For US Healthcare Professionals
For US Healthcare Professionals
For US Healthcare Professionals
TREMFYA® EFFICACY DATA IN PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
TREMFYA® CAN PROVIDE YOUR PATIENTS THE POTENTIAL FOR SKIN CLEARANCE
EMERGE TREMFYANT® With Complete Skin Clearance in a Majority of Patients
IGA 0 DATA FROM VOYAGE 1: PIVOTAL STUDY
IN VOYAGE 1 AT WEEK 48 (MAJOR SECONDARY ENDPOINT)
• 47% (54/115) of patients receiving TREMFYA® achieved IGA 0 compared with 24% (28/115) of patients receiving an active comparator (P<0.001)1,2*†
IN VOYAGE 2 AT WEEK 24 (MAJOR SECONDARY ENDPOINT)
• 48% (76/160) of patients receiving TREMFYA® achieved IGA 0 compared with 28% (23/81) of patients receiving an active comparator (P=0.005)1,2*†
*Nonresponder imputation (NRI) methods were used for analysis.
†Results from North American sites only, which used a US-licensed active comparator.
IGA=Investigator’s Global Assessment, IGA score of cleared (0) using a 5-point scale of overall disease severity.
References: 1. TREMFYA® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc. 3. 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.
PASI 100* Response Rates at Week 241
VOYAGE 1: PRESPECIFIED EXPLORATORY ENDPOINT AT WEEK 24
PASI 100 was a prespecified exploratory endpoint that was not adjusted for multiplicity; P values were considered nominal.
The same patients may not have responded at each time point.
Results from North American sites only, which used a US-licensed active comparator.
*PASI 100=Proportion of patients who achieved 100% reduction (or improvement) in PASI score from baseline.
Reference: 1. Data on file. Janssen Biotech, Inc.
TREMFYA®—Consistent IGA 0/1 Response Rates That Were Superior to Humira® at Weeks 16, 24, and 481,2
VOYAGE 1: MAJOR SECONDARY ENDPOINTS AT WEEKS 16, 24, AND 48 (NORTH AMERICAN ANALYSIS)*
*Nonresponder imputation (NRI) methods were used for analysis.
†P<0.001 vs Humira®.
The same patients may not have responded at each time point.
VOYAGE 2: MAJOR SECONDARY ENDPOINTS AT WEEKS 16 AND 24 (NORTH AMERICAN ANALYSIS)*
*Nonresponder imputation (NRI) methods were used for analysis.
‡P<0.027 vs Humira®.
§P=0.005 vs Humira®.
Results from North American sites only, which used US-licensed Humira®.
Humira is a registered trademark of AbbVie Inc.
References: 1. TREMFYA® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc.
TREMFYA®—Consistent PASI 90 Response Rates That Were Superior to Humira® at Weeks 16, 24, and 481,2
VOYAGE 1: MAJOR SECONDARY ENDPOINTS AT WEEKS 16, 24, AND 48 (NORTH AMERICAN ANALYSIS)
*P<0.001 vs Humira®.
The same patients may not have responded at each time point.
VOYAGE 2: MAJOR SECONDARY ENDPOINTS AT WEEKS 16 AND 24 (NORTH AMERICAN ANALYSIS)
†P<0.001 vs Humira®.
‡P=0.003 vs Humira®.
Results from North American sites only, which used US-licensed Humira®.
Humira is a registered trademark of AbbVie Inc.
References: 1. TREMFYA® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc.
Superior Skin Clearance vs Humira®: PASI 75* at Week 161,2
VOYAGE 1: MAJOR SECONDARY ENDPOINT AT WEEK 16 (NORTH AMERICAN ANALYSIS)
The same patients may not have responded at each time point.
*PASI 75=Proportion of patients who achieved 75% or more reduction (or improvement) in PASI score from baseline.
†P<0.001 vs Humira®.
‡PASI 75 at Weeks 24 and 48 were prespecified exploratory endpoints that were not adjusted for multiplicity; P values were considered nominal.
VOYAGE 2: MAJOR SECONDARY ENDPOINT AT WEEK 16 (NORTH AMERICAN ANALYSIS)
§P<0.001 vs Humira®.
Results from North American sites only, which used US-licensed Humira®.
Humira is a registered trademark of AbbVie Inc.
References: 1. TREMFYA® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc.
EMERGE TREMFYANT® With Complete Skin Clearance in a Majority of Patients
IGA 0 DATA FROM VOYAGE 1: PIVOTAL STUDY
patients (53%, 61/115) achieved IGA 0
after 4 injections (Week 24)1-3
compared with active comparator
(23%, 27/115) P<0.001*†
IN VOYAGE 1 AT WEEK 48 (MAJOR SECONDARY ENDPOINT)
• 47% (54/115) of patients receiving TREMFYA® achieved IGA 0 compared with 24% (28/115) of patients receiving an active comparator (P<0.001)1,2*†
IN VOYAGE 2 AT WEEK 24 (MAJOR SECONDARY ENDPOINT)
• 48% (76/160) of patients receiving TREMFYA®achieved IGA 0 compared with 28% (23/81) of patients receiving an active comparator (P=0.005)1,2*†
*Nonresponder imputation (NRI) methods were used for analysis.
†Results from North American sites only, which used US-licensed Humira®.
IGA=Investigator’s Global Assessment, IGA score of cleared (0) using a 5-point scale of overall disease severity.
References: 1. TREMFYA® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc. 3. 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.
PASI 100* Response Rates at Week 241
VOYAGE 1: PRESPECIFIED EXPLORATORY ENDPOINT AT WEEK 24
patients (50%, 58/115) were completely
achieved PASI 100 at Week 241
compared with active comparator (24%, 27/115)
PASI 100 was a prespecified exploratory endpoint that was not adjusted for multiplicity; P values were considered nominal.
The same patients may not have responded at each time point.
Results from North American sites only, which used a US-licensed active comparator.
*PASI 100=Proportion of patients who achieved 100% reduction (or improvement) in PASI score from baseline.
Reference: 1. Data on file. Janssen Biotech, Inc.
TREMFYA®—Consistent IGA 0/1 Response Rates That Were Superior to Humira® at Weeks 16, 24, and 481,2
VOYAGE 1: MAJOR SECONDARY ENDPOINTS AT WEEKS 16, 24, AND 48 (NORTH AMERICAN ANALYSIS)*
The same patients may not have responded at each time point.
*Nonresponder imputation (NRI) methods were used for analysis.
†P<0.001 vs Humira®.
VOYAGE 2: MAJOR SECONDARY ENDPOINTS AT WEEKS 16 AND 24 (NORTH AMERICAN ANALYSIS)*
*Nonresponder imputation (NRI) methods were used for analysis.
‡P<0.027 vs Humira®.
§P=0.005 vs Humira®.
Results from North American sites only, which used US-licensed Humira®.
Humira is a registered trademark of AbbVie Inc.
References: 1. TREMFYA® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc.
TREMFYA®—Consistent PASI 90 Response Rates That Were Superior to Humira® at Weeks 16, 24, and 481,2
VOYAGE 1: MAJOR SECONDARY ENDPOINTS AT WEEKS 16, 24, AND 48 (NORTH AMERICAN ANALYSIS)
The same patients may not have responded at each time point.
VOYAGE 2: MAJOR SECONDARY ENDPOINTS AT WEEKS 16 AND 24 (NORTH AMERICAN ANALYSIS)
†P<0.001 vs Humira®.
‡P=0.003 vs Humira®.
Results from North American sites only, which used US-licensed Humira®.
Humira is a registered trademark of AbbVie Inc.
References: 1. TREMFYA® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc.
Superior Skin Clearance vs Humira®: PASI 75* at Week 161,2
VOYAGE 1: MAJOR SECONDARY ENDPOINT AT WEEK 16 (NORTH AMERICAN ANALYSIS)
The same patients may not have responded at each time point.
*PASI 75=Proportion of patients who achieved 75% or more reduction (or improvement) in PASI score from baseline.
‡PASI 75 at Weeks 24 and 48 were prespecified exploratory endpoints that were not adjusted for multiplicity; P values were considered nominal.
VOYAGE 2: MAJOR SECONDARY ENDPOINT AT WEEK 16 (NORTH AMERICAN ANALYSIS)
§P<0.001 vs Humira®.
Results from North American sites only, which used US-licensed Humira®.
Humira is a registered trademark of AbbVie Inc.
References: 1. TREMFYA® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc.
