Guselkumab Beats Adalimumab for Moderate to Severe Psoriasis

By Will Boggs MD

January 17, 2017

NEW YORK (Reuters Health) - Guselkumab is effective for treating patients with moderate to severe psoriasis, according to results from Janssen's VOYAGE 1 and VOYAGE 2 trials.

"Guselkumab easily beat adalimumab by all measures and at all time points," Dr. Andrew Blauvelt from Oregon Medical Research Center in Portland told Reuters Health by email. "These data follow a trend of recent results in psoriasis where newer biologics that block IL-17A and IL-23 have demonstrated superior efficacy to older biologics that block TNF."

Both studies were published online January 2 in the Journal of the American Academy of Dermatology.

Guselkumab, an interleukin-23 blocker, had already been shown in a phase 2 trial to offer superior efficacy to adalimumab in treating moderate to severe psoriasis.

Dr. Blauvelt and colleagues in the VOYAGE 1 trial compared guselkumab (two 100-mg injections at weeks 0 and 4 and maintenance therapy every eight weeks) with adalimumab, a widely-used TNF-alpha inhibitor, and placebo in a phase 3 trial of 837 patients with moderate to severe psoriasis treated continuously for one year.

Guselkumab was superior to placebo and/or adalimumab for the coprimary endpoints - the proportions of patients achieving an Investigator Global Assessment (IGA) score of cleared/minimal disease (IGA 0/1) and 90% or greater improvement in Psoriasis Area and Severity Index (PASI 90) at week 16 - and all major secondary endpoints.

For instance, IGA was 85.1%, 65.9% and 6.9% (p<0.001) at week 16 for guselkumab, adalimumab and placebo, respectively, while PASI 90 was 73.3%, 49.7% and 2.9% (p<0.001). These superior responses were maintained at week 24 and at week 48.

Health-related quality of life measures also improved to a significantly greater extent among patients treated with guselkumab versus placebo or adalimumab.

The proportion of patients with at least one adverse event was comparable across treatment groups.

"Pending its approval (Janssen announced submission of guselkumab applications the U.S. and in Europe in November 2016), I would expect guselkumab to be an important new addition for dermatologists for those patients with moderate to severe plaque psoriasis who are candidates for biologic therapy," Dr. Blauvelt said.

In the VOYAGE 2 trial Dr. Kristian Reich from Dermatologikum Hamburg, in Hamburg, Germany, and colleagues evaluated the efficacy and safety of interrupted treatment with guselkumab (versus adalimumab and placebo) and assessed the transition from adalimumab to guselkumab in a phase 3 study of 992 patients with moderate to severe psoriasis.

As in VOYAGE 1, guselkumab was superior to both placebo and adalimumab with respect to the coprimary endpoints and all major secondary endpoints.

Beneficial effects were better maintained among patients who continued guselkumab after week 28 than among responders rerandomized to placebo, with differences emerging as early as week 32.

Moreover, outcomes improved among adalimumab nonresponders who were switched to guselkumab at week 28.

"Specific blockade of IL-23 comes with some of the highest clinical responses in psoriasis, a convenient injection scheme, and without specific safety signals," Dr. Reich told Reuters Health by email.

"Phase III VOYAGE 2 confirmed VOYAGE 1 results and demonstrated benefits of maintenance versus withdrawal therapy, and effective treatment with guselkumab among adalimumab nonresponders," the researchers conclude. "Data addressing treatment interruption and switching patients from adalimumab to this new, more effective agent are useful for guiding treatment decisions."

Janssen Research & Development, LLC funded the research, employed several authors of both reports and had various relationships with the rest.

SOURCE: http://bit.ly/2jPCKmS and http://bit.ly/2iZIOco

J Am Acad Dermatol 2017.

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