Efficacy and safety of guselkumab, an anti interleukin 23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double blinded, placebo and active comparator controlled VOYAGE 1 trial
Background: Guselkumab, an interleukin 23 blocker, was superior to adalimumab in treating moderate to severe psoriasis in a phase II trial. Objectives: We sought to compare efficacy and safety of guselkumab with adalimumab and placebo in patients with psoriasis treated for 1 year. Methods: Patients were randomized to guselkumab 100 mg (weeks 0 and 4, then every 8 weeks; n 329) placebo guselkumab (weeks 0, 4, and 12 then guselkumab at weeks 16 and 20, then every 8 weeks; n 174) or adalimumab (80 mg week 0, 40 mg week 1, then 40 mg every 2 weeks through week 47; n 334) Physician reported outcomes (Investigator Global Assessment, Psoriasis Area and Severity Index [PASI] patient reported outcomes (Dermatology Life Quality Index, Psoriasis Symptoms and Signs Diary) and safety were evaluated through week 48. Results: Guselkumab was superior (P .001) to placebo at week 16 (85.1% vs 6.9% [Investigator Global Assessment score of 0/1 (cleared/minimal) and 73.3% vs 2.9% [90% or greater improvement in PASI score from baseline (PASI 90) Guselkumab was also superior (P .001) to adalimumab for Investigator Global Assessment 0/1 and PASI 90 at week 16 (85.1% vs 65.9% and 73.3% vs 49.7% week 24 (84.2% vs 61.7% and 80.2% vs 53.0% and week 48 (80.5% vs 55.4% and 76.3% vs 47.9% Furthermore, guselkumab significantly improved patient reported outcomes through week 48. Adverse event rates were comparable between treatments. Limitations: Analyses were limited to 48 weeks. Conclusions: Guselkumab demonstrated superior efficacy compared with adalimumab and was well tolerated in patients with psoriasis through 1 year.
Journal of the American Academy of Dermatology