For US Healthcare Professionals
For US Healthcare Professionals
YEAR 1 TO YEAR 3
IN AN OPEN-LABEL EXTENSION STUDY IN MODERATE TO SEVERE PLAQUE PSORIASIS
VOYAGE 1: PRESPECIFIED SECONDARY ANALYSIS—RESULTS THROUGH YEAR 5* (AS-OBSERVED, GLOBAL ANALYSIS)†‡§||
In a prespecified secondary analysis of efficacy after Week 48 applying treatment failure rules (TFR)1‡§II¶:
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.
||Based on the results of an analysis of the 101 global sites from VOYAGE 1 (including North American sites [ie, United States and Canada]).
¶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.
VOYAGE 1: POST-HOC ANALYSIS MEAN PASI IMPROVEMENT (AS-OBSERVED, GLOBAL ANALYSIS)1†‡§||
VOYAGE 1: PRESPECIFIED OTHER SECONDARY ANALYSIS–MEAN PASI IMPROVEMENT FROM BASELINE (TFR, GLOBAL ANALYSIS)1†‡§||¶
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.
||Based on the results of an analysis of the 101 global sites from VOYAGE 1 (including North American sites [ie, United States and Canada]).
¶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.
VOYAGE 1: PRESPECIFIED SECONDARY ANALYSIS—RESULTS THROUGH YEAR 5* (AS-OBSERVED, GLOBAL ANALYSIS)†‡§||
In a prespecified secondary analysis of efficacy after Week 48 applying treatment failure rules (TFR)1‡§II¶:
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.
||Based on the results of an analysis of the 101 global sites from VOYAGE 1 (including North American sites [ie, United States and Canada]).
¶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.
VOYAGE 1: POST-HOC ANALYSIS MEAN PASI IMPROVEMENT (AS-OBSERVED, GLOBAL ANALYSIS)1†‡§||
VOYAGE 1: PRESPECIFIED OTHER SECONDARY ANALYSIS–MEAN PASI IMPROVEMENT FROM BASELINE (TFR, GLOBAL ANALYSIS)1†‡§||¶
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.
||Based on the results of an analysis of the 101 global sites from VOYAGE 1 (including North American sites [ie, United States and Canada]).
¶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.