Guselkumab demonstrates long-term efficacy and maintenance of treatment response postwithdrawal in systemic treatment-naïve patients and nonresponders to fumaric acid esters

• Verfasst von: Thaçi, Diamant [VerfasserIn]
• Verfasst von: Pinter, Andreas [VerfasserIn]
• Verfasst von: Sebastian, Michael [VerfasserIn]
• Verfasst von: Termeer, Christian [VerfasserIn]
• Verfasst von: Sticherling, Michael [VerfasserIn]
• Verfasst von: Gerdes, Sascha [VerfasserIn]
• Verfasst von: Schäkel, Knut [VerfasserIn]
• Verfasst von: Wegner, Sven [VerfasserIn]
• Verfasst von: Krampe, Stefanie [VerfasserIn]
• Verfasst von: Bartz, Holger [VerfasserIn]
• Verfasst von: Rausch, Christian [VerfasserIn]
• Verfasst von: Taut, Friedemann [VerfasserIn]
• Verfasst von: Eyerich, Kilian [VerfasserIn]
• Titel: Guselkumab demonstrates long-term efficacy and maintenance of treatment response postwithdrawal in systemic treatment-naïve patients and nonresponders to fumaric acid esters
• Titelzusatz: results from parts II and III of a randomized active-comparator-controlled phase IIIb trial (POLARIS)
• Verf.angabe: Diamant Thaçi, Andreas Pinter, Michael Sebastian, Christian Termeer, Michael Sticherling, Sascha Gerdes, Knut Schäkel, Sven Wegner, Stefanie Krampe, Holger Bartz, Christian Rausch, Friedemann Taut, Kilian Eyerich
• E-Jahr: 2024
• Jahr: July 2024
• Umfang: 13 S.
• Illustrationen: Illustrationen
• Fussnoten: Veröffentlicht: 22. Dezember 2023 ; Gesehen am 29.11.2024
• Titel Quelle: Enthalten in: British journal of dermatology
• Ort Quelle: Oxford : Oxford University Press, 1892
• Jahr Quelle: 2024
• Band/Heft Quelle: 191(2024), 1 vom: Juli, Seite 36-48
• ISSN Quelle: 1365-2133
• DOI: doi:10.1093/bjd/ljad523
• Datenträger: Online-Ressource
• Sprache: eng
• K10plus-PPN: 1909896233

Abstract

The anti-interleukin-23 antibody guselkumab (GUS) demonstrated favourable week 24 efficacy and safety over fumaric acid esters (FAE) in systemic treatment-naïve patients with moderate-to-severe plaque psoriasis (study part I).To compare, in study part II, the sustainability of treatment responses (weeks 24-32) in GUS- and FAE-treated patients and treatment responses (weeks 32-56) in patients treated with GUS and FAE and in FAE nonresponders switching to GUS; and, in part III, to investigate the maintenance of response through week 100 in patients withdrawn from GUS at week 56.At week 0, systemic treatment-naïve patients were randomized 1 : 1 to GUS or FAE as per label. At week 32, patients with a Psoriasis Area and Severity Index (PASI) 75 (≥ 75% improvement in PASI score) response (r) continued assigned treatment (GUSr-GUS; FAEr-FAE), whereas nonresponders (nr) received GUS (FAEnr-GUS; GUSnr-GUS). GUS-treated patients with a week 56 PASI 90 response (≥ 90% improvement in PASI score) were withdrawn (w) and followed until loss of response or week 100.At week 32, 98% (n = 54/55) of GUS- and 41% (n = 14/34) of FAE-treated patients were PASI 75 responders. At week 56, 91%, 50% and 80% of GUSr-GUS, FAEr-FAE and FAEnr-GUS patients, respectively, achieved a PASI 90 response; 72%, 29% and 45%, respectively, achieved a Dermatology Life Quality Index score of 0/1. At week 100, 44 weeks postwithdrawal, 47% (n = 17/36) and 25% (n = 3/12) of GUS-GUSw and FAE­GUSw patients, respectively, maintained a PASI score ≤ 5. Overall, the adverse event and discontinuation rates were lower for GUS than FAE.In these exploratory analyses, GUS, as a first-line systemic treatment or second-line systemic treatment in FAE nonresponders, was associated with long-term clinical efficacy up to week 100, including a withdrawal period.