives To evaluate maintenance of Week 16 responses with bimekizumab (BKZ) treatment through Year 3, in patients with moderate-to-severe plaque psoriasis. Methods Data were pooled from BKZ-treated patients in the 52-week (BE VIVID) and 56-week (BE READY and BE SURE) phase III studies, and their ongoing open-label extension (OLE), BE BRIGHT. Efficacy outcomes are reported through 3 years of BKZ treatment in patients with an efficacy response at Week 16. Missing data were imputed primarily using modified nonresponder imputation (mNRI), with nonresponder imputation and observed case data also reported. Results A total of 989 patients were randomized to BKZ at baseline in BE VIVID, BE READY and BE SURE. At Week 16, 693 patients achieved ≥ 90% reduction from baseline in Psoriasis Area and Severity Index (PASI 90), 503 achieved 100% reduction from baseline in PASI (PASI 100), 694 achieved absolute PASI ≤ 2 and 597 achieved body surface area (BSA) ≤ 1%, and continued into the OLE. Of these, 93.0% maintained PASI 90, 80.8% maintained PASI 100, 94.0% maintained PASI ≤ 2 and 90.3% maintained BSA ≤ 1% responses through to 3 years of BKZ treatment (mNRI). Among Week 16 PASI 90 responders, 96.8% and 72.5% also achieved Investigator’s Global Assessment 0/1 and PASI 100 at Week 16, respectively, and 92.2% and 73.4% achieved these responses at Year 3 (mNRI). Among Week 16 PASI 100 responders, 76.3% also achieved Dermatology Life Quality Index (DLQI) 0/1 at Week 16, and DLQI 0/1 response increased with continuous BKZ treatment to 89.0% at Year 3 (mNRI). Conclusions High levels of clinical response were maintained through to 3 years of BKZ treatment in the vast majority of Week 16 responders. Long-term treatment with BKZ was efficacious, with important benefits for health-related quality of life, in patients with moderate-to-severe plaque psoriasis.

Background: Cutaneous melanoma (CM) guidelines put forth by the eighth edition of the American Joint Committee on Cancer (AJCC8) and the National Comprehensive Cancer Network (NCCN) do not currently account for lesion genomics when assessing prognosis. Gene Expression Profile (GEP) tests have become a widely adopted tool to help clinicians identify patients at higher risk for metastasis and recurrence. Objective: To review the available literature that has been published since a consensus panel in 2018 on three commercially available GEP tests used in the prognostic assessment of CM and create updated guidelines and consensus statements for their optimal use. Methods: A comprehensive literature search of PubMed and Google Scholar was conducted for relevant English-language original research articles, meta-analyses, and systematic reviews published from 2019 through 2022. A panel of 6 key opinion leaders in dermatology with specialized expertise in diagnosing and managing CM then convened to review the articles and create guidelines. A modified Delphi process was used to approve each statement. The panel assigned each article a level of evidence and each consensus statement a strength of recommendation using Strength of Recommendation Taxonomy (SORT) criteria. Results: The literature search identified 785 articles that met the search criteria. Of these, there were 22 articles that validated the 31-GEP test, 2 that validated the 11-GEP test, and 7 that validated the 8-GEP + CP test. The panel unanimously approved 6 usage guidelines and 5 consensus supporting statements for the appropriate use of these tests. Conclusion: Based on the currently available literature, GEP tests provide valuable information beyond AJCC8 and NCCN guidelines for the prognostic assessment of CM. There are significantly more validation studies supporting the use of the 31-GEP test compared to the 11-GEP test and the 8-GEP + CP test.

Chronic spontaneous urticaria (CSU) is a debilitating skin disease characterized by intensely itchy wheals, angioedema, or both. Symptoms recur spontaneously, on a near-daily basis, over >6 weeks; many patients experience flare-ups over several years and, consequently, reduced quality of life. Differences between the inflammatory profiles of the skin of CSU patients (wheals and nonlesional sites) and healthy controls indicate that key drivers such as mast cells, eosinophils, and basophils interact, release vasoactive mediators, and prime the skin, leaving patients predisposed to symptoms. Many cytokines and chemokines involved in these inflammatory networks and their corresponding intracellular signaling cascades have been identified. These insights informed the development of therapies such as omalizumab, dupilumab, and Bruton's tyrosine kinase (BTK) inhibitors, marking a renewed focus on pathogenesis in CSU clinical research. Despite progress, current therapies provide symptomatic control but do not appear to redress the inflammatory balance in the skin permanently. A deeper understanding of CSU pathogenesis will permit a more targeted approach to developing novel treatments with curative intent. Here, we review what is known about the pathogenesis of CSU and consider how this can be used to identify rational targets to improve patient care further.

Background Discontinuation of biologics is common among patients with psoriasis due to treatment failure or adverse events. To achieve improvements in disease management, patients and clinicians may choose to switch biologics. Objectives To evaluate the efficacy and safety of switching to bimekizumab from adalimumab, ustekinumab and secukinumab. Methods Data are reported for up to 80 weeks after patients switched to bimekizumab from adalimumab at week 24 in BE SURE, ustekinumab at week 52 in BE VIVID [upon entry into the BE BRIGHT open-label extension (OLE)] and secukinumab at week 48 in BE RADIANT (upon entry into the BE RADIANT OLE). Efficacy outcomes are reported by number of weeks after switching to bimekizumab and were split based on whether patients had achieved a ≥ 90% improvement from baseline in Psoriasis Area and Severity Index (PASI 90) at the time of switch. Treatment-emergent adverse events (TEAEs) are reported using exposure-adjusted incidence rates (EAIRs) per 100 patient-years. Trial registration: BE SURE (NCT03412747), BE VIVID (NCT03370133), BE BRIGHT (NCT03598790), BE RADIANT (NCT03536884). Results Rapid and durable improvements in clinical responses and benefits in health-related quality of life were observed among PASI 90 nonresponders who switched to bimekizumab. Most PASI 90 nonresponders achieved PASI 90 4 weeks after switching to bimekizumab from adalimumab (67%), ustekinumab (79%) and secukinumab (53%). After 48 weeks of bimekizumab, 91%, 90% and 79% of PASI 90 nonresponders had achieved PASI 90 after switching from adalimumab, ustekinumab or secukinumab, respectively. Durable improvements were also observed for PASI 100, Investigator’s Global Assessment score 0/1, body surface area affected by psoriasis ≤ 1%, absolute PASI ≤ 2, and Dermatology Life Quality Index 0/1. Among PASI 90 responders, existing treatment responses were maintained or improved after switching to bimekizumab. The majority of TEAEs were mild or moderate. EAIRs were generally similar between active-comparator treatment periods and after switching to bimekizumab. EAIRs typically decreased with a longer duration of bimekizumab exposure. Conclusions High proportions of patients who did not adequately respond to adalimumab, ustekinumab or secukinumab achieved high levels of skin clearance after switching to bimekizumab. Bimekizumab was well tolerated and there were no new safety findings.

Background/Aims Ixekizumab (IXE) is a high-affinity, monoclonal antibody targeting IL-17A and is approved for the treatment of psoriasis (PsO), psoriatic arthritis (PsA), ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation. We report long-term, end-of-study-program, safety outcomes in adult patients with PsO, PsA and axSpA who received at least one dose of IXE over 5 years (PsO) or 3 years (PsA and axSpA). Methods An integrated safety analysis consisting of data from 25 randomised clinical trials (RCTs; 17 PsO, 4 PsA, 4 axSpA) was used to examine long-term safety of IXE. Rates of treatment-emergent adverse events (TEAEs), serious AEs (SAEs) and AEs of special interest were analyzed for all pooled studies by years of therapy and overall through March 2022, and reported as exposure-adjusted incidence rates (IRs) per 100 patient-years (PY) at successive year intervals. Additional safety outcomes included selected safety topics of interest (among others). Results A total of 6892 patients with PsO, 1401 patients with PsA, and 932 patients with axSpA, with a cumulative IXE exposure of 18025.7 PY for PsO, 2247.7 PY for PsA, and 2097.7 PY for axSpA were included in this analysis. The IRs per 100 PY for any TEAE were as follows: patients with PsO=32.5; PsA=50.3; axSpA=38.0. The most commonly reported TEAEs were nasopharyngitis (PsO, IR = 8.8; PsA, IR = 9.0; axSpA IR = 8.4) and upper respiratory tract infection (PsO, IR = 6.2; PsA, IR = 8.3; axSpA IR = 5.8). Serious AEs were reported by 969 patients with PsO (IR = 5.4), 134 patients with PsA (IR = 6), and 101 patients with axSpA (IR = 4.8). Forty-five deaths were reported (PsO=36 [IR = 0.2]; PsA=6 [IR = 0.3]; axSpA=3 [IR = 0.1]). The IRs per 100 PY of discontinuation from the study drug due to AE were as follows: PsO, 2.9; PsA, 5.1; axSpA, 3.1. IRs of injection site reactions were: PsO, 5.9; PsA, 11.6; axSpA, 7.4. IRs of allergic reactions were: PsO, 5.6; PsA, 4.5; axSpA, 4.2. IRs of serious infections were low (PsO, IR = 1.3; PsA, IR = 1.2; axSpA, IR = 1.1). IRs of Candida were low across all indications (PsO, 1.9; PsA, 2.0; axSpA, 1.2), as were IRs of opportunistic infections (PsO, 1.8; PsA, 1.8; axSpA, 1.3). IRs were also low across all indications for depression, major adverse cerebro-cardiovascular events and malignancies (all IRs ≤1.6). Cases of inflammatory bowel disease (IBD) were uncommon (IRs ≤0.8 across indications). Conclusion In this updated analysis with 18025.7 PY for PsO, 2247.7 PY for PsA, and 2097.7 PY for axSpA, IXE maintained a long-term safety profile up to 5 years, consistent with previous reports. Disclosure A. Deodhar: Grants/research support; A.D. received direct payments from Eli Lilly and Company as a scientific consultant/speaker, and payments (investigator) made to Oregon Medical Research Center. A. Blauvelt: Consultancies; A.B. received consulting fee from AbbVie, Abcentra, Affibody, Aligos, Almirall, Alumis, Amgen, Anaptysbio, Arcutis, Arena, Aslan, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Cara Therapeutics, Dermavant, EcoR1, Escient, Evelo, Evommune, Forte, Galderma, HighlightII Pharma, Incyte, Janssen, Landos, Leo, Merck, Novartis, Pfizer, Rapt, Regeneron, Sanofi Genzyme, Spherix Global Insights, TLL Pharmaceutical, TrialSpark, UCB Pharma, Vibliome, and Xencor. Member of speakers’ bureau; A.B. discloses direct payment for speaker bureaus from AbbVie, UCB. S. Schwartzman: Consultancies; S.S. is a consultant with AbbVie, Janssen, Lilly, Myriad, Novartis, Regeneron, Sanofi, UCB, Stelexis, Jubilant, and Teijin. Grants/research support; S.S. reports grants/contracts from Eli Lilly and Company, is a board member on the National Psoriasis Foundation Medical Board and part of the Scientific Advisory Board at Myriad. C. Salvarani: None. M. Feely: Shareholder/stock ownership; M.F. is an employee and shareholder at Eli Lilly and Company. Other; M.F. participated on a Data Safety Monitoring or Advisory Board at Eli Lilly and Company, is a Clinical Instructor in Dermatology at Mount Sinai and discloses previous employment with MC Medical Group, reimbursement of fees from Eli Lilly and Company and from Advisory Boards at the DREAM USA South Beach Symposium, is a current member of the AAD Investment Committee, Prevention Medical Review Board and ASDS Social Media Ambassador, and former member of the WDS Practice Advisory Committee, WDS Finance and Investment Committee, WDS Fundraising and Philanthropic Activities Committee, and former AAD Media Expert Team member and NPF Social Ambassador. A. Kronbergs: Shareholder/stock ownership; A.K. is an employee and shareholder at Eli Lilly and Company. N. Eberhart: Shareholder/stock ownership; N.E. is an employee and shareholder at Eli Lilly and Company. D. Zhu: Shareholder/stock ownership; D.Z. is an employee and shareholder at Eli Lilly and Company. E. Mevel: Shareholder/stock ownership; E.M. is an employee and shareholder at Eli Lilly and Company. T. Holzkaemper: Shareholder/stock ownership; T.H. is an employee and shareholder at Eli Lilly and Company. E. Krishnan: Shareholder/stock ownership; E.K. is an employee and shareholder at Eli Lilly and Company. M. Lebwohl: Consultancies; M.L. also reports consulting fees from AnaptysBio, Arcutis, Inc., Arena Pharmaceuticals, Aristea Therapeutics, Avotres Therapeutics, BioMX, Boehringer-Ingelheim, Brickell Biotech, Castle Biosciences,, Corevitas, Dermavant Sciences, Evommune, Inc., Facilitatation of International Dermatology Education, Forte Biosciences, Foundation for Research and Education in Dermatology, Hexima Ltd., Meiji Seika Pharma, Mindera, National Society of Cutaneous Medicine, New York College of Podiatric Medicine, Pfizer, Seanergy, SUN Pharma, Verrica, and Vial. Grants/research support; M.L. reports grants/contracts from Abbvie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Cara Therapeutics, Dermavant Sciences, Eli Lilly, Incyte, Inozyme, Janssen Research & Development, LLC, Ortho Dermatologics, Regeneron, and UCB, Inc. P. Rahman: Consultancies; P.R. received consulting fees from AbbVie, Janssen, Novartis, Eli Lilly and Company and Pfizer. Grants/research support; P.R. discloses grants or contracts received from Janssen and Novartis. H. Marzo-Ortega: Consultancies; H.M-O. also discloses consulting fees from Abbvie, Eli Lilly and Company, Janssen, Moonlake, Novartis, Pfizer, and UCB. Honoraria; H.M-O. discloses payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Abbvie, Biogen, Eli-Lilly, Janssen, Novartis, Pfizer, and UCB. Grants/research support; H.M-O. discloses grants or contracts received from Janssen, Novartis and UCB. Other; H. M-O. additionally discloses support for attending meetings and/or travel from UCB, participation on a Data Safety Monitoring Board or Advisory Board at Pfizer, leadership or fiduciary role in other board, society (paid or unpaid) in the Executive Committee ASAS, the Medical Advisory Board of NASS and as Chair of the British Society for Spondyloarthritis. C. Bullock: Shareholder/stock ownership; C. Bullock is an employee and minor shareholder in Lilly.

Background/Aims Guselkumab is a monoclonal antibody approved to treat moderate-to-severe plaque psoriasis and active psoriatic arthritis (PsA). In this analysis, safety data from 11 Phase 2/3 studies of guselkumab were pooled to evaluate guselkumab safety in a large population of patients with psoriatic disease. Methods Guselkumab was generally administered as 100-mg injections at Week (W)0, W4, then Q8W in 7 psoriasis studies and at W0, W4, then Q4W or Q8W in 4 PsA studies. Patients randomized to placebo crossed over to guselkumab Q8W at W16 in 5 PsO studies and to guselkumab Q4W or Q8W at W24 in all PsA studies. Safety data were summarized for the placebo-controlled period (W0-W16 in PsO; W0-W24 in PsA) and through the end of the reporting period (up to 5 years in PsO; up to 2 years in PsA). Incidence rates of key safety events were integrated post-hoc, adjusted for duration of follow-up, and reported per 100 patient-years (PY). Results During the placebo-controlled periods, 1061 patients received placebo (395 PY) and 2257 received guselkumab (856 PY). Through the long-term reporting periods, 4399 guselkumab-treated patients (PsO: 2891; PsA: 1508) contributed 10787 PY of follow-up (PsO: 8662 PY; PsA: 2125 PY). In PsO and PsA studies, pooled incidence rates of overall adverse events (AEs) were similar between guselkumab- and placebo-treated patients. Rates of serious AEs, AEs leading to discontinuation, serious infections, malignancy, and major adverse cardiovascular events were low and generally similar between guselkumab- and placebo-treated patients. Rates of safety events remained consistent through the long-term reporting period for guselkumab-treated patients (Table). No cases of Crohn’s disease or ulcerative colitis were reported in guselkumab-treated patients. No serum sickness-like or anaphylactic reactions related to guselkumab were reported. No opportunistic infections were reported in any guselkumab-treated PsO patient. Three cases of opportunistic infection were reported in pooled PsA studies (0.14/100 PY; all post-W52 in DISCOVER-2). No cases of active tuberculosis were reported across all studies. Conclusion In the most comprehensive analysis of guselkumab safety to date, AE rates in guselkumab-treated patients were similar to those observed with placebo and were stable throughout long-term follow-up. Disclosure B. Strober: Grants/research support; AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Janssen, Eli Lilly, Meiji Seika Pharma, Novartis, Pfizer, UCB Pharma, Sun Pharma, Regeneron, Dermira, Leo Pharma, Inc, Arcutis, Are. L. Coates: Grants/research support; AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Gilead, Galapagos, Janssen, Novartis, Pfizer, and UCB; grant/research support from AbbVie, Amgen, Celgene, Eli Lilly, Jan. J. Yu: Shareholder/stock ownership; Janssen Research & Development, LLC, Johnson & Johnson. K. Rowland: Shareholder/stock ownership; Janssen Scientific Affairs, LLC, Johnson & Johnson; E. Leibowitz, Janssen Scientific Affairs, LLC, Johnson & Johnson. E. Leibowitz: Shareholder/stock ownership; Janssen Scientific Affairs, LLC, Johnson & Johnson; E. Leibowitz, Janssen Scientific Affairs, LLC, Johnson & Johnson. M. Miller: Shareholder/stock ownership; Janssen Scientific Affairs, LLC, Johnson & Johnson; E. Leibowitz, Janssen Scientific Affairs, LLC, Johnson & Johnson. A. Kollmeier: Shareholder/stock ownership; Janssen Scientific Affairs, LLC, Johnson & Johnson; E. Leibowitz, Janssen Scientific Affairs, LLC, Johnson & Johnson. S. Li: Shareholder/stock ownership; Janssen Scientific Affairs, LLC, Johnson & Johnson; E. Leibowitz, Janssen Scientific Affairs, LLC, Johnson & Johnson. Y. Wang: Shareholder/stock ownership; Janssen Scientific Affairs, LLC, Johnson & Johnson; E. Leibowitz, Janssen Scientific Affairs, LLC, Johnson & Johnson. D. Chan: Shareholder/stock ownership; Janssen Scientific Affairs, LLC, Johnson & Johnson. S. Chakravarty: Shareholder/stock ownership; Janssen Scientific Affairs, LLC, Johnson & Johnson; Y. Yang, Janssen Pharmaceutical Companies, Johnson & Johnson. Y. Yang: Shareholder/stock ownership; Janssen Pharmaceutical Companies, Johnson & Johnson. M. Shawi: Shareholder/stock ownership; Janssen Pharmaceutical Companies of Johnson and Johnson. M. Lebwohl: Grants/research support; Arcutis, Boehringer Ingelheim, Bristol Myers Squibb, Verrica, AbbVie, Amgen, Eli Lilly, Janssen, Ortho Dermatologics, Pfizer, UCB Pharma, Avotres Therapeutics, AnaptysBio, Aristea Therapeutics, BioMX, Cara Therapeutics, Castle Biosciences, Dermavant, Evommune, Facilitatation of International Dermatology Education, Forte Biosciences, Foundation for Research and Education in Dermatology, Hexima, Meiji Seika Pharma, Mindera Health, Regeneron, Seanergy, Incyte, Arrive Technologies, Dr Reddy's Laboratories, Evelo Biosciences, Helsinn Therapeutics, LEO Pharma, Mount Sinai, CorEvitas (formerly Cor. P. Rahman: Shareholder/stock ownership; Janssen, Novartis, AbbVie, Eli Lilly and Company, Pfizer.

Real-world evidence has demonstrated the effectiveness of secukinumab in the treatment of psoriasis; however, limited data are available on patient profiles of US secukinumab initiators over time and clinical outcomes in biologic-naive patients. This study describes clinical characteristics of secukinumab initiators by year, and the clinical outcomes in patients after 6- and/or 12-month follow-up visits, stratified by prior biologic use.This observational study included patients enrolled in the CorEvitas (formerly Corrona) Psoriasis Registry. Analyses were conducted in two patient cohorts: (1) all secukinumab initiators, stratified by year, and (2) those who initiated and maintained secukinumab through a 6- and/or 12-month follow-up visit. For all secukinumab initiators, patient characteristics at initiation were described per calendar year; in initiators with follow-up visits, mean (SD) differences in percentage affected body surface area (BSA), five-point Investigator's Global Assessment (IGA), and Psoriasis Area and Severity Index (PASI) scores between baseline and follow-up visits were calculated. Analyses were conducted separately for biologic-naive and biologic-experienced patients.Between 2015 and 2020, the proportion of secukinumab initiators in the registry who were biologic-naive increased each year from 12.5% to 49.7%. Overall, 1518 patients initiated secukinumab at or after enrollment; 980 (64.6%) were biologic experienced, and 538 (35.4%) were biologic naive. At 6 months, biologic-experienced and biologic-naive patients reported mean (SD) decreases in BSA (-9.3 [14.5] versus -11.7 [16.6]), IGA (-1.4 [1.3] versus -1.7 [1.4]), and PASI (-5.2 [6.6] versus -6.7 [7.8]). The proportion of patients with an IGA score of clear/almost clear (0/1) increased over fivefold, irrespective of biologic experience. At 12 months, similar improvements were seen.The proportion of biologic-naive secukinumab initiators increased over time. Biologic-naive patients demonstrated similar improvements in clinical outcomes compared with biologic-experienced patients, suggesting that secukinumab may be considered as a first-line therapy for psoriasis.

An increasing number of reports have indicated correlation between COVID-19 vaccination and herpes zoster. While these outbreaks may be largely coincidental, the correlation warrants further investigation. Herein, we present 4 cases of herpes zoster in young healthy adults with no known risk factors for varicella virus reactivation. To date, most zoster outbreaks have been in patients above 60 years old. Thus, we believe that these cases point to a need for increased research on the topic.

Both early clinical improvement and long-term maintenance of clinical efficacy of treatments matter to patients with psoriasis. We compared cumulative clinical benefits of treatment with biologics over 1 year based on the area under the curve (AUC) for Psoriasis Area and Severity Index (PASI) 100 and PASI 90 responses in patients with moderate-to-severe psoriasis using a network meta-analysis (NMA).Published phase 3 randomized, placebo- or active-controlled clinical trial data for biologics approved for the treatment of moderate-to-severe psoriasis were obtained from a systematic literature review up to 30 September 2020. Eighteen clinical trials that included data from baseline to 48 or 52 weeks where AUC could be calculated were included. Data were compared using a fixed-effect model with a separate random-effect baseline model to account for effects of the placebo arm. Cumulative clinical benefit was estimated using the AUC for PASI 100 and PASI 90 responses (complete and almost-complete skin clearance, respectively). Normalized AUC was compared using Bayesian NMA. Cumulative days of response were calculated using normalized AUC and study duration.Interleukin (IL)-17 and IL-23 inhibitors demonstrated greater cumulative clinical benefits for both PASI 100 and PASI 90 versus IL-12/23 and tumor necrosis factor inhibitors. Over 52 weeks, cumulative days with PASI 100 were greatest with ixekizumab [158.7 (95% credible interval, 147.4, 170.0) days] followed by risankizumab [154.0 (144.9, 163.4) days]; PASI 90 days were greatest with risankizumab [249.3 (239.5, 259.2) days] followed by ixekizumab [238.8 (227.1, 250.8) days]. Both ixekizumab and risankizumab showed greater cumulative days with PASI 100 or PASI 90 responses versus secukinumab [117.9 (110.7, 125.2) and 215.5 (208.2, 223.1) days, respectively] and greater cumulative days with PASI 100 versus guselkumab [130.7 (120.5, 140.9) days].For complete and almost-complete skin clearance, ixekizumab and risankizumab provided the greatest cumulative clinical benefits over 1 year.

Background: Patients with generalized pruritus lacking primary skin lesions are typically subjected to extensive laboratory tests. For many, the results fail to reveal any clinically significant findings; the British Association of Dermatologists published detailed guidelines for the work-up and management of these patients. Our objectives were twofold: to evaluate the clinical utility of the diagnostic approach used in our practice, and to ascertain how closely we adhered to the suggested guidelines. Method: We conducted a retrospective chart review of 106 adult patients who presented with generalized pruritus without primary skin lesions. Results: While 82.1% of patients received at least a complete blood count, far fewer received serum ferritin (23.6%) or chest imaging (36.8%). Almost 11% of patients responded to empiric anti-scabetic treatment. Approximately 9% of the skin biopsies were consistent with bullous pemphigoid. One patient had resolution of their pruritus after discontinuing an angiotensin-converting-enzyme inhibitor. Conclusion: In conclusion, dermatologists should consider empiric anti-scabetic treatment, skin biopsies for patients over the age of 65, and discontinuation of an angiotensin-converting-enzyme inhibitor enzyme to better conform to existing guidelines.

Background In the SARS-CoV-2/COVID-19 pandemic, we need to understand the impact of immunomodulatory medications on COVID-19 symptom severity in patients with inflammatory diseases, including the type 2/Th2 polarized skin disease, atopic dermatitis (AD). Objective Because it is believed that type 1/Th1 immunity controls viral infections and that there is a Th1/Th2 counter-regulation, we hypothesized that Th2 targeting with the IL-4Rα-antagonist, dupilumab, in patients with moderate-to-severe AD would rebalance the Th1/Th2 axis, potentially leading to attenuated COVID-19 symptoms. Methods A total of 1237 patients with moderate-to-severe AD in the Icahn School of Medicine at Mount Sinai Department of Dermatology were enrolled in a registry. Patients were screened for COVID-19-related symptoms and assigned a severity score (asymptomatic [0]-fatal [5]). Scores were compared among 3 treatment groups: dupilumab (n = 632), other systemic treatments (n = 107), and limited/no treatment (n = 498). Demographic and comorbid covariates were adjusted by multivariate generalized logistic regression models. Results The dupilumab-treated group showed reduced incidence and severity of COVID-19 symptoms versus other treatment groups. Dupilumab-treated patients were less likely to experience moderate-to-severe symptoms versus patients on other systemics (P = .01) and on limited/no treatment (P = .04), and less likely to experience any symptoms versus patients on other systemics (P = .01). This effect was seen in our entire cohort and in the subgroup of patients with verified COVID-19 or high-risk exposure. Conclusions Patients on dupilumab experienced less severe COVID-19 manifestations and lesser symptoms compared with patients on other systemics and on limited/no treatment. These results suggest that Th2 modulation with dupilumab may have a protective effect on anti-viral immune response in patients with AD.

BACKGROUND Risankizumab has demonstrated efficacy and safety in patients with moderate-to-severe plaque psoriasis in randomized clinical trials. OBJECTIVES To evaluate safety data from risankizumab psoriasis phase I-III clinical trials. METHODS Short-term safety (through week 16) was analysed using integrated data from five phase II and III clinical trials. Long-term safety was evaluated using integrated data from 17 phase I-III completed and ongoing trials. RESULTS Short-term safety analyses included 1306 patients receiving risankizumab 150 mg and 300 patients receiving placebo [402·2 and 92·0 patient-years (PY) of exposure, respectively]. Long-term analyses included 3072 risankizumab-treated patients (exposure: 7927 PY). The median (excluding four outliers) treatment duration was 2·9 years (range 2 days to 5·9 years). Exposure-adjusted adverse event rates did not increase with long-term treatment (318 vs. 171 events per 100 PY for short- and long-term analyses). With long-term risankizumab treatment, rates of serious adverse events were 7·8 per 100 PY, serious infections 1·2 per 100 PY, nonmelanoma skin cancer (NMSC) 0·7 per 100 PY, malignant tumours excluding NMSC 0·5 per 100 PY, and adjudicated major adverse cardiovascular events 0·3 per 100 PY, with no important identified risks. Limitations include that the study inclusion and exclusion criteria varied and that three studies enrolled ≤ 50 patients. CONCLUSIONS Risankizumab demonstrated a favourable safety profile over short- and long-term treatment in patients with moderate-to-severe psoriasis.

Objective: To characterize and summarize clinical and demographic features in patients with post-COVID 19 Telogen Effluvium and compare with those reported in the literature. Design: A observational study of 10 patients who reported symptoms of Telogen Effluvium following COVID-19 symptoms. Medical history, physical exam and any relevant lab findings were conducted during an initial visit and patients were re-evaluated after 14 weeks. Setting: Patients presented to an outpatient dermatology clinic affiliated with a large, urban academic center New York City from May to August 2020, approximately 3 months after a surge in COVID-19 cases. Participants: Adult patients who were diagnosed with Telogen Effluvium and had laboratory evidence of previous COVID-19 infection who were seen in person or through telehealth virtual visits were consented for this study. Exposures: All participants had laboratory evidence and clinical symptoms consistent with previous COVID-19 symptoms. Main Outcomes and Measures: We collected data from 10 participants and measured average onset of TE from initial COVID-19 symptoms, medical intervention for COVID-19 infection, physical exam findings, and whether or not patient experienced resolution of TE symptoms after 14 weeks. We performed a literature review using the terms “telogen effluvium”, “covid” and “hair” and investigation was limited to adult case reports and cohort studies appearing in the English-Language literature as of March 2021. Clinical and demographic findings were analyzed and compared with those of our patient cohort. Results: Nine out of ten patients in our cohort had mild COVID-19 symptoms only with mean onset of hair shedding was 73 days following infection. None had previous history of hair loss. By contrast, of the 28 patients identified in the literature review 50% of these patients were hospitalized for severe COVID-19 infection with average onset of TE 87 day after infection. 12% of these patients had pre-existing androgenic alopecia. Conclusions and Relevance: Telogen Effluvium is a distressing, yet self-limited condition that can occur following both mild and severe COVID-19 infection. Dermatologists should expect an increase in TE in areas heavily affected by COVID-19 and reassure patients of the likely cause and that symptoms will resolve over time.

Background: Brodalumab is an interleukin-17 receptor A antagonist approved for the treatment of moderate-to-severe plaque psoriasis. Our prior publication reported significant disease improvement with brodalumab in psoriasis patients who had previously failed treatment with an anti-IL-17A agent. Objectives: We set out to investigate factors that differed between the patients who had treatment success with brodalumab and those who did not, including disease severity and underlying comorbidities. Other secondary endpoints included the extent of improvement in non-responders, characterization of the patients who discontinued early from the trial, and time to improvement on brodalumab. Methods: We conducted an Institutional Review Board (IRB)-approved open-label study of a total of 39 subjects enrolled at 3 sites with moderate-to-severe psoriasis. All patients previously failed treatment with an IL-17A agent. Subjects received brodalumab 210 mg via subcutaneous injection at weeks 0, 1, and 2, followed by 210 mg every 2 weeks, up to week 16. Subjects were evaluated monthly for improvement in PASI and sPGA. Results: Of the baseline comorbidities assessed, the only statistically significant difference between responders and non-responders was the presence of higher weight/BMI in non-responders in the AO dataset; this trend disappeared in the NRI dataset. Of the patients that dropped out of the trial early, 3 of the 5 had PASI improvements of >60%. A rapid onset to disease improvement was seen in the trial. Conclusion: These results indicate that brodalumab may be a good treatment choice for psoriasis patients, including those with severe disease and/or underlying comorbidities.

Background: Pseudoxanthoma elasticum (PXE) is a rare hereditary disease caused by mutations in the ABCC6 gene, characterized by ectopic calcification of connective tissue throughout the body. Vascular conditions associated with PXE have been well-documented in the literature, but to our knowledge, analysis of the myriad of PXE case reports with associated vascular diseases in addition to larger cohort studies, has not been undertaken. Objective: To review existing literature reporting peripheral vascular disease (PVD), cardiovascular disease (CVD), cerebrovascular disease (CeVD), hypertension, and carotid rete mirabile (CRM) in PXE patients as of June 2021. Methods: A search of the PubMed database using the key words “pseudoxanthoma elasticum” and “vascular” was performed. Results: A total of 345 cases of PVD, 97 cases of CVD, and 123 case of CeVD were reported. Additionally, 88 cases of hypertension and 5 cases of CRM were reported. Conclusions: PXE patients are at risk of developing serious vascular conditions, particularly peripheral vascular disease. This condition also appears to have some connection to carotid rete mirabile, which is extremely rare in humans. Further research should be conducted to analyze the connection between PXE and CRM in order to better understand and treat both conditions.

BACKGROUND Treatments for alopecia areata (AA) patients with extensive scalp hair loss are limited, and recent evidence supports a role for type 2 T-cell (Th2)-immune response in AA. Dupilumab, a monoclonal antibody inhibiting Th2 signaling, approved for type 2 diseases including atopic dermatitis, was evaluated in AA patients. METHODS Alopecia areata patients with and without concomitant atopic dermatitis were randomized 2:1 to receive weekly subcutaneous dupilumab (300 mg) or placebo for 24 weeks, followed by another 24-week dupilumab open-label phase. The primary outcome was change from baseline in the Severity of Alopecia Tool (SALT) score at week 24; secondary outcomes included a range of measures of hair regrowth. RESULTS Forty and 20 patients were assigned to the dupilumab and placebo arms, respectively. At week 24, disease worsening was documented in the placebo arm, with a least-squares mean change in the SALT score of -6.5 (95% confidence-interval [CI], -10.4 to -2.6), versus a change of 2.2 (95% CI, -0.6 to 4.94) in the dupilumab arm (p

Nonmedical switching (NMS) is a change in a patient's treatment regimen for reasons other than lack of efficacy, intolerance, adverse effects, or poor adherence. We describe the impact of NMS on patients, health care workers, and health systems, focusing on NMS to in-class biologic alternatives in US patients with chronic, immune-mediated rheumatic and dermatologic conditions. Additionally, we evaluate the ways in which the COVID-19 pandemic may exacerbate the physical, psychological, and economic impacts of NMS.Narrative review.We performed a search of MEDLINE's PubMed database from October 2015 to October 2020, with a repeat search in October 2021. Search terms included relevant keywords pertaining to NMS, biologics, and disease areas. Results were supplemented by a search of key congress abstracts from 2015 to 2021 and a targeted internet search.NMS increases medication abandonment, errors, and adverse effects, and it can lead to longer patient visits, increased follow-up visits, additional laboratory tests and procedures, and greater overall health care resource utilization (HCRU). The increased HCRU associated with NMS increases patients' financial burden due to additional co-pays and out-of-pocket costs.The decision to switch treatments should result from shared decision-making between health care providers (HCPs) and patients to achieve the best clinical outcomes and optimal HCRU. The issues related to NMS may be compounded by the financial and psychosocial stress on HCPs and patients created by the COVID-19 pandemic. HCPs should advocate for continuous patient treatment and be familiar with continuity of care legislation, appeals processes, and manufacturer assistance programs.

not available.

Erythema nodosum (EN) is a septal panniculitis characterized by raised, tender, red or purple lesions with a diameter of 1-5 cm. It is commonly treated with corticosteroids and can be an extra-intestinal manifestation of Crohn’s disease (CD). CD can be treated with ustekinumab, a monoclonal antibody that targets the p-40 subunit of the interleukin-12 (IL-12) and interleukin-23 (IL-23). A 78-year-old woman with erythema nodosum and Crohn’s disease presented with multiple erythematous nodules, which had been recurring on both of her legs for decades. The patient had failed many traditional EN treatments and was prescribed off-label ustekinumab, resulting in resolution of EN. This finding suggests that ustekinumab may be a potential treatment for EN in patients who also have CD.

Background Treating to absolute treatment targets rather than relative measures such as Psoriasis Area and Severity Index (PASI)-75 is emerging as an important clinical concept included in psoriasis guidelines and clinical practice. Achieving treatment targets is associated with achievement of long-term outcomes. Objective To evaluate the relationship between psoriasis severity, disease characteristics, and achievement of PASI ≤2 with apremilast in a pooled analysis of the phase 3 ESTEEM 1 and 2 (NCT01194219 and NCT01232283), phase 3b LIBERATE (NCT01690299), and phase 4 UNVEIL (NCT02425826) clinical trials. Methods Pooled data from patients with moderate to severe plaque psoriasis randomized to apremilast 30 mg BID were analyzed by baseline PASI quartiles (Q1: 2.4-13.1, Q2: 13.2-15.9, Q3: 16.0-20.0, Q4: 20.1-57.8). Assessments included PASI, Dermatology Life Quality Index (DLQI), Scalp Physician's Global Assessment (ScPGA, ScPGA ≥1), and target (worst) Nail Psoriasis Severity Index (NAPSI, NAPSI ≥1). Results Of 1,062 patients, 963 had ScPGA ≥1 and 643 had NAPSI ≥1, 771 patients with baseline and Week 32 PASI assessments were included in analyses of Week 32 PASI target achievement. Rates of PASI ≤2 at Week 32 were greater in lower PASI quartiles (Q1: 43.5%, Q2: 31.2%, Q3: 26.8%, Q4: 18.4%). Most patients achieving PASI ≤2 target (83.6%) achieved DLQI ≤5 at Week 32, 59.3% of patients who did not achieve PASI ≤2 target achieved DLQI ≤5. At Week 32, mean improvements in ScPGA and NAPSI were similar with more moderate versus more severe disease (ScPGA, range: 1.1-1.4, NAPSI, range: 1.6-2.5). In a subgroup analysis, achievement of PASI ≤2 target was higher in the lowest PASI quartile and with disease duration Conclusions Greater achievement of PASI ≤2 was observed in patients with more moderate versus more severe skin disease. Apremilast may be particularly beneficial in more moderate disease early in the treatment paradigm.

Introduction Atopic dermatitis (AD) is a chronic inflammatory skin disease often requiring long-term treatment. Crisaborole significantly improved global AD signs and symptoms in 28-day phase 3 studies of patients aged ≥ 2 years with mild-to-moderate AD (Investigator’s Static Global Assessment [ISGA] 2 or 3). A post hoc analysis of a long-term, open-label extension study was conducted to assess efficacy and safety trends of crisaborole in patients stratified by the number of initial consecutive crisaborole treatment cycles, defined as the number of treatment cycles completed before achievement of ISGA 0 (clear)/1 (almost clear). Methods Patients completing phase 3 studies without drug-related safety issues that precluded further crisaborole treatment were analyzed. Patients with ISGA 0/1 at baseline (the end of a 28-day cycle) did not receive crisaborole for the next 28-day cycle (off-treatment), whereas patients with ISGA ≥ 2 received crisaborole for the next 28-day cycle (on-treatment). Patients were stratified by number of initial consecutive crisaborole treatment cycles. Efficacy was assessed by achievement and maintenance of ISGA 0/1, and safety was assessed by incidence of treatment-emergent adverse events (TEAEs) and treatment-related AEs (TRAEs). Results Overall, 418 patients were included in exclusive cohorts based on number of consecutive on-treatment cycles (1 on-treatment cycle, n = 133; 2 consecutive on-treatment cycles, n = 106; 3 consecutive on-treatment cycles, n = 106; 4 consecutive on-treatment cycles, n = 73). After one to four initial consecutive on-treatment cycles, 77.6, 76.3, 59.4, and 43.1% of patients, respectively, achieved ISGA 0/1. Of these patients, 49.5, 37.8, 44.4, and 45.2%, respectively, maintained ISGA 0/1 at the end of a 28-day cycle off-treatment. Incidence of TRAEs was 4.5, 4.7, 3.8, and 1.4% for patients receiving one to four consecutive on-treatment cycles, respectively. One patient discontinued because of AEs. Conclusion These results support the efficacious and safe continuous, long-term use of crisaborole for the management of mild-to-moderate AD. Trial Registration ClinicalTrials.gov: NCT02118766, NCT02118792., Plain Language Summary Eczema is a skin disease that often requires long-term treatment. Crisaborole ointment improved mild-to-moderate eczema after 28 days of continuous use in two phase 3 clinical trials that included patients aged ≥ 2 years. In the study reported here we tested whether eczema improved with continuous crisaborole use after one to four back-to-back treatment periods, or 28–112 days. Patients who completed either of the aforementioned phase 3 clinical trials were included in this study. Patients received crisaborole for the next 28-day period if they had eczema rashes. Patients with clear or almost clear skin did not receive crisaborole for 28 days. Our study included a total of 418 patients. After one to four treatment periods, 78, 76, 59, and 43% of patients, respectively, had clear or almost clear skin. Of these patients, 50, 38, 44, and 45% still had clear or almost clear skin after stopping treatment for 28 days. Fewer than one in 20 patients had side effects related to crisaborole after one to four treatment periods. The most common side effect at the application site that was related to crisaborole was pain, particularly stinging and burning. Up to one in 50 patients had application site pain. One patient stopped taking crisaborole because of side effects. In conclusion, these results suggest that long-term crisaborole use is effective and safe.