Open Label Extension Data | TREMFYA® (guselkumab) | HCP

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

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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 includes 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 were used for analysis. 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.