LAUSR

BACKGROUND Long-term maintenance treatment is required for patients with psoriasis. OBJECTIVES To evaluate the efficacy and safety of guselkumab in patients with moderate-to-severe psoriasis through three years of treatment. METHODS In two on-going, phase 3 trials of guselkumab (VOYAGE 1 and VOYAGE 2), the proportions of patients achieving ≥90% and 100% improvement in the Psoriasis Area and Severity Index (PASI 90, PASI 100) as well as Investigator's Global Assessment (IGA) scores of 0/1 and 0 were summarized for the guselkumab group (including placebo-to-guselkumab crossover). Patients who met treatment failure rules were considered nonresponders. Safety outcomes (rates/100PY) were evaluated based on data pooled across studies through week 156. RESULTS Three-year response rates for the guselkumab group in VOYAGE 1 and VOYAGE 2, respectively, were 82.8% and 77.2% for PASI 90, 50.8% and 48.8% for PASI 100, 82.1% and 83.0% for IGA 0/1, and 53.1% and 52.9% for IGA 0. Safety event rates across studies occurred through week 156 as follows: SAEs (5.68/100PY), serious infections (1.15/100PY), NMSCs (0.28/100PY), malignancies other than NMSC (0.47/100PY), and MACE (0.28/100PY); week-156 and week-100 rates were consistent. LIMITATIONS There was no comparator arm beyond one year. CONCLUSIONS Guselkumab shows durable efficacy and a consistent safety profile in patients with moderate-to-severe psoriasis treated for up to three years.