title: 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.
abstract: BACKGROUND
  Guselkumab, an interleukin-23 blocker, was superior to adalimumab in treating moderate to severe psoriasis in a phase II trial.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Oregon Medical Research Center, Portland, Oregon. Electronic address: ablauvelt@oregonmedicalresearch.com.
authors.forename: Andrew
authors.initials: A
authors.lastname: Blauvelt
authors.affiliation: K. Papp Clinical Research and Probity Research Inc, Waterloo, Ontario, Canada.
authors.forename: Kim A
authors.initials: KA
authors.lastname: Papp
authors.affiliation: Dermatology Center, Salford Royal Hospital, University of Manchester, Manchester Academic Health Science Center, Manchester, United Kingdom.
authors.forename: Christopher E M
authors.initials: CE
authors.lastname: Griffiths
authors.affiliation: Janssen Research & Development LLC, Spring House, Pennsylvania; Department of Dermatology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.
authors.forename: Bruce
authors.initials: B
authors.lastname: Randazzo
authors.affiliation: Janssen Research & Development LLC, Spring House, Pennsylvania.
authors.forename: Yasmine
authors.initials: Y
authors.lastname: Wasfi
authors.affiliation: Janssen Research & Development LLC, Spring House, Pennsylvania.
authors.forename: Yaung-Kaung
authors.initials: YK
authors.lastname: Shen
authors.affiliation: Janssen Research & Development LLC, Spring House, Pennsylvania.
authors.forename: Shu
authors.initials: S
authors.lastname: Li
authors.affiliation: Department of Dermatology, Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Alexa B
authors.initials: AB
authors.lastname: Kimball
mesh_terms: D000068879:Adalimumab / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D003879:Dermatologic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D053759:Interleukin-23 / Q000037:antagonists & inhibitors; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011565:Psoriasis / Q000188:drug therapy*; D011788:Quality of Life; D012720:Severity of Illness Index
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D003879:Dermatologic Agents; D053759:Interleukin-23; D010919:Placebos; C000588857:guselkumab; D000068879:Adalimumab
keywords: VOYAGE 1; VOYAGE 2; adalimumab; efficacy; guselkumab; hand and foot psoriasis; nail psoriasis; psoriasis; safety; scalp psoriasis