For US Healthcare Professionals
For US Healthcare Professionals
For US Healthcare Professionals
TREMFYA® EFFICACY DATA IN PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
TREMFYA® EFFICACY ACROSS OTHER ENDPOINTS
Consistent Efficacy Between Doses
PASI 90 RESPONSE RATES WERE EVALUATED BETWEEN DOSES FROM WEEK 20 THROUGH WEEK 48
VOYAGE 1: PRESPECIFIED SECONDARY ANALYSIS—PASI 90 RESPONSE RATES THROUGH WEEK 481,2*
Data shown include patients randomized at Week 0 to the TREMFYA® arm.
The same patients may not have responded at each time point.
Placebo and active-comparator data are not shown in chart.
VOYAGE 2: PASI 90 at Weeks 16 and 24 (Major Secondary Endpoints, NRI)
- 64% (102/160) of patients receiving TREMFYA® achieved PASI 90 response at Week 163†‡
- 71% (113/160) of patients receiving TREMFYA® achieved PASI 90 response at Week 243†‡
DOSING AND ADMINISTRATION
- 100 mg administered by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter3
*NRI methods were used for analysis.
†Results from North American sites only, which used a US-licensed active comparator.
‡Active-comparator data not shown.
References: 1. Data on file. Janssen Biotech, Inc. 2. Blauvelt A, Papp KA, Griffiths CEM, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol. 2017;76(3):405-417. 3. TREMFYA® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
Early Results With TREMFYA®: 55% Mean PASI Improvement After Just 1 Injection1*
VOYAGE 1: PRESPECIFIED OTHER SECONDARY ANALYSIS—MEAN PASI IMPROVEMENT FROM BASELINE
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
In the controlled period, mean PASI improvement was a prespecified other secondary 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. Patients were considered to have no improvement (percent improvement=0) after meeting treatment failure criteria.
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 percentage improvement from baseline in psoriatic signs of redness, thickness, scale, and body surface area of involvement.
Reference: 1. Data on file. Janssen Biotech, Inc.
Retreatment With TREMFYA® After Withdrawal and Loss of ≥50% of PASI Response at Week 281
VOYAGE 2: PRESPECIFIED EXPLORATORY ENDPOINT—PROPORTION OF PATIENTS WITH ≥PASI 75 OR ≥PASI 90 AFTER 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.
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.
Consistent Efficacy Between Doses
PASI 90 response rates were evaluated between doses from Week 20 through Week 48
VOYAGE 1: PRESPECIFIED SECONDARY ANALYSIS—PASI 90 RESPONSE RATES WERE EVALUATED BETWEEN DOSES FROM WEEK 20 THROUGH WEEK 481,2*
Data shown include patients randomized at Week 0 to the TREMFYA® arm.
The same patients may not have responded at each time point.
Placebo and active-comparator data are not shown in chart.
VOYAGE 2: PASI 90 at Weeks 16 and 24 (Major Secondary Endpoints, NRI)
- 64% (102/160) of patients receiving TREMFYA® achieved PASI 90 response at Week 163†‡
- 71% (113/160) of patients receiving TREMFYA® achieved PASI 90 response at Week 243†‡
DOSING AND ADMINISTRATION
- 100 mg administered by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter3
*NRI methods were used for analysis.
†Results from North American sites only, which used a US-licensed active comparator.
‡Active-comparator data not shown
References: 1. Data on file. Janssen Biotech, Inc. 2. Blauvelt A, Papp KA, Griffiths CEM, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol. 2017;76(3):405-417. 3. TREMFYA® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
Early Results With TREMFYA®: 55% Mean PASI Improvement After Just 1 Injection1*
VOYAGE 1: PRESPECIFIED OTHER SECONDARY ANALYSIS—MEAN PASI IMPROVEMENT FROM BASELINE
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
In the controlled period, mean PASI improvement was a prespecified other secondary 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. Patients were considered to have no improvement (percent improvement=0) after meeting treatment failure criteria.
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 percentage improvement from baseline in psoriatic signs of redness, thickness, scale, and body surface area of involvement.
Reference: 1. Data on file. Janssen Biotech, Inc.
Retreatment With TREMFYA® After Withdrawal and Loss of ≥50% of PASI Response at Week 281
VOYAGE 2: PRESPECIFIED EXPLORATORY ENDPOINT—PROPORTION OF PATIENTS WITH ≥PASI 75 OR ≥PASI 90 AFTER 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.
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.
