Dermatology and Therapy最新文献

{"title":"A Pilot Study of Differences in Antibody Responses of Intradermal and Intramuscular Injections of Botulinum Toxin Type A.","authors":"Yuttana Srinoulprasert, Surachet Sirisuthivoranunt, Chattip Sripatumtong, Tunsuda Tansit, Chadakan Yan, Chalermkwan Apinuntham, Thanya Techapichetvanich, Sasima Eimpunth, Woraphong Manuskiatti, Rungsima Wanitphakdeedecha","doi":"10.1007/s13555-025-01530-y","DOIUrl":"https://doi.org/10.1007/s13555-025-01530-y","url":null,"abstract":"<p><strong>Introduction: </strong>Botulinum toxin type A (BoNT/A) is commonly used for both medical and aesthetic purposes. However, approximately 3% of long-term recipients develop resistance, potentially due to antibody formation. Injection technique may influence immunogenicity, yet comparative data remain limited.</p><p><strong>Methods: </strong>This pilot study evaluated antibody responses following intradermal versus intramuscular injection of six BoNT/A formulations: incobotulinumtoxinA, onabotulinumtoxinA, abobotulinumtoxinA, letibotulinumtoxinA1, letibotulinumtoxinA2, and prabotulinumtoxinA. A total of 120 subjects were divided into intradermal and intramuscular groups, with equal distribution across toxin types. Blood samples were collected and analyzed using ELISA to quantify human IgG (hIgG) targeting whole BoNT/A molecules, functional domains, and complexing proteins.</p><p><strong>Results: </strong>Intradermal injections consistently induced higher BoNT/A-specific hIgG levels than intramuscular injections, except with letibotulinumtoxinA. Anti-functional domain hIgG levels peaked at day 30 and declined thereafter, aligning with the 90-day retreatment interval commonly recommended. Anti-complexing protein hIgG levels remained relatively stable across time points. Notably, all antibody levels remained below thresholds associated with clinical nonresponse.</p><p><strong>Conclusion: </strong>Intradermal injection of BoNT/A appears to elicit a stronger immunogenic response than intramuscular administration, although antibody levels did not reach clinically significant thresholds. These findings underscore the importance of injection technique and interval planning to mitigate immunogenicity. Given the widespread use of intradermal techniques in aesthetic practice, this study provides important clinical insight into optimizing BoNT/A administration.</p><p><strong>Thai clinical trials registry number: </strong>TCTR20211215001.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144999899","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}

{"title":"Efficacy and Safety of Zabedosertib, an Interleukin-1 Receptor-Associated Kinase 4 Inhibitor, in Patients with Moderate-to-Severe Atopic Dermatitis: A Phase II Randomized Study.","authors":"Stefan J Jodl, Margitta Worm, Frauke Friedrichs, Ulrike Heinzel-Pleines, Andrea Wagenfeld, Maximilian Feldmüller, Stefan Klein, Ruiping Zhang, Kaweh Shakery, Ruth D Holzmann, Beate Rohde, Vidya Perera","doi":"10.1007/s13555-025-01505-z","DOIUrl":"https://doi.org/10.1007/s13555-025-01505-z","url":null,"abstract":"<p><strong>Introduction: </strong>Interleukin-1 receptor-associated kinase 4 (IRAK4) is expressed in various immune cells and regulates proinflammatory cytokine production. Its inhibition represents a novel, promising therapeutic option in the treatment of atopic dermatitis (AD). Zabedosertib (BAY1834845) is a potent, selective IRAK4 inhibitor that suppresses markers of local and systemic immune responses. This study aimed to evaluate the efficacy and safety of zabedosertib in adults with moderate-to-severe AD.</p><p><strong>Methods: </strong>DAMASK was a randomized, double-blind, 12-week, placebo-controlled, phase 2a, proof-of-concept study. Patients were randomized 2:1 to receive oral zabedosertib 120 mg twice daily or placebo. The primary efficacy endpoint was a composite of 75% reduction from baseline on the Eczema Area and Severity Index (EASI-75), no discontinuation of study medication for lack of efficacy, no rescue medication during the 4 weeks before Day 84, and no initiation of systemic AD treatment. Other efficacy assessments included validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD), Peak Pruritus numerical rating scale score, and affected body surface area (BSA); for safety, it included frequency and severity of treatment-emergent adverse events (TEAEs).</p><p><strong>Results: </strong>Of 77 randomized patients, 69 were included in the primary efficacy analysis (zabedosertib, n = 47; placebo, n = 22); 55 patients completed treatment. At Week 12, there was no significant difference between zabedosertib and placebo in the primary efficacy endpoint (32.3% vs. 37.4%) or percentage change in EASI from baseline (- 44.6% vs. - 55.9%). There were also no significant differences between zabedosertib and placebo at Week 12 in vIGA-AD response (15.9% vs. 28.5%), Peak Pruritus response (16.4% vs. 25.0%), percentage change in Peak Pruritus (- 20.7% vs. - 27.3%), or percentage change in BSA affected by AD (- 13.3% vs. - 20.3%). No severe or serious TEAEs were reported throughout the study.</p><p><strong>Conclusions: </strong>Zabedosertib was safe and well tolerated in adults with moderate-to-severe AD but showed no evidence of efficacy in reducing disease severity or pruritus in this placebo-controlled study.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT05656911.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144991774","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}

{"title":"Network Meta-analysis of 1.5% Ruxolitinib Cream Versus Systemic Agents in the Treatment of Moderate Atopic Dermatitis.","authors":"Melinda J Gooderham, H Chih-Ho Hong, Di Wang, Becky Hooper, Avery Hughes-Martin, Heather Cameron, Laura Pastor, Alicia Pepper, Ping Wu, Ali Mojebi, Grace Wong, Rafael Marino, Marie-Lise Dion, Mehdi Larbi","doi":"10.1007/s13555-025-01503-1","DOIUrl":"https://doi.org/10.1007/s13555-025-01503-1","url":null,"abstract":"<p><strong>Introduction: </strong>Atopic dermatitis (AD) is a chronic, highly pruritic, relapsing inflammatory disease associated with high quality-of-life burden. Topical 1.5% ruxolitinib cream is a selective Janus kinase (JAK)1/JAK2 inhibitor that is well tolerated and effective in improving itch and lesion clearance in patients ≥ 12 years old. This analysis estimates comparative efficacy for 1.5% ruxolitinib cream relative to systemic therapies for treatment of patients ≥ 12 years with AD.</p><p><strong>Methods: </strong>A systematic literature review (SLR) identified randomized controlled trials evaluating 1.5% ruxolitinib cream, oral JAK inhibitors, monoclonal antibodies, phosphodiesterase 4 inhibitors, and systemic immunosuppressants. A feasibility assessment evaluated whether indirect treatment comparison (ITC) was appropriate and determined appropriate ITC methods. This network meta-analysis (NMA) assessed the comparative efficacy of 1.5% ruxolitinib cream against systemic therapies in a \"systemic-eligible moderate AD\" subgroup defined as ≥ 12 years old and eligible for topical and systemic therapies (Investigator's Global Assessment [IGA] = 3, Eczema Area and Severity Index [EASI] ≥ 16, and body surface area ≥ 10%); an ITC with the full study populations was not feasible. A frequentist framework using a penalized likelihood NMA included outcomes of IGA 0/1 with at least a 2-point improvement from baseline, EASI-75, and Itch Numerical Rating Scale 4 (NRS4).</p><p><strong>Results: </strong>The SLR identified 25 studies, of which 12 reported outcomes for the relevant subgroup for four interventions: 1.5% ruxolitinib cream, dupilumab 300 mg, upadacitinib (15 mg, 30 mg), and abrocitinib (100 mg, 200 mg), which were compared against placebo or placebo + topical corticosteroids. There were no statistically significant differences between active comparators for IGA 0/1, EASI-75, and Itch NRS4, although point estimates numerically favored 1.5% ruxolitinib cream for IGA 0/1 and EASI‑75.</p><p><strong>Conclusion: </strong>For patients with moderate AD who are eligible for systemic therapies, 1.5% ruxolitinib cream might provide disease control comparable to systemic treatments, such as dupilumab, regarding IGA 0/1, EASI-75, and Itch NRS4.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144991768","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}

{"title":"Strategies for Optimal Use of Biological Therapies in Managing Psoriasis: Focus on Secukinumab.","authors":"Anna Balato, Martina Burlando, Anna Campanati, Antonio Costanzo, Andrea Chiricozzi, Paolo Gisondi, Piergiorgio Malagoli, Giuseppe Micali","doi":"10.1007/s13555-025-01515-x","DOIUrl":"https://doi.org/10.1007/s13555-025-01515-x","url":null,"abstract":"<p><strong>Introduction: </strong>Psoriasis (PsO) is a common inflammatory dermatological condition with a substantial negative impact on patient quality of life. Several biological agents are available for the treatment of PsO, and clinicians and patients must consider various factors when deciding on the most appropriate biological agent.</p><p><strong>Methods: </strong>Here, we report a set of consensus statements developed by an Italian PsO advisory board on use of the anti-interleukin-17A biological secukinumab in routine clinical practice.</p><p><strong>Results: </strong>The statements were developed under three main topics, the first of which was \"characteristics of secukinumab and criteria for patient selection to achieve long-term benefits\". This statement helps to identify patients most likely to benefit from secukinumab, including biological-naïve patients with moderate PsO; patients with PsO involving sensitive sites; patients in whom biosimilar anti-tumour necrosis factor-alpha treatment has proved ineffective; patients at high risk of developing psoriatic arthritis; lean or normal-weight patients; patients with active disease receiving conventional disease-modifying antirheumatic drugs; and patients with comorbidities, including cardiovascular disease. Under the second topic, \"strategies to maintain secukinumab effectiveness in the long term\", the advisors highlighted the importance of patient support to promote adherence; weight control; understanding that PsO can worsen for reasons unrelated to treatment; and understanding that appropriate treatment should depend on the severity of any disease worsening. The third topic, \"strategies for patient support to promote adherence to therapy\", noted the importance of patient education, accurate disease assessments and treatment tailoring.</p><p><strong>Conclusion: </strong>These consensus statements will help guide dermatologists in the selection of patients with PsO for whom secukinumab is the most appropriate treatment in real-world clinical practice in Italy.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144991777","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}

{"title":"Efficacy of Skin Patting and Iontophoresis with Dutasteride Gel in Male and Menopausal Female Androgenetic Alopecia: A Pilot Study.","authors":"Stephano Cedirian, Francesca Pampaloni, Federico Quadrelli, Luca Rapparini, Francesca Bruni, Ginevra Martelli, Bianca Maria Piraccini, Michela Starace","doi":"10.1007/s13555-025-01532-w","DOIUrl":"https://doi.org/10.1007/s13555-025-01532-w","url":null,"abstract":"<p><strong>Introduction: </strong>Androgenetic alopecia (AGA) is a chronic, progressive condition often resistant to conventional treatments. Transdermal delivery systems such as iontophoresis and skin patting (SPi) may enhance drug penetration and follicular targeting. Dutasteride, a potent dual 5α-reductase inhibitor, has shown superior efficacy to finasteride, but topical delivery is limited by variable absorption. In this pilot study, we evaluated the efficacy and safety of dutasteride gel delivered via SPi and iontophoresis in men and postmenopausal women with treatment-resistant AGA.</p><p><strong>Methods: </strong>In this single-center pilot study, 20 adults (10 males, 10 postmenopausal females) with AGA unresponsive to ≥ 12 months of standard therapy underwent four monthly sessions of SPi and iontophoresis with 6% dutasteride gel. Hair density, shaft diameter, and pull test results were assessed at baseline and 8 weeks post-treatment; patient satisfaction (0-4 scale) and safety were recorded. Paired tests were used to analyze the results, with p < 0.05 considered to indicate significance.</p><p><strong>Results: </strong>Hair density improved significantly in frontal (p < 0.001) and vertex (p < 0.001) regions. Shaft diameter increased in vertex (p < 0.001) and frontal areas (p = 0.046). Pull test scores improved (p < 0.001). Mean satisfaction was 3.4/4. No adverse events occurred.</p><p><strong>Conclusion: </strong>SPi with iontophoresis effectively delivered topical dutasteride, yielding significant clinical improvement and excellent safety in treatment-resistant AGA. Larger randomized trials are warranted to confirm these findings.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144946286","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}

{"title":"The Safety, Tolerability, and Pharmacokinetics of ALT-BB4 (A Novel Recombinant Hyaluronidase): A Randomized, Double-Blinded, Placebo-Controlled, Phase 1 Study in Healthy Volunteers.","authors":"Ji Su Lee, WonSerk Kim, Chong-Hyun Won, Yang-Won Lee, SeungHwan Lee, Heejae Won, Soon-Jae Park, Sunbae Lee, Seol-Hee Kim, Jiwon Yang, Gahee Bahn, Dong Hun Lee","doi":"10.1007/s13555-025-01507-x","DOIUrl":"https://doi.org/10.1007/s13555-025-01507-x","url":null,"abstract":"<p><strong>Introduction: </strong>Hyaluronidase has been used as an adjuvant to facilitate subcutaneous drug delivery by degrading hyaluronic acid, a viscoelastic barrier in subcutaneous tissue. However, traditional animal-derived hyaluronidases raise safety concerns, including risk of anaphylaxis and zoonoses. This study aimed to evaluate the safety, tolerability, and pharmacokinetics of ALT-BB4, a novel recombinant hyaluronidase derived from human hyaluronidase PH20, in healthy adults.</p><p><strong>Methods: </strong>This first-in-human, multicenter, randomized, double-blinded, placebo-controlled phase 1 study included 244 participants who received single intradermal or subcutaneous injections of ALT-BB4 or placebo. The study was conducted in three parts: part I assessed drug allergy reactions, part II-A evaluated pharmacokinetics, and part II-B assessed safety and tolerability.</p><p><strong>Results: </strong>Intradermal injection of ALT-BB4 exhibited a low incidence of drug allergy reactions (0.4%), with no significant difference compared with placebo (p = 0.317). Subcutaneous injection of ALT-BB4 resulted in more frequent injection site treatment emergent adverse events (TEAEs) compared with placebo (16.9% versus 0%; p < 0.001). All injection site TEAEs were mild, self-resolving, and did not require treatment. Systemic TEAEs were less frequent in the ALT-BB4 group compared with placebo (0.7% versus 5.6%; p = 0.045), and no serious adverse events were reported. Notably, no antidrug antibodies were detected. Pharmacokinetic analysis revealed minimal systemic absorption of ALT-BB4.</p><p><strong>Conclusions: </strong>Both intradermal and subcutaneous injection of ALT-BB4 demonstrated excellent safety and tolerability, supporting its potential as a promising alternative to traditional animal-derived hyaluronidases. Future studies are warranted to confirm these findings in broader clinical settings.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT05232175.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144946337","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}

{"title":"Translational Pharmacokinetics of Icotrokinra, a Targeted Oral Peptide that Selectively Blocks Interleukin-23 Receptor and Inhibits Signaling.","authors":"Beverly Knight, Brinda Tammara, Nishit B Modi, Shannon Dallas, Saro Mardirosian, Jianyao Wang, Aline Laenen, Laurent Leclercq, Karen DiLoreto, Lieve Adriaenssen, Darren Moss, David Polidori, Siladitya Ray Chaudhuri, Seonghee Park, Carlo Sensenhauser, Anthony Ndifor, Siddharth Sukumaran, Tristan Baguet, Yifan Shi, Shefali Patel, Brian Geist, Anne Fourie, Raymond Patch, Chengzao Sun, Stephanie A Barros, Sandeep Somani, Mario Monshouwer","doi":"10.1007/s13555-025-01454-7","DOIUrl":"10.1007/s13555-025-01454-7","url":null,"abstract":"<p><strong>Introduction: </strong>Icotrokinra (formerly JNJ-77242113 or PN-21235) is a targeted oral peptide that selectively inhibits interleukin-23 receptor signaling. The studies described here assessed its absorption, distribution, metabolism, and excretion (ADME), and potential for drug-drug interactions (DDI).</p><p><strong>Methods: </strong>In vitro assays evaluated permeability, plasma protein binding, blood-to-plasma partitioning, metabolic stability, and interactions with drug transporters and metabolic enzymes. The nonclinical pharmacokinetic properties of icotrokinra were studied in vivo in rats and monkeys. Phase 1 studies evaluated the pharmacokinetic profile, metabolic profile and excretion in healthy volunteers.</p><p><strong>Results: </strong>Icotrokinra demonstrated oral bioavailability of 0.1-0.3% in animals, with evidence of systemic pharmacodynamic activity, without the use of an absorption enhancer. The compound was stable across species in plasma, gastrointestinal matrices, and hepatocytes. Protein binding was low across species (~ 50% in human plasma), and icotrokinra distributed freely to tissues, including skin, joints, and gastrointestinal tissues. Following oral dosing in both rats and monkeys, fecal excretion of unabsorbed drug was the primary elimination route, and metabolite levels were low (each < 2% of dose) in plasma and excreta, with unchanged icotrokinra being the main circulating component. Icotrokinra was neither a substrate nor an inhibitor of prototypical drug transporters or cytochrome P450 enzymes. Icotrokinra exhibited dose-proportional pharmacokinetics from 25 mg to 1000 mg in a first-in-human study, and no serious adverse events were identified following single and multiple dose administrations. Unchanged icotrokinra was the only drug-related component in human plasma.</p><p><strong>Conclusions: </strong>Icotrokinra exhibited high stability and an ADME profile consistent with that of a small peptide, with no risk of DDI identified on the basis of in vitro studies. Clinical data demonstrated linear pharmacokinetics and no major metabolites.</p><p><strong>Trial registration number: </strong>ClinicalTrials.gov, NCT04621630. Euclinicaltrials.eu, EUCT: 2023-504720-26-00. A Graphical Abstract is available for this article.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2495-2520"},"PeriodicalIF":4.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12354395/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144590671","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":"Prognostic Factors Associated with Clinical Improvement Following Energy-Based Device Treatment in Thai Patients with Atrophic Acne Scars: A Retrospective Study.","authors":"Chadakan Yan, Phichayut Phinyo, Yuri Yogya, Mati Chuamanochan, Rungsima Wanitphakdeedecha","doi":"10.1007/s13555-025-01486-z","DOIUrl":"10.1007/s13555-025-01486-z","url":null,"abstract":"<p><strong>Introduction: </strong>Acne scarring is a prevalent complication of acne vulgaris, often resulting in significant psychosocial distress. While energy-based devices (EBDs), including fractional laser (FL) and fractional radiofrequency (FRF), are increasingly used for atrophic acne scars, limited data exist on prognostic factors predicting treatment outcomes, particularly in Asian populations. The study aims to identify clinical predictors of graded clinical improvement in patients with atrophic acne scars treated with FL and FRF.</p><p><strong>Methods: </strong>This retrospective cohort study was conducted at a university hospital in Bangkok, Thailand, from 2012 to 2023. Clinical improvement was assessed using standardized photographic evaluations and categorized into four levels: < 25%, 25-50%, 51-75%, and > 75% improvement. Univariable and multivariable ordinal logistic regression models were used to determine prognostic factors. Sensitivity analyses were performed to confirm the robustness of the findings.</p><p><strong>Results: </strong>A total of 397 patients were included, of whom 254 received FL and 143 received FRF treatments. Older age (per 5-year increase) (mOR: 1.24; 95% CI: 1.07-1.43), male sex (mOR: 1.29; 95% CI: 1.06-1.57), shorter scar duration (per 5 years) (mOR: 0.73; 95% CI: 0.56-0.97), lower Fitzpatrick skin phototypes, and completion of at least three treatment sessions (mOR: 1.33; 95% CI: 1.16-1.53) were independently associated with greater clinical improvement. Sensitivity analyses confirmed the robustness of these associations.</p><p><strong>Conclusions: </strong>Key clinical factors, including patient age, sex, scar duration, skin phototype, and completion of at least three treatment sessions, significantly influence treatment outcomes with EBDs. These findings support the development of personalized treatment strategies to optimize outcomes, particularly in patients with severe scarring.</p><p><strong>The trial registration number: </strong>TCTR20240512006.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2571-2581"},"PeriodicalIF":4.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12354357/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144616667","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":"Bimekizumab Impact on Patient-Reported Outcomes in Patients with Moderate to Severe Hidradenitis Suppurativa: Pooled 48-Week Results from BE HEARD I&II.","authors":"Vivian Y Shi, John R Ingram, Hadar Lev-Tov, Sylke Schneider-Burrus, Seth Forman, Martina L Porter, Koremasa Hayama, Linnea Thorlacius, Jérémy Lambert, Tom Vaux, Bartosz Lukowski, Robert L Rolleri, Jacek C Szepietowski","doi":"10.1007/s13555-025-01465-4","DOIUrl":"10.1007/s13555-025-01465-4","url":null,"abstract":"<p><strong>Introduction: </strong>Hidradenitis suppurativa (HS) symptoms (pain, itch, odour and drainage) impair quality of life (QoL). Bimekizumab, a humanised IgG1 monoclonal antibody, selectively inhibits interleukin (IL)-17A and IL-17F. The impact of bimekizumab on patient-reported outcomes (PROs) was assessed using pooled 48-week data from BE HEARD I&II (BHI&II) studies in moderate to severe HS.</p><p><strong>Methods: </strong>Patients received (initial/maintenance) bimekizumab 320 mg every 2 weeks (Q2W)/Q2W, bimekizumab Q2W/Q4W, bimekizumab Q4W/Q4W or placebo/bimekizumab Q2W. HS Symptom Daily Diary (HSSDD) and HS Symptom Questionnaire (HSSQ) captured HS-specific patient-reported symptoms; HS Quality of Life questionnaire (HiSQOL^©) and Dermatology Life Quality Index (DLQI) captured health-related QoL (HRQoL). Change from baseline (CfB) and proportions of patients achieving clinically meaningful improvement thresholds or low disease impact are reported to Week 48 (observed case).</p><p><strong>Results: </strong>Of 1014 randomised patients, 868 received bimekizumab and 146 placebo. Greater numerical reductions at Week 16 were observed across HSSDD/HSSQ scores with bimekizumab vs placebo. From Week 16 to 48, HSSQ scores further numerically reduced with continuous bimekizumab and substantially reduced for placebo/bimekizumab switchers. At Week 16, bimekizumab showed numerically greater improvement in HRQoL vs placebo (HiSQOL total score mean CfB: - 11.7 to - 10.3 vs - 5.5). HiSQOL response rate (21-point total score reduction) was numerically higher by Week 4 in bimekizumab-treated patients (17.2-21.4%) vs placebo (9.2%); rates increased to Week 48 with continuous bimekizumab (42.0-47.4%) and in switchers (55.0%). Patients with very severe disease impact (HiSQOL total score ≥ 24) decreased over time with bimekizumab. At Week 16, DLQI minimal clinically important difference (4-point decrease) achievement was numerically greater with bimekizumab vs placebo (54.9-64.6% vs 49.1%). Achievement increased to Week 48 and switchers attained similar proportions (63.5-74.5% vs 76.5%). Comparable trends were observed for DLQI score of 0/1 (no HRQoL impact) achievement rates.</p><p><strong>Conclusion: </strong>Bimekizumab demonstrated clinically meaningful improvements by Week 4 in HRQoL, which were maintained over 1 year across PROs in patients with moderate to severe HS. Graphical Abstract available for this article.</p><p><strong>Trial registration: </strong>NCT04242446; NCT04242498.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2553-2570"},"PeriodicalIF":4.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12354430/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144616665","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":"Time to Onset of Action for Biologics and Targeted Treatments in Psoriasis: Systematic Targeted Literature Review and Network Meta-Analysis.","authors":"Kim A Papp, Ron Vender, Kerri Purdy, Fiona Lovegrove, Irina Oroz, Parbeer Grewal, Perla Lansang, Laura Park-Wyllie, Nastaran Abbarin, Ya-Wen Yang, Becky Hooper, Sandra Vigelis, Tim Disher, Richard G Langley","doi":"10.1007/s13555-025-01463-6","DOIUrl":"10.1007/s13555-025-01463-6","url":null,"abstract":"<p><strong>Introduction: </strong>For some patients with plaque psoriasis (PsO), a rapid response (i.e. short interval to time to onset of action [TOA]) is desired. The primary objective was to determine average time to achieve a Psoriasis Area and Severity Index (PASI) 90 response (50% of patients) for individual biologics or targeted therapies. Secondary outcomes included the average time to achieve a PASI 75 response (50% of patients), as well as PASI 90 and PASI 75 responses over the first 16 weeks of therapy.</p><p><strong>Methods: </strong>A systematic targeted literature review was conducted to identify phase III and IV randomised, double-blinded trials according to pre-specified eligibility criteria that investigated interleukin (IL)-12/23 inhibitors, IL-17 inhibitors, IL-23 inhibitors, Janus kinase (JAK) inhibitors, and phosphodiesterase (PDE) inhibitors. Using proportions of patients achieving PASI 90 or 75 responses over 16 weeks, network meta-analyses were conducted to estimate response over time. This was presented as curves, and TOA was summarized as median time to reach the 50th percentile.</p><p><strong>Results: </strong>Forty-five trials were included in the main analyses. The IL-17 inhibitors bimekizumab, ixekizumab, brodalumab, and secukinumab 300 mg were estimated to provide the earliest onset of PASI 90 response at approximately 6 to 8 weeks. This was followed by the IL-23 inhibitors risankizumab and guselkumab at approximately 9-10 weeks, and the IL-12/23 inhibitor at 11-12 weeks. Although wide and overlapping credible intervals and similar point estimates were observed, these results suggest onset of action does not vary greatly across biologics in these classes. Onset of PASI 90 response could not be estimated by the model for tildrakizumab, and JAK and PDE4 inhibitors. Onset of PASI 75 response showed similar trends to PASI 90 response.</p><p><strong>Conclusions: </strong>IL-17 inhibitors, followed by IL-23 inhibitors, have the most rapid TOA among PsO biologics evaluated; any differences in onset of action between specific agents within the same drug class are not statistically or clinically significant. These analyses will allow clinicians to make more informed treatment decisions for their patients.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2615-2629"},"PeriodicalIF":4.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12354354/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144658669","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}