Open-Label Extension Data: Moderate to Severe Plaque PsO | TREMFYA® (guselkumab) HCP

YEAR 1 TO YEAR 3

IN AN OPEN-LABEL EXTENSION STUDY IN MODERATE TO SEVERE PLAQUE PSORIASIS

TREMFYA® DEMONSTRATED LASTING SKIN CLEARANCE AT 5 YEARS*

TREMFYA® DEMONSTRATED LASTING SKIN CLEARANCE AT 5 YEARS*

Durable Response Rates Over Time1

PASI 90 RESPONSE RATES WERE EVALUATED FROM WEEK 52 THROUGH WEEK 2521

VOYAGE 1: PRESPECIFIED SECONDARY ANALYSIS RESULTS THROUGH YEAR 5 (WEEK 252, AS-OBSERVED ANALYSIS)†‡§

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

  • Year 1: PASI 90, 80% (373/468); IGA 0, 54% (251/468)
  • Year 2#: PASI 90, 82% (368/448); IGA 0, 56% (249/448)
  • Year 3: PASI 90, 83% (358/432); IGA 0, 53% (229/430)
  • Year 4**: PASI 90, 82% (338/411); IGA 0, 57% (234/410)
  • Year 5*: PASI 90, 84% (329/391); IGA 0, 55% (214/391)

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.

*Year 5 represents Week 252.

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

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

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

||First selective interleukin-23 (IL-23) inhibitor phase 3 efficacy and safety data from a 5-year open-label extension presented at a scientific congress.

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 2 represents Week 100.

**Year 4 represents Week 204.

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

96% Mean PASI Improvement From Baseline at Year 51*

VOYAGE 1: POST-HOC ANALYSIS MEAN PASI IMPROVEMENT
(AS-OBSERVED,GLOBAL ANALYSIS)1§

MEAN PASI

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VOYAGE 1: PRESPECIFIED OTHER SECONDARY ANALYSIS–MEAN PASI IMPROVEMENT FROM BASELINE (TFR,GLOBAL ANALYSIS)1§

  • Mean PASI improvement from baseline with TREMFYA® was 93% at Week 52 (n=468), 94% at Week 100 (n=448), 94% at Week 156 (n=432), 93% at Week 204 (n=411), and 93% at Week 252 (n=391)

Patients who lose response or are unable to tolerate treatment are likely to discontinue treatment, which may increase the mean PASI percentage improvement in an as-observed analysis.

Mean PASI improvement is an assessment of the average percentage improvement from baseline in psoriatic signs of redness, thickness, scale, and body surface area of involvement.

*Year 5 represents Week 252.

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

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

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

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. Patients were considered to have no improvement (percentage improvement=0) after meeting treatment failure criteria.

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