TY - JOUR T1 - 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. AU - Blauvelt,Andrew, AU - Papp,Kim A, AU - Griffiths,Christopher E M, AU - Randazzo,Bruce, AU - Wasfi,Yasmine, AU - Shen,Yaung-Kaung, AU - Li,Shu, AU - Kimball,Alexa B, Y1 - 2017/01/02/ PY - 2016/09/28/received PY - 2016/11/17/revised PY - 2016/11/19/accepted PY - 2017/1/7/pubmed PY - 2017/4/28/medline PY - 2017/1/7/entrez KW - VOYAGE 1 KW - VOYAGE 2 KW - adalimumab KW - efficacy KW - guselkumab KW - hand and foot psoriasis KW - nail psoriasis KW - psoriasis KW - safety KW - scalp psoriasis SP - 405 EP - 417 JF - Journal of the American Academy of Dermatology JO - J Am Acad Dermatol VL - 76 IS - 3 N2 - 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. SN - 1097-6787 UR - https://www.unboundmedicine.com/medline/citation/28057360/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_ DB - PRIME DP - Unbound Medicine ER -