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¶Patients discontinued due to lack of efficacy, psoriasis worsening, or protocol-prohibited psoriasis treatment considered non-responders.2

*Includes patients randomized to Tremfya® at baseline and those randomized to placebo at baseline who crossed over to receive Tremfya® starting at week 16.2

†Includes patients randomized to adalimumab at baseline who crossed over to receive Tremfya® at week 52.2

PASI 90, 90% or greater improvement in Psoriasis Area and Severity Index score from baseline; TFR, Treatment Failure Rules

STUDY DETAILS:1

Objective: To evaluate the long-term efficacy and safety of guselkumab for the treatment of moderate-to-severe psoriasis.

Design:

VOYAGE 1 is an on-going, phase 3, randomized, double-blinded, placebo- and active comparator- controlled trial. The study consisted of the blinded treatment period, which comprised the placebo-controlled period (weeks 0–16) and the active comparator-controlled period (weeks 0–48; guselkumab versus adalimumab), and the open-label extension period (starting at week 52 and on-going). At baseline, 837 patients were randomized (2:1:2) to receive either:

(1) guselkumab 100mg at weeks 0, 4, and 12 and then every-8-weeks;

(2) placebo at weeks 0, 4, and 12 with crossover to guselkumab 100mg at weeks 16/20 and then every-8-weeks; or

(3) adalimumab 80mg at week 0, 40mg at week 1 followed by every-2-week dosing through week 47, with crossover to guselkumab 100mg every- 8-weeks at week 52 (adalimumab to guselkumab). Starting at week 52, all eligible patients continued open-label guselkumab treatment every-8-weeks through week 204.

References

[1] Griffiths CEM, Papp KA, Song M, et al. Continuous treatment with guselkumab maintains clinical responses through 4 years in patients with moderate-to-severe psoriasis: results from VOYAGE 1. J Dermatolog Treat. 2020:1-9.

CP-280986