Dermatology and Therapy最新文献

{"title":"Psychometric Validation of the Subject Sleep Diary in Patients with Moderate-to-Severe Atopic Dermatitis.","authors":"Jonathan I Silverberg, Danielle N Rodriguez, Carla Dias-Barbosa, Dina Filipenko, Liliana Ulianov, Christophe Piketty, Jorge Puelles","doi":"10.1007/s13555-025-01385-3","DOIUrl":"10.1007/s13555-025-01385-3","url":null,"abstract":"<p><strong>Introduction: </strong>A subject sleep diary (SSD) capturing 14 sleep parameters was developed to assess daily fluctuations in atopic dermatitis (AD)-associated sleep disturbance. This study aimed to evaluate the psychometric properties of the SSD using data including all randomized patients from the phase 3 ARCADIA 1 (NCT03985943) and ARCADIA 2 (NCT03989349) trials of nemolizumab in adults and adolescents (age ≥ 12 years) with moderate-to-severe AD.</p><p><strong>Methods: </strong>Reliability, validity, and responsiveness of the SSD were evaluated, and its relationship with the single-item Sleep Disturbance Numerical Rating Scale (SD NRS) was examined using the equipercentile linking method.</p><p><strong>Results: </strong>In ARCADIA 1 (N = 941), most SSD parameters showed good test-retest reliability (intraclass correlations ≥ 0.70) in patients with stable scores over 1 week on sleep disturbance or itch measures. The SSD parameters of wakefulness after sleep onset (WASO), total awake time (TWT), sleep efficiency (SE), number of times (NWASO-AD) and duration (WASO-AD) of AD-related WASO, and sleep quality/refresh (SQR) showed moderate or strong correlations (r = 0.30-0.66) at baseline, in the expected direction; with the SD NRS and at least one of the measures assessing itch and skin disease-related quality of life (Pruritus Categorical Scale, Peak Pruritus NRS, Average Pruritus NRS, and Dermatology Life Quality Index). Correlations with measures assessing distal concepts were weak for most sleep parameters. Sleep onset latency (SOL), WASO, TWT, SE, NWASO-AD, WASO-AD, and SQR demonstrated good known-groups validity at baseline and week 16, and showed responsiveness based on most anchors used in the analysis. Values of the same percentile rankings for the SD NRS and each SSD parameter were identified. Comparable results were obtained using ARCADIA 2 data (N = 787).</p><p><strong>Conclusions: </strong>The results provided evidence that the SSD, particularly its SOL, WASO, TWASO, TWT, SE, NWASO-AD, WASO-AD, and SQR parameters, is reliable and valid to measure multidimensional concepts of sleep disturbance in clinical studies.</p><p><strong>Clinical trial registration: </strong>NCT03985943, NCT03989349.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"963-995"},"PeriodicalIF":3.5,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11971097/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143673364","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":"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":"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":"1009-1024"},"PeriodicalIF":3.5,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11971113/pdf/","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":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cluster Analysis of Clinical Remission and Relapse Patterns in Chronic Urticaria: Results from the PREDICT-CU Study.","authors":"Maria-Magdalena Balp, Irina Pivneva, Andrii Danyliv, Kathleen Chen, Tom Cornwall, Jimmy Royer, James Signorovitch, Dhaval Patil, Ravneet K Kohli, Thomas Severin, Weily Soong, Alexander M Marsland","doi":"10.1007/s13555-025-01376-4","DOIUrl":"10.1007/s13555-025-01376-4","url":null,"abstract":"<p><strong>Introduction: </strong>Patients with chronic urticaria (CU) may have different clinical courses of disease including periods of active CU, clinical remission, and relapse. The objective of this study was to describe representative clinical remission and relapse profiles for patients with CU.</p><p><strong>Methods: </strong>Adults with a CU diagnosis and confirmation CU diagnosis/CU-related treatment at least 6 weeks later were identified in the Optum® de-identified Electronic Health Record dataset (2007-2018). Active CU was a period during which a patient was not in clinical remission. Clinical remission was defined as at least 12 months without CU diagnosis and/or treatment. Relapse was defined as having a CU diagnosis and/or treatment following clinical remission. A data-driven clustering algorithm grouped patients on the basis of clinical remission and relapse patterns.</p><p><strong>Results: </strong>The 112,443 patients were grouped into four clusters. Cluster 1 (N = 36,690 [32.6%]) had the shortest median time to clinical remission (4.1 months) and lowest relapse rate (38.0%). Cluster 2 (N = 29,834 [26.5%]) reached clinical remission later (10.0 months), with a higher relapse rate (52.3%). Clusters 3 (N = 24,093 [21.4%]) and 4 (N = 21,826 [19.4%]) had the longest median times to clinical remission (33.8 and 44.6 months) and highest relapse rates (75%). Cluster 4 had the most frequent CU diagnoses and treatments, and highest comorbidity burden, polypharmacy, and resource use.</p><p><strong>Conclusions: </strong>Patients in Clusters 3 and 4 had the lowest clinical remission and highest relapse rates relative to Clusters 1 and 2; additionally, Cluster 4 had higher resource use, more comorbidities, and polypharmacy. These cluster definitions could be used to develop a model to predict patients with relapsing and remitting patterns associated with higher disease burden who might require enhanced disease management.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"933-948"},"PeriodicalIF":3.5,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11971071/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143647823","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":"Life-Changing Decisions in Patients Suffering from Psoriasis: A Cross-Sectional Study.","authors":"Beata Bień, Piotr K Krajewski, Jacek C Szepietowski","doi":"10.1007/s13555-025-01370-w","DOIUrl":"10.1007/s13555-025-01370-w","url":null,"abstract":"<p><strong>Introduction: </strong>Psoriasis is a chronic inflammatory skin disease affecting over 60 million people worldwide, often linked to comorbidities such as psoriatic arthritis and cardiovascular disease. Beyond physical symptoms, psoriasis can significantly impact major life-changing decisions (MLCDs), leading to long-term consequences and missed opportunities. This study focused on assessing MLCDs and their correlations with quality of life (QoL), disease acceptance, and itch severity, emphasizing the need for early intervention to mitigate cumulative life course impairment.</p><p><strong>Methods: </strong>A total of 166 consecutive patients with psoriasis, comprising 101 men and 65 women, all with a minimum disease duration of 1 year, were included in the study. Clinical and psychological aspects of psoriasis were thoroughly evaluated using a range of standardized instruments, along with a questionnaire collecting demographic data.</p><p><strong>Results: </strong>Psoriasis affected at least one MLCD in 93.4% of patients, most commonly influencing decisions related to physical activity (77%), dietary habits (70%), smoking and alcohol consumption (58%), and job choices (30%). A significant correlation was found between the Major Life-Changing Decisions Profile (MLCDP) total score and QoL (r = 0.561, p < 0.001), psoriasis severity (r = 0.275, p < 0.001), and itch severity (r = 0.351, p < 0.001), as well as an inverse correlation with disease acceptance (r = - 0.545, p < 0.001).</p><p><strong>Conclusion: </strong>Psoriasis may affect MLCDs, reflecting the long-term consequences of the disease. A comprehensive approach is essential to prevent these impacts, especially in cases of early-onset psoriasis.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"841-855"},"PeriodicalIF":3.5,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11971106/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143572427","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":"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}

{"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}

{"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}

{"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}

{"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}

{"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}