For US Healthcare Professionals
For US Healthcare Professionals
For US Healthcare Professionals
TREMFYA® TREATMENT CONSIDERATIONS IN PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
DIFFICULT-TO-TREAT PATIENT TYPES
VOYAGE 1*
ss-IGA 0/1 and ≥2-Grade Improvement From Baseline1,2*
*In a subpopulation of patients with ss-IGA score ≥2 at baseline.
‡Prespecified other secondary analysis that was not adjusted for multiplicity; therefore, statistical significance has not been established.
Active comparator at Week 48 not shown.
VOYAGE 2: MAJOR SECONDARY ENDPOINT AT WEEK 161,3
• 81% (329/408) of patients receiving TREMFYA® achieved ss-IGA 0/1 vs 11% (22/202) of patients receiving placebo (P<0.001)
NRI methods were used for analysis.
ss-IGA=scalp-specific Investigator's Global Assessment;ss-IGA 0/1=Proportion of patients who achieved an ss-IGA score of absence of disease (0) or very mild (1) using a 5-point scale where scalp lesions were assessed in terms of clinical signs of redness, thickness, and scaliness on a scale of 0 to 4: absence of disease (0), very mild (1), mild (2), moderate (3), or severe (4).
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. Reich K, Armstrong AW, Foley P, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: results from the phase III, double-blind, placebo- and active comparator–controlled VOYAGE 2 trial. J Am Acad Dermatol. 2017;76(3):418-431.
Mean Percentage Improvement From Baseline NAPSI (Target Nail)1*†‡
*In a subpopulation of patients with NAPSI (target nail) score >0 at baseline.
†Fingernail psoriasis was assessed using NAPSI, in which the nail most affected by psoriasis (target nail) is divided into quadrants and graded for psoriasis of the nail matrix (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis) on a scale of 0 to 4 for a total score ranging from 0 to 8; a higher score indicates more severe disease.
‡Limitation: All 10 fingernails may also be evaluated using NAPSI.
§Prespecified other secondary analysis that was not adjusted for multiplicity; therefore, statistical significance has not been established.
Active comparator at Week 48 not shown.
NRI methods were used for analysis.
NAPSI=Nail Psoriasis Severity Index.
Reference: 1. 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.
hf-PGA 0/1 and ≥2-Grade Improvement From Baseline1*
*In a subpopulation of patients with hf-PGA score ≥2 at baseline.
†Prespecified other secondary analysis that was not adjusted for multiplicity; therefore, statistical significance has not been established.
Active comparator at Week 48 not shown.
NRI methods were used for analysis.
hf-PGA=Physician's Global Assessment of hands and/or feet; hf-PGA 0/1=Patients who achieved hf-PGA score of clear (0) or almost clear (1) using a 5-point scale based on the category that best describes the severity of psoriasis on the palms and soles on a scale of 0 to 4: clear, postinflammatory hyperpigmentation may be present (0), almost clear (1), mild (2), moderate (3), or severe (4).
Reference: 1. 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 90 Response With TREMFYA® by Baseline BMI1
BMI=body mass index (calculated as weight in kilograms divided by height in meters squared).
*This is a post hoc analysis; statistical significance has not been established and efficacy comparisons cannot be made.
Active comparator at Week 48 not shown.
VOYAGE 1: MAJOR SECONDARY ENDPOINT AT WEEK 481,2†
• 73% (84/115) of patients receiving TREMFYA® achieved PASI 90 vs 46% (53/115) of patients receiving an active comparator (P<0.001)
Results from North American sites only, which used a US-licensed active comparator.
†Nonresponder imputation (NRI) methods were used for analysis.
References: 1. TREMFYA® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc.
ss-IGA 0/1 and ≥2-Grade Improvement From Baseline1,2*
*In a subpopulation of patients with ss-IGA score ≥2 at baseline.
‡Prespecified other secondary analysis that was not adjusted for multiplicity; therefore, statistical significance has not been established.
Active comparator at Week 48 not shown.
VOYAGE 2: Major Secondary Endpoint at Week 161,3
• 81% (329/408) of patients receiving TREMFYA® achieved ss-IGA 0/1 vs 11% (22/202) of patients receiving placebo (P<0.001)
NRI methods were used for analysis.
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]).
ss-IGA=scalp-specific Investigator's Global Assessment; ss-IGA 0/1=Proportion of patients who achieved an ss-IGA score of absence of disease (0) or very mild (1) using a 5-point scale where scalp lesions were assessed in terms of clinical signs of redness, thickness, and scaliness on a scale of 0 to 4: absence of disease (0), very mild (1), mild (2), moderate (3), or severe (4).
Reference: 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. Reich K, Armstrong AW, Foley P, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: results from the phase III, double-blind, placebo- and active comparator–controlled VOYAGE 2 trial. J Am Acad Dermatol. 2017;76(3):418-431.
Mean Percentage Improvement From Baseline NAPSI (Target Nail)1*†‡
*In a subpopulation of patients with NAPSI (target nail) score >0 at baseline.
†Fingernail psoriasis was assessed using NAPSI, in which the nail most affected by psoriasis (target nail) is divided into quadrants and graded for psoriasis of the nail matrix (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis) on a scale of 0 to 4 for a total score ranging from 0 to 8; a higher score indicates more severe disease.
‡Limitation: All 10 fingernails may also be evaluated using NAPSI.
§Prespecified other secondary analysis that was not adjusted for multiplicity; therefore, statistical significance has not been established.
Active comparator at Week 48 not shown.
NRI methods were used for analysis.
NAPSI=Nail Psoriasis Severity Index.
Reference: 1. 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.
hf-PGA 0/1 and ≥2-Grade Improvement From Baseline1*
*In a subpopulation of patients with hf-PGA score ≥2 at baseline.
†Prespecified other secondary analysis that was not adjusted for multiplicity; therefore, statistical significance has not been established.
Active comparator at Week 48 not shown.
NRI methods were used for analysis.
hf-PGA=Physician's Global Assessment of hands and/or feet;
hf-PGA 0/1=Patients who achieved hf-PGA score of clear (0) or almost clear (1) using a 5-point scale based on the category that best describes the severity of psoriasis on the palms and soles on a scale of 0 to 4: clear, postinflammatory hyperpigmentation may be present (0), almost clear (1), mild (2), moderate (3), or severe (4).
Reference: 1. 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 90 Response With TREMFYA® by Baseline BMI1
BMI=body mass index (calculated as weight in kilograms divided by height in meters squared).
*This is a post hoc analysis; statistical significance has not been established and efficacy comparisons cannot be made.
Active comparator at Week 48 not shown.
VOYAGE 1: Major Secondary Endpoint at Week 481,2†
- 73% (84/115) of patients receiving TREMFYA® achieved PASI 90 vs 46% (53/115) of patients receiving an active comparator (P<0.001)
Results from North American sites only, which used a US-licensed active comparator.
†Nonresponder imputation (NRI) methods were used for analysis.
Reference: 1. Data on file. Janssen Biotech, Inc.
