Efficacy and safety of guselkumab in Chinese patients with moderate-to-severe plaque psoriasis: A randomized, double-blind, placebo-controlled trial.
Kun Huang, Songmei Geng, Xiaohua Tao et al.
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In 30 seconds
This phase 4 randomized, double-blind, placebo-controlled trial evaluated guselkumab in Chinese patients with moderate-to-severe plaque psoriasis. Among 327 treated participants, guselkumab was compared with placebo through week 16, after which the placebo group switched to guselkumab. At week 16, PASI 90 response was achieved by 82.4% with guselkumab versus 2.0% with placebo, and IGA 0/1 response by 88.8% versus 7.1% (both P <0.001). Responses were maintained or increased through week 48, and adverse-event incidence during the first 16 weeks was comparable between groups.
Key findings
- At week 16, PASI 90 response occurred in 82.4% with guselkumab versus 2.0% with placebo (P <0.001).
- At week 16, IGA 0/1 response occurred in 88.8% with guselkumab versus 7.1% with placebo (P <0.001).
- At week 48, PASI 90 and IGA 0/1 response rates were 79.2% and 82.4% in the guselkumab group, respectively.
- During the first 16 weeks, adverse events occurred in 41.9% with guselkumab and 39.1% with placebo; serious adverse events occurred in 0.9% and 5.5%, respectively.
Why it matters
The trial provides randomized evidence of substantial short-term skin-response benefits with guselkumab in Chinese patients, a population for which the abstract notes limited randomized-trial data. The week-48 results suggest responses persisted during continued treatment, while the reported adverse-event rates offer comparative safety information over the placebo-controlled period.
What to keep in mind
The placebo-controlled comparison lasted only through week 16; after that, the placebo group switched to guselkumab, limiting longer-term comparative assessment.