- 3-year Open-label Extension Data
YEAR 1 TO YEAR 3
TREMFYA® EFFICACY DATA IN PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
CONSISTENT RESPONSE RATES AT YEAR 1 AND YEAR 3 IN AN OPEN-LABEL EXTENSION1
VOYAGE 1 POST HOC ANALYSIS: RESULTS THROUGH YEAR 3 (AS-OBSERVED, GLOBAL ANALYSIS)*
*Available data at each visit were used; missing data were not included in the analysis.
The same patients may not have responded at each time point.
During clinical trials, patients who lose response or are unable to tolerate treatment are likely to discontinue treatment, which may increase the response rate in an as-observed analysis.
In a prespecified analysis of efficacy after Week 52 applying treatment failure rules (TFR):
- Year 1: PASI 75, 94% (439/468); PASI 90, 80% (373/468); IGA 0/1, 85% (396/468); IGA 0, 54% (251/468)
- Week 100: PASI 75, 96% (429/448); PASI 90, 82% (368/448); IGA 0/1, 83% (373/448); IGA 0, 56% (249/448)
- Year 3: PASI 75, 96% (413/431); PASI 90, 83% (357/431); IGA 0/1, 82% (352/429); IGA 0, 53% (228/429)
Treatment failure analysis=After Week 48, subjects who discontinued study agent due to lack of efficacy or an AE of worsening of psoriasis, or who started a protocol-prohibited medication including conventional and biologic systemic therapy, phototherapy, and/or ultra-high–potency corticosteroids were considered treatment failures. Other topical agents for psoriasis were permitted.
Post hoc, as-observed, and TFR analyses: Open-label extension (from Week 52 through Week 156) data from patients randomized at Week 0 to receive TREMFYA® and patients randomized at Week 0 to receive placebo who crossed over to receive TREMFYA® at Weeks 16, 20, and q8w thereafter.
Based on the results of an analysis of the 101 global sites from VOYAGE 1 (including North American sites [ie, US and Canada]).
Reference: 1. Data on file. Janssen Biotech, Inc.