Moderate to Severe Plaque Psoriasis Open-Label-Extension-Data | TREMFYA® (guselkumab) HCP
  1. Efficacy in PsO
  2. 4-year Week 204 Open-label Extension

YEAR 1 TO YEAR 3

TREMFYA® EFFICACY DATA IN PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
CONSISTENT RESPONSE RATES AT YEAR 1 AND YEAR 4* IN AN OPEN-LABEL EXTENSION1

View Study Design

VOYAGE 1: PRESPECIFIED SECONDARY ANALYSIS⁠—RESULTS THROUGH YEAR 4* (AS-OBSERVED, GLOBAL ANALYSIS)†

In a prespecified secondary analysis of efficacy after Week 48 applying treatment failure rules (TFR)1:

  • Year 1: PASI 75, 94% (439/468); IGA 0/1, 85% (396/468); PASI 90, 80% (373/468); IGA 0, 54% (251/468); PASI 100, 49% (230/468)
  • Week 100: PASI 75, 96% (429/448); IGA 0/1, 83% (373/448); PASI 90, 82% (368/448); IGA 0, 56% (249/448); PASI 100, 51% (229/448)
  • Year 3: PASI 75, 96% (414/432); IGA 0/1, 82% (353/430); PASI 90, 83% (358/432); IGA 0, 53% (229/430); PASI 100, 51% (220/432)
  • Year 4*: PASI 75, 93% (384/411); IGA 0/1, 82% (335/410); PASI 90, 82% (338/411); IGA 0, 57% (234/410); PASI 100, 56% (229/411)

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 or TFR analysis.

Data shown include patients randomized at Week 0 to TREMFYA® arm and placebo arm patients who crossed over to receive TREMFYA® at Weeks 16, 20, and q8w thereafter.

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

TFR methods: Patients who discontinued study agent due to lack of efficacy or an adverse event 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.

*Year 4 represents Week 204.

†Available data at each visit were used; missing data were not included in the analysis.

Based on the results of an analysis of the 101 global sites from VOYAGE 1 (including North American sites [ie, United States and Canada]).

Reference: 1. Data on file. Janssen Biotech, Inc.