Noninferiority of 16-Week vs 8-Week Guselkumab Dosing in Super Responders for Maintaining Control of Psoriasis

K. Eyerich,K. Asadullah,A. Pinter,P. Weisenseel,Kristian Reich,Carle Paul,R. Sabat,K. Wolk,S. Eyerich,F. Lauffer,J. Angsana,F. Taut,K. Kohler,Yanqing Chen,J. Sendecki,Monica Leung,S. Wegner,Y. Personke,M. Gómez,N. Krüger,S. Tabori,Knut Schäkel

Published 2024 in JAMA dermatology

ABSTRACT

Key Points Question Is guselkumab dosing every 16 weeks noninferior to standard dosing every 8 weeks for maintenance of psoriasis disease control, defined as a Psoriasis Area and Severity Index lower than 3 at week (W)68, in super responders (SRes)? Findings This phase 3b clinical trial randomized 149 guselkumab SRes to guselkumab every 16 weeks dosing and 148 SRes to every 8 weeks dosing at W28 and demonstrated noninferiority of every 16 weeks dosing for maintenance of disease control, meeting the primary end point; clinical effects corresponded with immunologic changes. Meaning The GUIDE randomized clinical trial is the first to demonstrate that disease activity in patients with early complete skin clearance may be controlled with an extended guselkumab dosing interval.

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