Marcus Maurer, Thomas B. Casale, Sarbjit S. Saini, Moshe Ben-Shoshan, Elizabeth Laws, Jennifer Maloney, Deborah Bauer, Allen Radin, Melanie Makhija
{"title":"Dupilumab Reduces Urticaria Activity, Itch, and Hives in Patients with Chronic Spontaneous Urticaria Regardless of Baseline Serum Immunoglobulin E Levels","authors":"Marcus Maurer, Thomas B. Casale, Sarbjit S. Saini, Moshe Ben-Shoshan, Elizabeth Laws, Jennifer Maloney, Deborah Bauer, Allen Radin, Melanie Makhija","doi":"10.1007/s13555-024-01231-y","DOIUrl":"https://doi.org/10.1007/s13555-024-01231-y","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>In chronic spontaneous urticaria (CSU), interleukin (IL)-4 and IL-13 may promote mast cell activation directly via IL-4 receptor expression, or indirectly via upregulated immunoglobulin E (IgE) production. Dupilumab significantly improved CSU signs and symptoms in the phase 3, randomized, placebo-controlled LIBERTY-CSU CUPID Study A. This analysis explores the impact of dupilumab on CSU signs and symptoms and serum IgE levels in patients from LIBERTY-CSU CUPID Study A with serum total IgE above and below 100 IU/mL at baseline.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>Patients with H1-antihistamine-refractory CSU received dupilumab (<i>n</i> = 70) or placebo (<i>n</i> = 68) for 24 weeks. Efficacy endpoints were change from baseline to weeks 12 and 24 in serum total IgE levels, Itch Severity Score over 7 days (ISS7), Urticaria Activity Score over 7 days (UAS7), and Hives Severity Score over 7 days (HSS7) in dupilumab- or placebo-treated patients with serum total IgE above and below 100 IU/mL at baseline.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>Dupilumab treatment significantly reduced median (interquartile range) IgE levels at week 12 [dupilumab: −31.9% (−41.9; −22.6); placebo: −6.3% (−21.3; 14.9)] and week 24 [dupilumab: −48.2% (−56.8; − 39.5); placebo: − 6.3% (−34.5; 14.8)]. Similar IgE reductions relative to baseline were observed in dupilumab-treated patients regardless of baseline IgE level. Dupilumab treatment improved ISS7, UAS7, and HSS7 over 12 and 24 weeks, regardless of baseline serum IgE level (interaction <i>p</i> ≥ 0.59 for all treatment by subgroup comparisons), with weak correlations (<i>r</i> < 0.2) observed between IgE level changes and ISS7, UAS7, and HSS7 outcomes.</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>Dupilumab significantly improved CSU signs and symptoms and reduced serum IgE, regardless of baseline IgE levels. In the current analysis, baseline total IgE had no predictive value as a dupilumab treatment response biomarker in CSU. Downregulation of IgE, a key mediator of mast cell activation and histamine release, may at least partially explain the effectiveness of dupilumab in reducing CSU signs and symptoms.</p><h3 data-test=\"abstract-sub-heading\">Trial Registration</h3><p>ClinicalTrials.gov Identifier: NCT04180488.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":"41 1","pages":""},"PeriodicalIF":3.4,"publicationDate":"2024-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141782982","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dermatology and TherapyPub Date : 2024-07-01Epub Date: 2024-06-11DOI: 10.1007/s13555-024-01197-x
Kimberly N Williams, Chrislene T Y Olukoga, Antonella Tosti
{"title":"Evaluation of the Safety and Effectiveness of Oral Minoxidil in Children: A Systematic Review.","authors":"Kimberly N Williams, Chrislene T Y Olukoga, Antonella Tosti","doi":"10.1007/s13555-024-01197-x","DOIUrl":"10.1007/s13555-024-01197-x","url":null,"abstract":"<p><p>The minimal adverse-effect profile and positive clinical response of low-dose oral minoxidil (LDOM) have recently caused the drug to gain popularity for the treatment of hair disorders in adults. However, in the pediatric population, hesitancy still surrounds the use of oral minoxidil given the wide profile of potential side effects the drug offers. This review aims to characterize the safety and use of oral minoxidil in children for the treatment of all disorders to equip physicians with ample knowledge when prescribing oral minoxidil in the pediatric population. A total of 41 studies (19 case reports, 10 cohort studies, 7 retrospective chart reviews, and 5 case series) that reported data on 442 pediatric patients for whom oral minoxidil was used for treatment were included. Conditions for which treatment with minoxidil was described were hair disorders (83.9%, 371/442) and hypertension (11.3%, 50/442); accidental usage (4.8%, 21/442) was also noted in the literature and included in this review. This review is broken down by dosage and describes the safety and efficacy of oral minoxidil in pediatric patients aged 0 to 18 years old for the treatment of hair disorders. This review found that LDOM may represent a safe option for the treatment of hair disorders in children. This study also suggests moderate and high doses of oral minoxidil may not be safe for use in children. Additional studies are needed to further understand this drug's efficacy and safety in children.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"1709-1727"},"PeriodicalIF":3.5,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11264662/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141300329","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Exploratory Efficacy Evaluation of Apremilast for the Treatment of Japanese Patients with Palmoplantar Pustulosis: 32-Week Results from a Phase 2, Randomized, Placebo-Controlled Study.","authors":"Yukari Okubo, Tadashi Terui, Satomi Kobayashi, Shigetoshi Sano, Akimichi Morita, Shinichi Imafuku, Yayoi Tada, Masatoshi Abe, Masafumi Yaguchi, Takeshi Kimura, Junichiro Shimauchi, Wendy Zhang, Hamid Amouzadeh, Masamoto Murakami","doi":"10.1007/s13555-024-01195-z","DOIUrl":"10.1007/s13555-024-01195-z","url":null,"abstract":"<p><strong>Introduction: </strong>Palmoplantar pustulosis (PPP) is a pruritic, painful, chronic dermatitis that greatly impacts functioning and quality of life and can be difficult to treat. Approved treatment options for PPP are limited, and many patients do not fully respond to current treatments.</p><p><strong>Methods: </strong>This was a randomized, double-blind, placebo-controlled, phase 2 study in Japanese patients with moderate to severe PPP and inadequate response to topical treatment. Patients were randomized 1:1 to receive apremilast 30 mg twice daily or placebo for 16 weeks followed by an extension phase where all patients received apremilast through week 32. PPP Area and Severity Index (PPPASI), modified PPPASI (which evaluates pustules and vesicles separately), and Palmoplantar Severity Index (PPSI) total scores and subscores (erythema, pustules/vesicles, and desquamation/scales) were evaluated over 32 weeks of apremilast treatment. Achievement of ≥ 50% improvement in PPPASI (PPPASI-50) was evaluated at week 16 among baseline demographic and clinical characteristic subgroups.</p><p><strong>Results: </strong>At week 16, improvements in total score and subscores for PPPASI, modified PPASI, and PPSI, as well as rates of PPPASI-50 were at least moderately greater with apremilast than placebo. Mean PPPASI total score decreased by - 68.3% from baseline to week 32 with continued apremilast treatment. At week 32, mean change from baseline in PPPASI/modified PPPASI subscores ranged from - 58.5% to - 77.0% with apremilast. At week 32, PPSI total score for physician and patient assessments decreased by - 51.3% and - 40.0%, respectively, with continued apremilast treatment. PPPASI-50 response at week 16 was greater with apremilast versus placebo in most demographic and baseline characteristic subgroups.</p><p><strong>Conclusions: </strong>Improvements in all PPPASI and PPSI total scores and subscores observed with apremilast over 16 weeks were maintained through 32 weeks in patients with moderate to severe PPP and inadequate response to topical treatment. Rates of PPPASI-50 response at week 16 were mostly consistent across patient subgroups.</p><p><strong>Clinicaltrials: </strong>GOV: NCT04057937.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"1863-1873"},"PeriodicalIF":3.5,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11264648/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141418301","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dermatology and TherapyPub Date : 2024-07-01Epub Date: 2024-06-19DOI: 10.1007/s13555-024-01209-w
Sofía Haselgruber, Pablo Fernández-Crehuet-Serrano, María Dolores Fernández-Ballesteros, Alicia Padial-Gómez, Juan Carlos Hernández-Rodríguez, Juan Ortiz-Álvarez, Pedro Navarro-Guillamón, Cristina Membrive-Jiménez, Carlos Cuenca-Barrales, Alejandro Molina-Leyva
{"title":"Insights into the Window of Opportunity and Outcome Measures in Patients with Moderate to Severe Hidradenitis Suppurativa Treated with Secukinumab: A Real-World Study.","authors":"Sofía Haselgruber, Pablo Fernández-Crehuet-Serrano, María Dolores Fernández-Ballesteros, Alicia Padial-Gómez, Juan Carlos Hernández-Rodríguez, Juan Ortiz-Álvarez, Pedro Navarro-Guillamón, Cristina Membrive-Jiménez, Carlos Cuenca-Barrales, Alejandro Molina-Leyva","doi":"10.1007/s13555-024-01209-w","DOIUrl":"10.1007/s13555-024-01209-w","url":null,"abstract":"<p><strong>Introducion: </strong>The concept of a window of opportunity in hidradenitis suppurativa (HS) management suggests that early initiation of biological therapy leads to better outcomes, though its timing remains uncertain.</p><p><strong>Methods: </strong>We conducted a retrospective observational multicenter study, including consecutive patients with moderate to severe HS who initiated secukinumab treatment following prior failure with systemic antibiotics or adalimumab. Therapeutic burden was defined as the sum of previous systemic treatment cycles and previous major surgical interventions for HS. Patients were followed up for 24 weeks. Main outcomes were safety and effectiveness, assessed through the proportion of patients achieving HS Clinical Response (HiSCR) and a 55% reduction in International HS Severity Score System (IHS4-55). Additionally, potential predictors of response to secukinumab were studied. Analysis was performed on an intention-to-treat basis.</p><p><strong>Results: </strong>A total of 67 patients (33 men, 34 women) were included, with a mean age of 41.55 (11.94) years and a mean baseline IHS4 of 17.88 (11.13). The mean therapeutic burden was 6.06 (3.49). At week 24, 10.45% (7/67) of patients experienced adverse events, with three leading to treatment discontinuation. At week 24, 41.79% (28/67) of patients achieved HiSCR, and 44.78% (30/67) of patients achieved IHS4-55. HiSCR could not be calculated in 12 patients with a baseline AN count < 3. A lower therapeutic burden was significantly associated with a higher likelihood of achieving HiSCR and IHS4-55 at week 24.</p><p><strong>Conclusions: </strong>Secukinumab showed safety and efficacy in real-world patients with HS, and the inverse correlation found between therapeutic burden and treatment response supports the concept of a window of opportunity, offering insights into its timing.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"1875-1890"},"PeriodicalIF":3.5,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11264522/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141418302","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dermatology and TherapyPub Date : 2024-07-01Epub Date: 2024-06-19DOI: 10.1007/s13555-024-01183-3
April W Armstrong, Andrew F Alexis, Andrew Blauvelt, Jonathan I Silverberg, Claire Feeney, Mark Levenberg, Gary Chan, Fan Zhang, Luke Fostvedt
{"title":"Predicting Abrocitinib Efficacy at Week 12 Based on Clinical Response at Week 4: A Post Hoc Analysis of Four Randomized Studies in Moderate-to-Severe Atopic Dermatitis.","authors":"April W Armstrong, Andrew F Alexis, Andrew Blauvelt, Jonathan I Silverberg, Claire Feeney, Mark Levenberg, Gary Chan, Fan Zhang, Luke Fostvedt","doi":"10.1007/s13555-024-01183-3","DOIUrl":"10.1007/s13555-024-01183-3","url":null,"abstract":"<p><strong>Introduction: </strong>Early prediction of abrocitinib efficacy in atopic dermatitis (AD) could help identify candidates for an early dose increase. A predictive model determined week 12 efficacy based on week 4 responses in patients receiving abrocitinib 100 mg/day and assessed the effect of an abrocitinib dose increase on platelet counts.</p><p><strong>Methods: </strong>Analysis included the phase 3 trials JADE MONO-1 (NCT03349060), MONO-2 (NCT03575871), COMPARE (NCT03720470), and TEEN (NCT03796676). For platelet counts and simulations, a phase 2 psoriasis trial (NCT02201524) and phase 2b (NCT02780167) and phase 3 (MONO-1, MONO-2, and REGIMEN (NCT03627767)) abrocitinib trials were pooled. A training-and-validation framework assessed potential predictors of response at week 4: score and score change from baseline in the Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), and Peak Pruritus Numerical Rating Scale (PP-NRS), and percentage change from baseline in EASI. The dependent variables at week 12 were ≥ 75% improvement in EASI (EASI-75) and IGA score of 0 (clear) or 1 (almost clear) and ≥ 2-point improvement from baseline. The probability of each variable to predict week 12 EASI-75 and IGA responses was calculated.</p><p><strong>Results: </strong>In the training cohort (n = 453), 72% of the ≥ 50% improvement in EASI (EASI-50) at week 4 responders and 16% of the nonresponders with abrocitinib 100 mg achieved EASI-75 at week 12; 48% and 6% of the week 4 EASI-50 responders and nonresponders, respectively, achieved week 12 IGA response. Similar results occurred with week 4 IGA = 2, ≥ 4-point improvement from baseline in PP-NRS, or EASI = 8 responders/nonresponders. Platelet counts after an abrocitinib dose increase from 100 to 200 mg were similar to those seen with continuous dosing with abrocitinib 100 mg or 200 mg.</p><p><strong>Conclusion: </strong>Achieving week 4 clinical responses with abrocitinib 100 mg may be useful in predicting week 12 responses. Week 4 nonresponders may benefit from a dose increase to abrocitinib 200 mg, and those that receive this dose increase are likely to achieve treatment success at week 12, with no significant impact on platelet count recovery. Video abstract available for this article.</p><p><strong>Clinical trial registration: </strong>NCT03349060, NCT03575871, NCT03720470, NCT03796676, NCT02201524, NCT02780167 and NCT03627767.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"1849-1861"},"PeriodicalIF":3.5,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11264490/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141418303","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dermatology and TherapyPub Date : 2024-07-01Epub Date: 2024-06-24DOI: 10.1007/s13555-024-01214-z
Bárbara R Ferreira, Olivia M Katamanin, Mohammad Jafferany, Laurent Misery
{"title":"Psychodermatology of Chronic Pruritus: An Overview of the Link Between Itch and Distress.","authors":"Bárbara R Ferreira, Olivia M Katamanin, Mohammad Jafferany, Laurent Misery","doi":"10.1007/s13555-024-01214-z","DOIUrl":"10.1007/s13555-024-01214-z","url":null,"abstract":"<p><p>Chronic pruritus (CP) is defined as an unpleasant sensation causing a desire to scratch and lasting > 6 weeks. It has a multifactorial etiology but is more frequently associated with chronic inflammatory dermatoses and systemic disorders. Psychogenic pruritus and neurological disorders are other less common etiologies, while, in some patients, it is idiopathic. CP appears to be processed by non-histaminergic pathway, contributing to its complexity and therapeutic challenge. Moreover, regardless of the etiology, it is multidimensional, including cognitive, motivational and affective components. There is a close link between psychological distress and pruritus, with particular clinical expression in chronic inflammatory dermatoses, involving the activation of the hypothalamic-pituitary-adrenal axis (and its cutaneous equivalent), the sympathetic nervous system, the release of hormones and peptides, the role of immune cells (T and B cells, macrophages) and immune-related cells in the skin (mast cells, dendritic cells and keratinocytes). Moreover, there is strong evidence that psychological factors influence the experience of pruritus. CP can also cause psychiatric disorders, including but not limited to anxiety and depression, and also lead to significant quality of life (QoL) impairment. Thereby, although a psychodermatological assessment should ideally be carried out in the context of a specific psychodermatology consultation, a brief mental health assessment could be part of the general dermatological approach to these patients. Considering that mental health, QoL and pruritus are closely linked, psychotherapeutic interventions and/or psychotropic drugs should thus be considered in some patients as an adjunct to the pharmacological treatment of CP.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"1799-1809"},"PeriodicalIF":3.5,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11265050/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141445821","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dermatology and TherapyPub Date : 2024-07-01Epub Date: 2024-06-22DOI: 10.1007/s13555-024-01201-4
April W Armstrong, Sang Hee Park, Vardhaman Patel, Pierre Nicolas, Wei-Jhih Wang, Matthew J Colombo, Viktor Chirikov
{"title":"Cumulative Benefit Over 52 Weeks With Deucravacitinib Versus Apremilast in Moderate to Severe Plaque Psoriasis: POETYK PSO-1 Post Hoc Analysis.","authors":"April W Armstrong, Sang Hee Park, Vardhaman Patel, Pierre Nicolas, Wei-Jhih Wang, Matthew J Colombo, Viktor Chirikov","doi":"10.1007/s13555-024-01201-4","DOIUrl":"10.1007/s13555-024-01201-4","url":null,"abstract":"<p><strong>Introduction: </strong>Deucravacitinib demonstrated superior efficacy to apremilast in patients with moderate to severe plaque psoriasis in the POETYK PSO-1 and PSO-2 clinical trials. In the study reported here, we aimed to determine the overall 52-week cumulative clinical benefit of treatment initiated with deucravacitinib versus apremilast and to compare the 52-week cumulative benefit of initiating and staying on deucravacitinib versus initiating apremilast and continuing or switching to deucravacitinib at week 24 of treatment.</p><p><strong>Methods: </strong>This post hoc analysis of POETYK PSO-1 data (ClinicalTrials.gov identifier: NCT03624127) determined the cumulative clinical benefit of deucravacitinib 6 mg once daily and apremilast 30 mg twice daily in adults with moderate to severe plaque psoriasis. Patients treated with apremilast who did not achieve a 50% reduction in the Psoriasis Area and Severity Index (PASI 50) at week 24 were switched to deucravacitinib. The cumulative clinical benefit of deucravacitinib versus apremilast over 52 weeks was based on cumulative measures of ≥ 75% improvement from baseline in PASI score (PASI 75) and the proportion of patients with a static Physician Global Assessment score of 0 or 1 (sPGA 0/1). Ratios of area under the curve estimates between treatments were calculated and compared based on analysis of covariance regression models.</p><p><strong>Results: </strong>Patients initiating deucravacitinib (N = 332) had a greater cumulative benefit as measured by the PASI 75 and sPGA 0/1 than those initiating apremilast (N = 168). Over 52 weeks, those initiating deucravacitinib experienced 50% more benefit as measured by PASI 75 and 58% more benefit as measured by sPGA 0/1 than those initiating apremilast. Results were consistent with the primary analysis when patients were classified by prior systemic and prior biologic therapy exposure.</p><p><strong>Conclusion: </strong>Results from this analysis corroborate the primary efficacy analysis supporting the use of deucravacitinib compared with apremilast for moderate to severe plaque psoriasis, regardless of prior systemic or biologic use.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"1891-1899"},"PeriodicalIF":3.5,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11265040/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141440310","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dermatology and TherapyPub Date : 2024-07-01Epub Date: 2024-06-22DOI: 10.1007/s13555-024-01202-3
Wioletta Baranska-Rybak, José V Lajo-Plaza, Lee Walker, Navid Alizadeh
{"title":"Late-Onset Reactions after Hyaluronic Acid Dermal Fillers: A Consensus Recommendation on Etiology, Prevention and Management.","authors":"Wioletta Baranska-Rybak, José V Lajo-Plaza, Lee Walker, Navid Alizadeh","doi":"10.1007/s13555-024-01202-3","DOIUrl":"10.1007/s13555-024-01202-3","url":null,"abstract":"<p><p>Hyaluronic acid (HA) dermal fillers, generally considered low-risk, can lead to rare late-onset reactions (LORs) manifesting between 3 and 4 months postinjection, occasionally even as early as 24 h postinjection. The Complication Assessment and Risk Evaluation (CARE) board was established to review these reactions. In this publication, the authors aims to explore the etiological hypotheses underlying LORs, associated risk factors, prevention, and management approaches suggested by the CARE board. The CARE board identified three etiological hypotheses contributing to LORs. Firstly, the physicochemical structure of the filler, particularly low molecular weight HA, which may trigger an immune response. Secondly, infection, potentially introduced during injection or by dormant biofilm activation. Lastly, an imbalance in the host immune system, caused by factors like autoimmune diseases or viral infections, may lead to extended foreign body reactions, delayed type IV hypersensitivity, or adjuvant-based reactions. Based on these hypotheses, the board categorized various risk factors as patient-related (e.g., recent dental treatment, current medical status, active autoimmune disease), product-related (e.g., molecular weight), and procedure-related (e.g., aseptic technique and trauma). To reduce the risk of LORs, the CARE board recommends diligent patient selection, including comprehensive medical history assessment and informed consent. Practitioners should maintain an effective aseptic technique, and choose an appropriate product and injection depth for the anatomical location. Post-procedure, patients should receive education on proper filler care. Management of LORs depends on the suspected etiology, and the CARE board has proposed an algorithm to determine the most appropriate treatment. Hyaluronidase is recommended for noninflammatory reactions in the absence of active infection, while watchful waiting and/or steroid treatment may be preferred for inflammatory reactions. Hyaluronidase is not recommended as a first-line treatment for infections, which require drainage, bacterial culture, and antibiotic treatment. However, the board emphasizes the need for individualized evaluation and treatment in all cases.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"1767-1785"},"PeriodicalIF":3.5,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11265052/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141440311","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dermatology and TherapyPub Date : 2024-07-01Epub Date: 2024-06-16DOI: 10.1007/s13555-024-01205-0
Allison R Loiselle, Raj Chovatiya, Isabelle J Thibau, Jessica K Johnson, Michele Guadalupe, Wendy Smith Begolka
{"title":"Evaluating Access to Prescription Medications in the Atopic Dermatitis Patient Population in the USA.","authors":"Allison R Loiselle, Raj Chovatiya, Isabelle J Thibau, Jessica K Johnson, Michele Guadalupe, Wendy Smith Begolka","doi":"10.1007/s13555-024-01205-0","DOIUrl":"10.1007/s13555-024-01205-0","url":null,"abstract":"<p><strong>Introduction: </strong>Despite advances in atopic dermatitis (AD) treatments, many patients face challenges obtaining medications. This study aimed to determine the frequency and causes of insurance coverage delays and denials for AD prescriptions and characterize the associated wait times and extent to which patients understand what to do when faced with a coverage issue.</p><p><strong>Methods: </strong>This was a cross-sectional, observational study in which adult U.S. residents (aged 18+ years) with AD or caregivers of pediatric U.S. patients with AD (aged 0-17 years) completed an online survey (3 June-16 July 2021).</p><p><strong>Results: </strong>Respondents (N = 978) were primarily adults with AD (81.8%), female (67.7%), and white (70.2%). There were 645 insurance delays or denials for AD prescriptions, with 48.1% (470/978) of respondents experiencing at least one delay/denial in the past year. Most delays/denials were for topical steroids (39.2%, 253/645), the most highly used prescription treatment class (83.9%, 821/978). However, the highest rate of delay/denials was for biologics, of which 43.6% (109/250) of all prescriptions faced a delay or denial. Denials were caused primarily by step therapy (27.6%) and delays by prior authorization (55.1%). Only 56.0% of respondents said they would know what to do if they faced an issue with AD prescription coverage.</p><p><strong>Conclusions: </strong>Patients with AD frequently experience insurance-related barriers to obtaining recommended therapies, and many do not know how to respond when these barriers arise. Strategies to improve timely therapeutic access are needed.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"1811-1821"},"PeriodicalIF":3.5,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11264656/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141330550","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dermatology and TherapyPub Date : 2024-07-01Epub Date: 2024-06-26DOI: 10.1007/s13555-024-01212-1
David Rosmarin, Ahmed M Soliman, Simran Marwaha, James Piercy, Heidi S Camp, Peter Anderson, Khaled Ezzedine
{"title":"Disease Course, Treatment Patterns and Goals Among Patients with Non-segmental Vitiligo Across Europe and the United States.","authors":"David Rosmarin, Ahmed M Soliman, Simran Marwaha, James Piercy, Heidi S Camp, Peter Anderson, Khaled Ezzedine","doi":"10.1007/s13555-024-01212-1","DOIUrl":"10.1007/s13555-024-01212-1","url":null,"abstract":"<p><strong>Introduction: </strong>There is currently a lack of research regarding disease course and burden as well as treatment patterns and goals in patients with non-segmental vitiligo (NSV). The aim of this analysis was to evaluate disease course, treatment patterns and goals in patients with NSV.</p><p><strong>Methods: </strong>This analysis used secondary data from the Adelphi Real World Vitiligo Disease Specific Programme<sup>™</sup> 2021, specifically, a survey of physicians and their adult and adolescent patients with NSV. Physicians categorized patients by the extent of NSV at time of survey completion as mild, moderate or severe/very severe. Physician-reported patient information included demographics, current/previously prescribed NSV therapies, treatment satisfaction and the Vitiligo Noticeability Scale (VNS). Patients completed a survey on treatment satisfaction and the VNS. Treatment pattern data were stratified by disease extent and Fitzpatrick skin type.</p><p><strong>Results: </strong>At survey completion, physicians reported that 38, 50 and 12% of patients (N = 1865) had improving, stable and deteriorating/progressing disease, respectively. Most patients (96%) with mild disease at treatment initiation still had mild disease at the time of survey completion. More than half of patients with moderate disease (62%) or severe/very severe disease (57%) at treatment initiation still had moderate or severe/very severe disease at survey completion. Topical calcineurin inhibitors (TCIs) were the most common treatment in 40% of patients followed by phototherapy in 30%. Patients hoped for re-pigmentation (mild 56%, moderate 62%, severe/very severe 66%), reduction (mild 50%, moderate 56%, severe/very severe 49%) or cessation of affected areas with vitiligo (mild 48%, moderate 54%, severe/very severe 43%).</p><p><strong>Conclusion: </strong>The study findings indicate that a significant proportion of patients with NSV are not improving on current treatments, most commonly TCIs and phototherapy. The results highlight the unmet need for novel and effective therapies to substantially improve re-pigmentation, an important treatment goal for patients with NSV.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"1945-1957"},"PeriodicalIF":3.5,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11265022/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141455831","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}