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

• Published in: Journal of the American Academy of Dermatology Vol. 76; no. 3; pp. 405 - 417
• Main Authors: Blauvelt, Andrew, Papp, Kim A., Griffiths, Christopher E.M., Randazzo, Bruce, Wasfi, Yasmine, Shen, Yaung-Kaung, Li, Shu, Kimball, Alexa B.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.03.2017
• Subjects: adalimumab; Adalimumab - adverse effects; Adalimumab - therapeutic use; Adult; Antibodies, Monoclonal - adverse effects; Antibodies, Monoclonal - therapeutic use; Dermatologic Agents - adverse effects; Dermatologic Agents - therapeutic use; Dermatology; Double-Blind Method; efficacy; Female; guselkumab; hand and foot psoriasis; Humans; Interleukin-23 - antagonists & inhibitors; Male; Middle Aged; nail psoriasis; Placebos; psoriasis; Psoriasis - drug therapy; Quality of Life; safety; scalp psoriasis; Severity of Illness Index; VOYAGE 1; VOYAGE 2; DLQI; PASI 90; scalp psoriasis; PASI 75; guselkumab; adalimumab; hand and foot psoriasis; PASI 100; Th; safety; HRQoL; IGA; PASI; IL; AE; ISR; PGA; efficacy; f-PGA; PSSD; nail psoriasis; VOYAGE 2; TNF-α; VOYAGE 1; psoriasis; NAPSI; Psoriasis Symptoms and Signs Diary; injection site reaction; 90% or greater improvement in Psoriasis Area and Severity Index score from baseline; Psoriasis Area and Severity Index; 100% improvement in Psoriasis Area and Severity Index score from baseline; Investigator Global Assessment; tumor necrosis factor-alpha; interleukin; T helper; adverse event; health-related quality of life; 75% or greater improvement in Psoriasis Area and Severity Index score from baseline; Physician Global Assessment; Dermatology Life Quality Index; Fingernail Physician Global Assessment; Nail Psoriasis Severity Index
• ISSN: 0190-9622; 1097-6787; 1097-6787
• DOI: 10.1016/j.jaad.2016.11.041

Guselkumab, an interleukin-23 blocker, was superior to adalimumab in treating moderate to severe psoriasis in a phase II trial. We sought to compare efficacy and safety of guselkumab with adalimumab and placebo in patients with psoriasis treated for 1 year. 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. 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. Analyses were limited to 48 weeks. Guselkumab demonstrated superior efficacy compared with adalimumab and was well tolerated in patients with psoriasis through 1 year.