Dermatology and Therapy最新文献

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Biologic Therapy and Cardiometabolic Risk in Psoriasis: A Retrospective Review.
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-01-01 Epub Date: 2025-01-22 DOI: 10.1007/s13555-024-01327-5
Annika Smith, Aidin Karahasan, Deborah Yi, Sanjay Yapabandara, James Elhindi, Pablo Fernandez-Penas, Clara Chow, Sarah Zaman
{"title":"Biologic Therapy and Cardiometabolic Risk in Psoriasis: A Retrospective Review.","authors":"Annika Smith, Aidin Karahasan, Deborah Yi, Sanjay Yapabandara, James Elhindi, Pablo Fernandez-Penas, Clara Chow, Sarah Zaman","doi":"10.1007/s13555-024-01327-5","DOIUrl":"10.1007/s13555-024-01327-5","url":null,"abstract":"<p><strong>Introduction: </strong>Psoriasis is a systemic inflammatory disease with increased cardiometabolic risk including dyslipidaemia and diabetes. Biologic therapy effectively treats the cutaneous inflammatory burden of psoriasis and evolving evidence suggests potential to reduce systemic inflammatory sequalae that can elevate cardiovascular risk. This study aimed to assess the change in cardiometabolic risk markers in a cohort of patients with psoriasis treated with 1 year of continuous biologic treatment.</p><p><strong>Methods: </strong>A retrospective review was conducted of patients receiving biologic therapy for chronic plaque psoriasis in a single dermatology centre at a major tertiary hospital in Sydney, Australia. The effect of biologic therapy on psoriasis was assessed using the psoriasis area severity index (PASI). Cardiometabolic risk markers assessed included lipid profile (total cholesterol [TC], low-density lipoprotein [LDL] cholesterol, high-density lipoprotein [HDL] cholesterol and triglycerides [TG]) and haemoglobin A1c (HbA1c). Measurements at baseline and 1 year were compared using paired t tests for analysis of the parameters which approximated normal distribution (TC, LDL, HDL) and Wilcoxon signed-rank test for analysis of those which did not (TG, HbA1c, PASI). Two-tailed P values < 0.05 were considered significant.</p><p><strong>Results: </strong>A total of 200 patients were reviewed, of which 39 had complete data sets. The participants' ages ranged from 21 to 85 years (mean 51, SD 16.9). Of the 39 participants, 31 (79.5%) were male, 8 (20.5%) were female; 26 (67%) were biologic experienced (BE) and 13 (33%) were biologic naïve (BN). The mean PASI at baseline (for BN + BE) was 13.4 (SD 9.8). The biologic agents used, according to frequency, included risankizumab, with 14 participants (35.9%), secukinumab by 7 (17.9%), ustekinumab by 6 (15.4%), ixekizumab by 6 (15.4%), guselkumab by 3 (7.7%), infliximab by 2 (5.1%), and adalimumab by 1 (2.6%). After 12 months, significant skin improvement was seen [PASI reduced from 13.43 (SD 9.8) to 1.1 (SD 2.1), p < 0.001]. There was no significant change in lipid profile, including TC (mean difference - 0.1 mmol/L, p = 0.532), LDL-C (mean difference = - 0.1 mmol/L, p = 0.476), HDL (mean difference = - 0.1 mmol/L, p = 0.125), triglycerides (mean difference = 0.0 mmol/l, p = 0.748) or HbA1c (mean difference 0.38%, p = 0.468).</p><p><strong>Conclusion: </strong>Markers of cardiometabolic risk (lipid profile and HbA1c) did not significantly improve after 1 year of biologic therapy despite significant reduction in psoriasis skin severity. Further research in larger cohorts is needed to elucidate the benefits, if any, of biologic therapy on cardiometabolic parameters in individuals with psoriasis, in order to optimise care for this vulnerable cohort.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"201-212"},"PeriodicalIF":3.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11785865/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143022494","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}
引用次数: 0
Chlormethine Gel for Treatment of Patients with Mycosis Fungoides: Best Practices and Guidance to Clinicians. 治疗真菌病患者的氯甲胺凝胶:最佳实践与临床医师指南》。
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-01-01 Epub Date: 2024-11-27 DOI: 10.1007/s13555-024-01305-x
Larisa Geskin, Christiane Querfeld, Emmilia Hodak, Neda Nikbakht, Evangelia Papadavid, Marco Ardigò, Ulrike Wehkamp, Martine Bagot
{"title":"Chlormethine Gel for Treatment of Patients with Mycosis Fungoides: Best Practices and Guidance to Clinicians.","authors":"Larisa Geskin, Christiane Querfeld, Emmilia Hodak, Neda Nikbakht, Evangelia Papadavid, Marco Ardigò, Ulrike Wehkamp, Martine Bagot","doi":"10.1007/s13555-024-01305-x","DOIUrl":"10.1007/s13555-024-01305-x","url":null,"abstract":"<p><strong>Background: </strong>Mycosis fungoides (MF) is the most common form of cutaneous T cell lymphoma. While multiple guidelines provide treatment recommendations, there are currently no clear treatment algorithms for MF. Chlormethine gel is recommended by major treatment guidelines as a first-line option for stage IA-IIA disease, and, on the basis of these guidelines, used in combination with other therapies in patients with advanced-stage MF in clinical practice.</p><p><strong>Objectives: </strong>To provide guidance regarding the use of chlormethine gel for patients with all stages of MF, based on clinical expertise.</p><p><strong>Methods: </strong>Opinions on best practices regarding the use of chlormethine gel were collected through discussions that involved eight clinicians with extensive experience in treating patients with MF.</p><p><strong>Results: </strong>Chlormethine gel can be used as monotherapy in first- or second-line treatment of early-stage MF. In first-line, chlormethine gel monotherapy is prescribed for stage IA MF, and is particularly convenient for patients unable/unwilling to travel for hospital-based phototherapy, patients with thick plaques or palmoplantar involvement, when ultraviolet treatment is contraindicated, and for sanctuary sites. Chlormethine gel is also an appropriate first-line monotherapy for patients with stage IB or IIA MF; it may be used as part of combination regimens in these patients as well. For patients with late-stage MF, skin-directed treatments such as chlormethine gel should be combined with systemic therapies.</p><p><strong>Conclusions: </strong>Chlormethine gel is a safe and effective treatment option that can be used in all stages of MF, either as monotherapy or in combination, depending on disease stage and patient characteristics and needs.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"61-73"},"PeriodicalIF":3.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11785887/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142726884","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}
引用次数: 0
Successful Achievement of Demanding Outcomes in Upadacitinib-Treated Atopic Dermatitis Patients: A Real-World, 96-Week Single-Centre Study. upadacitinib治疗特应性皮炎患者的疗效:一项真实世界96周单中心研究
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-01-01 Epub Date: 2025-01-15 DOI: 10.1007/s13555-024-01334-6
Stamatios Gregoriou, Ioannis-Alexios Koumprentziotis, Ileana Afroditi Kleidona, Michail Bakakis, Eleni Hatzidimitriou, Theodora Douvali, Aikaterini Tsiogka, Styliani Mastraftsi, Aristeidis Vaiopoulos, Alexander Stratigos
{"title":"Successful Achievement of Demanding Outcomes in Upadacitinib-Treated Atopic Dermatitis Patients: A Real-World, 96-Week Single-Centre Study.","authors":"Stamatios Gregoriou, Ioannis-Alexios Koumprentziotis, Ileana Afroditi Kleidona, Michail Bakakis, Eleni Hatzidimitriou, Theodora Douvali, Aikaterini Tsiogka, Styliani Mastraftsi, Aristeidis Vaiopoulos, Alexander Stratigos","doi":"10.1007/s13555-024-01334-6","DOIUrl":"10.1007/s13555-024-01334-6","url":null,"abstract":"<p><strong>Introduction: </strong>Results from randomized controlled trials of upadacitinib, a Janus kinase (JAK) inhibitor, have led to its approval for the treatment of moderate-to-severe atopic dermatitis (AD) in patients aged ≥ 12 years. The aim of this study was to report the effectiveness and safety of upadacitinib in real-world settings over a period of 96 weeks.</p><p><strong>Methods: </strong>This retrospective study included all patients treated with upadacitinib at our centre between April 2022 and September 2024. Clinical and patient-reported outcomes were recorded and assessed at each follow-up visit and included the eczema area severity index (EASI), investigator global assessment (IGA), scoring atopic dermatitis (SCORAD), dermatology life quality index (DLQI) and the worst pruritus numerical scale score (WP-NRS). All drug-related adverse events (AEs) were documented.</p><p><strong>Results: </strong>In total, 36 patients (44.4% female) were retrospectively included. After 4 weeks of treatment, the mean EASI was reduced from 29.97 to 3.72 with 83.3/52.8/19.4% achieving EASI75/90/100 respectively. Similar reductions were observed in the DLQI, which was reduced from 20.78 to 2.92, and in the WP-NRS, from 7.78 to 1.31. Further improvements were observed at week 16, with a mean EASI of 0.75 and 96.4% of the patients achieving EASI75 and EASI90. At week 48 of treatment, EASI75/90/100 were achieved by 100/93.8/81.3% along with a mean DLQI and pruritus NRS of 0.81. All nine patients that reached the 72- and 96-week timepoints had clear skin with no pruritus. Six (16.7%) patients experienced AEs with four of them discontinuing medication; no patient discontinued because of upadacitinib inefficacy.</p><p><strong>Conclusion: </strong>This long-term real-world study of patients with moderate-to-severe AD receiving upadacitinib demonstrated that treatment success (EASI75/90/100) can be achieved in a high proportion of patients by week 16 and can be maintained for up to 96 weeks along with substantial improvements in pruritus and quality of life.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"227-235"},"PeriodicalIF":3.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11785836/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142983019","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}
引用次数: 0
Long-Term Safety of Ixekizumab Treatment in Patients with Psoriasis, Psoriatic Arthritis, or Axial Spondyloarthritis: a Post Hoc Analysis of Cerebro-Cardiovascular Events.
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-01-01 Epub Date: 2025-01-22 DOI: 10.1007/s13555-024-01323-9
Mark Lebwohl, Atul Deodhar, Sergio Schwartzman, Carlo Salvarani, Meghan Feely McDonald, Natalia Bello, Elsie L Grace, Elsa Inman, Andris Kronbergs, Marcus Ngantcha, Proton Rahman, Kim A Papp, Joseph F Merola, Alice B Gottlieb, Andrew Blauvelt
{"title":"Long-Term Safety of Ixekizumab Treatment in Patients with Psoriasis, Psoriatic Arthritis, or Axial Spondyloarthritis: a Post Hoc Analysis of Cerebro-Cardiovascular Events.","authors":"Mark Lebwohl, Atul Deodhar, Sergio Schwartzman, Carlo Salvarani, Meghan Feely McDonald, Natalia Bello, Elsie L Grace, Elsa Inman, Andris Kronbergs, Marcus Ngantcha, Proton Rahman, Kim A Papp, Joseph F Merola, Alice B Gottlieb, Andrew Blauvelt","doi":"10.1007/s13555-024-01323-9","DOIUrl":"10.1007/s13555-024-01323-9","url":null,"abstract":"<p><strong>Introduction: </strong>Psoriasis (PsO), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) may confer an increased risk for cardiovascular (CV) disease, including major adverse cerebro-cardiovascular events (MACE), deep vein thrombosis (DVT), and pulmonary embolism (PE). Patients with these conditions are often exposed for extended time periods to biologics, such as ixekizumab (IXE). Therefore, understanding the risk of CV events, especially MACE, in patients with PsO, PsA, and axSpA exposed to IXE is important.</p><p><strong>Methods: </strong>The incidence of MACE (i.e., adjudicated cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke), DVT, and PE was assessed in adults who received ≥ 1 dose of IXE across 25 randomized clinical trials (17 PsO, 4 PsA, 4 axSpA). Rates of CV events were analyzed for pooled studies by indication and analyzed from treatment initiation up to the end of the study program. Exposure-adjusted incidence rates per 100 patient-years (IR/100 PY) are reported.</p><p><strong>Results: </strong>This integrated safety analysis included 6892 patients with PsO, 1401 with PsA, and 932 with axSpA. The median duration of IXE exposure was 478.5 days (1.3 years) for patients with PsO, 504.5 days (1.4 years) for patients with PsA, and 981.0 days (2.7 years) for patients with axSpA. The incidence of adjudicated MACE was low (IR/100 PY: PsO = 0.5; PsA = 0.5; axSpA = 0.3) and stable over the treatment periods. The most common types of MACE reported were non-fatal myocardial infarction (IR/100 PY: PsO = 0.3; PsA = 0.3; axSpA = 0.3), followed by non-fatal stroke (IR/100 PY: PsO = 0.1; PsA = 0.2; axSpA = 0.0), and cardiovascular death (IR/100 PY: PsO = 0.1; PsA = 0.1; axSpA = 0.0). The incidences of DVT (IR/100 PY: PsO = 0.1; PsA = 0.1; axSpA = 0.1) and PE (IR/100 PY: PsO = 0.1; PsA = 0.0; axSpA = 0.0) were low.</p><p><strong>Conclusion: </strong>This integrated safety analysis of 25 randomized clinical trials showed that the incidence of adjudicated MACE was low among adult patients with PsO, PsA, and axSpA and that the rates did not increase with increasing IXE exposure.</p><p><strong>Trial registration: </strong>The supplementary Table S1 provides a comprehensive list of clinical trials and their registration numbers.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"161-188"},"PeriodicalIF":3.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11785857/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143022497","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}
引用次数: 0
Tapinarof Improved Outcomes and Sleep for Patients and Families in Two Phase 3 Atopic Dermatitis Trials in Adults and Children. 在成人和儿童的两项3期特应性皮炎试验中,Tapinarof改善了患者和家属的结局和睡眠。
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-01-01 Epub Date: 2025-01-07 DOI: 10.1007/s13555-024-01318-6
Eric L Simpson, Adelaide A Hebert, John Browning, Rocco T Serrao, Howard Sofen, Philip M Brown, Stephen C Piscitelli, David S Rubenstein, Anna M Tallman
{"title":"Tapinarof Improved Outcomes and Sleep for Patients and Families in Two Phase 3 Atopic Dermatitis Trials in Adults and Children.","authors":"Eric L Simpson, Adelaide A Hebert, John Browning, Rocco T Serrao, Howard Sofen, Philip M Brown, Stephen C Piscitelli, David S Rubenstein, Anna M Tallman","doi":"10.1007/s13555-024-01318-6","DOIUrl":"10.1007/s13555-024-01318-6","url":null,"abstract":"<p><strong>Introduction: </strong>Tapinarof is a topical aryl hydrocarbon receptor (AhR) agonist in development for the treatment of atopic dermatitis (AD). In two phase 3 trials (ADORING 1 and 2), tapinarof cream 1% once daily (QD) demonstrated significant efficacy and was well tolerated in patients down to age 2 years with AD. Here, we evaluate patient-reported outcomes (PROs), including family impact, with tapinarof in ADORING 1 and 2.</p><p><strong>Methods: </strong>In ADORING 1 and 2, 813 patients were randomized to tapinarof or vehicle QD for 8 weeks. PROs were assessed using the Dermatology Life Quality Index (DLQI), Children's Dermatology Life Quality Index (CDLQI), Infants' Dermatitis Quality of Life Index (IDQOL), Dermatitis Family Impact Questionnaire (DFI), and Patient Oriented Eczema Measure (POEM).</p><p><strong>Results: </strong>Mean baseline DLQI, CDLQI, IDQOL, and DFI scores indicated that the impact on families and patients' quality of life (QoL) of AD was moderate to very large. Mean POEM scores indicated moderate to severe AD symptoms at baseline. Tapinarof improved QoL versus vehicle across all endpoints at week 8: DLQI, - 6.2 vs - 3.5 (P = 0.0031) and - 5.5 vs - 3.5 (P = 0.0028); DFI, - 5.6 vs - 2.9 (P < 0.0001) and - 5.6 vs - 3.8 (P = 0.0037), in ADORING 1 and 2, respectively. Similar improvements in CDLQI and IDQOL were reported with tapinarof versus vehicle. Tapinarof also significantly improved CDLQI, DFI, and POEM sleep subdomain scores versus vehicle. POEM scores also improved with tapinarof versus vehicle: ≥ 12 years, - 9.4 vs - 5.3 and - 10.6 vs - 3.6 (both P < 0.0001); < 12 years, - 11.4 vs - 5.7 (P < 0.0001), and - 10.8 vs - 7.3 (P = 0.0005).</p><p><strong>Conclusions: </strong>Tapinarof significantly improved QoL across PROs, including sleep and family impact, regardless of age, from week 1 (the earliest evaluation) through week 8. Tapinarof is a once-daily, non-steroidal cream that rapidly improves AD symptoms, sleep, and QoL in patients down to age 2 years with AD.</p><p><strong>Trial registration: </strong>Clinical Trials.gov identifier: NCT05014568; NCT05032859.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"111-124"},"PeriodicalIF":3.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11785891/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142946215","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}
引用次数: 0
Two Patients with Therapy-Resistant Pemphigus Vulgaris and Severe Underlying Disease Showing Good Response to a New IVIg Preparation. 两例治疗难治性寻常型天疱疮和严重基础疾病患者对新型IVIg制剂表现出良好的反应。
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-01-01 Epub Date: 2025-01-03 DOI: 10.1007/s13555-024-01326-6
Katharina Hogrefe, Julia K Winkler, Alexander H Enk
{"title":"Two Patients with Therapy-Resistant Pemphigus Vulgaris and Severe Underlying Disease Showing Good Response to a New IVIg Preparation.","authors":"Katharina Hogrefe, Julia K Winkler, Alexander H Enk","doi":"10.1007/s13555-024-01326-6","DOIUrl":"10.1007/s13555-024-01326-6","url":null,"abstract":"<p><p>Pemphigus vulgaris is a severe and often therapy-resistant bullous autoimmune disease. Standard therapy with steroids often administered together with another immunosuppressant does not respond in all patients or may not be a good therapeutic option in patients with severe underlying diseases. Intravenous immunoglobulins (IVIgs) represent a treatment alternative, often showing a rapid response which allows one to reduce concomitant immunosuppression. Here, we report on two patients with a complex disease history suffering from severe pemphigus vulgaris who received treatment with a new IVIg preparation (Yimmugo<sup>®</sup>, 2 g per kg body weight every 4 weeks). IVIg preparations differ regarding manufacturing process and show a varying side effect profile. Both of our patients did not experience any side effects from IVIgs and showed a significant improvement of skin and mucosal erosions. More reports on IVIgs are desirable to help in selecting the optimal preparation and dosing regarding tolerability and effectiveness for individual patients.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"237-244"},"PeriodicalIF":3.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11785848/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142921198","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}
引用次数: 0
Brodalumab: Six-Year US Pharmacovigilance Report. Brodalumab:美国药物警戒六年报告。
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-01-01 Epub Date: 2024-11-26 DOI: 10.1007/s13555-024-01304-y
Mark G Lebwohl, John Y Koo, April W Armstrong, Bruce E Strober, Soo Han Yoon, Nicole N Rawnsley, Earl L Goehring, Gina D Mangin, Abby A Jacobson
{"title":"Brodalumab: Six-Year US Pharmacovigilance Report.","authors":"Mark G Lebwohl, John Y Koo, April W Armstrong, Bruce E Strober, Soo Han Yoon, Nicole N Rawnsley, Earl L Goehring, Gina D Mangin, Abby A Jacobson","doi":"10.1007/s13555-024-01304-y","DOIUrl":"10.1007/s13555-024-01304-y","url":null,"abstract":"<p><strong>Introduction: </strong>Brodalumab is a human interleukin-17 receptor A antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. In the USA, brodalumab has a boxed warning regarding suicidal ideation and behavior and is only available under a Risk Evaluation and Mitigation Strategy, but no causal association has been established. To assess long-term safety of brodalumab, we summarize pharmacovigilance data from 6 years of real-world clinical practice.</p><p><strong>Methods: </strong>Crude adverse event (AE) reporting rates per 100 patients were calculated for common AEs and AEs of special interest reported to Ortho Dermatologics by US patients and healthcare providers from August 15, 2017 through August 14, 2023. Brodalumab exposure was estimated as time from the first to last prescription-dispensing authorization dates. Adverse events were defined by Medical Dictionary for Regulatory Activities v26.0 Preferred Terms and standardized MedDRA queries.</p><p><strong>Results: </strong>Data were collected from 5138 US patients (estimated exposure of 6900 patient-years). Over 6 years, 13 cases of adjudicated major adverse cardiovascular events were reported (0.25 events/100 patients). The rate of serious infections was 2.20 events/100 patients. Since the 5-year report, there was one new case of Candida infection and a serious fungal infection of the elbow. Among 57 reported malignancies affecting 49 patients, 4 were deemed possibly related to brodalumab. One new case of indeterminate inflammatory bowel disease unrelated to brodalumab was reported. No new suicide attempts were reported in year 6, and there were no completed suicides throughout 6 years.</p><p><strong>Conclusion: </strong>Pharmacovigilance data throughout 6 years are consistent with the safety profile of brodalumab established in clinical trials and previous US pharmacovigilance reports, with no completed suicides and a low fungal infection rate.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"213-222"},"PeriodicalIF":3.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11785849/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142715658","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}
引用次数: 0
Influence of Cosmetic Skincare Products with pH < 5 on the Skin Microbiome: A Randomized Clinical Evaluation. pH值< 5的化妆品护肤品对皮肤微生物组的影响:随机临床评价
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-01-01 Epub Date: 2024-12-21 DOI: 10.1007/s13555-024-01321-x
Ciska Janssens-Böcker, Claudia Doberenz, Marta Monteiro, Marta de Oliveira Ferreira
{"title":"Influence of Cosmetic Skincare Products with pH < 5 on the Skin Microbiome: A Randomized Clinical Evaluation.","authors":"Ciska Janssens-Böcker, Claudia Doberenz, Marta Monteiro, Marta de Oliveira Ferreira","doi":"10.1007/s13555-024-01321-x","DOIUrl":"10.1007/s13555-024-01321-x","url":null,"abstract":"<p><strong>Introduction: </strong>The human skin acts as a protective barrier against external pathogens and hosts a diverse microbiome consisting of bacteria, fungi, viruses, and archaea. Disruptions to the skin microbiome can impact immune function, leading to inflammatory and autoimmune conditions. The importance of pH for the microbiome is paramount. Cosmetic skincare products interact with the skin microbiome and skin pH, playing a key role in maintaining microbial balance. Research suggests that products with non-physiological pH levels may disrupt the skin microbiota. Our clinical study aimed to evaluate the effects of low-pH cosmetic products (pH < 5) on the skin microbiome, contributing to improved skin health.</p><p><strong>Methods: </strong>The clinical study focused on evaluating the skin microbiome diversity following the application for 28 days of four different low-pH cosmetic products (vitamin C, resveratrol, a collagen mask, and a native algae mask) on the forearms of post-menopausal women with skin pH > 5.5.</p><p><strong>Results: </strong>The diversity of the natural skin microbiome increased consistently throughout the study, evident in both the untreated area and after the application of the Vitamin C Concentrate, Resveratrol Concentrate, Collagen Mask, and Native Algae Mask, as indicated by Shannon's diversity index. The native algae mask notably reduced the Corynebacterium genus and significantly lowered the pH. The skin pH changes corresponded with microbiota stability.</p><p><strong>Conclusions: </strong>In conclusion, enhanced diversity of the natural skin microbiome was observed over the study duration. None of the investigational products caused significant disruption to the skin microbiome diversity, as evidenced by the stable Shannon's diversity index and relative abundance of specific genera. Notably, the native algae mask significantly decreased the presence of the opportunistic pathogenic Corynebacterium genus, which is likely attributable to a minor reduction in skin pH following extended product use. The findings suggest that the use of low-pH skincare products, like the native algae mask, do not disrupt skin microbiome diversity and may have the potential to positively impact skin microbiome diversity and health by reducing certain pathogenic microbial populations.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"141-159"},"PeriodicalIF":3.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11785879/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142871727","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}
引用次数: 0
The Skin-Lightening Power of Tirbanibulin 1% Ointment. 1%替巴尼布林软膏的亮肤作用。
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-01-01 Epub Date: 2024-11-30 DOI: 10.1007/s13555-024-01310-0
Federica Li Pomi, Andrea d'Aloja, Michelangelo Rottura, Mario Vaccaro, Francesco Borgia
{"title":"The Skin-Lightening Power of Tirbanibulin 1% Ointment.","authors":"Federica Li Pomi, Andrea d'Aloja, Michelangelo Rottura, Mario Vaccaro, Francesco Borgia","doi":"10.1007/s13555-024-01310-0","DOIUrl":"10.1007/s13555-024-01310-0","url":null,"abstract":"<p><strong>Background: </strong>Tirbanibulin 1% ointment has been licensed to treat non-hyperkeratotic actinic keratosis (AK) on the face and scalp in adults. Recent evidence suggests that, besides the antineoplastic effect, tirbanibulin may also confer substantial cosmetic benefits to patients.</p><p><strong>Methods: </strong>We report a single-center retrospective study of patients affected by solar lentigines (SLs) and AKs in the context of field cancerization treated with tirbanibulin 1% ointment.</p><p><strong>Results: </strong>Among 42 patients, 35% (n = 15) experienced complete clearance of SLs, while partial clearance was observed in 50% (n = 21) of patients. Regarding AKs, complete and partial clearance were observed in 52% (n = 22) and 40% (n = 17) of patients, respectively. Major study limitations are the small sample size and the absence of a control group.</p><p><strong>Conclusions: </strong>Our results suggest that tirbanibulin 1% ointment may offer the dual benefit of treating AKs while simultaneously lightening aesthetically bothersome and difficult-to-treat lesions like SLs with just 5 days of application.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"95-110"},"PeriodicalIF":3.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11785872/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142767058","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}
引用次数: 0
Hormonal Therapies for Acne: A Comprehensive Update for Dermatologists. 痤疮激素疗法:皮肤科医生全面更新。
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-01-01 Epub Date: 2025-01-03 DOI: 10.1007/s13555-024-01324-8
Courtney A Smith, Emily Gosnell, Turkan Banu Karatas, Chelsea Deitelzweig, Elizabeth M B Collins, Howa Yeung
{"title":"Hormonal Therapies for Acne: A Comprehensive Update for Dermatologists.","authors":"Courtney A Smith, Emily Gosnell, Turkan Banu Karatas, Chelsea Deitelzweig, Elizabeth M B Collins, Howa Yeung","doi":"10.1007/s13555-024-01324-8","DOIUrl":"10.1007/s13555-024-01324-8","url":null,"abstract":"<p><strong>Introduction: </strong>Acne impairs quality of life, often leads to permanent scars, and causes psychological distress. This review aims to update dermatologists on the Federal Drug Administration (FDA)-approved and off-label use of combined oral contraceptives (COC), clascoterone, spironolactone, and emerging hormonal therapies for acne treatment.</p><p><strong>Methods: </strong>We reviewed current literature on hormonal acne treatments and discussed common patient concerns, barriers to care, and individualized care needs.</p><p><strong>Results: </strong>Different brands and dosings of COC have generally similar efficacy in treating acne. Dermatologists should discuss contraceptive options and provide individualized shared decision-making with patients based on patient preferences, contraceptive needs, comorbidity profile, access, and cost. Spironolactone is an effective acne treatment with clinical trial data to support its use as a first-line acne treatment for women with acne. Potassium monitoring is of low value for patients on spironolactone unless patients have specific risk factors for hyperkalemia. Clascoterone is a safe and effective topical anti-androgen for the treatment of acne in men and women with limited systemic effects on reproductive hormones.</p><p><strong>Conclusion: </strong>Hormonal therapies are essential strategies to treat acne. Clinicians should expand the use of existing and emerging hormone therapy as part of their acne treatment strategies.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"45-59"},"PeriodicalIF":3.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11785877/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142921194","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}
引用次数: 0
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