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(guselkumab)

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TREMFYA® (guselkumab)

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TREMFYA - Overview of VISIBLE Clinical Trial

Last Updated: 12/18/2025

SUMMARY

  • VISIBLE (NCT05272150) is an ongoing, multicenter (eg, United States and Canada), double-blind, randomized phase 3b clinical trial evaluating the safety and efficacy of TREMFYA compared with placebo (PBO) in patients with skin of color (self-identified as non-White) with predominantly moderate to severe body plaque psoriasis (PsO) and/or scalp PsO. The study is comprised of 2 cohorts through week 112: cohort A and cohort B.1-3
    • In cohort A, the coprimary endpoints of Investigator’s Global Assessment (IGA) score of 0 or 1 and Psoriasis Area and Severity Index (PASI) 90 were achieved by significantly more patients receiving TREMFYA (74% and 57.1%, respectively) compared to patients receiving PBO (0% and 3.8%, respectively; P<0.001) at week 16.2 
      • At week 48, the proportion of patients achieving IGA 0/1 and PASI 90, respectively, was 70.1% and 76.6% in the TREMFYA group and 84.0% and 76.0% in the PBO→TREMFYA group.4
      • At week 100, the proportion of patients achieving IGA 0/1 and PASI 90 was 69.6% each among those in the TREMFYA Combined group.5
    • In cohort B, the coprimary endpoints of scalp-specific Investigator’s Global Assessment (ss-IGA) 0/1 and Psoriasis Scalp Severity Index (PSSI) 90 were achieved by significantly more patients receiving TREMFYA (68.4% and 65.8%, respectively) compared to patients receiving PBO (11.5% and 3.8%; P<0.001) at week 16.3 
      • At week 48, the proportion of patients achieving ss-IGA 0/1 and PSSI 90, respectively, was 85.5% and 80.3% in the TREMFYA group and 73.9% and 78.3% in the PBO→TREMFYA group.3 
      • At week 100, the overall proportion of patients achieving ss-IGA 0/1 and PSSI 90 was 78.8% and 71.7%, respectively, in the TREMFYA Combined group.6 
    • Pooled safety results of TREMFYA through week 112 were generally consistent with the known safety profile of TREMFYA in moderate to severe plaque PsO. No new safety signals were identified through week 112.5-7

CLINICAL Data

Alexis et al (2025)2 and McMichael et al (2025)3 reported data from VISIBLE, a multicenter, double-blind, randomized, phase 3b clinical trial evaluating the safety and efficacy of TREMFYA compared to PBO in patients with skin of color (self-identified as non-White) with predominantly moderate to severe body plaque PsO and/or scalp PsO.

Study Design/Methods

  • VISIBLE consists of 2 cohorts including adult patients with moderate to severe body plaque PsO (cohort A) and/or moderate to severe scalp PsO (cohort B). Select inclusion criteria for each cohort are given below1-3:
    • Cohort A: diagnosis of plaque PsO (with or without psoriatic arthritis [PsA]) for at least 6 months before the first administration of the study drug; self-identifying as non-White or non-Caucasian; body surface area (BSA) involvement of ≥10%, PASI ≥12, and IGA ≥3 at screening and baseline, and were candidates for phototherapy or systemic treatment for PsO
    • Cohort B: diagnosis of moderate to severe scalp PsO; scalp surface area (SSA) ≥30%, PSSI ≥12, ss-IGA ≥3, and at least 1 plaque outside of the scalp at screening and at baseline; and candidate for phototherapy or systemic treatment for PsO
  • Select exclusion criteria: nonplaque form of PsO (eg, erythrodermic, guttate, or pustular); receipt of ustekinumab, ixekizumab, secukinumab, or brodalumab within 12 weeks of the first dose of the study drug; history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances; history or current serious infection (eg, sepsis, pneumonia, pyelonephritis), or had been hospitalized or received intravenous antibiotics for an infection during 2 months before screening.1,2
  • Colorimetry was used to determine skin tone at a non-sun-exposed area (eg, upper medial arm) based on the individual typology angle (ITA) and melanin index.2,3 
  • The ITA and melanin index of each patient were fitted to a Fitzpatrick Skin Type (FST) category. In case of discordance, investigators used FST at randomization; however, for data analysis, FST was assigned based on ITA alone.2,3 
  • Clinician-reported efficacy measures included IGA, PASI, BSA, ss-IGA, PSSI, and SSA.2,3
  • Patient-reported outcomes were assessed using the Dermatology Life Quality Index (DLQI), Psoriasis Symptoms and Signs Diary (PSSD), Scalp Itch Numeric Rating Scale (NRS) and Skin Discoloration Impact Evaluation Questionnaire (SDIEQ).2,3 
  • Patients who discontinued the treatment due to lack of efficacy, worsening PsO, or use of prohibited PsO treatment before a scheduled visit were considered as not achieving the binary endpoint, and nonresponder imputation (NRI) was used for missing data.2,3 
  • The study design is shown in Figure: VISIBLE Study Design.

VISIBLE Study Design2,3

Abbreviations: BSA, body surface area; FST, Fitzpatrick skin type; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PASI 90, ≥90% improvement in Psoriasis Area and Severity Index score from baseline; PsO, psoriasis; PSSI, Psoriasis Scalp Severity Index; q8w, every 8 weeks; R, randomization; SC, subcutaneous; SSA, scalp surface area; ss-IGA, scalp-specific Investigator’s Global Assessment.
aSkin PsO was defined as BSA involvement of ≥10%, PASI ≥12, IGA ≥3 at screening and baseline; FSTs I-III, N <50%; FSTs IV-VI, N ≥50%.
bScalp PsO was defined as SSA ≥30%, PSSI ≥12, ss-IGA ≥3, and at least 1 plaque outside of the scalp at screening and at baseline; FSTs I-III, N <50%; FSTs IV-VI, N ≥50%.


VISIBLE Clinical Trial Outcome Measures1-3,5,6,8,9
Cohort
Time Frame
Coprimary Outcome Measures
Percentage of patients who achieved PASI 90 response
Cohort A
Week 16
Percentage of patients who achieved IGA score of cleared (0) or minimal (1)
Week 16
Percentage of patients who achieved PSSI 90 response
Cohort B
Week 16
Percentage of patients who achieved ss-IGA score of absence of disease (0) or very mild disease (1)
Week 16
Multiplicity-Controlled Major Secondary Outcome Measures
Percentage of patients who achieved IGA score of cleared (0)
Cohort A
Week 16
Percentage of patients who achieved PASI 100 response
Cohort A
Week 16
Change from baseline in PASI score
Cohort A
Week 16
Change from baseline in BSA
Cohort A
Week 16
Time to ≥90% reduction in PASI score
Cohort A
Week 16
Percentage of patients who achieved ≥4-point reduction from baseline PSSD itch score among patients with baseline PSSD itch score ≥4
Cohort A
Week 16
Percentage of patients who achieved ss-IGA score of absence of disease (0)
Cohort B
Week 16
Change from baseline PSSI
Cohort B
Week 16
Change from baseline SSA
Cohort B
Week 16
Percentage of patients who achieved PSSI 100 response
Cohort B
Week 16
Time to ≥90% reduction in PSSI score
Cohort B
Week 16
Percentage of patients with ≥4-point reduction from baseline in scalp itch NRS score among patients with baseline scalp itch score ≥4
Cohort B
Week 16
Percentage of patients who achieved PSSD symptom score 0 among patients with baseline PSSD symptom score ≥1
Cohort A and B
Week 16
Change from baseline DLQI
Cohort A and B
Week 16
Change from baseline PSSD symptom score
Cohort A and B
Week 16
Number of patients with AEs
Cohort A and B
Week 112
Number of patients with SAEs
Cohort A and B
Week 112
Other Prespecified Endpoints
Percentage of patients who achieved PASI 90 response
Cohort A
Week 100
Percentage of patients who achieved IGA score of cleared (0) or minimal (1)
Week 100
Percentage of patients who achieved PSSI 90 response
Cohort B
Week 100
Percentage of patients who achieved ss-IGA score of absence of disease (0) or very mild disease (1)
Week 100
Percentage of patients who achieved IGA score of cleared (0)
Cohort A
Week 100
Percentage of patients who achieved PASI 100 response
Cohort A
Week 100
Change from baseline in PASI score
Cohort A
Week 100
Change from baseline in BSA
Cohort A
Week 100
Percentage of patients who achieved ss-IGA score of absence of disease (0)
Cohort B
Week 100
Change from baseline PSSI
Cohort B
Week 100
PSSI 100
Cohort B
Week 100
Change from baseline SSA
Cohort B
Week 100
Percentage of patients with ≥4-point reduction from baseline in scalp itch NRS score among patients with baseline scalp itch score ≥4
Cohort B
Week 100
DLQI 0/1
Cohort A and B
Week 100
PsAID-12
Cohort A and B
Week 100
SDIEQ
Cohort A and B
Week 100
Change from baseline PSSD symptom score
Cohort A and B
Week 100
PSSD 0
Cohort A and B
Week 100
Note: Additional details regarding study outcome definitions can be found on clinicaltrials.gov.
Abbreviations: AE, adverse event; BSA, body surface area; DLQI, Dermatology Life Quality Index; IGA, Investigator’s Global Assessment; NRS, Numeric Rating Scale; PASI, Psoriasis Area and Severity Index; PASI 90, ≥90% improvement in PASI; PASI 100, 100% improvement in PASI; PsAID-12, Psoriatic Arthritis Impact of Disease-12; PSSD, Psoriasis Symptoms and Signs Diary; PSSI, Psoriasis Scalp Severity Index; SAE, serious adverse event; SDIEQ, Skin Discoloration Impact Evaluation Questionnaire; SSA, scalp surface area; ss-IGA, scalp-specific Investigator’s Global Assessment.

Results

Cohort A - Moderate to Severe Body Plaque PsO

Patient Characteristics

Cohort A: Select Baseline Disease and Clinical Characteristics (Full Analysis Set)2 
TREMFYA
(n=77)
Placebo
(n=26)
Total
(N=103)
Age, mean (SD; range), years
44.7 (11.8; 19-69)
42.3 (15.7; 20-74)
44.1 (12.9; 19-74)
Male, n (%)
55 (71.4)
19 (73.1)
74 (71.8)
BMI, mean (SD), kg/m2
32.6 (8.9)
32.7 (8.5)
32.6 (8.8)
Race and ethnicity, n (%)a
   Asian
16 (20.8)
8 (30.8)
24 (23.3)
   Black
9 (11.7)
2 (7.7)
11 (10.7)
   Middle Eastern
6 (7.8)
2 (7.7)
8 (7.8)
   Non-White Hispanic or Latino
40 (51.9)
12 (46.2)
52 (50.5)
   Pacific Islander or Native Hawaiian
0
1 (3.8)
1 (1.0)
   Multiracial
4 (5.2)
1 (3.8)
5 (4.9)
   Other
2 (2.6)
0
2 (1.9)
Fitzpatrick skin type stratum, n (%)b
   I-III
24 (31.2)
8 (30.8)
32 (31.1)
   IV-VI
53 (68.8)
18 (69.2)
71 (68.9)
PsO disease duration, mean (SD), years
14.9 (11.0)
14.9 (8.8)
14.9 (10.5)
PASI, mean (SD); range, 0-72
21.2 (9.9)
19.8 (6.2)
20.8 (9.1)
IGA, n (%); range, 0-4
   Moderate (3)
57 (74.0)
21 (80.8)
78 (75.7)
   Severe (4)
20 (26.0)
5 (19.2)
25 (24.3)
BSA, mean (SD), n (%)
27.0 (20.4)
26.1 (15.9)
26.8 (19.3)
DLQI, mean (SD); range, 0-30
15.6 (7.7)
14.2 (8.1)
15.3 (7.8)
PSSD symptom score, mean (SD); range, 0-100
66.1 (25.0)
61.8 (27.0)
65.0 (25.5)
PSSD itch score, mean (SD); range, 0-10
7.5 (2.2)
7.6 (2.3)
7.5 (2.2)
Previous treatments, n (%)
   Topical agents
61 (79.2)
19 (73.1)
80 (77.7)
   Phototherapyc
14 (18.2)
6 (23.1)
20 (19.4)
   Nonbiologic systemic therapyd
12 (15.6)
6 (23.1)
18 (17.5)
   Biologicse
22 (28.6)
8 (30.8)
30 (29.1)
Abbreviations: BMI, body mass index; BSA, body surface area; DLQI, Dermatology Life Quality Index; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PsO, psoriasis; PSSD, Psoriasis Symptoms and Signs Diary; PUVA, psoralen plus ultraviolet A; SD, standard deviation; UVB, ultraviolet B.
aInclusion criteria included self-identification as race or ethnicity other than White. Patients reported race or ethnicity using a questionnaire that included predefined categories and the option for an open-ended response.
bFitzpatrick skin type was determined using colorimetry (individual topology angle and melanin index).
cIncludes PUVA or UVB.
dIncludes PUVA, methotrexate, cyclosporine, and acitretin.
eIncludes etanercept, infliximab, adalimumab, certolizumab, brodalumab, ixekizumab, secukinumab, and ustekinumab.
  • At baseline, 82 patients also had scalp PsO. Of those with baseline scalp PsO measures, 77 patients had at least mild scalp PsO (ss-IGA 2 [mild, 22.1%], 3 [moderate, 63.6%], and 4 [severe, 14.3%]), a mean baseline PSSI score (0-72) of 21.2, mean SSA of 33%, and a mean scalp itch NRS score (0-10) of 6.9.10,11
Efficacy
Week 16
  • The coprimary endpoints of IGA 0/1 and PASI 90 were achieved by significantly more patients receiving TREMFYA (57/77 [74%] and 44/77 [57.1%], respectively) compared to patients receiving PBO (0/26 [0%] and 1/26 [3.8%], respectively; P<0.001).2
  • The median (interquartile range [IQR]) time to a PASI 90 response was 13.2 weeks (8.4 to not reached) in patients receiving TREMFYA; a PASI 90 response was not achieved before week 16 in the PBO group (P<0.001).2
  • Major secondary endpoints are described in Table: Cohort A: Major Secondary Endpoints in at Week 16.
  • Among patients with at least mild scalp PsO at baseline, scalp PsO responses are described in Table: Cohort A: Scalp PsO Results Among Patients with At Least Mild Scalp PsO at Baseline through Week 16.

Cohort A: Major Secondary Endpoints at Week 162,12 

TREMFYA
Placebo
P-Value
n=77
n=26
Patients who achieved IGA 0, n (%)
25 (32.5)
0 (0)
<0.001
Patients who achieved PASI 100,a n (%)
23 (29.9)
0 (0)
0.002
Patients who achieved PSSD symptom score 0 from baseline PSSD symptom score ≥1, n (%)
8 (10.4)
0 (0)
0.09
n=75
n=25
Improvement from baseline (LS mean) PASI,b % (95% CI)
84.5 (78.1 to 90.9)
8.3 (-2.4 to 19.0)
<0.001
   Between-group difference,
   % (95% CI)
76.2 (64.0 to 88.4)
<0.001
Patients who achieved ≥4-point reduction from baseline PSSD itch score ≥4, n (%)
48 (66.7)
4 (16.7)
<0.001
Change from baseline (LS mean) PSSD itch scoreb
-4.7
-0.7
<0.001
Change from baseline (LS mean) PSSD symptom score,b % (95% CI)
-49.4 (-54.0 to -44.9)
-8.2 (-15.8 to -0.6)
<0.001
   Between-group difference,
   % (95% CI)
-41.3 (-49.9 to -32.6)
<0.001
n=74
n=25
Improvement from baseline (LS mean) BSA, % (95% CI)
78.0 (69.4 to 86.6)
-0.4 (-14.7 to 13.8)
   Between-group difference,
   % (95% CI)
78.4 (62.3 to 94.6)
<0.001
n=76
n=25
Improvement from baseline (LS mean) DLQI, % (95% CI)
-12.1 (-13.2 to -10.9)
-2.5 (-4.4 to -0.6)
   Between-group difference,
   % (95% CI)
-9.6 (-11.8 to -7.4)
<0.001
Abbreviations: BSA, body surface area; CI, confidence interval; CMH, Cochran-Mantel-Haenszel; DLQI, Dermatology Life Quality Index; IGA, Investigator’s Global Assessment; LS, least square; MMRM, mixed-effect model repeated measures; PASI, Psoriasis Area and Severity Index; PASI 100, 100% improvement in PASI; PsO, psoriasis; PSSD, Psoriasis Symptoms and Signs Diary.
aP-values are based on a CMH test stratified by the Fitzpatrick Skin Type (I-III/ IV-VI). Nonresponder imputation was used; patients who discontinued study agent due to lack of efficacy, worsening of PsO, or use of a prohibited PsO treatment prior to week 16 and patients with missing data were considered nonresponders.
bLS means and P-values were based on MMRM. Zero change from baseline was assigned after intercurrent events; missing data were handled using a mixed model for repeated measures under a missing-at-random assumption.

Cohort A: Scalp PsO Results Among Patients with At Least Mild Scalp PsOa at Baseline through Week 1610,11
TREMFYA
Placebo
Improvement from baseline (LS mean) PSSI,b %
n=56
n=20
   Week 4
53.8; P<0.01
12.3
   Week 12
71.6; P<0.01
20.7
   Week 16
81.0; P<0.001
12.1
Patients who achieved ss-IGA 0,c %
n=57
n=20
   Week 4
26.3; P<0.01
0
   Week 12
61.4; P<0.001
10.0
   Week 16
71.9; P<0.001
10.0
Patients who achieved ss-IGA 0/1,c %
n=57
n=20
   Week 4
50.9; P<0.001
5.0
   Week 12
73.7; P<0.001
15.0
   Week 16
84.2; P<0.001
20.0
n=57
n=20
Mean SSA at week 16, %
3.1
17.9
   Change from baseline (LS mean) SSAb
-29.8; P<0.001
-14.2
Change from baseline (LS mean) scalp itch NRS score at week 16d
-4.3; P<0.001
-1.3
Abbreviations: ANCOVA, analysis of covariance; CMH, Cochran-Mantel-Haenszel; LS, least square; MMRM, mixed-effect model repeated measures; NRS, Numeric Rating Scale; PsO, psoriasis; PSSI, Psoriasis Scalp Severity Index; SSA, scalp surface area; ss-IGA, scalp-specific Investigator’s Global Assessment.
ass-IGA ≥2 at baseline.
bLS means and P-value were based on MMRM. Zero change was assigned after patients discontinued study agent due to lack of efficacy/worsening of PsO or initiated a prohibited PsO treatment. Missing data was handled by MMRM under missing at random assumption.
cP-values are based on CMH test stratified by Fitzpatrick Skin Type (I-III/ IV-VI). Nonresponder imputation was used; patients who discontinued study agent due to lack of efficacy, worsening of PsO, or use of a prohibited PsO treatment prior to week 16 were considered nonresponders. Patients with missing data were considered nonresponders.
dLS means and P-value were based on ANCOVA. Zero change was assigned after patients discontinued study agent due to lack of efficacy/worsening of PsO or initiated a prohibited PsO treatment. Missing data were not explicitly imputed.
Week 48
  • At week 48, the proportion of patients achieving IGA 0/1 and PASI 90 was 70.1% (54/77) and 76.6% (59/77) in the TREMFYA group, and 84.0% (21/25) and 76.0% (19/25) in the PBO→TREMFYA group, respectively.4
  • Mean percent improvement from baseline at week 48 in BSA and PASI was 94.4% and 94.9% in patients treated with TREMFYA, and 87.2% and 91.1% in the PBO→TREMFYA group, respectively.4
  • The overall proportion of patients achieving IGA 0 and PASI 100 at week 48 were 54.5% (42/77) and 54.5% (42/77) in the TREMFYA group, and 48.0% (12/25) and 44.0% (11/25) in the PBO→TREMFYA group, respectively.4
Week 100
  • The proportion of patients achieving IGA 0/1 and PASI 90 through week 100 was 69.6% each among those in the TREMFYA Combined group, which included patients randomized to TREMFYA at baseline and those initially randomized to PBO who crossed over to TREMFYA at or after week 16.5 
  • At week 100, mean percent improvement from baseline in BSA and PASI were 95.3% (n=68) and 95.2% (n=68), respectively, in patients treated with TREMFYA, and 92.1% (n=22) and 91.3% (n=22) in the PBO→TREMFYA group, respectively. Only patients who crossed over to TREMFYA at or after week 16 were included in the PBO→TREMFYA group.5 
  • The overall proportion of patients achieving IGA 0 and PASI 100 at week 100 was 51.0% each among those in the TREMFYA Combined group.5 
  • Among patients with baseline DLQI>1, the proportion of patients achieving a DLQI score of 0/1 through week 100 was 56.6% in the TREMFYA group and 62.5% in the PBO→TREMFYA group.8 
  • Mean PSSD itch symptom score through week 100 was 1.7 in the TREMFYA group (n=68) and 1.4 in the PBO→TREMFYA group (n=22), with a mean improvement from baseline of -5.7.8
  • Mean PSSD symptom score through week 100 was 10.0 in the TREMFYA group (n=68) and 9.6 in the PBO→TREMFYA group (n=22), with a mean improvement from baseline of -54.5.8 

Cohort B - Moderate to Severe Scalp PsO

Patient Characteristics

Cohort B: Select Baseline Demographics and Clinical Characteristics (Efficacy Analysis Set)3,a
TREMFYA
(n=76)
Placebo
(n=26)
Total
(N=102)
Age, mean (SD; range), years
42.9 (13.9; 19-75)
41.1 (13.1; 20-63)
42.5 (13.6; 19-75)
Male, n (%)
40 (52.6)
18 (69.2)
58 (56.9)
BMI, mean (SD), kg/m2
31.6 (8.2)
28.3 (6.3)
30.8 (7.9)
Fitzpatrick skin type stratum, n (%)b
   I-III
28 (36.8)
10 (38.5)
38 (37.3)
   IV-VI
48 (63.2)
16 (61.5)
64 (62.7)
Race/ethnicity composition, n (%)c
   Asian
27 (35.5)
12 (46.2)
39 (38.2)
   Black
8 (10.5)
3 (11.5)
11 (10.8)
   Middle Eastern
4 (5.3)
1 (3.8)
5 (4.9)
   Non-White Hispanic or Latino
31 (40.8)
8 (30.8)
39 (38.2)
   Multiracial
4 (5.3)
2 (7.7)
6 (5.9)
   American Indian or Alaska Native
1 (1.3)
0
1 (1.0)
   Otherd
1 (1.3)
0
1 (1.0)
PsO disease duration, mean (SD), years
11.3 (9.8)
11.3 (12.8)
11.3 (10.6)
ss-IGA (0-4), n (%)
   Moderate (3)
64 (84.2)
20 (76.9)
84 (82.4)
   Severe (4)
12 (15.8)
6 (23.1)
18 (17.6)
PSSI, mean (SD); range, 0-72
34.4 (13.7)
34.0 (11.8)
34.3 (13.2)
SSA, mean (SD), %
60.8 (27.1)
56.6 (22.4)
59.8 (26.0)
IGA, n (%); range, 0-4
   Minimal (1)
1 (1.3)
0
1 (1.0)
   Mild (2)
3 (3.9)
0
3 (2.9)
   Moderate (3)
60 (78.9)
19 (73.1)
79 (77.5)
   Severe (4)
12 (15.8)
7 (26.9)
19 (18.6)
PASI, mean (SD); range, 0-72
13.7 (9.6)
17.1 (8.2)
14.6 (9.3)
BSA, mean (SD), %
15.7 (15.0)
19.1 (12.1)
16.6 (14.4)
DLQI, mean (SD); range, 0-30
13.2 (7.7)
17.1 (6.6)
14.2 (7.6)
PSSD symptom score, mean (SD); range, 0-100
61.9 (24.7)
67.8 (20.1)
63.4 (23.6)
Scalp Itch NRS, mean (SD); range, 0-10
7.5 (2.1)
7.8 (2.0)
7.6 (2.0)
Previous treatments, n (%)
   Topical agents
65 (85.5)
26 (100)
91 (89.2)
   Phototherapye
7 (9.2)
5 (19.2)
12 (11.8)
   Nonbiologic systemic therapyf
15 (19.7)
3 (11.5)
18 (17.6)
   Biologicsg
9 (11.8)
4 (15.4)
13 (12.7)
Abbreviations: BMI, body mass index; BSA, body surface area; DLQI, Dermatology Life Quality Index; IGA, Investigator’s Global Assessment; NRS, Numeric Rating Scale; PASI, Psoriasis Area and Severity Index; PsO, psoriasis; PSSD, Psoriasis Symptoms and Signs Diary; PSSI, Psoriasis Scalp Severity Index; PUVA, psoralen plus ultraviolet A; SD, standard deviation; SSA, scalp surface area; ss-IGA, scalp-specific Investigator’s Global Assessment; UVB, ultraviolet B.
aEfficacy analysis population excludes 6 patients who should have been randomized to VISIBLE Cohort A.
bFitzpatrick skin type was determined using colorimetry (individual topology angle and melanin index).
cInclusion criteria included self-identification as race or ethnicity other than White. Patients reported race or ethnicity using a questionnaire that included predefined categories and the option for open-ended response.
dThe other category was self-reported.
eIncludes PUVA or UVB.
fIncludes PUVA, methotrexate, cyclosporine, and acitretin.
gIncludes etanercept, infliximab, adalimumab, certolizumab, brodalumab, ixekizumab, secukinumab, and ustekinumab.
Efficacy
Week 16
  • The coprimary endpoints of ss-IGA 0/1 and PSSI 90 were achieved by significantly more patients receiving TREMFYA (52/76 [68.4%] and 50/76 [65.8%], respectively, compared to patients receiving PBO (3/26 [11.5%] and 1/26 [3.8%], respectively; P<0.001).3
  • The median (IQR) time to a PSSI 90 response was 11.6 (6.0-15.3) weeks in patients receiving TREMFYA; a PSSI 90 response was not achieved before week 16 in the PBO group (P<0.001).3
  • Major secondary endpoints are described in Table: Cohort B: Major Secondary Endpoints at Week 16.

Cohort B: Major Secondary Endpoints at Week 163
TREMFYA
Placebo
P-Value
n=75
n=23
Improvement from baseline (LS mean) PSSI,a % (95% CI)
87.6 (81.8 to 93.4)
37.8 (27.5 to 48.1)
<0.001
n=76
n=26
Patients who achieved ss-IGA 0,bn (%)
44 (57.9)
1 (3.8)
<0.001
Patients who achieved PSSI 100,bn (%)
45 (59.2)
1 (3.8)
<0.001
n=75
n=23
Improvement from baseline (LS mean) SSA,a% (95% CI)
86.6 (79.7 to 93.4)
33.4 (21.1 to 45.7)
<0.001
Patients with ≥4-point reduction from baseline in scalp itch NRS score among patients with baseline scalp itch ≥4, n/N (%)
50/72 (69.4)
6/25 (24.0)
<0.001
Patients who achieved PSSD symptom score 0 among patients with baseline scores ≥1, n (%)
16 (21.3)
1/26 (3.8)
0.04
Change from baseline (LS mean) PSSD symptom score, % (95% CI)
-44.8
(-50.6 to -39.1)
-8.3
(-18.4 to 1.9)
   Between-group difference,
   % (95% CI)
-36.5 (-48.1 to -25.0)
<0.001
n=75
n=26
Improvement from baseline (LS mean) DLQI, % (95% CI)
-9.7 (-11.1 to -8.2)
-2.2 (-4.8 to 0.4)
   Between-group difference,
   % (95% CI)
-7.5 (-10.4 to -4.6)
<0.001
Abbreviations: CI, confidence interval; CMH, Cochran-Mantel-Haenszel; DLQI, Dermatology Life Quality Index; LS, least square; MMRM, mixed-effect model repeated measures; NRS, Numeric Rating Scale; PsO, psoriasis; PSSD, Psoriasis Symptoms and Signs Diary; PSSI, Psoriasis Scalp Severity Index; SSA, scalp surface area; ss-IGA, scalp-specific Investigator’s Global Assessment.
aLS means and P-value were based on MMRM. Zero change was assigned for patients who discontinued study agent due to lack of efficacy, worsening of PsO or initiated a prohibited PsO treatment prior to week 16. Missing data was handled by MMRM under missing at random assumption.
bP-values are based on CMH test stratified by Fitzpatrick Skin Type (I-III/ IV-VI). Nonresponder imputation was used; patients who discontinued study agent due to lack of efficacy, worsening of PsO, or use of a prohibited PsO treatment prior to week 16, and patients with missing data were considered nonresponders.
Week 48
  • At week 48, the proportion of patients achieving ss-IGA 0/1 and PSSI 90 was 85.5% (65/76) and 80.3% (61/76) in the TREMFYA group and 73.9% (17/23) and 78.3% (18/23) in the PBO→TREMFYA group, respectively.13
  • At week 48, the mean (standard deviation [SD]) percent improvement from baseline in SSA and PSSI was 94.8% (16.2) and 94.6% (12.2) in the TREMFYA group and 92.1% and 92.2% in the PBO→TREMFYA group, respectively.3,13
  • At week 48, ss-IGA 0 and PSSI 100 responses were reported in 67.1% (51/76) and 68.4% (52/76) of patients in the TREMFYA group and 56.5% (13/23) and 56.5% (13/23) of patients in the PBO→TREMFYA group, respectively.3,13
  • At week 48, patients receiving TREMFYA achieved a high level of scalp clearance across baseline BSA subgroups3,13:
    • High BSA subgroup: ss-IGA 0/1 and ss-IGA 0 were achieved by 93.0% (40/43) and 72.1% (31/43) of patients, respectively; the mean (SD) percent improvement from baseline in PSSI and SSA was 96.5% (7.4) and 96.1% (12.7%), respectively.
    • Low BSA subgroup: ss-IGA 0/1 and ss-IGA 0 were achieved by 73.1% (19/26) and 57.7% (15/26) of patients, respectively; the mean (SD) percent improvement from baseline in PSSI and SSA was 90.1% (18.2) and 91.2% (22.4), respectively.
  • At week 48, a PSSD symptom score of 0 was achieved by 34.7% (26/75) of patients in the TREMFYA group and 34.8% (8/23) of patients in the PBO→TREMFYA group.3
Week 100
  • At week 100, the overall proportion of patients achieving ss-IGA 0/1 and PSSI 90 was 78.8% and 71.7%, respectively, in the TREMFYA Combined group.6 
  • Mean percent improvement from baseline in SSA was 97.3% in the TREMFYA group (n=72) and 85.0% in the PBO→TREMFYA group (n=21).6 
  • Mean percent improvement from baseline in PSSI was 96.2% in the TREMFYA group (n=72) and 87.5% in the PBO→TREMFYA group (n=21).6 
  • The overall proportion of patients achieving ss-IGA 0 and PSSI 100 was 66.7% each in the TREMFYA Combined group.6 
  • Among patients with baseline DLQI>1, the proportion of patients achieving a DLQI score of 0/1 was 66.7% in the TREMFYA group and 56.5% in the PBO→TREMFYA group.9 
  • Mean scalp itch NRS score was 1.6 in the TREMFYA group (n=72) and 2.0 in the PBO→TREMFYA group (n=21), with a mean improvement from baseline of -5.9.9 
  • Mean PSSD symptom score was 10.8 in the TREMFYA group (n=72) and 17.8 in the PBO→TREMFYA group (n=21), with a mean improvement from baseline of -51.2.9
Safety
Cohort A - Through Week 112
  • Through week 16, 37.7% (29/77) of patients receiving TREMFYA and 19.2% (5/26) of patients receiving PBO reported ≥1 adverse event (AE). See Table: Cohort A: Cumulative Rates of Key AEs.2 
  • No new safety signals were identified through week 112.5 

Cohort A: Cumulative Rates of Key AEs2,5 
Week 0-16
(PBO-Controlled Period)
Week 16-112
Week 0-112
TREMFYA
PBO
PBO→TREMFYAa
TREMFYA
Safety analysis set, n
77
26
25
77
Mean weeks of follow-up
16.1
16.0
91.5
104.4
Patients with ≥1 AE, n (%)
29 (37.7)
5 (19.2)
13 (52.0)
58 (75.3)
   AEs leading to study drug
   discontinuationb
1 (1.3)
0
0
2 (2.6)
   SAEsc
0
0
1 (4.0)
3 (3.9)
AEs of interest, n (%)
   Infectionsd
16 (20.8)
3 (11.5)
7 (28.0)
38 (49.4)
   Serious infections
0
0
1 (4.0)
3 (3.9)
   Clinically important hepatic
   disordere
0
0
0
0
   MACEf
0
0
0
0
   Malignancy
0
0
0
0
   Venous thromboembolism
0
0
0
0
   Serum sickness-like or anaphylaxis
0
0
0
0
   TB
0
0
0
0
   Inflammatory bowel diseaseg
0
0
0
0
Abbreviations: AEs, adverse events; CD, Crohn’s disease; COVID-19, coronavirus disease 2019; IBD, inflammatory bowel disease; MACE, major adverse cardiovascular event; MedDRA, medical dictionary for regulatory activities; PBO, placebo; SAEs, serious adverse events; SMQ, Standardised MedDRA Queries; TB, tuberculosis; UC, ulcerative colitis.
Note: Patients were counted only once for any given event, regardless of the number of times they experienced the event. AEs were coded using MedDRA version 27.1.
aIncludes only PBO patients who crossed over to receive TREMFYA.
bWeeks 0-16: One patient in the TREMFYA group discontinued study agent due to impetiginized atopic dermatitis; Weeks 0-112: One patient in the TREMFYA group discontinued due to pregnancy and one patient in the TREMFYA group who discontinued at weeks 0-16.
cWeeks 16-112: One patient in PBO→TREMFYA group had localized cellulitis of the right hand/wrist; Weeks 0-112: One patient in the TREMFYA group had a gallbladder abscess and perforation of the bile duct, one patient in the TREMFYA group had appendicitis, and one patient in the TREMFYA group had pyelonephritis.
dThe most common infections for all patients treated with TREMFYA (>5%) included upper respiratory tract infections (16.9%), nasopharyngitis (11.7%), and COVID-19 (6.5%).
eNo clinically important hepatic disorder AEs were based on a narrow Hepatic Disorders SMQ search and recorded on the case report form as serious or leading to study treatment discontinuation.
fMACE includes sudden cardiac death, nonfatal myocardial infarction, and nonfatal stroke.
gIBD includes preferred terms of CD, UC, and IBD.
  • Two patients treated with TREMFYA reported AEs leading to discontinuation.2 
    • TREMFYA was discontinued in 1 patient due to pregnancy and in 1 patient due to impetigo atopic dermatitis.

Cohort B – Through Week 112

  • Through week 16, 35.8% (29/81) of patients receiving TREMFYA and 11.1% (3/27) of patients receiving PBO reported at least 1 AE. See Table: Cohort B: Cumulative Rates of Key AEs.3 
  • No new safety signals were identified through week 112.6 

Cohort B: Cumulative Rates of Key AEs3,6
Week 0-16
(PBO-Controlled Period)
Week 16-112
Week 0-112
TREMFYA
PBO
PBO→TREMFYAa
TREMFYA
Safety analysis set, n
81
27
24
81
Total PYs of follow-up
25.1
8.0
40.9
168.1
Median PYs of follow-up
0.3
0.3
1.8
2.1
Patients with ≥1 AE, events per 100 PYs (95% CI)
143.4
(100.5-198.6)
62.6
(20.3-146.2)
105.2
(76.2-141.8)
129.7
(113.0-148.1)
   AEs leading to study drug
   discontinuation
0 (0-11.9)
0 (0-37.5)
0 (1-7.3)
0 (0-1.8)
   SAEsb
0 (0-11.9)
12.5 (0.3-69.8)
0 (0-7.3)
1.8 (0.4-5.2)
AEs of interest, events per 100 PYs (95% CI)
   Infectionsc
0
(0-11.9)
0
(0-37.5)
36.7
(20.6-60.6)
45.2
(35.6-56.6)
   Serious infections
0 (0-11.9)
0 (0-37.5)
0 (0-7.3)
0.59 (0.0-3.3)
   Clinically important hepatic
   disorderd
0 (0-11.9)
0 (0-37.5)
0 (0-7.3)
0 (0-1.8)
   MACEe
0 (0-11.9)
0 (0-37.5)
0 (0-7.3)
0 (0-1.8)
   Malignancy
0 (0-11.9)
0 (0-37.5)
0 (0-7.3)
0 (0-1.8)
   Venous thromboembolism
0 (0-11.9)
0 (0-37.5)
0 (0-7.3)
0 (0-1.8)
   Serum sickness-like or
   anaphylaxis
0 (0-11.9)
0 (0-37.5)
0 (0-7.3)
0 (0-1.8)
   TB
0 (0-11.9)
0 (0-37.5)
0 (0-7.3)
0 (0-1.8)
   Inflammatory bowel diseasef
0 (0-11.9)
0 (0-37.5)
0 (0-7.3)
0 (0-1.8)
Abbreviations: AE, adverse event; CD, Crohn’s disease; CI, confidence interval; COVID-19, coronavirus disease 2019; IBD, inflammatory bowel disease; MACE, major adverse cardiovascular event; MedDRA, medical dictionary for regulatory activities; PBO, placebo; PYs, patient-years; SAEs, serious adverse events; SMQ, Standardised MedDRA Queries; TB, tuberculosis; UC, ulcerative colitis; UTI, urinary tract infection.
Note: Patients were counted only once for any given event, regardless of the number of times they experienced the event. AEs were coded using MedDRA version 27.1.
aIncludes only PBO patients who crossed over to receive TREMFYA.
bWeeks 0-16: One patient in the PBO group had a viral rash; Weeks 0-112: One patient in the TREMFYA group had angina pectoris, one patient in the TREMFYA group had pancreatitis, and one patient in the TREMFYA group had right lower lobe pneumonia.
cThe most common infections for all TREMFYA-treated patients (>5%) included upper respiratory tract infections (24.7%), COVID-19 (16.0%), and nasopharyngitis (7.4%).
dNo clinically important hepatic disorder AEs were based on a narrow Hepatic Disorders SMQ search and recorded on the case report form as serious or leading to study treatment discontinuation.
eMACE includes sudden cardiac death, nonfatal myocardial infarction, and nonfatal stroke.
fIBD includes preferred terms of CD, UC, and IBD.
Pooled Analysis (Cohort A and Cohort B) - PBO→TREMFYA Crossover (Weeks 16-48)
  • Through weeks 16-48 in the PBO→TREMFYA crossover period, 28.6% (14/49) of patients reported at least 1 AE.7
    • At least 1 serious adverse event (SAE) was reported in 2% (1/49) of patients.
    • Infections and serious infections were reported in 18.4% (9/49) and 2% (1/49) of patients, respectively.
Pooled Analysis (Cohort A and Cohort B) - TREMFYA (Weeks 0-48)
  • Through week 0-48, 62.7% (99/158) and 1.9% (3/158) of patients treated with TREMFYA reported at least 1 AE and 1 SAE, respectively.7
    • Infections and serious infections were reported in 34.8% (55/158) and 0.6% (1/158) of patients treated with TREMFYA, respectively.
    • Injection site reaction was reported in 0.6% (1/158) of patients treated with TREMFYA.
    • Two patients (1.3%) discontinued TREMFYA due to pregnancy and impetiginized atopic dermatitis.
  • Through week 48, no death, malignancies, active tuberculosis, inflammatory bowel disease, major adverse cardiovascular event, anaphylaxis, or serum-like sickness were reported in either groups.7
  • Pooled safety results of TREMFYA through week 48 were generally consistent with the known safety profile of TREMFYA in moderate to severe plaque PsO. No new safety signals were identified.7

LITERATURE SEARCH

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 26 November 2025.

 

References

Show
1 Janssen Research & Development, LLC. Study of guselkumab in skin of color participants with moderate-tosevere plaque and/or scalp psoriasis (VISIBLE). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 September 12]. Available from: https://clinicaltrials.gov/study/NCT05272150 NLM Identifier: NCT05272150.  
2 Alexis A, McMichael A, Soung J, et al. Guselkumab for moderate to severe psoriasis across all skin tones: cohort A of the VISIBLE randomized clinical trial. [published online ahead of print June 25, 2025]. JAMA Dermatol. doi:10.1001/jamadermatol.2025.1836.  
3 McMichael A, Shahriari M, Gold LS, et al. Guselkumab for moderate to severe scalp psoriasis across all skin tones: cohort B of the VISIBLE randomized clinical trial. [published online ahead of print June 25, 2025]. JAMA Dermatol. doi:10.1001/jamadermatol.2025.1849.  
4 Alexis A, Rodriguez AO, Yadav G, et al. VISIBLE cohort A: guselkumab demonstrated skin clearance through week 48 in participants with moderate-to-severe plaque psoriasis across all skin tones. Poster presented at: Skin of Color Update; September 13-15, 2024; New York, NY.  
5 Alexis A, Rodriguez AO, Yadav G, et al. VISIBLE cohort A: guselkumab skin clearance results through week 100 in participants with moderate to severe plaque psoriasis across all skin tones. Poster presented at: Skin of Color Update (SOCU); October 3-5, 2025; New York, NY.  
6 McMichael A, Bhutani T, Kindred C, et al. VISIBLE cohort B: guselkumab scalp clearance results through week 100 in participants with moderate-to-severe scalp psoriasis across all skin tones. Poster presented at: Skin of Color Update (SOCU); October 3-5, 2025; New York, NY.  
7 Soung J, Kindred C, Kerdel F, et al. VISIBLE: guselkumab pooled safety across all skin tones through week 48. Poster presented at: Skin of Color Update; September 13-15, 2024; New York, NY.  
8 Alexis A, Rodriguez AO, Yadav G, et al. VISIBLE cohort A: long-term patient-reported outcomes through week 100 in participants with moderate-to-severe psoriasis. Poster presented at: Skin of Color Update (SOCU); October 3-5, 2025; New York, NY.  
9 McMichael A, Bhutani T, Smith S, et al. VISIBLE cohort B: long-term patient-reported outcomes through week 100 in participants with moderate-to-severe scalp psoriasis. Poster presented at: Skin of Color Update (SOCU); October 3-5, 2025; New York, NY.  
10 McMichael A, Gold LS, Soung J, et al. VISIBLE: guselkumab demonstrated rapid and significant scalp psoriasis clearance in participants with moderate-to-severe plaque psoriasis across all skin tones. Poster presented at: Fall Clinical Dermatology Conference; October 19-22, 2023; Las Vegas, NV.  
11 McMichael A, Gold LS, Soung J, et al. VISIBLE: guselkumab demonstrated significant scalp psoriasis clearance and scalp itch improvements at week 16 in skin of color participants with moderate-to-severe plaque psoriasis. Poster presented at: American Academy of Dermatology Annual Meeting; March 8-12, 2024; San Diego, CA.  
12 Alexis A, McMichael A, Choi O, et al. VISIBLE: guselkumab demonstrated skin clearance at week 16 in participants with moderate-to-severe plaque psoriasis across all skin tones. Poster presented at: Fall Clinical Dermatology Conference; October 19-22, 2023; Las Vegas, NV.  
13 McMichael A, Bhutani T, Smith S, et al. VISIBLE cohort B: guselkumab demonstrated scalp clearance through week 48 in participants with moderate-to-severe scalp psoriasis across all skin tones. Poster presented at: Skin of Color Update; September 13-15, 2024; New York, NY.