Moderate to Severe Plaque Psoriasis Efficacy Data | TREMFYA® (guselkumab) HCP

TREMFYA® EFFICACY DATA IN PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
OTHER EFFICACY ENDPOINTS

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*

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VOYAGE 2: PRESPECIFIED EXPLORATORY ENDPOINT—MAINTENANCE AND DURABILITY OF PASI 90 RESPONSE1-3

maintenace-durability

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response was 15 weeks (23 weeks after last TREMFYA® dose) for patients at Week 28 who were re-randomized to placebo and withdrawn from TREMFYA®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, United States and Canada]).

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

*Patients randomized to TREMFYA® at Week 0 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).

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

Early Results With TREMFYA®: 55% Mean PASI Improvement After Just 1 Injection1*

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VOYAGE 1: PRESPECIFIED EXPLORATORY ANALYSIS: MEAN PASI IMPROVEMENT FROM BASELINE (GLOBAL ANALYSIS)

IN VOYAGE 2

  • Mean PASI improvement from baseline at Week 4 was 54% (n=496) with TREMFYA® vs 16% (n=248) with placebo
  • Mean PASI improvement from baseline at Week 16 was 89% (n=496) with TREMFYA® vs 20% (n=248) with placebo

Mean PASI improvement was a prespecified exploratory analysis that was not adjusted for multiplicity; P values were considered nominal.

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

Treatment failure rules method: 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 topical therapies for psoriasis, were considered treatment failures.

After treatment failure rules were applied, last observation carried forward was applied for any missing data.

*Mean PASI improvement is an assessment of the average improvement from baseline to a set point in time in psoriatic signs of redness, thickness, scale, and body surface area of involvement.

Based on the results of an analysis of the 101 global sites from VOYAGE 1 and 115 global sites from VOYAGE 2 (including North American site [ie, United States and Canada]).

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

Retreatment With TREMFYA® After Withdrawal and Loss of 50% of PASI Response at Week 281

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VOYAGE 2: PRESPECIFIED EXPLORATORY ENDPOINT—PROPORTION OF PATIENTS WITH PASI 75 OR PASI 90 AFTER RETREATMENT

RETREATMENT

At Week 0 of VOYAGE 2, patients were randomized to TREMFYA® 100 mg at Weeks 0, 4, 12, and 20. At Week 28, PASI 90 responders were re-randomized to either continue TREMFYA® or to receive placebo. Upon loss of ≥50% of the improvement in PASI achieved at Week 28, patients in the placebo arm were re-treated with TREMFYA® and evaluated for PASI 75 and PASI 90 response. This analysis includes patients who lost ≥50% of the improvement in PASI achieved at Week 28 by Week 32, 36, 40, 44, 48, or 52.

Upon retreatment, patients were re-treated with 100 mg, then 100 mg 4 weeks later, and then 100 mg every 8 weeks.

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 topical therapies for psoriasis, were considered treatment failures.

Limitations:

  • The criterion for retreatment was patient specific (ie, based on the patient’s baseline value and amount of improvement) and therefore includes a range of PASI scores
  • The same patients may not have responded at each time point

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

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