Eyal Taleb, Oriol Yélamos, Marco Ardigo, Rachel E. Christensen, Shamir Geller
{"title":"Non-invasive Skin Imaging in Cutaneous Lymphomas","authors":"Eyal Taleb, Oriol Yélamos, Marco Ardigo, Rachel E. Christensen, Shamir Geller","doi":"10.1007/s40257-023-00824-1","DOIUrl":"10.1007/s40257-023-00824-1","url":null,"abstract":"<div><p>The diagnosis of cutaneous lymphomas is challenging and requires skin tissue for histology and immunophenotyping using immunohistochemistry and molecular studies. In recent years, the role of non-invasive imaging techniques has been described as part of the clinical assessment of cutaneous lymphoma lesions. Imaging modalities such as dermoscopy, reflectance confocal microscopy (RCM), and high frequency ultrasound (HFUS) have been shown to be very valuable in raising the clinical suspicion for lymphomas of the skin, and in distinguishing cutaneous lymphomas from inflammatory dermatoses such as lupus, psoriasis, or eczema. These non-invasive methods can be used to direct the clinician to the optimal biopsy site to maximize the histopathological results and minimize false negatives. These methods also have a potential place in monitoring treatment response. In this review we present a concise summary of the dermoscopic imaging, RCM, and HFUS features seen in cutaneous T-cell lymphomas (CTCL) and B-cell lymphomas (CBCL).</p></div>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":"25 1","pages":"79 - 89"},"PeriodicalIF":8.6,"publicationDate":"2023-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"107589995","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Luca Stingeni, Andrea Chiricozzi, Piergiacomo Calzavara-Pinton, Maddalena Napolitano, Ketty Peris, Donatella Schena, Cataldo Patruno, Mariateresa Rossi, Caterina Foti, Maria C. Fargnoli, Monica Corazza, Silvia M. Ferrucci, Paolo D. Pigatto, Marco Romanelli, Gabriella Fabbrocini, Giampiero Girolomoni, Maria Passante, Paolo Romita, Maria Esposito, Natale Schettini, Angelo V. Marzano, Giulia Tonini, Rossella Marietti, Gabriele Casciola, Giuseppe Argenziano, Katharina Hansel, AtopyReg® study group
{"title":"Correction to: AtopyReg®, the Prospective Italian Patient Registry for Moderate-to-Severe Atopic Dermatitis in Adults: Baseline Demographics, Disease Characteristics, Comorbidities, and Treatment History","authors":"Luca Stingeni, Andrea Chiricozzi, Piergiacomo Calzavara-Pinton, Maddalena Napolitano, Ketty Peris, Donatella Schena, Cataldo Patruno, Mariateresa Rossi, Caterina Foti, Maria C. Fargnoli, Monica Corazza, Silvia M. Ferrucci, Paolo D. Pigatto, Marco Romanelli, Gabriella Fabbrocini, Giampiero Girolomoni, Maria Passante, Paolo Romita, Maria Esposito, Natale Schettini, Angelo V. Marzano, Giulia Tonini, Rossella Marietti, Gabriele Casciola, Giuseppe Argenziano, Katharina Hansel, AtopyReg® study group","doi":"10.1007/s40257-023-00822-3","DOIUrl":"10.1007/s40257-023-00822-3","url":null,"abstract":"","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":"25 1","pages":"161 - 161"},"PeriodicalIF":8.6,"publicationDate":"2023-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10796682/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71477204","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Atopic Dermatitis: Fertility, Pregnancy, and Treatment Perspectives","authors":"Mónica Munera-Campos, Jose Manuel Carrascosa","doi":"10.1007/s40257-023-00821-4","DOIUrl":"10.1007/s40257-023-00821-4","url":null,"abstract":"<div><p>Hormonal and immunologic changes during pregnancy can contribute to the development of different dermatoses, the most common of which is atopic eruption of pregnancy (AEP). Of atopic dermatitis (AD) cases during pregnancy, 80% are new-onset presentations, while 20% represent recurrences or exacerbations of preexisting disease. Evidence on the effects of previous AD on fertility is limited. Different factors influence women’s desire to conceive in this setting, and it has been hypothesized that barrier defects and systemic inflammation could contribute to biologic infertility, although more data are needed. Clinical practice suggests a tendency toward undertreatment in pregnant woman due to concerns about potential effects on obstetric and fetal outcomes. However, pregnant women should be offered adequate and safe treatments, preferably on an individual basis. The aim of this review was to summarize the evidence on disease course in pregnant women with AD and the challenges associated with its diagnosis and management. We also review the current evidence on the use of conventional and novel systemic therapies for AD in this population.</p></div>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":"25 1","pages":"55 - 66"},"PeriodicalIF":8.6,"publicationDate":"2023-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71410240","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Luis Puig, Antonio Costanzo, Elke M. G. J. de Jong, Tiago Torres, Richard B. Warren, Robert Wapenaar, Sven Wegner, Patricia Gorecki, Talia Gramiccia, Maria Jazra, Jozefien Buyze, Curdin Conrad
{"title":"Guselkumab-Treated Patients with Plaque Psoriasis Who Achieved Complete Skin Clearance for ≥ 156 Consecutive Weeks: A Post-Hoc Analysis From the VOYAGE 1 Clinical Trial","authors":"Luis Puig, Antonio Costanzo, Elke M. G. J. de Jong, Tiago Torres, Richard B. Warren, Robert Wapenaar, Sven Wegner, Patricia Gorecki, Talia Gramiccia, Maria Jazra, Jozefien Buyze, Curdin Conrad","doi":"10.1007/s40257-023-00816-1","DOIUrl":"10.1007/s40257-023-00816-1","url":null,"abstract":"<div><h3>Background</h3><p>Treatment of moderate-to-severe plaque psoriasis with biologics, such as guselkumab, has demonstrated greater efficacy over traditional non-biologic treatments. However, given patient diversity, greater understanding of the relationship between patient characteristics, positive clinical outcomes, and long-term response to biologics is crucial for optimizing treatment choices.</p><h3>Materials and Methods</h3><p>This post-hoc analysis of the 5-year VOYAGE 1 clinical trial compares baseline characteristics of patients maintaining a Psoriasis Area and Severity Index (PASI) score of 0 at all visits for ≥ 156 consecutive weeks (PASI = 0 group) with those that never achieve PASI = 0 (comparator group), using descriptive statistics and a multiple logistic regression model. Guselkumab plasma trough concentrations in both response groups were assessed from Weeks 4–156.</p><h3>Results</h3><p>Of patients who started guselkumab treatment at Week 0 or at Week 16 after switching from placebo, 22.7% (112/494) maintained PASI = 0 for ≥ 156 consecutive weeks. Numerical differences in baseline characteristics, including age, obesity, diabetes, PASI score, disease duration, smoking status, and psoriatic arthritis comorbidity, were identified between the PASI = 0 group and comparator group. Plasma guselkumab levels were consistently higher in the PASI = 0 group. Multiple logistic regression analysis revealed absence of diabetes, lower Dermatology Life Quality Index score at baseline, and higher Week 4 guselkumab plasma concentration as significantly (<i>p</i> < 0.05) associated with the PASI = 0 group.</p><h3>Conclusion</h3><p>A substantial (22.7%) number of guselkumab-treated patients in the VOYAGE 1 clinical trial maintained complete skin clearance for a consecutive period of ≥ 156 weeks. Factors associated with this outcome may suggest clinical benefits of holistic treatment approaches.</p><h3>Trial Registration</h3><p>NCT02207231.</p></div>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":"25 2","pages":"315 - 325"},"PeriodicalIF":8.6,"publicationDate":"2023-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10866772/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41091517","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Eric L. Simpson, Andrew Blauvelt, Jonathan I. Silverberg, Michael J. Cork, Norito Katoh, Thomas Mark, Shannon K. R. Schneider, Andreas Wollenberg
{"title":"Tralokinumab Provides Clinically Meaningful Responses at Week 16 in Adults with Moderate-to-Severe Atopic Dermatitis Who Do Not Achieve IGA 0/1","authors":"Eric L. Simpson, Andrew Blauvelt, Jonathan I. Silverberg, Michael J. Cork, Norito Katoh, Thomas Mark, Shannon K. R. Schneider, Andreas Wollenberg","doi":"10.1007/s40257-023-00817-0","DOIUrl":"10.1007/s40257-023-00817-0","url":null,"abstract":"<div><h3>Background and Objective</h3><p>Investigator’s Global Assessment of clear/almost clear skin (IGA 0/1) is a difficult endpoint to achieve after short-term treatment of chronic moderate-to-severe atopic dermatitis, and does not fully reflect clinically meaningful changes in other parameters. We assessed the impact of tralokinumab versus placebo on other clinically meaningful parameters in patients not achieving IGA 0/1 at week 16 using pooled data from two monotherapy phase III trials, ECZTRA 1 and 2.</p><h3>Methods</h3><p>This post hoc analysis included patients (<i>n</i> = 1328) from ECZTRA 1 and 2 who did not achieve the co-primary endpoint, IGA 0/1 at week 16 without rescue medication. Endpoints evaluating atopic dermatitis extent and severity included proportions of patients achieving IGA 0/1, 50%, 75%, and 90% improvement in Eczema Area and Severity Index (EASI-50/75/90); endpoints evaluating patient-reported outcomes included a ≥ 3-point improvement in worst daily pruritus Numerical Rating Scale (NRS), a ≥ 3-point improvement in eczema-related sleep interference (sleep) NRS, a ≥ 4-point improvement in Dermatology Life Quality Index (DLQI), and DLQI ≤ 5. Specifically, clinically meaningful responses were defined as EASI-50, a ≥ 3-point improvement in itch NRS, or a ≥ 4-point improvement in DLQI at week 16.</p><h3>Results</h3><p>Among ECZTRA 1 and 2 patients who did not achieve IGA 0/1 at week 16 without rescue medication, a significantly greater proportion of patients receiving tralokinumab versus placebo achieved EASI-50 (33.0% vs 13.0%), a ≥ 3-point improvement in itch NRS (22.6% vs 9.4%), or a ≥ 4-point improvement in DLQI (41.2% vs 24.5%) at week 16. In addition, compared with placebo, a numerically greater proportion of tralokinumab-treated patients achieved all three measures of clinically meaningful response (30% vs 18%) or a clinically meaningful change in at least one outcome (48.8% vs 28.5%). Significantly greater proportions of patients receiving tralokinumab versus placebo achieved additional clinician-reported and patient-reported outcomes, such as EASI-75 (13.5% vs 4.1%), EASI-90 (3.5% vs 1.1%), DLQI ≤ 5 (22.5% vs 12.5%), and a ≥ 3-point improvement in sleep NRS (24.5% vs 11.5%).</p><h3>Conclusions</h3><p>Tralokinumab provided clinically meaningful responses in patients with moderate-to-severe atopic dermatitis who did not achieve IGA 0/1 at week 16 and/or used rescue medication. Using multiple validated outcome measures of both efficacy and quality of life, alongside IGA scores, can better characterize tralokinumab treatment responses in patients with moderate-to-severe atopic dermatitis. [Video abstract available]</p><h3>Clinical Trial Registration</h3><p>NCT03131648 (ECZTRA 1); study start date: 30 May, 2017; primary completion date: 7 August, 2018; study completion date: 10 October, 2019. NCT03160885 (ECZTRA 2); study start date: 12 June, 2017; primary completion date: 4 September, 2019; study completion date: 14 Au","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":"25 1","pages":"139 - 148"},"PeriodicalIF":8.6,"publicationDate":"2023-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10796753/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41102294","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Luca Stingeni, Andrea Chiricozzi, Piergiacomo Calzavara-Pinton, Maddalena Napolitano, Ketty Peris, Donatella Schena, Cataldo Patruno, Mariateresa Rossi, Caterina Foti, Maria C. Fargnoli, Monica Corazza, Silvia M. Ferrucci, Paolo D. Pigatto, Marco Romanelli, Gabriella Fabbrocini, Giampiero Girolomoni, Maria Passante, Paolo Romita, Maria Esposito, Natale Schettini, Angelo V. Marzano, Giulia Tonini, Rossella Marietti, Gabriele Casciola, Giuseppe Argenziano, Katharina Hansel, AtopyReg® study group
{"title":"AtopyReg®, the Prospective Italian Patient Registry for Moderate-to-Severe Atopic Dermatitis in Adults: Baseline Demographics, Disease Characteristics, Comorbidities, and Treatment History","authors":"Luca Stingeni, Andrea Chiricozzi, Piergiacomo Calzavara-Pinton, Maddalena Napolitano, Ketty Peris, Donatella Schena, Cataldo Patruno, Mariateresa Rossi, Caterina Foti, Maria C. Fargnoli, Monica Corazza, Silvia M. Ferrucci, Paolo D. Pigatto, Marco Romanelli, Gabriella Fabbrocini, Giampiero Girolomoni, Maria Passante, Paolo Romita, Maria Esposito, Natale Schettini, Angelo V. Marzano, Giulia Tonini, Rossella Marietti, Gabriele Casciola, Giuseppe Argenziano, Katharina Hansel, AtopyReg® study group","doi":"10.1007/s40257-023-00819-y","DOIUrl":"10.1007/s40257-023-00819-y","url":null,"abstract":"<div><h3>Background and Objective</h3><p>AtopyReg<sup>®</sup> is a multicenter, prospective, observational, non-profit cohort study on moderate-to-severe atopic dermatitis in adults promoted in 2018 by the Italian Society of Dermatology and Venereology (SIDeMaST). We aimed to describe baseline demographics, disease characteristics, comorbidities, and therapeutic data of adult patients affected by moderate-to-severe atopic dermatitis.</p><h3>Methods</h3><p>Patients were selected based on the following inclusion criteria: age ≥ 18 years; Eczema Area and Severity Index score ≥ 16 or localization in visible or sensitive areas (face, neck, hands, or genitalia), or a Numeric Rating Scale itch score ≥ 7 or a Numeric Rating Scale sleep loss score ≥ 7, or a Dermatology Life Quality Index score ≥ 10. Demographic and clinical data at baseline were recorded and analyzed.</p><h3>Results</h3><p>A total of 1170 patients (male 51.1%; mean age: 44.7 years; range 18–90 years) were enrolled by 12 Italian Dermatology Units between January 2019 and November 2022. Skin lesions were eczematous in 83.2% of patients, the most involved site were the flexures (53.9%), face (50.9%), and neck (48.0%). Mean Eczema Area and Severity Index score was 22.3, mean Dermatology Life Quality Index value was 17.6, mean Patient Oriented Eczema Measure score was 13.1, and mean Numeric Rating Scale itch and sleep loss scores were 7.6 and 5.9, respectively. Previous systemic therapies were corticosteroids in 77.7% of patients, antihistamines in 50.3% of patients, and cyclosporine A in 42.6% of patients.</p><h3>Conclusions</h3><p>This baseline data analysis deriving from AtopyReg<sup>®</sup> provides real-life evidence on patients with moderate-to-severe atopic dermatitis in Italy confirming the high burden of atopic dermatitis with a significant impact on patients’ quality of life.</p></div>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":"25 1","pages":"149 - 160"},"PeriodicalIF":8.6,"publicationDate":"2023-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10796485/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41100080","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Chronic Prurigo Including Prurigo Nodularis: New Insights and Treatments","authors":"Svenja Müller, Claudia Zeidler, Sonja Ständer","doi":"10.1007/s40257-023-00818-z","DOIUrl":"10.1007/s40257-023-00818-z","url":null,"abstract":"<div><p>Chronic prurigo (CPG) is a neuroinflammatory, fibrotic dermatosis that is defined by the presence of chronic pruritus (itch lasting longer than 6 weeks), scratch-associated pruriginous skin lesions and history of repeated scratching. Patients with CPG experience a significant psychological burden and a notable impairment in their quality of life. Chronic prurigo of nodular type (CNPG; synonym: prurigo nodularis) represents the most common subtype of CPG. As CNPG is representative for all CPG subtypes, we refer in this review to both CNPG and CPG. We provide an overview of the clinical characteristics and assessment of CPG, the burden of disease and the underlying pathophysiology including associated therapeutic targets. The information provided results from a PubMed search for the latest publications and a database search for current clinical trials (ClinicalTrials.gov, EU Clinical Trials Register [European Medicines Agency]; using the following terms or combinations of terms: ‘chronic prurigo’, ‘prurigo’, ‘prurigo nodularis’, ‘pathophysiology’, ‘therapy’, ‘biologics’, ‘treatment’). Dupilumab is the first authorized systemic therapy by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for CNPG to date. Topical and systemic agents that are currently under investigation in clinical randomized, placebo-controlled phase II and III trials such as biologics (e.g., nemolizumab, vixarelimab/KPL-716, barzolvolimab/CDX-0159), small molecules (ruxolitinib cream, povorcitinib/INCB054707, abrocitinib) and the opioid modulator nalbuphine are highlighted. In the last past 15 years, several milestones have been reached regarding the disease understanding of CPG such as first transcriptomic analysis, first terminology, first guideline, and first therapy approval in 2022, which contributed to improved medical care of affected patients. The broad range of identified targets, current case observations and initiated trials offers the possibility of more drug approvals in the near future.</p></div>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":"25 1","pages":"15 - 33"},"PeriodicalIF":8.6,"publicationDate":"2023-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10796623/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10633569","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Oral Lichen Planus: An Update on Diagnosis and Management","authors":"Agathe Louisy, Eiryann Humbert, Mahtab Samimi","doi":"10.1007/s40257-023-00814-3","DOIUrl":"10.1007/s40257-023-00814-3","url":null,"abstract":"<div><p>Oral lichen planus (OLP) is a chronic inflammatory disease whose pathogenesis involves a T-cell mediated, epithelium-directed inflammation in response to unknown antigen(s). The disease evolves by intermittent flares and displays polymorphous clinical features (reticular, erosive, atrophic, plaque, papular, bullous, etc.). When present, symptoms vary depending on the clinical form and range from discomfort to severe pain. Topical superpotent corticosteroids constitute the first-line treatment of symptomatic flares, whereas a wide range of second/third-line treatments are available among topical calcineurin inhibitors, systemic corticosteroids, systemic retinoids, topical/systemic immunomodulators, etc. Follow-up of patients is necessary to detect transformation into squamous cell carcinoma, occurring in approximately 1% of patients.</p></div>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":"25 1","pages":"35 - 53"},"PeriodicalIF":8.6,"publicationDate":"2023-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10247640","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jonathan I. Silverberg, April Armstrong, Andrew Blauvelt, Kristian Reich
{"title":"Assessment of Efficacy and Safety Outcomes Beyond Week 16 in Clinical Trials of Systemic Agents Used for the Treatment of Moderate to Severe Atopic Dermatitis in Combination with Topical Corticosteroids","authors":"Jonathan I. Silverberg, April Armstrong, Andrew Blauvelt, Kristian Reich","doi":"10.1007/s40257-023-00809-0","DOIUrl":"10.1007/s40257-023-00809-0","url":null,"abstract":"<div><p>Atopic dermatitis (AD) is a chronic inflammatory disease requiring efficacious and safe long-term therapy. Several new systemic treatments have recently been approved for use in patients with moderate to severe AD. However, head-to-head comparisons have not been conducted for all the currently available treatments for AD. Multiple network meta-analyses have compared efficacy of these different therapies during the initial 16-week treatment period, but not beyond week 16. Therefore, understanding the differences in key trial design and statistical methods is essential for evaluating long-term efficacy, making cross-trial comparisons, and informing treatment decisions. This focused narrative review provides an overview of data and trial methodology to guide clinicians in evaluating longer-term efficacy and safety of currently approved systemic treatments for patients with AD. We discuss important elements of longer-term trial designs and statistical analysis strategies that should be considered based on our experience as clinical trialists. In addition, a summary of key efficacy results of published, longer-term, phase III clinical trials of US Food and Drug Administration-approved, novel systemic treatments (i.e., dupilumab, tralokinumab, abrocitinib, and upadacitinib) is provided, including the design and data handling methods used. Long-term safety considerations and differences in the time-effect and safety profiles of various medications are also noted to help inform clinical decisions for individual patients. Overall, the findings of these trials support efficacy in long-term treatment with novel systemic agents for patients with AD.</p></div>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":"24 6","pages":"913 - 925"},"PeriodicalIF":7.3,"publicationDate":"2023-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/cd/c1/40257_2023_Article_809.PMC10570226.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10194451","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Correction to: Authors’ Reply to Chen and Chen: Comment on: “Isotretinoin Exposure and Risk of Inflammatory Bowel Disease: A Systematic Review with Meta-Analysis and Trial Sequential Analysis”","authors":"Chia-Ling Yu, Po-Yi Chou, Chih-Sung Liang, Li-Huei Chiang, Tzu-Yu Wang, Yu-Kang Tu, Ching-Chi Chi","doi":"10.1007/s40257-023-00820-5","DOIUrl":"10.1007/s40257-023-00820-5","url":null,"abstract":"","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":"24 6","pages":"1003 - 1003"},"PeriodicalIF":7.3,"publicationDate":"2023-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"50466591","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}