For US Healthcare Professionals
For US Healthcare Professionals
TREMFYA® EFFICACY DATA IN PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
OTHER EFFICACY ENDPOINTS
VOYAGE 2: PRESPECIFIED EXPLORATORY ENDPOINT—MAINTENANCE AND DURABILITY OF PASI 90 RESPONSE1-3
†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.
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.
VOYAGE 1: PRESPECIFIED OTHER SECONDARY ANALYSIS: MEAN PASI IMPROVEMENT FROM BASELINE (GLOBAL ANALYSIS)
IN VOYAGE 2
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.
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 sites [ie, United States and Canada]).
Reference: 1. Data on file. Janssen Biotech, Inc.
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.
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:
Reference: 1. Data on file. Janssen Biotech, Inc.
VOYAGE 2: PRESPECIFIED EXPLORATORY ENDPOINT—MAINTENANCE AND DURABILITY OF PASI 90 RESPONSE1-3
†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.
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.
VOYAGE 1: PRESPECIFIED OTHER SECONDARY ANALYSIS: MEAN PASI IMPROVEMENT FROM BASELINE (GLOBAL ANALYSIS)
IN VOYAGE 2
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.
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.
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.
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:
Reference: 1. Data on file. Janssen Biotech, Inc.