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Generalized Pustular Psoriasis Brazilian Experts Survey: Challenges in Disease Management.
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-04-01 DOI: 10.1007/s13555-025-01392-4
Ricardo Romiti, André V E de Carvalho, Cinara P C C Soares, Gleison Duarte
{"title":"Generalized Pustular Psoriasis Brazilian Experts Survey: Challenges in Disease Management.","authors":"Ricardo Romiti, André V E de Carvalho, Cinara P C C Soares, Gleison Duarte","doi":"10.1007/s13555-025-01392-4","DOIUrl":"https://doi.org/10.1007/s13555-025-01392-4","url":null,"abstract":"<p><strong>Introduction: </strong>Generalized pustular psoriasis (GPP) is a rare and severe form of psoriasis. Diagnosis involves several steps due to its rarity and the similarity to other pustular skin conditions. There is a lack of standardized guidelines for managing patients. The objective of this survey was to understand how Brazilian dermatologists manage GPP.</p><p><strong>Methods: </strong>Three dermatologists, authors of this study, compiled a list of 57 Brazilian dermatologists who had treated patients with GPP in the last 5 years. A questionnaire composed of 28 questions about diagnosis, treatment, and follow-up of patients with GPP was sent to all dermatologists listed.</p><p><strong>Results: </strong>A total of 32 dermatologists answered the survey. Most were female, had more than 15 years of clinical practice, and had treated at least 3 patients in the last 5 years. The diagnosis was based on the presence of pustules, worsening skin lesions, and erythema. More than half of the participants cited inflammatory markers used for screening. Triggering factors for flares included steroid withdrawal, infection, and stress. Most of them reported that their patients experienced at least one flare per year, lasting 2-4 weeks. Pustules are the first sign of resolution and scaling skin could last more than 6 months. Hospitalization was considered common or very common, often lasting more than 1 week. During GPP flares, the most recommended treatments were cyclosporine. For residual disease treatment, retinoids were the most cited. In addition, 63% of dermatologists think that the options to resolve flares are too slow and 66% consider that options do not prevent new flares.</p><p><strong>Conclusions: </strong>GPP is a challenging disorder. In Brazil, Brazilian patients with GPP often require longer hospitalization when compared with Europe and USA. A local consensus on GPP management is urgently needed to establish the goals and the standard of care for these patients.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751548","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}
引用次数: 0
Risk Assessment in Atopic Dermatitis: Guidance from a Multidisciplinary Expert Panel.
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-03-31 DOI: 10.1007/s13555-025-01391-5
Alessandra Narcisi, Vito Di Lernia, Maria Esposito, Vittorio Forte, Silvia Mariel Ferrucci, Lorenzo Gerratana, Pietro Morrone, Saverio Muscoli, Maddalena Napolitano, Michela Ortoncelli, Marina Talamonti
{"title":"Risk Assessment in Atopic Dermatitis: Guidance from a Multidisciplinary Expert Panel.","authors":"Alessandra Narcisi, Vito Di Lernia, Maria Esposito, Vittorio Forte, Silvia Mariel Ferrucci, Lorenzo Gerratana, Pietro Morrone, Saverio Muscoli, Maddalena Napolitano, Michela Ortoncelli, Marina Talamonti","doi":"10.1007/s13555-025-01391-5","DOIUrl":"https://doi.org/10.1007/s13555-025-01391-5","url":null,"abstract":"<p><p>Guidelines recommend that patients with severe atopic dematitis (AD) be treated with Janus kinase inhibitors (JAKi). Recently, the safety of JAKi as a class was reviewed by the European Medicines Agency, leading to a modification of the Summaries of Product Characteristics. For upadacitinib, changes involve reduced posology and restriction of its use to patients with no other alternative amongst the elderly and those at an increased risk of major adverse cardiovascular events (MACE), cancer and venous thromboembolism (VTE). Risk assessment may be daunting and clarity regarding definitions and data is needed. An interdisciplinary workshop, termed the Multiple In-treatment Risk Assessment & Management, was conceived to provide dermatologists with a platform for multidisciplinary exchange on risk assessment in patients with MACE, cancer and VTE to correctly recognise patients with increased risk. In this review, we characterised common and less common patient profiles in order to assess the risk. With the cooperation of a cardiologist, oncologist, respiratory medicine specialist and haematologists, we identified the risk factors for MACE, cancer and VTE. The results show that taking a careful medical history is the basis of risk assessment and that a careful medical history should be performed regardless of the intended therapy in AD. We propose that risk levels be used in the general population as a benchmark to evaluate risk levels in patients with AD, and provide a checklist to support such risk assessments in routine clinical practice. Our work provides a clear framework for risk assessment to the community of dermatologists and, therefore, contributes to improving the standard of care in AD.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751551","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}
引用次数: 0
Systematic Literature Review and Network Meta-Analysis of Clinical Efficacy and Safety of Topical Treatments for Patients with Atopic Dermatitis.
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-03-29 DOI: 10.1007/s13555-025-01390-6
Hiroyuki Murota, Takeshi Nakahara, Xinyu Wang, Miyuki Matsukawa, Hiroe Takeda, Tomohiro Kondo, Kentaro Yamato
{"title":"Systematic Literature Review and Network Meta-Analysis of Clinical Efficacy and Safety of Topical Treatments for Patients with Atopic Dermatitis.","authors":"Hiroyuki Murota, Takeshi Nakahara, Xinyu Wang, Miyuki Matsukawa, Hiroe Takeda, Tomohiro Kondo, Kentaro Yamato","doi":"10.1007/s13555-025-01390-6","DOIUrl":"https://doi.org/10.1007/s13555-025-01390-6","url":null,"abstract":"<p><strong>Introduction: </strong>In Japan, atopic dermatitis (AD) is one of the most common skin diseases, with the number of patients steadily increasing in recent years. Thus, it is crucial to assess the efficacy and safety of currently existing and recently introduced new treatments.</p><p><strong>Methods: </strong>A systematic literature review (SLR) and network meta-analysis (NMA) was conducted to evaluate the clinical efficacy and safety of existing standard topical therapies and new topical treatments for AD. Medline, Embase, Cochrane, and ICHUSHI were used to select studies. The Eczema Area and Severity Index (EASI) score and Investigator Global Assessment (IGA) score were efficacy outcomes, whereas any serious adverse events (AEs), acne, and skin infections were safety outcomes. A Bayesian multiple treatment NMA with fixed effects was performed. Odds ratio with 95% credible interval (CrI) was used to compare the outcomes of different topical medications including placebo for AD.</p><p><strong>Results: </strong>A total of 11 randomised controlled trials (RCTs) conducted in adult patients with varying degrees of AD severity were selected for NMA. The systematic review showed improvement in EASI scores with difamilast 0.3% and 1% and tacrolimus 0.1% as well as in IGA score success rates with difamilast 1%, delgocitinib 3%, and tacrolimus 0.1%. According to NMA, at week 4, difamilast 1% twice daily (BID) showed a significant improvement in the IGA score and percent EASI score change from baseline versus placebo; however, compared to other comparators, point estimates numerically favoured difamilast 1% but were not statistically significant. Difamilast 1% BID showed a significantly lower incidence of acne than delgocitinib 0.3% BID. There was no statistically significant difference in the incidence of serious AEs, acne, and skin infections compared to placebo or other comparators.</p><p><strong>Conclusion: </strong>This study establishes the efficacy and safety of current topical treatment options and recently marketed delgocitinib and difamilast ointments for AD in Japan.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143742631","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}
引用次数: 0
Randomized Phase IIa Trial of Purified Candida Antigen for Common Warts: Evaluating the Safety and Efficacy Across Multiple Dosing Regimens.
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-03-29 DOI: 10.1007/s13555-025-01387-1
Stacy R Smith, Robert E Esch, H S Nielsen, Sandra Marchese Johnson
{"title":"Randomized Phase IIa Trial of Purified Candida Antigen for Common Warts: Evaluating the Safety and Efficacy Across Multiple Dosing Regimens.","authors":"Stacy R Smith, Robert E Esch, H S Nielsen, Sandra Marchese Johnson","doi":"10.1007/s13555-025-01387-1","DOIUrl":"https://doi.org/10.1007/s13555-025-01387-1","url":null,"abstract":"<p><strong>Introduction: </strong>Non-standardized Candida albicans antigens are commonly used for the treatment of common warts (verruca vulgaris); however, clinical studies thus far have not determined optimal dosing. This study assessed three dosing schemes using Candin®, a standardized purified Candida antigen (PCA), for the treatment of common warts.</p><p><strong>Methods: </strong>This placebo-controlled, randomized phase IIa clinical trial included participants that had 3 to 20 injectable common warts on prespecified anatomical regions. PCA was administered intralesionally for up to 10 injections every 2 weeks, with adjustments to every 3 weeks for local tolerance issues. Three dosing regimens were evaluated: 0.3 or 0.5 mL into a single wart (cohorts 1 and 2, respectively), or 0.3 mL into up to four warts (cohort 3). Total injection volumes in cohorts 2 and 3 were larger than the typical off-label use of C. albicans. The primary outcome was complete resolution of injected warts, while secondary outcomes included safety, tolerability, and the clearance of untreated common warts.</p><p><strong>Results: </strong>The incidence of clearance of the primary injected wart in placebo participants was 41.9%, compared to 65.9% (relative risk [RR] 1.57; 95% confidence interval [CI] 1.02, 2.42; P = 0.03) in cohort 1, 79.5% (RR 1.89; 95% CI 1.27, 2.82; P = 0.0007) in cohort 2, and 72.5% (RR 1.74; 95% CI 1.19, 2.50; P = 0.005) in cohort 3, and treatment was well tolerated. Injection of 0.5 mL PCA into a single wart also resulted in a significantly higher rate of clearance of untreated common warts compared to placebo (RR 3.2, 95% CI 1.2, 8.0, P = 0.001).</p><p><strong>Conclusion: </strong>All three dosing regimens of PCA were safe, well tolerated, and resulted in significantly greater clearance of the primary treated wart(s) compared to placebo, but only 0.5 mL injected into a single wart was significantly better than placebo at clearing untreated warts. Typically, a volume of 0.3 mL C. albicans antigen is injected into a single wart; however, these results suggest that a larger volume of 0.5 mL may have greater benefit for patients. A phase III clinical trial is currently underway to confirm these findings.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT02393417.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143742629","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}
引用次数: 0
Efficacy and Safety of Ruxolitinib Cream in Vitiligo by Patient Characteristic Subgroups: Descriptive Pooled Analysis From Two Phase 3 Studies.
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-03-29 DOI: 10.1007/s13555-025-01381-7
Julien Seneschal, Albert Wolkerstorfer, Seemal R Desai, Pearl Grimes, Khaled Ezzedine, Amit G Pandya, Deanna Kornacki, Shaoceng Wei, Thierry Passeron, David Rosmarin
{"title":"Efficacy and Safety of Ruxolitinib Cream in Vitiligo by Patient Characteristic Subgroups: Descriptive Pooled Analysis From Two Phase 3 Studies.","authors":"Julien Seneschal, Albert Wolkerstorfer, Seemal R Desai, Pearl Grimes, Khaled Ezzedine, Amit G Pandya, Deanna Kornacki, Shaoceng Wei, Thierry Passeron, David Rosmarin","doi":"10.1007/s13555-025-01381-7","DOIUrl":"https://doi.org/10.1007/s13555-025-01381-7","url":null,"abstract":"<p><strong>Introduction: </strong>Two phase 3 trials (TRuE-V1 and TRuE-V2) demonstrated that a topical formulation of the Janus kinase (JAK) 1/JAK2 inhibitor ruxolitinib significantly improved repigmentation versus vehicle cream in adolescent and adult patients with vitiligo. This post hoc analysis of pooled TRuE-V1/TRuE-V2 data evaluated efficacy and safety by baseline demographics and clinical characteristics.</p><p><strong>Methods: </strong>Patients aged ≥ 12 years with nonsegmental vitiligo were randomized to vehicle cream or 1.5% ruxolitinib cream twice daily for 24 weeks, after which all patients could apply ruxolitinib cream through Week 52. Efficacy was evaluated using achievement of ≥ 75% improvement from baseline in facial Vitiligo Area Scoring Index [F-VASI75] at Week 52. Safety assessments included the frequency of treatment-emergent adverse events (AEs) and treatment-related AEs.</p><p><strong>Results: </strong>The TRuE-V studies enrolled 674 patients. Week 52 F-VASI75 was achieved by 50.3% (176/350) of patients who applied ruxolitinib cream throughout and 28.2% (46/163) who crossed over from vehicle to ruxolitinib cream after Week 24. F-VASI75 responses were observed across subgroups regardless of patient age, sex, Fitzpatrick skin type, affected facial body surface area, disease duration, disease stability, and prior treatment status. Treatment-emergent AEs occurred in 52.1% (332/637) of patients, and treatment-related AEs occurred in 13.7% (87/637); rates were generally similar across demographic subgroups.</p><p><strong>Conclusions: </strong>Adolescent and adult patients with vitiligo who applied ruxolitinib cream could achieve clinically meaningful repigmentation per F-VASI75 response at 1 year, regardless of their baseline demographics or clinical characteristics. Ruxolitinib cream was well tolerated, with a similar incidence of treatment-emergent and treatment-related AEs across subgroups.</p><p><strong>Trial registration: </strong>NCT04052425/NCT04057573.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143742628","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}
引用次数: 0
Single-Injection Options for Administering a 320 mg Dose of Bimekizumab: 2 mL Safety Syringe and Auto-injector.
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-03-29 DOI: 10.1007/s13555-025-01366-6
Michael Sebastian, Jerry Bagel, Bengt Hoepken, Bertram Knapp, Ceyhun Bicer, Merran MacPherson, Richard G Langley
{"title":"Single-Injection Options for Administering a 320 mg Dose of Bimekizumab: 2 mL Safety Syringe and Auto-injector.","authors":"Michael Sebastian, Jerry Bagel, Bengt Hoepken, Bertram Knapp, Ceyhun Bicer, Merran MacPherson, Richard G Langley","doi":"10.1007/s13555-025-01366-6","DOIUrl":"https://doi.org/10.1007/s13555-025-01366-6","url":null,"abstract":"<p><strong>Introduction: </strong>Bimekizumab has a favourable safety profile and has demonstrated rapid and superior efficacy, compared with placebo, adalimumab, ustekinumab, and secukinumab, in treating psoriasis. A previous study demonstrated the safe and effective subcutaneous self-injection of 320 mg bimekizumab via two 1 mL (2 × 160 mg) doses using safety syringe (SSy) or auto-injector (AI) devices. Delivery of 320 mg bimekizumab via a single 2 mL self-injection could lead to an improved treatment experience for patients.</p><p><strong>Methods: </strong>We describe the results from four studies. Two self-injection experience studies (DV0002 [n = 38] and DV0006 [n = 89], sub-studies of the phase 3 study BE BRIGHT [NCT03598790]) assessed the safe and effective self-administration of bimekizumab at week 8 and baseline, as well as patient self-injection experience and pain, in patients with moderate to severe plaque psoriasis using the 2 mL SSy or AI. Additionally, we report on two bioequivalence studies (UP0068 [n = 71] and UP0119 [n = 121]) that describe pharmacokinetic profiles for two 1 mL injections and a single 2 mL injection, delivered by SSy or AI devices in healthy participants.</p><p><strong>Results: </strong>All patients were able to administer safe and effective self-injections at baseline and week 8 using the different 2 mL devices, except one patient that administered an incomplete dose as a result of injection site pain that was mild. Overall, bimekizumab was generally well tolerated and all adverse device effects reported were mild and did not lead to discontinuation. Patients reported a positive self-injection experience with low pain scores (all ≤ 12.0/100). Bioequivalence was demonstrated for bimekizumab between a single 2 mL injection and two 1 mL injections, using both the SSy and AI.</p><p><strong>Conclusion: </strong>The 2 mL SSy and AI devices offer patients with moderate to severe plaque psoriasis two different safe and effective options for the delivery of bimekizumab, empowering individuals to select a device on the basis of personal preference. Graphical abstract available for this article.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT03766685.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143742630","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}
引用次数: 0
Hidradenitis Suppurativa Symptom Daily Diary (HSSDD) and Questionnaire (HSSQ): Psychometric Validation and Interpretation Threshold Derivation Using Phase 3 Study Data.
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-03-28 DOI: 10.1007/s13555-025-01346-w
John R Ingram, Jérémy Lambert, Valerie Ciaravino, Robert Rolleri, Ingrid Pansar, Luke Peterson, Christopher G Pelligra, Linnea Thorlacius
{"title":"Hidradenitis Suppurativa Symptom Daily Diary (HSSDD) and Questionnaire (HSSQ): Psychometric Validation and Interpretation Threshold Derivation Using Phase 3 Study Data.","authors":"John R Ingram, Jérémy Lambert, Valerie Ciaravino, Robert Rolleri, Ingrid Pansar, Luke Peterson, Christopher G Pelligra, Linnea Thorlacius","doi":"10.1007/s13555-025-01346-w","DOIUrl":"https://doi.org/10.1007/s13555-025-01346-w","url":null,"abstract":"<p><strong>Introduction: </strong>Hidradenitis suppurativa (HS) is a chronic inflammatory disease characterised by painful skin lesions which negatively impact patients' physical and mental wellbeing. The HS Symptom Daily Diary (HSSDD) and HS Symptom Questionnaire (HSSQ) are patient-reported outcome (PRO) tools capturing patient-perceived severity of HS symptoms. Here, we report the psychometric properties of HSSDD and HSSQ along with score interpretation thresholds.</p><p><strong>Methods: </strong>Pooled data from patients with moderate to severe HS in two phase 3 studies (BE HEARD I II) were analysed. Test-retest reliability was evaluated using intraclass correlation coefficients (ICCs). Convergent validity was assessed between the HSSDD (N = 934) and HSSQ (N = 1007) compared with relevant PROs and clinician-reported outcomes (ClinROs) at baseline and Week (Wk)16. Known-groups validity was assessed, comparing HSSDD and HSSQ scores between participant subgroups pre-defined using PRO/ClinRO measures (Patient Global Impression [PGI] of HS severity, Hurley stage, International HS Severity Score System). Responsiveness was evaluated by correlating changes from baseline to Wk16 in HSSDD and HSSQ scores with changes in PGI scales. Clinically meaningful within-patient improvement thresholds were estimated using anchor- and distribution-based analyses. Symptom/impact severity thresholds were estimated using receiver operating characteristic curve analyses.</p><p><strong>Results: </strong>At Wk16, HSSDD and HSSQ completion rates were 70.1% and 90.2%, respectively. Test-retest reliability analyses demonstrated good score reproducibility (ICC: HSSDD: 0.80-0.86; HSSQ: 0.73-0.82). Correlations between HSSDD and HSSQ scores and other PROs/ClinROs were generally consistent with predefined hypotheses, indicating good convergent validity. HSSDD and HSSQ scores discriminated between pre-defined subgroups, confirming known-groups validity. Sixteen-wk changes from baseline in HSSDD and HSSQ scores and anchors were moderately to strongly correlated (> 0.30), establishing responsiveness. Interpretation thresholds for both HSSDD and HSSQ were estimated.</p><p><strong>Conclusion: </strong>HSSDD and HSSQ item scores demonstrated good psychometric performance in participants with moderate to severe HS. The clinically meaningful severity thresholds defined here could be used to assess treatment efficacy.</p><p><strong>Clinical trial registration: </strong>NCT04242446; NCT04242498.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143735763","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}
引用次数: 0
CT-P17 Adalimumab Biosimilar in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: An Open-Label Extension of a Phase 3 Interchangeability Study.
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-03-27 DOI: 10.1007/s13555-025-01383-5
David M Pariser, Mark G Lebwohl, Janusz Jaworski, Jakub Trefler, Stefan Daniluk, Anna Dudek, Wojciech Baran, Witold Owczarek, Pawel Brzewski, Mariusz Sikora, Marek Krogulec, SungHyun Kim, JeeHye Suh, EunJin Choi, JungBin Cha, HyunJin Lee, SungJeong Lee, John Y Koo
{"title":"CT-P17 Adalimumab Biosimilar in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: An Open-Label Extension of a Phase 3 Interchangeability Study.","authors":"David M Pariser, Mark G Lebwohl, Janusz Jaworski, Jakub Trefler, Stefan Daniluk, Anna Dudek, Wojciech Baran, Witold Owczarek, Pawel Brzewski, Mariusz Sikora, Marek Krogulec, SungHyun Kim, JeeHye Suh, EunJin Choi, JungBin Cha, HyunJin Lee, SungJeong Lee, John Y Koo","doi":"10.1007/s13555-025-01383-5","DOIUrl":"https://doi.org/10.1007/s13555-025-01383-5","url":null,"abstract":"<p><strong>Introduction: </strong>A 27-week analysis of this phase 3 study demonstrated the interchangeability of the adalimumab biosimilar CT-P17 and reference adalimumab. The current 52-week analysis reports secondary data from the open-label extension period (OLE) of the study.</p><p><strong>Methods: </strong>In this randomized, double-blind, active-controlled phase 3 study, adults with moderate-to-severe chronic plaque psoriasis received (via prefilled syringe) 80 mg subcutaneous reference adalimumab on day 1, then 40 mg 1 week later, and every other week (EOW) until week 11. At week 13, patients were randomized (1:1) to continue reference adalimumab (\"continuous\" group) or undergo repeated switching between CT-P17 and reference adalimumab (\"switching\" group) until week 25. Thereafter, patients entered an OLE and received 40 mg CT-P17 EOW from week 27 to 49, with an end-of-study visit at week 52. Here we present findings from the OLE. Pharmacokinetics (PK), efficacy (including mean percent improvement from baseline in Psoriasis Area Severity Index [PASI] score), safety, and immunogenicity were evaluated. Post hoc subgroup analyses were also conducted.</p><p><strong>Results: </strong>Of 327 patients who initiated the OLE, 152 and 160 patients from the switching group and continuous group, respectively, completed the study. Mean serum concentrations were similar between groups throughout the OLE. Efficacy improvements observed up to week 27 were maintained during the OLE and were comparable between groups. At week 52, overall mean (standard deviation [SD]) improvement from baseline in PASI score was 90.34% (16.59). Safety profiles were similar between groups, and immunogenicity did not increase during the OLE. The mean (SD) percent improvement from baseline in PASI score was slightly lower in patients who were antidrug antibody (ADA)-positive versus those who were ADA-negative (89.57 [17.27] versus 97.29 [4.08]) at week 52.</p><p><strong>Conclusions: </strong>PK, efficacy, safety, and immunogenicity findings remained consistent throughout the OLE, regardless of prior treatment, and were generally comparable across timepoints.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT05495568.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143729084","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}
引用次数: 0
Treating Generalized Pustular Psoriasis (GPP): Timing and Rationale for Biologic Treatment Switching-A Japanese e-Delphi Survey.
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-03-22 DOI: 10.1007/s13555-025-01377-3
Yayoi Tada, Shinichi Imafuku, Kazumitsu Sugiura, Hideki Fujita, Noriko Tsuruta, Teruyuki Mitsuma, Ayumi Yoshizaki, Masatoshi Abe, Yukie Yamaguchi, Akimichi Morita
{"title":"Treating Generalized Pustular Psoriasis (GPP): Timing and Rationale for Biologic Treatment Switching-A Japanese e-Delphi Survey.","authors":"Yayoi Tada, Shinichi Imafuku, Kazumitsu Sugiura, Hideki Fujita, Noriko Tsuruta, Teruyuki Mitsuma, Ayumi Yoshizaki, Masatoshi Abe, Yukie Yamaguchi, Akimichi Morita","doi":"10.1007/s13555-025-01377-3","DOIUrl":"https://doi.org/10.1007/s13555-025-01377-3","url":null,"abstract":"<p><strong>Introduction: </strong>Generalized pustular psoriasis (GPP) is a chronic, inflammatory disease characterized by the sudden and recurrent development of widespread sterile pustules on the skin. The treatment of GPP includes non-biologic and biologic therapies. In Japan, biologic agents are being increasingly used as first-line treatment, with more biologics approved in Japan than in other countries. A previous secondary data-based study utilizing data in the Medical Data Vision database and the Japan Medical Data Center in Japan demonstrated heterogeneity in real-world biologic treatment patterns, with at least one switch during the follow-up period (mean n switches 3.8; mean length of follow-up 3.3 years) for approximately one third of patients with GPP treated with a biologic drug. The aim of this study was to evaluate where consensus lies among experts regarding switching biologic treatments for patients with GPP in Japan.</p><p><strong>Methods: </strong>A Delphi exercise that consists of three survey rounds was performed with ten Japanese dermatologists. Participants were asked to respond to questions related to experts' experience with specific biologics, experience with switching, timing of switches and importance of specific criteria (drivers) when making the decision to switch. The consensus threshold was 70%.</p><p><strong>Results: </strong>Based on the results of the Delphi exercise, most experts rarely (60%) or never (20%) switch a biologic agent and only 20% switch often during acute symptoms/GPP flare driven by the short time of the flare; this result may be different during the maintenance phase. Lack of efficacy, loss of efficacy due to long-term use, side effects, contraindications, new products with better efficacy and safety evidence, risk of infection, and lack of adherence play an important role in making the decision to switch.</p><p><strong>Conclusion: </strong>Switches may occur for patients on biologics when flares occur (loss of effectiveness) or when there is insufficient response (lack of effectiveness). The decision to switch a biologic is impacted by several other criteria, including safety and the availability of more efficacious and better tolerated therapies. Overall, there is still an unmet need for robust evidence to inform GPP treatment choice.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143691455","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}
引用次数: 0
Disease Burden and Treatment-Seeking Behaviour of Adults with Atopic Dermatitis in Singapore: An Online Cross-Sectional Survey.
IF 3.5 3区 医学
Dermatology and Therapy Pub Date : 2025-03-21 DOI: 10.1007/s13555-025-01379-1
Yik Weng Yew, Malvin Kang, Sharanya Jois, Adrien Gras, Christian Apfelbacher
{"title":"Disease Burden and Treatment-Seeking Behaviour of Adults with Atopic Dermatitis in Singapore: An Online Cross-Sectional Survey.","authors":"Yik Weng Yew, Malvin Kang, Sharanya Jois, Adrien Gras, Christian Apfelbacher","doi":"10.1007/s13555-025-01379-1","DOIUrl":"https://doi.org/10.1007/s13555-025-01379-1","url":null,"abstract":"<p><strong>Introduction: </strong>Atopic dermatitis (AD) is a chronic systemic inflammatory skin disease with a notably high prevalence in Singapore. Despite available treatments, a significant proportion of patients remain untreated, highlighting a critical need to understand treatment-seeking behaviours and address the multi-faceted disease burden.</p><p><strong>Methods: </strong>An online survey was conducted among 344 adult patients and caregivers answering on behalf of patients to obtain data on clinical impact and quality-of life (QoL), current treatment goals, management, financial impact and treatment-seeking behaviours. This study analysed the differences between patients with different AD severity using data initially collected in Excel and processed in SPSS.</p><p><strong>Results: </strong>AD patients in Singapore face challenges like self-consciousness due to appearance (38%), treatment costs (36%) and the need for additional skincare (34%), with severe AD patients significantly more affected by these issues. Key symptoms like skin dryness (61%), itchiness (56%) and red/scaly skin (48%) worsen with disease severity. AD's impact on patients intensifies with severity, with 100% of severe AD patients rating their condition as 'very serious', correlating with a higher Dermatology Life Quality Index (DLQI) score. Management strategies for AD flare-ups include lifestyle changes (53%) and home remedies (48%). Financial burden is considerable, averaging US dollars (USD) 1368 per month, with 82% perceiving it as 'extreme', affecting treatment adherence.</p><p><strong>Conclusion: </strong>The study underscores the significant burden and impact on QoL faced by adult AD patients in Singapore. It highlights the necessity for targeted research on economic impacts and treatment behaviours in specific groups and the urgent need for effective interventions to enhance QoL, particularly for those with severe AD.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143673271","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}
引用次数: 0
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