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Long-term data from the VOYAGE 1 phase 3 trial of guselkumab (Tremfya; Janssen) showed that treatment with the interleukin-23 antagonist maintained Psoriasis Area Severity Index (PASI 90) response and Investigator’s Global Assessment (IGA) 0/1 at week 204 in patients with moderate-to-severe plaque psoriasis.
VOYAGE 1 was a 52-week, double-blind, placebo- and active-controlled trial that compared the efficacy and safety of guselkumab with placebo and adalimumab in adult patients with moderate-to-severe plaque psoriasis (N=837). Patients were randomized to receive placebo at weeks 0, 4, and 12 followed by crossover to guselkumab 100mg at weeks 16 and 20 then every 8-weeks thereafter; guselkumab 100mg at weeks 0, 4 and 12, then every 8-week dosing; or adalimumab 80mg at week 0 and 40mg at week 1, followed by every 2-week dosing through week 47, with crossover to guselkumab every 8-weeks at week 52.
Following completion at week 52, patients continued into an open-label extension period with guselkumab through week 204. Efficacy was evaluated based on the proportion of patients achieving PASI 90, PASI 100, IGA of 0/1, and IGA of 0.
Results showed that at week 204, 82% of patients in the combined group (initially randomized to guselkumab or placebo with crossover to guselkumab at week 16) achieved a PASI 90 response and an IGA of 0/1. Moreover, PASI 100, IGA 0/1, and IGA 0 clear skin responses were found to be consistent at week 52 and at week 204 in patients in the combined group. In addition, the proportion of patients with Psoriasis Symptoms and Signs Diary (PSSD) symptom scores of 0 (no symptoms of psoriasis) were also consistent at week 76 and week 204.
“When approaching treatment for a lifelong, chronic condition like psoriasis, it’s important to be informed about how available medicines work over time,” said Andrew Blauvelt, MD, MBA, President, Oregon Medical Research Center, and VOYAGE 1 study steering committee member. “These findings demonstrated maintenance of PASI 90 and IGA 0/1 response rates for 4 years in adults with moderate-to-severe plaque psoriasis.”
For more information visit janssen.com.
