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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 - 18/04/17

Doi : 10.1016/j.jaad.2016.11.041 
Andrew Blauvelt, MD, MBA a, , Kim A. Papp, MD, PhD b, Christopher E.M. Griffiths, MD c, Bruce Randazzo, MD, PhD d, e, Yasmine Wasfi, MD, PhD d, Yaung-Kaung Shen, PhD d, Shu Li, PhD d, Alexa B. Kimball, MPH, MD f
a Oregon Medical Research Center, Portland, Oregon 
b K. Papp Clinical Research and Probity Research Inc, Waterloo, Ontario, Canada 
c Dermatology Center, Salford Royal Hospital, University of Manchester, Manchester Academic Health Science Center, Manchester, United Kingdom 
d Janssen Research & Development LLC, Spring House, Pennsylvania 
e Department of Dermatology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 
f Department of Dermatology, Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, Massachusetts 

Reprint requests: Andrew Blauvelt, MD, MBA, Oregon Medical Research Center, 9495 SW Locust St, Suite G, Portland, OR 97223.Oregon Medical Research Center9495 SW Locust St, Suite GPortlandOR97223

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.

Le texte complet de cet article est disponible en PDF.

Key words : adalimumab, efficacy, guselkumab, hand and foot psoriasis, nail psoriasis, psoriasis, safety, scalp psoriasis, VOYAGE 1, VOYAGE 2

Abbreviations used : AE, DLQI, f-PGA, HRQoL, IGA, IL, ISR, NAPSI, PASI, PASI 75, PASI 90, PASI 100, PGA, PSSD, Th, TNF-α


Plan


 Supported by Janssen Research & Development LLC, Spring House, PA.
 Disclosure: Dr Blauvelt has served as a scientific adviser and clinical study investigator for AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, Genentech, GSK, Janssen, Eli Lilly, Merck, Novartis, Pfizer, Regeneron, Sandoz, Sanofi-Genzyme, Sun, UCB, and Valeant, and as a paid speaker for Eli Lilly. Dr Papp has received honoraria or clinical research grants as a consultant, speaker, scientific officer, advisory board member, and/or steering committee member for AbbVie, Akesis, Akros, Allergan, Alza, Amgen, Anacor, Artax, Astellas, AstraZeneca, Baxalta, Baxter, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, CanFite, Celgene, Celtic, Cipher, Dermira, Dow Pharmaceuticals, Eli Lilly, Ferring Pharmaceuticals, Formycon, Forward Pharma, Funxional Therapeutics, Fujisawa, Galderma, Genentech, Genexion, Genzyme, Gilead, GSK, Janssen, Kyowa Hakko Kirin, Leo, Lypanosys, Medimmune, Meiji Seika Pharma, Merck (MSD), Merck-Serono, Mitsubishi Pharma, Mylan, Novartis, NovImmune, Pan Genetics, Pfizer, Regeneron, Roche, Sanofi-Aventis, Stiefel, Takeda, UCB, Vertex, and Valeant. Dr Griffiths has received honoraria and/or grants as an investigator, speaker, and/or advisory board member for AbbVie, Eli Lilly, Janssen, Leo, Novartis, Pfizer, Sandoz, and Sun Pharma. Dr Kimball has received honoraria as a consultant for AbbVie, BMS, Dermira, Eli Lilly ICOS LLC, Merck, and Novartis; and received grants and/or funding for research or the residency/fellowship program as a principal investigator for AbbVie, Amgen, Boehringer Ingelheim, Dermira, Janssen, Merck, and Novartis. Drs Randazzo, Wasfi, Shen, and Li are all employees of Janssen Research & Development LLC (subsidiary of Johnson & Johnson) and own stock in Johnson & Johnson.
 Some of the data reported in this article were presented at the 25th European Academy of Dermatology and Venereology Congress (Vienna, Austria; September 28-October 2, 2016), the 35th Anniversary Fall Clinical Dermatology Conference (Las Vegas, NV; October 20-23, 2016), and Skin Disease Education Foundation 17th Annual Las Vegas Dermatology Seminar (Las Vegas, NV; November 10-12, 2016).


© 2016  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 76 - N° 3

P. 405-417 - mars 2017 Retour au numéro
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  • Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: Results from the phase III, double-blind, placebo- and active comparator–controlled VOYAGE 2 trial
  • Kristian Reich, April W. Armstrong, Peter Foley, Michael Song, Yasmine Wasfi, Bruce Randazzo, Shu Li, Y.-K. Shen, Kenneth B. Gordon

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