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TREMFYA®

(guselkumab)

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TREMFYA® (guselkumab)

Medical Information

TREMFYA - Treatment of Scalp Psoriasis

Last Updated: 02/10/2026

SUMMARY

  • The company cannot recommend any practices, procedures or usage that deviate from the approved labeling.
  • Clinical studies have described the use of TREMFYA in patients with scalp psoriasis (PsO).1-10 

CLINICAL DATA

VISIBLE

Alexis et al (2025)1 and McMichael et al (2025)2 presented data from VISIBLE, a phase 3b, large-scale, prospective, double-blind, randomized clinical trial evaluating the efficacy and safety of TREMFYA compared with placebo (PBO) in patients with moderate to severe plaque PsO who self-identify as non-White.

Study Design/Methods

  • Adult patients (≥18 years of age) with skin PsO who self-identify as non-White, and all Fitzpatrick skin types (I-VI; as determined by colorimetry) were eligible for enrollment. Select inclusion criteria for each cohort were as follows1,2,11:
    • Cohort A: diagnosis of plaque PsO (with or without psoriatic arthritis [PsA]) for at least 6 months before the first administration of study drug; self-identify as non-White; candidate for phototherapy or systemic treatment for PsO; body surface area (BSA) involvement of ≥10%, Psoriasis Area and Severity Index (PASI) ≥12, Investigator’s Global Assessment (IGA) ≥3 at screening and baseline.
    • Cohort B: Scalp Surface Area (SSA) ≥30%, Psoriasis Scalp Severity Index (PSSI) ≥12, scalp-specific Investigator’s Global Assessment (ss-IGA) ≥3, 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.1,11
  • The study design is shown in Figure: VISIBLE Study Design.

VISIBLE Study Design1,2

Abbreviations: BSA, body surface area; FST, Fitzpatrick skin type; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; 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 is 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 is 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%.

Results: Cohort A - Moderate to Severe Body Plaque PsO

Patient Characteristics

Cohort A: Select Baseline Disease and Clinical Characteristics (Full Analysis Set)1 
TREMFYA
(n=77)
PBO
(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; PBO, placebo; 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 6.9.12,13
Efficacy

Cohort A: Scalp PsO Results Among Patients with At Least Mild Scalp PsOa at Baseline through Week 1612,13
TREMFYA
PBO
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; PBO, placebo; 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). Non-responder 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.
Safety
  • 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.1 

Cohort A: Cumulative Rates of Key AEs1,14 
Week 0-16
(PBO-Controlled Period)
TREMFYA
PBO
Safety analysis set, n
77
26
Mean weeks of follow-up
16.1
16.0
Patients with ≥1 AE, n (%)
29 (37.7)
5 (19.2)
   AEs leading to study drug discontinuationa
1 (1.3)
0
   SAEs
0
0
AEs of interest, n (%)
   Infectionsb
16 (20.8)
3 (11.5)
   Serious infections
0
0
   Clinically important hepatic disorderc
0
0
   MACEd
0
0
   Malignancy
0
0
   Venous thromboembolism
0
0
   Serum sickness-like or anaphylaxis
0
0
   TB
0
0
   Inflammatory bowel diseasee
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.
aOne patient in the TREMFYA group discontinued study agent due to impetiginized atopic dermatitis.
bThe 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%).
cNo 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.
dMACE includes sudden cardiac death, nonfatal myocardial infarction, and nonfatal stroke.
eIBD includes preferred terms of CD, UC, and IBD.
  • Two patients treated with TREMFYA reported AEs leading to discontinuation.1 
    • TREMFYA was discontinued in 1 patient due to pregnancy and in 1 patient due to impetigo atopic dermatitis.

Results: Cohort B - Moderate to Severe Scalp PsO

Patient Characteristics

Cohort B: Select Baseline Demographics and Clinical Characteristics (Efficacy Analysis Set)2
TREMFYA
(n=76)
PBO
(n=26)
Totala
(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; PBO, placebo; 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
  • At week 16, the coprimary endpoints of ss-IGA score of 0 or 1 and PSSI 90 were achieved by significantly more patients receiving TREMFYA (n=76; 68.4% and 65.8%, respectively) compared to patients receiving PBO (n=26; 11.5% and 3.8%; P<0.001).2 
  • 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).2 
  • Select major secondary endpoints are described in Table: Cohort B: Select Major Secondary Endpoints at Week 16.

Cohort B: Select Major Secondary Endpoints at Week 162
TREMFYA
PBO
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)
P<0.001
n=76
n=26
Patients who achieved ss-IGA 0,bn (%)
44 (57.9)
1 (3.8)
P<0.001
Patients who achieved PSSI 100,bn (%)
45 (59.2)
1 (3.8)
P<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)
P<0.001
n=72
n=25
Patients with ≥4-point reduction from baseline in scalp itch NRS score among patients with baseline scalp itch ≥4, n (%)
50 (69.4)
6 (24.0)
P<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; PBO, placebo; 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.
Efficacy - Week 48
  • At week 48, the proportion of patients achieving ss-IGA 0/1 and PSSI 90, respectively, 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 crossover group.15
  • At week 48, the mean percent improvement from baseline in SSA and PSSI, respectively, was 94.8% and 94.6% in the TREMFYA group and 92.1% and 92.2% in the PBO→TREMFYA crossover group.2,15 
  • At week 48, ss-IGA 0 and PSSI 100, respectively, were reported in 67.1% (51/76) and 68.4% (52/76) of patients in the TREMFYA group and in 56.5% (13/23) and 56.5% (13/23) of patients in the PBO→TREMFYA crossover group.2,15 
  • At week 48, patients receiving TREMFYA achieved a high level of scalp clearance across baseline BSA subgroups2,15:
    • 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.
Efficacy - 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.16 
  • 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).16 
  • 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).16 
  • The overall proportion of patients achieving ss-IGA 0 and PSSI 100 was 66.7% each in the TREMFYA Combined group.16 
  • 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 -5.9.17 
Safety
  • 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.2 
  • No new safety signals were identified through week 112.16 

Cohort B: Cumulative Rates of Key AEs2,16
Week 0-16
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.

SPECTREM

Gold et al (2026),3 Gottlieb et al (2024),18 and Soung et al (2024)19 reported week 16 results from SPECTREM, a multicenter, double-blind, randomized, phase 3b clinical trial that evaluated the safety and efficacy of TREMFYA compared with PBO in adult patients with low BSA, moderate plaque PsO with ≥1 high-impact site involvement.

Study Design/Methods

SPECTREM Study Design3,20 

Note: Additional detail regarding study outcome definitions can be found on clinicaltrials.gov.
Abbreviations: BSA, body surface area; DLQI, Dermatology life quality index; f-IGA, facial Investigator’s Global Assessment; genital-PGA-genital physician global assessment; IGA, Investigator’s Global Assessment; i-IGA, intertriginous Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PASI 90, > 90% improvement in Psoriasis Area and Severity Index; PASI 100, 100% improvement in Psoriasis Area and Severity Index; PBO, placebo; PGA, Physician’s global assessment; PsA, Psoriatic Arthrtis; PsO, Psoriasi; PSSD, Psoriasis Symptoms and Signs Diary; sPGA-G, static Physician’s Global Assessment of Genitalia; ss-IGA, scalp-specific Investigator’s Global Assessment.

Results

Patient Characteristics
  • A total of 338 patients were randomized 2:1 to receive TREMFYA 100 mg (n=225) or PBO (n=113) subcutaneously at weeks 0 and 4 and then every 8 weeks, with PBO crossover to TREMFYA at week 16.3
  • Overall, 94.1% of patients (318/338) completed the 16-week treatment period and continued in the study. Baseline characteristics are described in Table: Baseline Demographics and Clinical Characteristics (Full Analysis Set).3 

Baseline Demographics and Clinical Characteristics (Full Analysis Set)3
TREMFYA
(n=225)
PBO
(n=113)
Total
(N=338)
Demographics
   Age, years, mean (SD)
47.0 (14.7)
44.5 (14.9)
46.2 (14.8)
   Male, n (%)
116 (51.6)
57 (50.4)
173 (51.2)
   BMI, kg/m2, mean (SD)
30.9 (7.5)
31.0 (7.5)
30.9 (7.5)
   White, n (%)
166 (73.8)
83 (73.5)
249 (73.7)
Characteristics
   PsO disease duration,
   years, mean (SD)
18.4 (14.9)
14.0 (11.9)
16.9 (14.1)
   PASI (0-72), mean (SD)
9.1 (3.8)
9.0 (3.9)
9.0 (3.8)
   IGA, moderate (3), n (%)
224 (99.6)a
113 (100)
337 (99.7)a
   BSA, %, mean (SD)
7.6 (3.7)
7.5 (3.7)
7.6 (3.7)
Patients with scalp-IGA ≥1, n (%)
184 (81.8)
97 (85.8)
281 (83.1)
Previous treatments, n (%)
   Topical agents
225 (100)
113 (100)
338 (100)
   Phototherapyb,c
46 (20.5)
16 (14.3)
62 (18.5)
   Conventional systemicsb,d
31 (13.8)
15 (13.4)
46 (13.7)
   Advanced oralsb,e
11 (4.9)
4 (3.6)
15 (4.5)
Patients with ≥1 special site, n (%)
   Scalp
184 (81.8)
97 (85.8)
281 (83.1)
   Face
136 (60.4)
71 (62.8)
207 (61.2)
   Intertriginous
137 (60.9)
66 (58.4)
203 (60.1)
   Genital
99 (44.0)
49 (43.4)
148 (43.8)
Patient-reported outcomes, mean (SD)
   PSSD symptom score
   (0-100)f
53.3 (23.7)
54.9 (22.0)
53.8 (23.2)
   PSSD itch score (0-10)f
6.7 (2.2)
6.8 (2.0)
6.8 (2.2)
Abbreviations: BMI, body mass index; BSA, body surface area; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PBO, placebo; PsO, plaque psoriasis; PSSD, psoriasis symptoms and signs diary; PUVA, Psoralen plus ultraviolet A; SD, standard deviation; UVB, ultraviolet B.
aOne TREMFYA-randomized patient deviated from the inclusion criteria with a baseline IGA score of 4.
bPBO, n=112; TREMFYA, n=224; Total, N=336.
cPUVA, UVB.
dPUVA, methotrexate, cyclosporine, acitretin.
eApremilast, deucravacitinib.
fPBO, n=112; Total, N=337.
Efficacy
  • At week 16, the primary endpoint of IGA 0/1 was achieved by significantly more patients receiving TREMFYA vs PBO (74.2% vs 12.4%, P<0.001).3
  • At week 16, site-specific complete clearance was achieved by majority of patients treated with TREMFYA vs PBO (P<0.001)3:
    • ss-IGA 0, 60.3% (111/184)
  • Among patients with ss-IGA ≥3 at baseline, 75% (114/152) and 14.5% (11/76) achieved ss-IGA 0/1 response at week 16 in the TREMFYA and PBO groups, respectively (P<0.001).3,21 
Safety

Cumulative Rates of Key Safety Events through Week 163
TREMFYA
(n=225)
PBO
(n=113)
Mean duration of follow-up, weeks
15.9
15.8
Mean number of study agent administrations
2.9
2.9
≥1 AE, n (%)
85 (37.8)
45 (39.8)
≥1 SAE, n (%)
3 (1.3)a
1 (0.9)
AE leading to study drug discontinuation, n (%)
0
4 (3.5)
Common AEs, n (%)b
   Upper respiratory tract infection
16 (7.1)
3 (2.7)
   Nasopharyngitis
8 (3.6)
8 (7.1)
AEs of interest, n (%)
   Infections
50 (22.2)
23 (20.4)
      Serious infections
0
1 (0.9)
   Injection site reactions
6 (2.7)
1 (0.9)
   AEs of PsOc
0
3 (2.7)
   MACEd
1 (0.4)
0
   AEs leading to death
0
0
   IBDe
0
0
   Malignancy
0
0
   Serum-like sickness or anaphylaxis
0
0
   Tuberculosis
0
0
Abbreviations: AE, adverse event; IBD, inflammatory bowel disease; MACE, major adverse cardiovascular event; PBO, placebo; PsO, psoriasis; SAE, serious adverse event.
aOne event each of upper limb fracture, renal colic, and cerebrovascular accident.
bOccurred in at least 5% of patients in any treatment group through week 16.
cIncludes preferred terms of dermatitis psoriasiform, erythrodermic PsO, genital PsO, PsO, PsO aggravated, exacerbation of PsO, PsO flare-up, psoriatic plaque, plaque PsO, and pustular PsO.
dIncludes myocardial infarction and ischemic central nervous system vascular conditions.
eIncludes preferred terms of Crohn’s disease, ulcerative colitis, and IBD.

Strober et al (2025)4 evaluated the efficacy of TREMFYA based on high-impact site skin clearance and itch improvement through week 48 in patients with low BSA, moderate PsO in SPECTREM.

  • Patients with baseline site-specific IGA/PGA ≥3 were included, and skin clearance was assessed based on the following4:
    • ss-IGA 0/1 and ss-IGA 0

Results

Efficacy

Response Rates for Scalp-Specific IGA through Week 484

Response Rate at Week 16, %
Response Rate at Week 48, %
TREMFYA
(n=152)
PBO
(n=76)
TREMFYA (n=152)
PBO→TREMFYA (n=70)
ss-IGA 0/1
75.0a
14.5
84.9
78.6
ss-IGA 0
55.9b
6.6
75.0
67.1
Note: P-value is based on the chi-squared test and not adjusted for baseline stratification factor. NRI was used. Patients who discontinued the study agent due to lack of efficacy, worsening of PsO, or use of a prohibited PsO treatment prior to the designated visit were considered nonresponders from that point forward. Patients with missing data were considered nonresponders. For patients who were randomized to PBO at week 0, only those patients who crossed over to TREMFYA at or after week 16 were included in the PBO→TREMFYA group.
Abbreviations: IGA, Investigator’s Global Assessment; IGA 0= cleared; IGA 1=minimal; NRI, nonresponder imputation; PBO, placebo; PsO, psoriasis; ss-IGA, scalp-specific Investigator’s Global Assessment; ss-IGA 0, absence of disease; ss-IGA 1, very mild disease.
aP<0.001 TREMFYA vs PBO.bNominal P<0.001 for TREMFYA vs PBO. The endpoint was not controlled for multiple comparisons. Therefore, the P-value is nominal and statistical significance has not been established.
  • Overall, 50% of patients treated with TREMFYA achieved site-specific IGA 0 in 6-10 weeks.4
    • ss-IGA 0 (n=184): 10.0 weeks
Safety
  • TREMFYA was well tolerated; safety results through week 56 were consistent with the known safety profile of TREMFYA. No new safety signals were identified. For more details, see Table: Safety Results through Week 56.

Safety Results through Week 564
PBO→TREMFYA
(Weeks 16-56; n=104)a
TREMFYA
(Weeks 0-56; (n=225)
Mean follow-up duration, weeks
38.5
53.4
≥1 AE, n (%)
56 (53.8)
138 (61.3)
AEs leading to discontinuation of the study drug, n (%)
1 (1.0)
4 (1.8)
Serious AEs, n (%)
2 (1.9)
12 (5.3)
AEs of interest, n (%)
   Infections
42 (40.4)
85 (37.8)
   Serious infections
1 (1.0)b
2 (0.9)c
   MACEd
0
4 (1.8)e
   Malignancyf
0
2 (0.9)f
      NMSCf
0
2 (0.9)f
      Excluding NMSC
0
0
   VTE
0
1 (0.4)g
   Serum-like sickness or anaphylaxis
0
0
   Active tuberculosis
0
0
   Inflammatory bowel disease
0
0
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.
Abbreviations: AE, adverse event; MACE, major adverse cardiovascular event; MedDRA, Medical dictionary for regulatory activities; NMSC, nonmelanoma skin cancer; PBO, placebo; VTE, venous thromboembolism.
aPBO→TREMFYA column only includes PBO patients who crossed over to receive TREMFYA.
bOne patient had appendicitis.
cOne patient had pelvic abscess, and 1 patient had acute osteomyelitis of the cervical spine and sepsis.
dIncludes myocardial infarction and ischemic central nervous system vascular conditions.
eDuring weeks 0-16, 1 patient had a cerebrovascular accident; from weeks 16-56, myocardial infarction, coronary artery occlusion, and unstable angina were reported in 1 patient each.
fIncludes 2 patients with basal cell carcinoma.
gOne patient had bilateral pulmonary embolism.

VOYAGE 1

Blauvelt et al (2017)5 assessed improvement in scalp PsO in the VOYAGE 1 trial, a phase 3, randomized, double-blind, PBO and active comparator-controlled, multicenter study, evaluating the efficacy and safety of TREMFYA compared to PBO and adalimumab in 837 patients with moderate to severe plaque PsO.

Study Design/Methods

• Adult patients (≥18 years of age) with a diagnosis of plaque PsO for ≥6 months who were candidates for phototherapy or systemic therapy and had a baseline IGA score ≥3, a PASI score ≥12, and ≥10% of their BSA involved were eligible for enrollment.

VOYAGE 1 Study Design5,a

Abbreviations: IGA, Investigator’s Global Assessment; PASI 90, ≥90% improvement in Psoriasis Area and Severity Index score from baseline; q2w, every 2 weeks; q8w, every 8 weeks; R, randomization; SE, secondary endpoint.
aTo maintain blinding, both guselkumab and adalimumab placebos were administered, as necessary.
bProportions of patients achieving an IGA score of cleared/minimal disease (IGA 0/1) and PASI 90 at week 16 in the guselkumab vs placebo
group.

  • Improvement in scalp PsO was evaluated by ss-IGA (range from 0-4 [0, absence of disease; 1, very mild disease; 2, mild disease; 3, moderate disease; 4, severe disease]).

Results

Patient Characteristics

Baseline Scalp Psoriasis Characteristics - Randomized Patients in VOYAGE 15
TREMFYA
PBO
Adalimumab
Total
Randomized patients, n
329
174
334
837
ss-IGA score (0-4), n (%)
291 (88.4)
150 (86.2)
295 (88.3)
736 (87.9)
   Very mild (1), n (%)
14 (4.8)
5 (3.3)
9 (3.1)
28 (3.8)
   Mild (2), n (%)
49 (16.8)
31 (20.7)
54 (18.3)
134 (18.2)
   Moderate (3), n (%)
171 (58.8)
89 (59.3)
175 (59.3)
435 (59.1)
   Severe (4), n (%)
57 (19.6)
25 (16.7)
57 (19.3)
139 (18.9)
Abbreviation: PBO, placebo; ss-IGA, scalp-specific Investigator’s Global Assessment.
Efficacy
  • Scalp PsO outcomes at weeks 16, 24, and 48 are noted in Table: Scalp Psoriasis Outcomes at Weeks 16, 24, and 48 - Randomized Patients in VOYAGE 1.
  • The proportion of patients in the TREMFYA group achieving ss-IGA 0/1 (absent/very mild scalp PsO) was significantly higher compared with PBO (83.4% vs 14.5%, P<0.001) at week 16; significantly better responses to TREMFYA vs adalimumab were observed at weeks 24 and 48.

Scalp Psoriasis Outcomes at Weeks 16, 24, and 48 - Randomized Patients in VOYAGE 15
Week 16
Week 24
Week 48
TREMFYA
PBO
Adalimumab
TREMFYA
Adalimumab
TREMFYA
Adalimumab
Baseline ss-IGA score ≥2, n
277
145
286
277
286
277
286
   ss-IGA 0/1,a
   n (%)
231
(83.4)
21
(14.5)
201
(70.3)
234
(84.5)
198
(69.2)
217
(78.3)
173
(60.5)
Abbreviations: PBO, placebo; ss-IGA, scalp-specific Investigator’s Global Assessment.
aIncludes only patients achieving ≥2-grade improvement in ss-IGA score.
Safety
  • For the proportion of patients with an AE, AEs leading to treatment discontinuation, and ≥1 SAE through week 48, see Table: AEs Through Week 48

AEs Through Week 485 
Through Week 16
Through Week 48
TREMFYA
(n=329)
PBO
(n=174)
Adalimumab
(n=333)
TREMFYA
(n=329)
Adalimumab
(n=333)
≥1 AE, n (%)
170 (51.7)
86 (49.4)
170 (51.1)
243 (73.9)
248 (74.5)
Most common AEs (occurring in ≥5% of patients in any group), n (%)
   Nasopharyngitis
30 (9.1)
17 (9.8)
35 (10.5)
83 (25.2)
74 (22.2)
   Upper respiratory tract infection
25 (7.6)
9 (5.2)
16 (4.8)
47 (14.3)
42 (12.6)
   Injection-site erythema
6 (1.8)
1 (0.6)
15 (4.5)
8 (2.4)
22 (6.6)
   Headache
12 (3.6)
7 (4.0)
13 (3.9)
18 (5.5)
25 (7.5)
   Arthralgia
11 (3.3)
3 (1.7)
9 (2.7)
18 (5.5)
16 (4.8)
   Pruritus
5 (1.5)
10 (5.7)
7 (2.1)
8 (2.4)
12 (3.6)
   Back pain
6 (1.8)
2 (1.1)
4 (1.2)
12 (3.6)
17 (5.1)
Discontinued treatment due to AE, n (%)
4 (1.2)
2 (1.1)
3 (0.9)
9 (2.7)
12 (3.6)
≥1 SAEs, n (%)
8 (2.4)
3 (1.7)
6 (1.8)
16 (4.9)
15 (4.5)
Infections, n (%)
85 (25.8)
44 (25.3)
85 (25.5)
172 (52.3)
167 (50.2)
   Requiring treatment
20 (6.1)
13 (7.5)
24 (7.2)
54 (16.4)
60 (18.0)
   Serious infections
0
0
2 (0.6)
2 (0.6)
3 (0.9)
Malignancies, n (%)
0
0
0
2 (0.6)a
0
NMSCb, n (%)
1 (0.3)
0
0
2 (0.6)
1 (0.3)
MACEc, n (%)
1 (0.3)
0
1 (0.3)
1 (0.3)
1 (0.3)
Abbreviations: AEs, adverse events; MACE, major cardiovascular events; MI, myocardial infarction; NMSC, nonmelanoma skin cancer; PBO, placebo; SAEs, serious adverse events.
aIncludes malignancies other than NMSC (i.e. prostate and breast cancer).
bIncludes 3 basal cell carcinomas.
cIncludes sudden cardiac death, MI, and stroke.
  • Through week 48, injection-site reactions (ISRs) occurred in 2.2% of patients receiving TREMFYA and in 9.0% of patients receiving adalimumab. Most ISRs were deemed as mild.

VOYAGE 2

Reich et al (2017)6 assessed improvement in scalp PsO in the VOYAGE 2 trial, a phase 3, multicenter, randomized, double-blind, PBO- and active comparator-controlled study, evaluating the efficacy and safety of TREMFYA compared to PBO and adalimumab in 992 patients with moderate to severe plaque PsO.

Study Design/Methods

  • Adult patients (≥18 years of age) with a diagnosis of plaque PsO for ≥6 months who were candidates for phototherapy or systemic therapy, and had a baseline IGA score ≥3, a PASI score ≥12, and ≥10% of their BSA involved were eligible for enrollment.
  • The study design is shown in Figure: VOYAGE 2 Study Design.

VOYAGE 2 Study Design6,a

Abbreviations: IGA, Investigator’s Global Assessment; Nonres, nonresponders; PASI 90, ≥90% improvement in Psoriasis Area and Severity
Index score from baseline; q2w, every 2 weeks; q8w, every 8 weeks; R, randomization; Res, responders; SE, secondary endpoint.
aTo maintain blinding, both guselkumab and adalimumab placebos were administered, as necessary.
bAt week 28, guselkumab-treated patients achieving ≥PASI 90 from baseline were randomized in a 1:1 ratio to guselkumab or placebo.
cUpon loss of ≥50% of week-28 PASI 90 response, patients were retreated with guselkumab.
dPatients with <PASI 90.
ePatients with ≥PASI 90 from baseline at week 28.
fGuselkumab was started at week 28 (5 weeks after the last dose of adalimumab).
gProportions of patients achieving an IGA score of cleared/minimal disease (IGA 0/1) and PASI 90 at week 16 in the guselkumab group.

  • Improvement in scalp PsO was evaluated by ss-IGA.

Results

Patient Characteristics

Baseline Scalp Psoriasis Characteristics - Randomized Patients in VOYAGE 26
TREMFYA
PBO
Adalimumab
Total
Randomized patients, n
496
248
248
992
ss-IGA score (0-4), n (%)
423 (85.3)
212 (85.5)
205 (82.7)
840 (84.7)
   Absence of disease (0), n (%)
0 (0.0)
0 (0.0)
0 (0.0)
0 (0.0)
   Very mild (1), n (%)
15 (3.5)
10 (4.7)
11 (5.4)
36 (4.3)
   Mild (2), n (%)
80 (18.9)
33 (15.6)
43 (21.0)
156 (18.6)
   Moderate (3), n (%)
267 (63.1)
133 (62.7)
118 (57.6)
518 (61.7)
   Severe (4), n (%)
61 (14.4)
36 (17.0)
33 (16.1)
130 (15.5)
Abbreviations: PBO, placebo; ss-IGA, scalp-specific Investigator’s Global Assessment.
Efficacy

Scalp Psoriasis Outcomes at Weeks 16 and 24 - Randomized Patients in VOYAGE 26
Week 16
Week 24
TREMFYA
PBO
Adalimumab
TREMFYA
Adalimumab
Baseline ss-IGA score ≥2, n
408
202
194
408
194
   ss-IGA 0/1,a n (%)
329 (80.6)
22 (10.9)
130 (67.0)
348 (85.3)
131 (67.5)
Abbreviations: PBO, placebo; ss-IGA, scalp-specific Investigator’s Global Assessment.
aIncludes only patients achieving ≥2-grade improvement in ss-IGA score.
Safety

For the proportion of patients with AE, AEs leading to treatment discontinuation, and ≥1 SAE through week 48, see Table: AEs Through Week 48.


AEs Through Week 485 
PBO-Controlled Period
(Weeks 0-16)
Active Comparator Period
(Weeks 0-28)
Randomized Withdrawal and Retreatment Period
(Weeks 28-48)
TREMFYA
(n=494)
PBO
(n=248)
Adalimumab
(n=248)
TREMFYA
(n=494)
Adalimumab
(n=248)
PBO→TREMFYAa
(n=233)
Maintenance Groupb
(n=192)
Withdrawal Groupc
(n=182)
≥1 AE
235 (47.6)
111 (44.8)
120 (48.4)
288 (58.3)
156 (62.9)
78 (33.5)
99 (51.6)
81 (44.5)
Common AEs (occurring in ≥5% of patients in any group)
   Nasopharyngitis
35 (7.1)
16 (6.5)
20 (8.1)
51 (10.3)
34 (13.7)
12 (5.2)
22 (11.5)
23 (12.6)
   Headache
25 (5.1)
7 (2.8)
5 (2.0)
29 (5.9)
9 (3.6)
5 (2.1)
3 (1.6)
2 (1.1)
   URTI
16 (3.2)
10 (4.0)
4 (1.6)
25 (5.1)
10 (4.0)
5 (2.1)
9 (4.7)
10 (5.5)
D/C treatment due to AE
7 (1.4)
2 (0.8)
4 (1.6)
11 (2.2)
6 (2.4)
1 (0.4)
0 (0.0)
0 (0.0)
≥1 SAEs
8 (1.6)
3 (1.2)
6 (2.4)
18 (3.6)
9 (3.6)
4 (1.7)
2 (1.0)
3 (1.6)
Infections
106 (21.5)
46 (18.5)
58 (23.4)
153 (31.0)
87 (35.1)
41 (17.6)
55 (28.6)
50 (27.5)
   Requiring treatment
35 (7.1)
17 (6.9)
19 (7.7)
58 (11.7)
29 (11.7)
19 (8.2)
23 (12.0)
9 (4.9)
   Serious infections
1 (0.2)
1 (0.4)
2 (0.8)
3 (0.6)
3 (1.2)
1 (0.4)
1 (0.5)
0 (0.0)
Malignanciesd
0 (0.0)
0 (0.0)
0 (0.0)
1 (0.2)
0 (0.0)
0 (0.0)
0 (0.0)
0 (0.0)
NMSCe
0 (0.0)
0 (0.0)
0 (0.0)
1 (0.2)
0 (0.0)
1 (0.4)
0 (0.0)
0 (0.0)
MACEf
0 (0.0)
0 (0.0)
0 (0.0)
1 (0.2)
1 (0.4)
0 (0.0)
0 (0.0)
0 (0.0)
Note: Data presented as n (%).
Abbreviations: AEs, adverse events; D/C, discontinued; MACE, major cardiovascular events; MI, myocardial infarction; NMSC, nonmelanoma skin cancer; PASI, Psoriasis Area and Severity Index; PBO, placebo; q8w, every 8 weeks; SAEs, serious adverse events; URTI, upper respiratory tract infection.
aWeeks 16 to 28
bIncludes TREMFYA week-28 PASI 90 responders rerandomized at week 28 to continue TREMFYA 100 mg q8w.
cIncludes TREMFYA week-28 PASI 90 responders rerandomized at week 28 to PBO (withdrawal), then retreated withTREMFYA 100 mg q8w after 50% or more loss of week 28 PASI 90 response.
dIncludes malignancies other than NMSC (prostate cancer, n=1).
eIncludes basal cell and squamous cell carcinomas.
fIncludes sudden cardiac death, MI, and stroke.
  • Injection-site reactions occurred in 2.6% of patients receiving TREMFYA compared to 6.9% of patients receiving adalimumab during the PBO-controlled period (weeks 0-16).
  • No AEs were reported among the 16 patients who were retreated during randomized withdrawal and retreatment period (Weeks 28-48).
  • Additional safety through week 48 included:
    • One additional NMSC occurred in the PBO→TREMFYA group.
    • One additional MACE (myocardial infarction) was reported in the PBO→TREMFYA group.
    • No serious infections, malignancies, or MACE occurred in the adalimumab→TREMFYA group.
    • No deaths, opportunistic infections, hypersensitivities, or anaphylactic reactions occurred through week 48.

Sonkoly et al (2022)7 evaluated efficacy of TREMFYA in a post hoc analysis of VOYAGE 2 in patients with moderate to severe PsO and scalp disease at baseline.

Study Design/Methods

  • For the VOYAGE 2 study design, please refer to Figure: VOYAGE 2 Study Design.
  • Patients randomized to receive TREMFYA with moderate to severe PsO and scalp disease at baseline were assigned to the following groups:
    • TREMFYA responder (R) Continuation included patients with a PASI 90 response at week 28 and randomized to continue TREMFYA treatment (n=159).
    • TREMFYA nonresponder (NR) Continuation included patients without a PASI 90 response at week 28 and continued TREMFYA treatment (n=84).
    • TREMFYA R Withdrawal included patients with a PASI 90 response at week 28 and re-randomized to PBO (n=164).
  • Total PASI (range: 0-72), PASI head (range: 0-7.2), ss-IGA (range: 0-4) and Dermatology Life Quality Index (DLQI; range: 0-30) scores were assessed at weeks 0, 16, 24 and 48.

Results

Patient Characteristics

Baseline Characteristics Among Patients Randomized to Receive TREMFYA with Scalp Psoriasis7
TREMFYA R Continuation
TREMFYA NR Continuation
TREMFYA R Withdrawal
Randomized patients, n
159
84
164
Male, %
65.4
76.2
73.8
BMI, kg/m2, mean(SD)
29.5 (6.1)
31.1 (6.6)
28.7 (6.3)
Current or former smoker, %
51.6
44.0
51.8
Previous biologic use, %
17.6
28.6
20.1
Comorbid PsA
15.7
20.2
19.5
PsO duration, years, mean (SD)
18.1 (11.9)
18.2 (11.1)
17.8 (11.8)
PASI score, mean (SD)
21.9 (8.6)
21.5 (9.1)
22.6 (9.0)
ss-IGA score, mean (SD)
2.9 (0.7)a
2.8 (0.7)c
2.9 (0.7)d
DLQI score, mean (SD)
14.9 (6.3)b
15.3 (7.9)
14.8 (6.5)
Abbreviations: BMI, body mass index; DLQI, Dermatology Life Quality Index; NR, nonresponder (patient not achieving PASI 90 at week 28); PASI, Psoriasis Area and Severity Index; PASI 90, ≥90% improvement in Psoriasis Area and Severity Index score from baseline; PsA, psoriatic arthritis; PsO, psoriasis; R, responder (patient achieving PASI 90 at week 28); SD, standard deviation; ss-IGA, scalp-specific Investigator’s Global Assessment.
an=157.
bn=158.
cn=83.
dn=162.
Efficacy

Clinical Outcomes through Week 48 - Post Hoc Analysis of VOYAGE 27
TREMFYA R Continuationa
TREMFYA NR Continuationb
TREMFYA R Withdrawalc
Mean ss-IGA score
   Week 0
2.9
2.8
2.9
   Week 24
0.2
0.7
0.2
   Week 48
0.3
0.6
1.3
Mean PASI score
   Week 0
21.9
21.5
22.6
   Week 24
0.6
4.3
0.6
   Week 48
1.0
4.3
4.8
Mean DLQI score
   Week 0
14.9
15.3
14.8
   Week 24
2.1
4.3
2.2
   Week 48
1.9
3.9
5.9
Abbreviations: DLQI, Dermatology Life Quality Index; NR, nonresponder (patient not achieving PASI 90 at week 28); PASI, Psoriasis Area and Severity Index; PASI 90, ≥90% improvement in Psoriasis Area and Severity Index score from baseline; PBO, placebo; R, responder (patient achieving PASI 90 at week 28); ss-IGA, scalp-specific Investigator’s Global Assessment.
aIncluded patients with a PASI 90 response at week 28 and randomized to continue TREMFYA through week 48.
bIncluded patients without a PASI 90 response at week 28 and continued TREMFYA through week 48.
cIncluded patients with a PASI 90 response at week 28 and randomized to receive PBO starting at week 28 through week 48.

POOLED EFFICACY AND SAFETY ANALYSIS

Orbai et al (2023)8,9conducted a post hoc analysis evaluating the efficacy and safety of TREMFYA on regional PsO in a subgroup of patients with self-reported PsA from VOYAGE 1 and VOYAGE 2.

Study Design/Methods

  • For the VOYAGE 1 and VOYAGE 2 study designs, please refer to Figures: VOYAGE 1 Study Design and VOYAGE 2 Study Design.
  • The coprimary endpoints in both studies were IGA 0/1 and PASI 90 at week 16. Improvement in scalp PsO was assessed using ss-IGA at weeks 16 and 24.

Results

Patient Characteristics

Select Baseline Demographics and Clinical Characteristics of Patients with Self-Reported PsA in the Pooled Analysis9
TREMFYA
(n=153)
PBO
(n=76)
Adalimumab
(n=106)
Total
(N=335)
Age, years, mean (SD)
47.5 (11.0)
47.9 (11.1)
43.4 (10.8)
46.3 (11.1)
Male, n (%)
100 (65.4)
55 (72.4)
72 (67.9)
227 (67.8)
BMI, kg/m2, mean (SD)
30.0 (6.0)
28.6 (5.4)
30.6 (7.5)a
29.9 (6.4)
PASI score (0-72), mean (SD)
25.1 (11.3)
22.7 (9.5)
24.2 (10.0)
24.3 (10.5)
ss-IGA score (0-4), n
135
67
95
297
   Cleared (0), n (%)
0
0
0
0
   Very mild (1), n (%)
6 (4.4)
1 (1.5)
1 (1.1)
8 (2.7)
   Mild (2), n (%)
22 (16.3)
7 (10.4)
20 (21.1)
49 (16.5)
   Moderate (3), n (%)
87 (64.4)
48 (71.6)
59 (62.1)
194 (65.3)
   Severe (4), n (%)
20 (14.8)
11 (16.4)
15 (15.8)
46 (15.5)
Abbreviations: BMI, body mass index; PASI, Psoriasis Area and Severity Index; PBO, placebo; PsA, psoriatic arthritis; SD, standard deviation; ss-IGA, scalp-specific Investigator’s Global Assessment.
aThe number of patients with available BMI for adalimumab was 105.
Efficacy

Proportion of Patients Achieving an ss-IGA 0/1 and ss-IGA 0 at Week 16 and Week 248
TREMFYA
(n=129)
PBO
(n=66)
Adalimumab
(n=94)
Week 16
   ss-IGA 0/1, %
80.6a
22.7
66.0b
   ss-IGA 0, %
63.6a
16.7
55.3b
Week 24
   ss-IGA 0/1, %
77.5
-
58.5c
   ss-IGA 0, %
62.8
-
45.7c
Abbreviations: PBO, placebo; ss-IGA, scalp-specific Investigator’s Global Assessment.
aNominal P-value <0.001 for PBO vs TREMFYA. The endpoint was not controlled for multiple comparisons. Therefore, the P-value is nominal and statistical significance has not been established.
bNominal P-value <0.001 for PBO vs adalimumab. The endpoint was not controlled for multiple comparisons. Therefore, the P-value is nominal and statistical significance has not been established.
cNominal P-value <0.05 for PBO vs adalimumab. The endpoint was not controlled for multiple comparisons. Therefore, the P-value is nominal and statistical significance has not been established.
Safety

AEs Through Week 28 in VOYAGE 1 and 29 
PBO-Controlled Period
(Weeks 0-16)
Active Comparator Period
(Weeks 0-28)
TREMFYA
(n=153)
PBO
(n=76)
Adalimumab
(n=106)
TREMFYA
(n=153)
Adalimumab
(n=106)
≥1 AE
69 (45.1)
31 (40.8)
53 (50.0)
87 (56.9)
69 (65.1)
≥1 SAE
3 (2.0)
1 (1.3)
4 (3.8)
5 (3.3)
6 (5.7)
Discontinued treatment due to AE
6 (3.9)
2 (2.6)
2 (1.9)
6 (3.9)
3 (2.8)
≥1 infections
29 (19.0)
16 (21.1)
29 (27.4)
40 (26.1)
40 (37.7)
   Serious infections
0
0
1 (0.9)
1 (0.7)
1 (0.9)
Candida infection
0
0
0
0
0
TB
0
0
0
0
0
NMSC
0
0
0
0
0
Malignanciesa
0
0
0
0
0
MACEb
0
0
1 (0.9)
0
1 (0.9)
Deaths
0
0
0
0
0
Note: Data presented as n (%).
Abbreviations: AEs, adverse events; MACE, major cardiovascular events; MI, myocardial infarction; NMSC, nonmelanoma skin cancer; PBO, placebo; SAEs, serious adverse events; TB, tuberculosis.
aExcludes NMSC
bIncludes sudden cardiac death, MI, and stroke.

Jo et al (2023)10 conducted a post hoc analysis evaluating the efficacy of TREMFYA for the treatment of PsO in difficult-to-treat regions, specifically in the Asian subpopulation (Taiwan and South Korea) from VOYAGE 1 and VOYAGE 2.

Study Design/Methods

  • For the VOYAGE 1 and VOYAGE 2 study designs, please refer to Figures: VOYAGE 1 Study Design and VOYAGE 2 Study Design.
  • The TREMFYA and adalimumab groups were compared with the PBO group at week 16, and the active treatment groups (TREMFYA vs adalimumab) were compared at week 24. Patients who crossed over from PBO to TREMFYA were excluded from the week 24 analysis.
  • Efficacy was also evaluated in a pooled subset of patients with or without prior biologic experience from baseline through week 24.
  • Endpoint included the proportion of patients achieving clear/near-clear status (scores of 0/1) for ss-IGA (used for grading scalp PsO) at weeks 16 and 24.

Results

Patient Characteristics

Select Baseline Demographics and Disease Characteristics of Randomized Asian Patients10
TREMFYA
(n=94)
PBO
(n=45)
Adalimumab
(n=60)
Age, years, mean (SD)
41.2 (12.20)
42.6 (11.75)
38.1 (10.14)
Male, n (%)
73 (77.7)
31 (68.9)
50 (83.3)
BMI, kg/m2, mean (SD)
26.6 (5.19)
26.1 (4.18)
27.8 (4.59)
Duration of PsO, years, mean (SD)
15.3 (9.84)
12.6 (6.32)
12.1 (7.10)
PASI (0-72), mean (SD)a
24.7 (9.01)
24.6 (9.20)
26.8 (12.61)
ss-IGA score, n
88
40
54
   Very mild, n (%)
4 (4.5)
3 (7.5)
2 (3.7)
   Mild, n (%)
27 (30.7)
14 (35.0)
13 (24.1)
   Moderate, n (%)
40 (45.5)
15 (37.5)
33 (61.1)
   Severe, n (%)
17 (19.3)
8 (20.0)
6 (11.1)
Abbreviations: BMI, body mass index; PASI, Psoriasis Area and Severity Index; PBO, placebo; PsO, psoriasis; SD, standard deviation; ss-IGA, scalp-specific Investigator’s Global Assessment.
aScores range from 0 to 72, with lower scores indicating less severe disease.
bA score of 0 or 1 indicates no effect of PsO or its treatment on health-related quality of life.
Efficacy

Proportion of Asian Patients Achieving an ss-IGA 0/1 and ss-IGA 0 for Regional PsO at Weeks 16 and 2410
TREMFYA
PBO
Adalimumab
ss-IGA ≥2 from baseline, n
84
37
52
Week 16
   ss-IGA 0/1, n (%)
72 (85.7)a
7 (18.9)
35 (67.3)b
   ss-IGA 0, n (%)
42 (50.0)a
2 (5.4)
-
Week 24
   ss-IGA 0/1, n (%)
72 (85.7)
-
35 (67.3)c
   ss-IGA 0, n (%)
48 (57.1)
-
20 (38.5)c
   Biologic naïve
      ss-IGA 0, n
62
-
37
   Biologic experienced
      ss-IGA 0, n
22
-
15
Abbreviations: PBO, placebo; PsO, psoriasis; ss-IGA, scalp-specific Investigator’s Global Assessment.
aNominal P-value <0.001 for PBO vs TREMFYA. The endpoint was not controlled for multiple comparisons. Therefore, the P-value is nominal and statistical significance has not been established.
bNominal P-value <0.001 for PBO vs adalimumab. The endpoint was not controlled for multiple comparisons. Therefore, the P-value is nominal and statistical significance has not been established.
cNominal P-value <0.05 for PBO vs adalimumab. The endpoint was not controlled for multiple comparisons. Therefore, the P-value is nominal and statistical significance has not been established.
Safety
  • The proportion of Asian patients treated with TREMFYA, adalimumab, and PBO experiencing ≥1 AEs through week 28 was 60.6%, 40.0%, 50.0%, respectively.10
    • Most AEs in patients treated with TREMFYA included, nasopharyngitis and upper respiratory tract infection.

LITERATURE SEARCH

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 3 February 2026.

 

References

Show
1 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.  
2 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.  
3 Gold LS, Gottlieb AB, Armstrong AW, et al. SPECTREM phase 3b clinical trial results through week 16: guselkumab efficacy and safety for the treatment of low body surface area, moderate psoriasis with high-impact site involvement. Br J Dermatol. 2026;194:25-36.  
4 Strober B, Papp KA, Armstrong AW, et al. SPECTREM: high-impact site skin clearance and itch improvement through week 48 with guselkumab in participants with low body surface area, moderate psoriasis. Poster presented at: Fall Clinic Dermatology Conference; October 23-26, 2025; Las Vegas, NV.  
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.  
7 Sonkoly E, Maul J, Fabbrocini G, et al. Guselkumab in patients with scalp psoriasis: a post hoc analysis of the VOYAGE 2 trial. Poster presented at: American Academy of Dermatology Annual Meeting 2023; March 17-21, 2023; New Orleans, LA.  
8 Orbai AM, Chakravarty SD, You Y, et al. Efficacy of guselkumab in treating nails, scalp, hands, and feet in patients with psoriasis and self-reported psoriatic arthritis. Dermatol Ther (Heidelb). 2023;13(11):2859-2868.  
9 Orbai AM, Chakravarty SD, You Y, et al. Supplement to: Efficacy of guselkumab in treating nails, scalp, hands, and feet in patients with psoriasis and self-reported psoriatic arthritis. Dermatol Ther (Heidelb). 2023;13(11):2859-2868.  
10 Jo SJ, Huang YH, Tsai TF, et al. Efficacy of guselkumab in difficult-to-treat psoriasis regions: data from VOYAGE 1 and VOYAGE 2 Asian subpopulations. J Dermatol. 2023;50(9):1180-1189.  
11 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.  
12 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.  
13 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.  
14 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.  
15 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.  
16 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.  
17 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.  
18 Gottlieb A, Krueger J, Gordon K, et al. SPECTREM: guselkumab demonstrates significant clearance at week 16 across special sites in participants with low body surface area, moderate psoriasis. Poster presented at: Fall Clinical Dermatology Conference; October 24-27, 2024; Las Vegas, NV.  
19 Soung J, Kelley V, Wiseman M, et al. SPECTREM: guselkumab significantly improves patient reported outcomes at week 16 in participants with low body surface area moderate psoriasis with special site involvement. Poster presented at: Fall Clinical Dermatology Conference; October 24-27, 2024; Las Vegas, NV.  
20 Janssen Research & Development, LLC. Study of guselkumab versus placebo for the treatment of low body surface area moderate plaque psoriasis (SPECTREM). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 July 18]. Available from: https://clinicaltrials.gov/study/NCT06039189 NLM Identifier: NCT06039189.  
21 Gold LS, Gottlieb AB, Armstrong AW, et al. Supplement to: SPECTREM phase 3b clinical trial results through week 16: guselkumab efficacy and safety for the treatment of low body surface area, moderate psoriasis with high-impact site involvement. Br J Dermatol. 2026;194:25-36.