Steven R Feldman, Joanna Narbutt, Giampiero Girolomoni, Jan Brzezicki, Nataliya Reznichenko, Maria Agnieszka Zegadlo-Mylik, Grazyna Pulka, Magdalena Dmowska-Stecewicz, Elżbieta Kłujszo, Dmytro Rekalov, Lidia Rajzer, Jiyoon Lee, Minkyung Lee, Young Hee Rho
BACKGROUND: Ustekinumab is a safe and effective treatment for moderate-to-severe psoriasis. OBJECTIVES: To compare efficacy, safety, pharmacokinetics (PK), and immunogenicity of the proposed ustekinumab biosimilar SB17 with reference ustekinumab (UST) in subjects with moderate to severe plaque psoriasis. METHODS: In this randomized double-blind study, subjects were randomized to receive 45 mg of SB17 or UST subcutaneously at Week 0, 4, and every 12 weeks...
April 27, 2024: Journal of the American Academy of Dermatology