Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): A double-blind, randomised, placebo-controlled phase 3 trial
The Lancet Apr 09, 2020
Mease PJ, Rahman P, Gottlieb AB, et al. - A double-blind, randomised, placebo-controlled phase 3 trial was designed to evaluate guselkumab in biologic-naive patients with psoriatic arthritis. This study was conducted at 118 sites in 13 countries across Asia, Europe, and North America. Analysis recruited biologic-naive patients 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. The outcomes of this research exhibit that guselkumab, a human monoclonal antibody that specifically inhibits IL-23 by binding the cytokine's p19 subunit, was efficacious and indicated an acceptable benefit–risk profile in patients with active psoriatic arthritis who were naive to treatment with biologics. This study recommended the use of selective inhibition of IL-23 to treat psoriatic arthritis.
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