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Skin of color unmet need
Minority representation has been less than ~30% in PsO biologic trials2
Participants in select industry-sponsored PsO biologic trials2
Underrepresentation in clinical trials may help to explain challenges facing patients with skin of color.
Factors that may impact patients with skin of color
Wait 3x longer
for final
diagnosis4
4x more
likely
to require a
biopsy to confirm
diagnosis4
Dark skin
ranged from
4-19%
of images in
dermatology
textbooks5-7
Further investment in research and clinical study efforts will be key to closing these education gaps and improving diagnosis and care for patients of color.
References: 1. Data on file. Janssen Biotech, Inc. 2. Kaufman BP, Alexis AF. Psoriasis in skin of color: insights into the epidemiology, clinical presentation, genetics, quality-of-life impact, and treatment of psoriasis in non-white racial/ethnic groups. Am J Clin Dermatol. 2018;19(3):405-423. 3. Armstrong AW, Mehta MD, Schupp CW, et al. Psoriasis prevalence in adults in the United States. JAMA Dermatol. 2021;157(8 ):940-946. 4. Dickerson T, Pratt A, O’Quinn M, et al. Racial disparities in the diagnosis of psoriasis. Cutis. 2022;110:26-28. 5. Wilson BN, Sun M, Ashbaugh AG, et al. Assessment of skin of color and diversity and inclusion content of dermatologic published literature: an analysis and call to action. Int J Women’s Derm. 2021;7:391-397. 6. Ebede T, Papier A. Disparities in dermatology educational resources. J Am Acad Dermatol. 2006;55(4):687-690. 7. Adelekun A, Onyekaba G, Lipoff JB. Skin color in dermatology textbooks: an updated evaluation and analysis. J Am Acad Dermatol. 2021;84(1):194-196.
IN MODERATE TO SEVERE PLAQUE PSORIASIS (PsO)
VISIBLE demonstrated significant clearance across all skin
tones* at Week 164,5
VOYAGE 1 and VOYAGE 2 co-primary endpoints at Week 16 (NRI)1,3:
VOYAGE 1—PASI 90: TREMFYA® 73% (241/329), placebo 3% (5/174) (P<0.001). IGA 0/1: TREMFYA® 85% (280/329), placebo 7% (12/174) (P<0.001). VOYAGE 2—PASI 90: TREMFYA® 70% (347/496), placebo 2% (6/248) (P<0.001). IGA 0/1: TREMFYA® 84% (417/496), placebo 8% (21/248) (P<0.001).
NRI=nonresponder imputation; PASI=Psoriasis Area and Severity Index.
See the difference TREMFYA® makes
Fitzpatrick IV
BEFORE
Week 0
PASI=41.5
AFTER
Week 16
PASI=1.6
(96% PASI improvement)
Actual patient from the VISIBLE study. Individual results may vary.
Images are Janssen-owned from blinded trial: NCT05272150.
IN MODERATE TO SEVERE PLAQUE PsO
Significant scalp clearance across all skin tones*
at Week 164,6
In VOYAGE 1 and VOYAGE 2, an improvement was seen in psoriasis involving the scalp in patients randomized to TREMFYA® compared to placebo at Week 16.
§Nonresponder imputation (NRI) methods were used for analysis.
See the difference TREMFYA® makes
Fitzpatrick III
BEFORE
Week 0
PSSI=60
AFTER
Week 16
PSSI=6
(90% PSSI improvement)
Actual patient from the VISIBLE study. Individual results may vary.
Images are Janssen-owned from blinded trial: NCT05272150.
References: 1. TREMFYA® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Blauvelt A, Papp KA, Griffiths CEM, et al. J Am Acad Dermatol. 2017;76(3):405-417. 3. Reich K, Armstrong AW, Foley P, et al. J Am Acad Dermatol. 2017;76(3):418-431. 4. Data on file. Janssen Biotech, Inc. 5. Alexis A, et al. Presentation at: Fall Clinical Dermatology Conference; October 19-22, 2023; Las Vegas, NV. 6 Alexis A, et al. Presented at: Maui Derm Hawaii; January 22-26, 2024; Maui, HI.
IN MODERATE TO SEVERE PLAQUE PSORIASIS (PsO)
Complete skin clearance rates after 3 doses1,2
VISIBLE Cohort A major secondary endpoint: PASI 100 response at Week 16 (NRI)
VOYAGE 1 and VOYAGE 2 co-primary endpoints at Week 16 (NRI)1,3:
VOYAGE 1—PASI 90: TREMFYA® 73% (241/329), placebo 3% (5/174) (P<0.001). IGA 0/1: TREMFYA® 85% (280/329), placebo 7% (12/174) (P<0.001). VOYAGE 2—PASI 90: TREMFYA® 70% (347/496), placebo 2% (6/248) (P<0.001). IGA 0/1: TREMFYA® 84% (417/496), placebo 8% (21/248) (P<0.001).
In VOYAGE 1 and VOYAGE 2 at Week 24 (major secondary endpoint, NRI)4-6*:
- 53% (61/115) of patients in VOYAGE 1 and 48% (76/160) of patients in VOYAGE 2 achieved IGA 0
*Results from North American sites only, which used a US-licensed active comparator. Active-comparator data not shown.
See the difference TREMFYA® makes
Fitzpatrick V
BEFORE
Week 0
PASI=31
AFTER
Week 16
PASI=0
(100% PASI improvement)
Actual patient from the VISIBLE study. Individual results may vary.
Images are Janssen-owned from blinded trial: NCT05272150.
IN MODERATE TO SEVERE PLAQUE PSORIASIS (PsO)
Complete scalp clearance rates after 3 doses1,3
VISIBLE Cohort B major secondary endpoint: ss-IGA 0 at Week 16 (NRI)
In VOYAGE 1 and VOYAGE 2, an improvement was seen in psoriasis involving the scalp in patients randomized to TREMFYA® compared to placebo at Week 16.
See the difference TREMFYA® makes
Fitzpatrick VI
BEFORE
Week 0
PSSI=72
AFTER
Week 16
PSSI=0
(100% PSSI improvement)
Actual patient from the VISIBLE study. Individual results may vary.
Images are Janssen-owned from blinded trial: NCT05272150.
IGA=Investigator’s Global Assessment; PASI=Psoriasis Area and Severity Index; PSSI=Psoriasis Scalp Severity Index; ss-IGA=scalp-specific Investigator’s Global Assessment.
References: 1. Data on file. Janssen Biotech, Inc. 2. Alexis A, et al. Presented at: Fall Clinical Dermatology Conference; October 19-22, 2023; Las Vegas, NV. 3. Alexis A, et al. Presented at: Maui Derm Hawaii; January 22-26, 2024; Maui, HI. 4. TREMFYA® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 5. 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. 6. 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.
IN MODERATE TO SEVERE PLAQUE PSORIASIS (PsO)
Mean percent PASI improvement from baseline1,2*†
VISIBLE Cohort A major secondary endpoint: Mean percent PASI improvement (LS mean) from baseline at Week 161,2*†‡§
Mean percent PASI improvement from baseline at Week 161,2*†‡§
VOYAGE 1 and VOYAGE 2 co-primary endpoints at Week 16 (NRI)1,3:
VOYAGE 1—PASI 90: TREMFYA® 73% (241/329), placebo 3% (5/174) (P<0.001). IGA 0/1: TREMFYA® 85% (280/329), placebo 7% (12/174) (P<0.001). VOYAGE 2—PASI 90: TREMFYA® 70% (347/496), placebo 2% (6/248) (P<0.001). IGA 0/1: TREMFYA® 84% (417/496), placebo 8% (21/248) (P<0.001).
*Patients received 100 mg TREMFYA® at Week 0, Week 4, and every 8 weeks thereafter.
†Efficacy measures at Week 4 and Week 12 were prespecified and were not multiplicity controlled. Therefore, P values are nominal and no statistical comparisons can be made.
‡Mean PASI improvement is an assessment of the average percentage improvement from baseline in psoriatic signs of redness, thickness, scaling, and body surface area of involvement.
§Patients who discontinued study agent due to lack of efficacy, or worsening of PsO, or who initiated a protocol-prohibited PsO treatment prior to Week 16 were considered as zero change. Patients with missing data were not explicitly imputed; they were accounted for in the analysis model.
LS=least squares; PASI=Psoriasis Area and Severity Index.
See the difference TREMFYA® makes
Fitzpatrick III
BEFORE
Week 0
PASI=20.6
AFTER
Week 16
PASI=2.9
(86% PASI improvement)
Actual patient from the VISIBLE study. Individual results may vary.
Images are Janssen-owned from blinded trial: NCT05272150.
IN MODERATE TO SEVERE PLAQUE PSORIASIS (PsO)
Mean BSA improvement from baseline after 3 doses1
VISIBLE Cohort A major secondary endpoint: Mean BSA improvement (LS mean) from baseline at Week 16*†
VOYAGE 1 and VOYAGE 2 co-primary endpoints at Week 16 (NRI)1,3:
VOYAGE 1—PASI 90: TREMFYA® 73% (241/329), placebo 3% (5/174) (P<0.001). IGA 0/1: TREMFYA® 85% (280/329), placebo 7% (12/174) (P<0.001). VOYAGE 2—PASI 90: TREMFYA® 70% (347/496), placebo 2% (6/248) (P<0.001). IGA 0/1: TREMFYA® 84% (417/496), placebo 8% (21/248) (P<0.001).
*Mean BSA improvement is an assessment of the average percentage improvement in body surface area involvement.
†Patients who discontinued study agent due to lack of efficacy, worsening of PsO, or who initiated a protocol-prohibited PsO treatment prior to Week 16 were considered as zero change. Patients with missing data were not explicitly imputed; they were accounted for in the analysis model.
‡P<0.001.
BSA=body surface area.
See the difference TREMFYA® makes
Fitzpatrick VI
BEFORE
Week 0
PASI=45.1
AFTER
Week 16
PASI=9.6
(79% PASI improvement)
Actual patient from the VISIBLE study. Individual results may vary.
Images are Janssen-owned from blinded trial: NCT05272150.
References: 1. Data on file. Janssen Biotech, Inc. 2. Alexis A, Desai SR, Choi O, et al. Advancing diversity in dermatology research: the VISIBLE study experience. Poster presented at: 2023 American Academy of Dermatology Annual Meeting; March 17-21, 2023; New Orleans, LA.
IN MODERATE TO SEVERE PLAQUE PSORIASIS (PsO)
VISIBLE safety data were consistent with pivotal trials1,2
VOYAGE 1 and VOYAGE 2 (pooled pivotal trials): Adverse events in the 16-week, placebo-controlled period1,2
VISIBLE trial: Adverse events in the 16-week, placebo-controlled period (pooled data from Cohorts A and B)1*
No new safety signals were reported in VISIBLE through Week 16
*Study is blinded and currently ongoing.
†Patients received 100 mg TREMFYA® at Week 0, Week 4, and every 8 weeks thereafter.
PYs=patient-years.
References: 1. Data on file. Janssen Biotech, Inc. 2. TREMFYA® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
