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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 - 18/04/17

Doi : 10.1016/j.jaad.2016.11.042 
Kristian Reich, MD a, , April W. Armstrong, MD, MPH b, Peter Foley, MD c, d, Michael Song, MD e, Yasmine Wasfi, MD, PhD e, Bruce Randazzo, MD, PhD e, Shu Li, PhD e, Y.-K. Shen, PhD e, Kenneth B. Gordon, MD f
a Dermatologikum Hamburg and SCIderm Research Institute, Hamburg, Germany 
b University of Southern California, Los Angeles, California 
c University of Melbourne, St Vincent's Hospital, Melbourne, Australia 
d Skin and Cancer Foundation Inc, Carlton, Australia 
e Janssen Research & Development, LLC, Spring House, Pennsylvania 
f Northwestern University, Feinberg School of Medicine, Chicago, Illinois 

Reprint requests: Kristian Reich, MD, Dermatologikum Hamburg, Stephansplatz 5, Hamburg 20354, Germany.Dermatologikum HamburgStephansplatz 5Hamburg20354Germany

Abstract

Background

Phase II data suggested that guselkumab, an anti-interleukin-23 monoclonal antibody, was efficacious in psoriasis.

Objective

We sought to assess efficacy and safety of guselkumab in moderate to severe psoriasis versus placebo and adalimumab, including interrupted treatment and switching adalimumab nonresponders to guselkumab.

Methods

Patients were randomized to guselkumab 100 mg (weeks 0 and 4, then every 8 weeks; n = 496); placebo→guselkumab (weeks 0, 4, and 12 then guselkumab at weeks 16 and 20; n = 248); or adalimumab (80 mg week 0, then 40 mg week 1, and every 2 weeks through week 23; n = 248). At week 28, guselkumab 90% or greater improvement in Psoriasis Area and Severity Index (PASI) score from baseline (PASI 90) responders were rerandomized to guselkumab or placebo with guselkumab after loss of response. Placebo→guselkumab responders and adalimumab responders received placebo, then guselkumab after loss of response. Nonresponders received guselkumab.

Results

At week 16, more patients receiving guselkumab achieved an Investigator Global Assessment (IGA) score 0/1 (cleared/minimal) (84.1% vs 8.5%) and PASI 90 (70.0% vs 2.4%) versus placebo (coprimary end points). Guselkumab was superior to adalimumab at week 16 (IGA score 0/1, 75% or greater improvement in PASI score from baseline, and PASI 90) and week 24 (IGA score 0/1 and 0, PASI 90, 100% improvement in PASI score from baseline) (P < .001). From weeks 28 to 48, better persistence of response was observed in guselkumab maintenance versus withdrawal groups (P < .001). Of adalimumab nonresponders who switched to guselkumab, 66.1% achieved PASI 90 at week 48. Guselkumab improved patient-reported outcomes. Adverse events were comparable among groups.

Limitations

One-year follow-up limits retreatment data.

Conclusions

Guselkumab is a highly effective, well-tolerated, maintenance therapy, including in adalimumab nonresponders.

Le texte complet de cet article est disponible en PDF.

Key words : adalimumab, efficacy, guselkumab, interleukin-23, psoriasis, safety, switching, VOYAGE 1, VOYAGE 2

Abbreviations used : AE, DLQI, IGA, IL, ISR, MACE, NMSC, PASI, PASI 75, PASI 90, PASI 100, PSSD, q8w, SAE


Plan


 Supported by Janssen Research & Development, LLC.
 Disclosure: Dr Reich has served as advisor and/or paid speaker for and/or participated in clinical trials sponsored by AbbVie, Amgen, Biogen, Boehringer Ingelheim Pharma, Celgene, Covagen, Eli Lilly, Forward Pharma, GlaxoSmithKline, Janssen, Leo, Medac, Merck Sharp & Dohme, Novartis, Ocean Pharma, Pfizer, Regeneron, Takeda, UCB Pharma, and Xenoport. Dr Armstrong has served as investigator and/or advisor/consultant for AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Merck, Novartis, and Pfizer. Dr Foley has served as a consultant, investigator, speaker, and/or advisor for and/or received travel grants from 3M/iNova/Valeant, Abbott/AbbVie, Amgen, Biogen Idec, BMS, Boehringer Ingelheim, Celtaxsys, Celgene, Cutanea, Eli Lilly, Galderma, GSK/Stiefel, Janssen, LEO/Peplin, Novartis, Regeneron, Schering-Plough/MSD, UCB, and Wyeth/Pfizer. Dr Gordon has received research support from AbbVie, Amgen, Boeringher Ingelheim, Eli Lilly, and Janssen, and consultant/honoraria from AbbVie, Amgen, Boeringher Ingelheim, Celgene, Eli Lilly, Janssen, Novartis, and Pfizer. Drs Song, Wasfi, Randazzo, Li, and Shen are all employees of Janssen Research & Development, LLC (subsidiary of Johnson & Johnson) and own stock in Johnson & Johnson.
 Some of these results were submitted in an abstract at the American Academy of Dermatology Annual Meeting, Orlando, FL, March 3-7, 2017.


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

P. 418-431 - mars 2017 Retour au numéro
Article précédent Article précédent
  • 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
  • Andrew Blauvelt, Kim A. Papp, Christopher E.M. Griffiths, Bruce Randazzo, Yasmine Wasfi, Yaung-Kaung Shen, Shu Li, Alexa B. Kimball
| Article suivant Article suivant
  • Short- and long-term safety outcomes with ixekizumab from 7 clinical trials in psoriasis: Etanercept comparisons and integrated data
  • Bruce Strober, Craig Leonardi, Kim A. Papp, Ulrich Mrowietz, Mamitaro Ohtsuki, Robert Bissonnette, Laura K. Ferris, Carle Paul, Mark Lebwohl, Daniel K. Braun, Lotus Mallbris, Stefan Wilhelm, Wen Xu, Anders Ljungberg, Nayan Acharya, Kristian Reich

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