TREMFYA® Maintenance and Durability | TREMFYA® (guselkumab) | HCP

TREMFYA® EFFICACY DATA IN PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
THERAPEUTIC LONGEVITY: NEARLY 9 OUT  OF 10
PATIENTS WHO ACHIEVED PASI 90 AT WEEK 28 WITH
TREMFYA® MAINTAINED THIS RESPONSE AT WEEK 48
WITH A CONSISTENT RESPONSE RATE AT WEEK 721*

VOYAGE 2: PRESPECIFIED EXPLORATORY ENDPOINT—MAINTENANCE AND DURABILITY OF PASI 90 RESPONSE1-3

PASI 90

Maintenance and durability of PASI 90 response at Weeks 48 and 72 were prespecified exploratory endpoints that were not adjusted ‭for multiplicity; P  values were considered nominal.‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬

  • Major Secondary Endpoint: Median time to loss of PASI 90 response was 15 weeks (23 weeks after last TREMFYA® dose) for patients at Week 28 who were re-randomized to placebo and withdrawn from TREMFYA®

Based on the results of an analysis of the 115 global sites from VOYAGE 2 (including North American sites [ie, United States and Canada]).

The same patients may not have responded at each time point.

*Patients randomized to TREMFYA® at Week 0 and who were PASI 90 responders at Week 28 were re-randomized to either continue treatment with TREMFYA® q8w (maintenance group) or receive placebo (withdrawal group).

References: 1. TREMFYA® (guselkumab) [prescribing information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc. 3. Reich K, Armstrong AW, Foley P, et al. 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. J Am Acad Dermatol.  2017;76(3):418-431.