- Maintenance and Durability
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
†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response was 15 weeks (23 weeks after last TREMFYA® dose) for patients at Week 28 who were re-randomized to placebo and withdrawn from TREMFYA®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, US 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.