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J Am Acad Dermatol. 2017 Mar;76(3):418-431. doi: 10.1016/j.jaad.2016.11.042. Epub 2017 Jan 2.

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.

Author information

1
Dermatologikum Hamburg and SCIderm Research Institute, Hamburg, Germany. Electronic address: kreich@dermatologikum.de.
2
University of Southern California, Los Angeles, California.
3
University of Melbourne, St Vincent's Hospital, Melbourne, Australia; Skin and Cancer Foundation Inc, Carlton, Australia.
4
Janssen Research & Development, LLC, Spring House, Pennsylvania.
5
Northwestern University, Feinberg School of Medicine, Chicago, Illinois.

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.

KEYWORDS:

VOYAGE 1; VOYAGE 2; adalimumab; efficacy; guselkumab; interleukin-23; psoriasis; safety; switching

PMID:
28057361
DOI:
10.1016/j.jaad.2016.11.042
[Indexed for MEDLINE]
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