Andrew Blauvelt1, Kim A Papp2, Christopher E M Griffiths3, Bruce Randazzo4, Yasmine Wasfi5, Yaung-Kaung Shen5, Shu Li5, Alexa B Kimball6. 1. Oregon Medical Research Center, Portland, Oregon. Electronic address: ablauvelt@oregonmedicalresearch.com. 2. K. Papp Clinical Research and Probity Research Inc, Waterloo, Ontario, Canada. 3. Dermatology Center, Salford Royal Hospital, University of Manchester, Manchester Academic Health Science Center, Manchester, United Kingdom. 4. Janssen Research & Development LLC, Spring House, Pennsylvania; Department of Dermatology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania. 5. Janssen Research & Development LLC, Spring House, Pennsylvania. 6. Department of Dermatology, Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Abstract
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.
RCT Entities:
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.
Authors: Peter Foley; Kenneth Gordon; Christopher E M Griffiths; Yasmine Wasfi; Bruce Randazzo; Michael Song; Shu Li; Yaung-Kaung Shen; Andrew Blauvelt Journal: JAMA Dermatol Date: 2018-06-01 Impact factor: 10.282