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New insights on hidradenitis suppurativa phenotypes and treatment response: An exploratory automated analysis of the SUNSHINE and SUNRISE trials.

التفاصيل البيبلوغرافية
العنوان: New insights on hidradenitis suppurativa phenotypes and treatment response: An exploratory automated analysis of the SUNSHINE and SUNRISE trials.
المؤلفون: Passera A; Novartis Pharma AG, Basel, Switzerland., Muscianisi E; Novartis Gene Therapies, Bannockburn, Illinois, USA., Demanse D; Novartis Pharma AG, Basel, Switzerland., Okoye GA; Department of Dermatology, Howard University College of Medicine, Washington, D.C., USA., Jemec GBE; University of Copenhagen, Copenhagen, Denmark., Mayo T; University of Alabama at Birmingham, Birmingham, Alabama, USA., Hsiao J; University of Southern California, Los Angeles, California, USA., Shi VY; Department of Dermatology, University of Washington, Seattle, Washington, USA., Byrd AS; Department of Dermatology, Howard University College of Medicine, Washington, D.C., USA., Wei X; Novartis Pharma Shanghai, Shanghai, China., Uhlmann L; Novartis Pharma AG, Basel, Switzerland., Vandemeulebroecke M; Novartis Pharma AG, Basel, Switzerland., Ravichandran S; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA., Porter ML; Department of Dermatology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA.
المصدر: Journal of the European Academy of Dermatology and Venereology : JEADV [J Eur Acad Dermatol Venereol] 2024 Aug 05. Date of Electronic Publication: 2024 Aug 05.
Publication Model: Ahead of Print
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 9216037 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1468-3083 (Electronic) Linking ISSN: 09269959 NLM ISO Abbreviation: J Eur Acad Dermatol Venereol Subsets: MEDLINE
أسماء مطبوعة: Publication: Oxford : Wiley-Blackwell
Original Publication: Amsterdam ; New York : Elsevier Science Publishers, c1992-
مستخلص: Background: Defining hidradenitis suppurativa (HS) subtypes was previously limited by small sample sizes and poor interrater reliability; no study has investigated subtype treatment responses. The objective of this analysis was to characterize HS clusters in adult patients with moderate to severe HS and evaluate secukinumab treatment responses between clusters.
Methods: Clusters were identified via an unsupervised machine learning clustering analysis using baseline data from the randomized, placebo-controlled SUNSHINE (NCT03713619) and SUNRISE (NCT03713632) phase 3 trials. To assess treatment responses, patients received secukinumab every 2 (SECQ2W) or 4 weeks (SECQ4W) or placebo, for 16 weeks, after which, placebo patients randomly switched to SECQ2W/SECQ4W, and SECQ2W/SECQ4W patients maintained their original treatment, until week 52. Baseline outcomes included patient characteristics, disease characteristics and severity, HS-associated comorbidities and previous treatment exposures. Treatment response was assessed via the HS clinical response (HiSCR), abscess and inflammatory nodule (AN) count, flares and NRS30 (skin pain).
Results: Based on baseline data, three clusters were identified from 1084 patients (Cluster 1: 54.1%, Cluster 2: 17.8%, Cluster 3: 28.1%). Cluster 1 was predominantly female (65.4%) and was characterized by milder HS. Cluster 2 had more patients from the Asia Pacific, Middle East and Africa region (58.5%) and was characterized by moderate HS. Cluster 3 had the highest rates of previous exposure to biologics (45.9%) and prior HS-related surgeries (47.5%) and was characterized by severe HS. SECQ2W and SECQ4W demonstrated efficacy versus placebo in all clusters at week 16; SECQ2W and SECQ4W efficacy was maintained to week 52. SECQ2W treatment showed a trend for greater efficacy versus SECQ4W in Cluster 3 through week 52.
Conclusions: Three HS clusters were identified. Secukinumab demonstrated benefit over placebo in all clusters. However, patients with more severe disease may take longer to respond and more frequent secukinumab dosing may be required for these patients.
Trial Registration: SUNSHINE (NCT03713619) and SUNRISE (NCT03713632).
(© 2024 The Author(s). Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.)
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معلومات مُعتمدة: Novartis Pharma AG
سلسلة جزيئية: ClinicalTrials.gov NCT03713632; NCT03713619
تواريخ الأحداث: Date Created: 20240805 Latest Revision: 20240805
رمز التحديث: 20240805
DOI: 10.1111/jdv.20234
PMID: 39101698
قاعدة البيانات: MEDLINE
الوصف
تدمد:1468-3083
DOI:10.1111/jdv.20234