[Articles] guselkumab in biologic-naive patients with active psoriatic arthritis (discover-2): a double-blind, randomised, placebo-controlled phase 3 trial
The Lancet Mar 22, 2020
Mease PJ, Rahman P, Gottlieb AB, et al. - A double-blind, randomised, placebo-controlled phase 3 trial was designed to evaluate the utility and safety of guselkumab in biologic-naive individuals with active psoriatic arthritis (DISCOVER-2). This study conducted at 118 sites in 13 countries across Asia, Europe, and North America. Researchers recruited biologic-naive individuals with active psoriatic arthritis (at least five swollen joints, at least five tender joints, and C-reactive protein ≥ 0·6 mg/dL) despite standard therapies. Individuals were allocated randomly (1:1:1, computer-generated permuted blocks; stratified by baseline disease-modifying antirheumatic drug use and C-reactive protein concentration) to subcutaneous injections of guselkumab 100 mg every 4 weeks; guselkumab 100 mg at weeks 0, 4, then every 8 weeks; or placebo. They screened 1,153 individuals, of whom 741 were randomized to receive guselkumab every 4 weeks (n=246), every 8 weeks (n=248), or placebo (n=247) between July 13, 2017, to Aug 3, 2018. The results of this study suggested that guselkumab, a human monoclonal antibody that specifically inhibits IL-23 by binding the cytokine's p19 subunit, was effective and indicated an acceptable benefit–risk profile in individuals with active psoriatic arthritis who were naive to treatment with biologics.
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