دورية أكاديمية
New insights on hidradenitis suppurativa phenotypes and treatment response: An exploratory automated analysis of the SUNSHINE and SUNRISE trials.
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.) |
References: | Jemec GB, Kimball AB. Hidradenitis suppurativa: epidemiology and scope of the problem. J Am Acad Dermatol. 2015;73(5 Suppl 1):S4–S7. Zouboulis CC, Del Marmol V, Mrowietz U, Prens EP, Tzellos T, Jemec GB. Hidradenitis suppurativa/acne Inversa: criteria for diagnosis, severity assessment, classification and disease evaluation. Dermatology. 2015;231(2):184–190. Saunte DML, Jemec GBE. Hidradenitis suppurativa: advances in diagnosis and treatment. JAMA. 2017;318(20):2019–2032. Prens E, Deckers I. Pathophysiology of hidradenitis suppurativa: an update. J Am Acad Dermatol. 2015;73(5 Suppl 1):S8–S11. Zouboulis CC, Bechara FG, Dickinson‐Blok JL, Gulliver W, Horváth B, Hughes R, et al. Hidradenitis suppurativa/acne inversa: a practical framework for treatment optimization – systematic review and recommendations from the HS ALLIANCE working group. J Eur Acad Dermatol Venereol. 2019;33(1):19–31. van der Zee HH, Laman JD, Boer J, Prens EP. Hidradenitis suppurativa: viewpoint on clinical phenotyping, pathogenesis and novel treatments. Exp Dermatol. 2012;21(10):735–739. Zouboulis CC, Desai N, Emtestam L, Hunger RE, Ioannides D, Juhász I, et al. European S1 guideline for the treatment of hidradenitis suppurativa/acne inversa. J Eur Acad Dermatol Venereol. 2015;29(4):619–644. Alikhan A, Sayed C, Alavi A, Alhusayen R, Brassard A, Burkhart C, et al. North American clinical management guidelines for hidradenitis suppurativa: a publication from the United States and Canadian hidradenitis suppurativa foundations: part II: topical, intralesional, and systemic medical management. J Am Acad Dermatol. 2019;81(1):91–101. Hendricks AJ, Hsiao JL, Lowes MA, Shi VY. A comparison of international management guidelines for hidradenitis suppurativa. Dermatology. 2021;237(1):81–96. Loftus TJ, Shickel B, Balch JA, Tighe PJ, Abbott KL, Fazzone B, et al. Phenotype clustering in health care: a narrative review for clinicians. Front Artif Intell. 2022;5:842306. Hendricks RM, Khasawneh MT. A systematic review of Parkinson's disease cluster analysis research. Aging Dis. 2021;12(7):1567–1586. Kirby JS. Unraveling the heterogeneity of hidradenitis suppurativa with phenotype schema. J Invest Dermatol. 2021;141(5):1136–1138. Jørgensen AR, Thomsen SF, Ring HC. Clinical phenotypes of hidradenitis suppurativa. J Eur Acad Dermatol Venereol. 2019;33(3):e111–e112. Canoui‐Poitrine F, Le Thuaut A, Revuz JE, Viallette C, Gabison G, Poli F, et al. Identification of three hidradenitis suppurativa phenotypes: latent class analysis of a cross‐sectional study. J Invest Dermatol. 2013;133(6):1506–1511. Cazzaniga S, Pezzolo E, Bettoli V, Abeni D, Marzano AV, Patrizi A, et al. Characterization of hidradenitis suppurativa phenotypes: a multidimensional latent class analysis of the National Italian Registry IRHIS. J Invest Dermatol. 2021;141(5):1236–1242.e1. González‐Manso A, Agut‐Busquet E, Romaní J, Vilarrasa E, Bittencourt F, Mensa A, et al. Hidradenitis suppurativa: proposal of classification in two endotypes with two‐step cluster analysis. Dermatology. 2021;237(3):365–371. Martorell A, Jfri A, Koster SBL, Gomez‐Palencia P, Solera M, Alfaro‐Rubio A, et al. Defining hidradenitis suppurativa phenotypes based on the elementary lesion pattern: results of a prospective study. J Eur Acad Dermatol Venereol. 2020;34(6):1309–1318. Naasan H, Affleck A. Atypical hidradenitis suppurativa. Clin Exp Dermatol. 2015;40(8):891–893. van der Zee HH, Jemec GB. New insights into the diagnosis of hidradenitis suppurativa: clinical presentations and phenotypes. J Am Acad Dermatol. 2015;73(5 Suppl 1):S23–S26. van Straalen KR, Verhagen T, Horváth B, Ardon C, Vossen A, Driessen R, et al. Poor interrater reliability of hidradenitis suppurativa phenotypes. J Am Acad Dermatol. 2018;79(3):577–578. Frew JW, Hawkes JE, Sullivan‐Whalen M, Gilleaudeau P, Krueger JG. Inter‐rater reliability of phenotypes and exploratory genotype‐phenotype analysis in inherited hidradenitis suppurativa. Br J Dermatol. 2019;181(3):566–571. Kimball AB, Jemec GBE, Alavi A, Reguiai Z, Gottlieb AB, Bechara FG, et al. Secukinumab in moderate‐to‐severe hidradenitis suppurativa (SUNSHINE and SUNRISE): week 16 and week 52 results of two identical, multicentre, randomised, placebo‐controlled, double‐blind phase 3 trials. Lancet. 2023;401:747–761. Josse J, Husson F. missMDA: a package for handling missing values in multivariate data analysis. J Stat Softw. 2016;70(1):1–31. Josse J, editor. Principal component methods – hierarchical clustering – partitional clustering: why would we need to choose for visualizing data? 2010. Frew JW, Vekic DA, Woods J, Cains GD. Phenotypic heterogeneity implies heterogeneous pathogenic pathways in hidradenitis suppurativa. Exp Dermatol. 2015;24(5):338–339. Gotesman RD, Choi C, Alavi A. Hidradenitis suppurativa in east and southeast Asian populations: a systematic review and meta‐analysis. Int J Dermatol. 2021;60(11):e433–e439. Matusiak Ł, Bieniek A, Szepietowski JC. Hidradenitis suppurativa and associated factors: still unsolved problems. J Am Acad Dermatol. 2009;61(2):362–365. Shih T, Seivright JR, McKenzie SA, Harview CL, Truong AK, Shi VY, et al. Gender differences in hidradenitis suppurativa characteristics: a retrospective cohort analysis. Int J Womens Dermatol. 2021;7(5Part B):672–674. Kokolakis G, Wolk K, Schneider‐Burrus S, Kalus S, Barbus S, Gomis‐Kleindienst S, et al. Delayed diagnosis of hidradenitis suppurativa and its effect on patients and healthcare system. Dermatology. 2020;236(5):421–430. Saunte DM, Boer J, Stratigos A, Szepietowski JC, Hamzavi I, Kim KH, et al. Diagnostic delay in hidradenitis suppurativa is a global problem. Br J Dermatol. 2015;173(6):1546–1549. Dufour DN, Emtestam L, Jemec GB. Hidradenitis suppurativa: a common and burdensome, yet under‐recognised, inflammatory skin disease. Postgrad Med J. 2014;90(1062):216–221. Schrader AM, Deckers IE, van der Zee HH, Boer J, Prens EP. Hidradenitis suppurativa: a retrospective study of 846 Dutch patients to identify factors associated with disease severity. J Am Acad Dermatol. 2014;71(3):460–467. Kimball AB, Okun MM, Williams DA, Gottlieb AB, Papp KA, Zouboulis CC, et al. Two phase 3 trials of adalimumab for hidradenitis suppurativa. N Engl J Med. 2016;375(5):422–434. Amir Ali A, Seng EK, Alavi A, Lowes MA. Exploring changes in placebo treatment arms in hidradenitis suppurativa randomized clinical trials: a systematic review. J Am Acad Dermatol. 2020;82(1):45–53. Frew JW, Jiang CS, Singh N, Grand D, Navrazhina K, Vaughan R, et al. Clinical response rates, placebo response rates, and significantly associated covariates are dependent on choice of outcome measure in hidradenitis suppurativa: a post hoc analysis of PIONEER 1 and 2 individual patient data. J Am Acad Dermatol. 2020;82(5):1150–1157. Canoui‐Poitrine F, Revuz JE, Wolkenstein P, Viallette C, Gabison G, Pouget F, et al. Clinical characteristics of a series of 302 French patients with hidradenitis suppurativa, with an analysis of factors associated with disease severity. J Am Acad Dermatol. 2009;61(1):51–57. |
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 |
كن أول من يترك تعليقا!