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TREMFYA® (guselkumab)

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TREMFYA - Treatment of Scalp Psoriasis

Last Updated: 05/09/2025

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^-¹⁶

CLINICAL DATA

VISIBLE

McMichael et al (2023 and 2024)¹^,² and Alexis et al (2024)³^,⁴ presented data through week 16 and 48 from VISIBLE, a phase 3b, large-scale, prospective, double-blind, randomized clinical trial evaluating the efficacy and safety of TREMFYA compared with placebo 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 follows⁵:
- 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, and at least one plaque outside of the scalp at screening and at baseline.
Select exclusion criteria: non-plaque form of PsO (eg, erythrodermic, guttate, or pustular); receipt of ustekinumab, ixekizumab, secukinumab, or brodalumab within 12 weeks of first dose of 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 the 2 months before screening.⁵
The study design is shown in Figure: VISIBLE Study Design.

VISIBLE Study Design¹^,⁶

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; 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

A total of 103 patients were included in cohort A with 82 patients reporting scalp PsO at baseline. Of these, 77 patients had at least mild scalp PsO (ss-IGA 2 [mild, 22.1%]; 3 [moderate, 63.6%]; and 4 [severe, 14.3%]), mean baseline PSSI score (0-72) of 21.2, mean SSA of 33% and mean scalp itch numeric rating scale (NRS; 0-10) of 6.9.¹^,²
Baseline disease and clinical characteristics of patients with scalp PsO in cohort A are given in Table: Select Baseline Disease and Clinical Characteristics of Cohort A.

Select Baseline Disease and Clinical Characteristics of Cohort A¹

	TREMFYA	Placebo	Total
Full analysis set with baseline ss-IGA ≥2
Number of patients, n	57	20	77
Age at diagnosis, years, mean (SD)	29.1 (12.64)	25.2 (15.15)	28.1 (13.35)
PsO duration, years, mean (SD)	13.1 (9.48)	15.5 (9.22)	13.7 (9.41)
PASI (0-72), mean (SD)	22.7 (10.79)	20.0 (6.67)	22.0 (9.92)
IGA, n (%)
Moderate (3)	42 (73.7)	16 (80.0)	58 (75.3)
Severe (4)	15 (26.3)	4 (20.0)	19 (24.7)
PSSI (0-72), mean (SD)	21.6 (14.25)	20.3 (9.12)	21.2 (13.07)
ss-IGA, n (%)
Mild (2)	11 (19.3)	6 (30.0)	17 (22.1)
Moderate (3)	36 (63.2)	13 (65.0)	49 (63.6)
Severe (4)	10 (17.5)	1 (5.0)	11 (14.3)
Abbreviations: IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PsO, psoriasis; PSSI, Psoriasis Scalp Severity Index; SD, standard deviation; ss-IGA, scalp-specific Investigator’s Global Assessment.

Efficacy

Scalp PsO outcomes at weeks 4, 12, and 16 are given in Table: Scalp PsO Results Among Patients with At Least Mild Scalp PsO at Baseline through Week 16.

Scalp PsO Results Among Patients with At Least Mild Scalp PsO^a at Baseline through Week 16¹^,²

	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) SSA^b	-29.8; P<0.001	-14.2
Change from baseline (LS Mean) Scalp Itch NRS Score at Week 16^d	-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. ^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; participants 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. Participants with missing data were considered nonresponders. ^dLS Means and P-value were based on ANCOVA. Zero change was assigned after participants discontinued study agent due to lack of efficacy/worsening of psoriasis or initiated a prohibited psoriasis treatment. Missing data were not explicitly imputed.

Results: Cohort B - Moderate to Severe Scalp PsO

Patient Characteristics

Cohort B included a total of 108 patients with 102 patients correctly randomized in the efficacy analysis population and all randomized patients (n=108) to the safety analysis population. Baseline characteristics are described in Table: Baseline Demographics and Disease Characteristics of Cohort B (Efficacy Analysis Set).

Baseline Demographics and Disease Characteristics of Cohort B (Efficacy Analysis Set)⁴

	TREMFYA (n=76)	Placebo (n=26)	Total (N=102)
Age, years, mean (SD)	42.9 (13.9)	41.1 (13.1)	42.5 (13.6)
Male, n (%)	40 (52.6)	18 (69.2)	58 (56.9)
BMI, kg/m², mean (SD)	31.6 (8.2)	28.3 (6.3)	30.8 (7.9)
Fitzpatrick Skin Type, n (%)
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, %
Hispanic or Latino	40.8	30.8	-
Asian	35.5	46.2	-
Black	10.5	11.5	-
Middle Eastern	5.3	3.8	-
Multiracial	5.3	7.7	-
American Indian or Alaska Native	1.3	-	-
Other	1.3	-	-
PsO disease duration, years, mean (SD)	11.3 (9.8)	11.3 (12.8)	11.3 (10.6)
ss-IGA, n (%)
Moderate (3)	64 (84.2)	20 (76.9)	84 (82.4)
Severe (4)	12 (15.8)	6 (23.1)	18 (17.6)
PSSI (0-72), mean (SD)	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 (%)
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 (0-72), mean (SD)	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)
Abbreviations: BMI, body mass index; BSA, body surface area; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PsO, plaque psoriasis; PSSI, Psoriasis Scalp Severity Index; SD, standard deviation; SSA, scalp surface area; ss-IGA, scalp-specific Investigator’s Global Assessment.

Efficacy

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 placebo (n=26; 11.5% and 3.8%; P<0.001).
Major secondary endpoints are described in Table: Major Secondary Endpoints of Cohort B at Week 16.

Major Secondary Endpoints of Cohort B at Week 16⁴

	TREMFYA	Placebo
	n=75	n=25
Improvement from baseline (LS Mean) PSSI,^a %	87.6; P<0.001	37.8
	n=76	n=26
Patients who achieved ss-IGA 0,^b%	57.9; P<0.001	3.8
Patients who achieved PSSI 100,^b%	59.2; P<0.001	3.8
	n=75	n=23
Improvement from baseline (LS Mean) SSA,^a%	86.6; P<0.001	33.4
Abbreviations: CMH, Cochran-Mantel-Haenszel; LS, least square; MMRM, mixed-effect model repeated measures; PsO, psoriasis; PSSI, Psoriasis Scalp Severity Index; PSSI 100, 100% improvement in PSSI; 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). 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, and patients with missing data were considered nonresponders.

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 placebo→TREMFYA crossover group.⁷
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 placebo→TREMFYA crossover group.
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 placebo→TREMFYA crossover group.

Safety

Through week 16, 35.8% (29/81) of patients receiving TREMFYA and 11.1% (3/27) of patients receiving placebo reported at least 1 AE.⁴
- Infections were reported in 14.8% (12/81) of patients receiving TREMFYA and in 3.7% (1/27) of patients receiving placebo.
- Serious infection was reported in 3.7% (1/27) of patients receiving placebo.
- At least 1 SAE was reported in 3.7% (1/27) of patients receiving placebo compared to 0 events reported in patients receiving TREMFYA.
- At least 1 injection site reaction was reported in 1.2% (1/81) of patients receiving TREMFYA compared to 0 events reported in patients receiving placebo.
Through week 48, 63.0% (51/81) of patients receiving TREMFYA and 37.5% (9/24) of patients in the placebo→TREMFYA crossover group reported at least 1 AE.⁷
- Infections were reported in 33.3% (27/81) of patients receiving TREMFYA and in 16.7% (4/24) of patients in the placebo→TREMFYA crossover group.
- At least 1 SAE was reported in 2.5% (2/81) of patients receiving TREMFYA.
- At least 1 injection site reaction was reported in 1.2% (1/81) of patients receiving TREMFYA and compared to 0 events reported in the placebo→TREMFYA crossover group.
Through week 48, there were no cases of serious infections, deaths, malignancies, active, MACE, IBD, and serum-sickness or anaphylaxis reported in either of the groups.

SPECTREM

Gold et al (2024),⁸ Gottlieb et al (2024),⁹ and Soung et al (2024)¹⁰ reported week 16 results from SPECTREM, a multicenter, double-blind, randomized, phase 3b clinical trial evaluating the safety and efficacy of TREMFYA vs placebo in adult patients with low BSA, moderate plaque PsO with ≥1 special site involvement.

Study Design/Methods

Key inclusion criteria are as follows⁸^,¹¹:
- Patients (≥18 years of age) with a diagnosis of plaque PsO (with or without PsA) established at least 6 months prior to administration of the study intervention
- IGA=3
- BSA=2-15%, with ≥1 plaque outside of the special site(s)
- Involvement of ≥1 special site with at least moderate severity (scalp with ss-IGA ≥3, face with facial IGA ≥3, intertriginous with intertriginous psoriasis IGA ≥3, or genital with Static Physician’s Global Assessment of Genitalia [sPGA-G] ≥3)
- Inadequately controlled with or intolerant of at least 1 prior topical therapy for treatment of PsO
Key exclusion criteria are as follows¹¹:
- Non-plaque form of PsO (eg, erythrodermic, guttate, or pustular)
- Patients with palmoplantar involvement with confounding diagnoses
- Biologic-experienced for treatment of PsO, PsA, or any other indications that could impact the assessment of PsO
Primary and secondary outcome measures are described in Table: SPECTREM Clinical Trial Outcome Measures.

SPECTREM Clinical Trial Outcome Measures¹¹

Outcome Measures	Time Frame
Primary Outcome Measure
Percentage of patients who achieved an IGA score of cleared (0) or minimal (1)	Week 16
Secondary Outcome Measures
Percentage of patients who achieved an IGA score of cleared (0)	Week 16
Percentage of patients who achieved a PASI 90 response	Week 16
Change from baseline in the total PASI score	Week 16
Change from baseline in BSA affected with PsO	Week 16
Percentage of patients who achieved a PASI 100 response	Week 16
Percentage of patients who achieved an ss-IGA score of absence of disease (0) or very mild disease (1) among patients with an ss-IGA score of ≥3 at baseline	Week 16
Percentage of patients who achieved an sPGA-G score of clear (0) or minimal (1) among patients with an sPGA-G score of ≥3 at baseline	Week 16
Percentage of patients who achieved an i-IGA score of clear (0) or minimal (1) among patients with an i-IGA score of ≥3 at baseline	Week 16
Percentage of patients who achieved an f-IGA score of clear (0) or minimal (1) among patients with an f-IGA score of ≥3 at baseline	Week 16
Change from baseline in the PSSD total symptom score	Week 16
Percentage of patients with a ≥4-point reduction from baseline in the PSSD itch score among patients with a PSSD itch score of ≥4 at baseline	Week 16
Percentage of patients with a PSSD individual symptom scale score of 0 among patients with a baseline PSSD symptom score of >0	Week 16
Number of patients with AEs	Up to Week 56
Number of patients with SAEs	Up to Week 56
Note: Additional details regarding study outcome definitions can be found on clinicaltrials.gov. Abbreviations: AE, adverse event; BSA, body surface area; f-IGA, facial Investigator’s Global Assessment; IGA, Investigator’s Global Assessment; i-IGA, intertriginous Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PASI 100, 100% improvement in the Psoriasis Area and Severity Index from baseline; PsO, psoriasis; PSSD, psoriasis symptoms and signs diary; SAE, serious adverse event; 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 placebo (n=113) subcutaneously at weeks 0 and 4 and then every 8 weeks, with placebo crossover to TREMFYA at week 16.⁸
Baseline characteristics are described in Table: Baseline Demographics and Clinical Characteristics (Full Analysis Set).⁸^-¹⁰

Baseline Demographics and Clinical Characteristics (Full Analysis Set)⁸^-¹⁰

	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)
BSA, mean (SD)	7.6 (3.7)	7.5 (3.7)	7.6 (3.7)
Previous treatments, n (%)
Topical agents^b	225 (100)	113 (100)	338 (100)
Phototherapy^c,d	46 (20.5)	16 (14.3)	62 (18.5)
Conventional systemics^c,e	31 (13.8)	15 (13.4)	46 (13.7)
Advanced orals^c,f	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)^g	53.3 (23.7)	54.9 (22.0)	53.8 (23.2)
PSSD itch score (0-10)^g	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. ^bTopical, anthralin, keratolytics, tar. ^cPBO, n=112; TREMFYA, n=224; Total, N=336. ^dPUVA, UVB. ^ePUVA, methotrexate, cyclosporine, acitretin. ^fApremilast, deucravacitinib. ^gPBO, n=112.

Efficacy

At week 16, the primary endpoint of IGA 0/1 was achieved by significantly more patients receiving TREMFYA than those receiving the placebo (74% [167/225] vs 12% [14/113]; P<0.001).⁸
At week 16, a major secondary endpoint of the percentage of patients with ss-IGA ≥3 at baseline who achieved ss-IGA 0/1 was 75% (114/152) in the TREMFYA group, and 14% (11/76) in the placebo group (P<0.001).⁸^-¹⁰
- The P-value was based on the chi-squared test and was not adjusted for a baseline stratification factor. Nonresponder imputation was used; patients who discontinued the study agent due to lack of efficacy, worsening of PsO, or receipt of a prohibited PsO therapy prior to the designated visit were considered nonresponders from that point forward. Patients with missing data were considered nonresponders.

Safety

Cohort A

Through week 16, 37.7% (29/77) of patients receiving TREMFYA and 19.2% (5/26) of patients receiving placebo reported ≥1 adverse event (AE).¹
- Infection was reported in 20.8% (16/77) of patients receiving TREMFYA and 11.5% (3/26) of patients receiving placebo.
- One patient (1.3%) discontinued TREMFYA due to impetigo and atopic dermatitis.
Through week 16, there were no cases of serious infections, deaths, malignancies including nonmelanoma skin cancer (NMSC), active tuberculosis (TB), major adverse cardiovascular events (MACE), and inflammatory bowel disease (IBD) reported in either of the groups.
Through week 48, 62.3% (48/77) of patients receiving TREMFYA and 20.0% (5/25) of patients in the placebo→TREMFYA crossover group reported ≥1 AE.³
- At least 1 serious adverse event (SAE) was reported in 1.3% (1/77) patients receiving TREMFYA and 4.0% (1/25) of patients in the placebo→TREMFYA crossover group.
- Infection was reported in 36.4% (28/77) of patients receiving TREMFYA and 20.0% (5/25) of patients in the placebo→TREMFYA crossover group.
- One patient (1.3%) discontinued TREMFYA due to pyelonephritis and one patient (4.0%) discontinued in the placebo→TREMFYA crossover group due to cellulitis.
Through week 48, there were no cases of deaths, malignancies, active TB, MACE, IBD, and serum-sickness or anaphylaxis reported in either of the groups.

Cohort B

Through week 16, 37.8% (85/225) of patients receiving TREMFYA and 39.8% (45/113) of patients receiving placebo reported ≥1 AE.⁸
- At least 1 serious adverse event was reported in 1.3% (3/225) of patients in the TREMFYA group compared to 0.9% (1/113) patients in the placebo group.
- Infection was reported in 22.2% (50/225) of patients receiving TREMFYA and 20.4% (23/113) of patients receiving placebo.
  - At least 1 serious infection was reported in 0.9% (1/113) of patients in the placebo group compared to 0 in the TREMFYA group.
- At least 2.7% (6/225) of patients receiving TREMFYA reported ≥1 injection site reaction compared to 0.9% (1/113) of patients in the placebo group.
- Major adverse cardiovascular event was reported in 0.4% (1/225) of patients in the TREMFYA group compared to 0 events reported in the placebo group.
Through week 16, no death, malignancies, active tuberculosis, inflammatory bowel disease, anaphylaxis, or serum-like sickness were reported in either group.

VOYAGE 1

Blauvelt et al (2017)¹² assessed improvement in scalp PsO in the VOYAGE 1 trial, a phase 3, randomized, double-blind, placebo and active comparator-controlled, multicenter study, evaluating the efficacy and safety of TREMFYA compared to placebo 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.

The study design is shown in Figure: VOYAGE 1 Study Design.

VOYAGE 1 Study Design¹²^,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 PsO characteristics are noted in Table: Baseline Scalp Psoriasis Characteristics - Randomized Patients in VOYAGE 1.

Baseline Scalp Psoriasis Characteristics - Randomized Patients in VOYAGE 1¹²

	TREMFYA	Placebo	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: 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 placebo (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 1¹²

	Week 16			Week 24		Week 48
	TREMFYA	Placebo	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: 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 48¹²

	Through Week 16			Through Week 48
	TREMFYA (n=329)	Placebo (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
NMSC^b, n (%)	1 (0.3)	0	0	2 (0.6)	1 (0.3)
MACE^c, 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; 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)¹³ assessed improvement in scalp PsO in the VOYAGE 2 trial, a phase 3, multicenter, randomized, double-blind, placebo and active comparator-controlled study, evaluating the efficacy and safety of TREMFYA compared to placebo 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 Design¹³^,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 PsO characteristics are noted in Table: Baseline Scalp Psoriasis Characteristics - Randomized Patients in VOYAGE 2.

Baseline Scalp Psoriasis Characteristics - Randomized Patients in VOYAGE 2¹³

	TREMFYA	Placebo	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: ss-IGA, scalp-specific Investigator’s Global Assessment.

Efficacy

Scalp PsO outcomes at weeks 16 and 24 are noted in Table: Scalp Psoriasis Outcomes at Weeks 16 and 24 - Randomized Patients in VOYAGE 2.
Patients treated with TREMFYA achieved greater improvement in ss-IGA score 0/1 compared with placebo at week 16.
Greater improvements in ss-IGA score 0/1 were observed at week 24 in patients receiving TREMFYA vs adalimumab.

Scalp Psoriasis Outcomes at Weeks 16 and 24 - Randomized Patients in VOYAGE 2¹³

	Week 16			Week 24
	TREMFYA	Placebo	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: 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 48¹²

	Placebo-Controlled Period (Weeks 0-16)			Active-Comparator Period (Weeks 0-28)			Randomized Withdrawal and Retreatment Period (Weeks 28-48)
	TREMFYA (n=494)	Placebo (n=248)	Adalimumab (n=248)	TREMFYA (n=494)	Adalimumab (n=248)	Placebo→TREMFYA^a (n=233)	Maintenance Group^b(n=192)	Withdrawal Group^c (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)
Upper respiratory tract infection	16 (3.2)	10 (4.0)	4 (1.6)	25 (5.1)	10 (4.0)	5 (2.1)	9 (4.7)	10 (5.5)
Discontinued 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)
Malignancies^d	0 (0.0)	0 (0.0)	0 (0.0)	1 (0.2)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
NMSC^e	0 (0.0)	0 (0.0)	0 (0.0)	1 (0.2)	0 (0.0)	1 (0.4)	0 (0.0)	0 (0.0)
MACE^f	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; PASI, Psoriasis Area and Severity Index; PASI 90, ≥90% improvement in Psoriasis Area and Severity Index score from baseline; MACE, major cardiovascular events; MI, myocardial infarction; NMSC, nonmelanoma skin cancer; SAEs, serious adverse events; q8w, every 8 weeks. ^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 placebo (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 placebo-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 placebo→TREMFYA group.
- One additional MACE (myocardial infarction) was reported in the placebo→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)¹⁴ 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 placebo (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

A total of 496 patients were randomized to receive TREMFYA at baseline, of which 407 (82%) had scalp PsO. Baseline characteristics are noted in Table: Baseline Characteristics Among Patients Randomized to Receive TREMFYA with Scalp Psoriasis.

Baseline Characteristics Among Patients Randomized to Receive TREMFYA with Scalp Psoriasis¹⁴

	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

Mean ss-IGA, PASI, and DLQI scores through week 48 are noted in Table: Clinical Outcomes through Week 48 - Post Hoc Analysis of VOYAGE 2.

Clinical Outcomes through Week 48 - Post Hoc Analysis of VOYAGE 2¹⁴

	TREMFYA R Continuation^a	TREMFYA NR Continuation^b	TREMFYA R Withdrawal^c
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; 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 placebo starting at week 28 through week 48.

POOLED EFFICACY AND SAFETY ANALYSIS

Orbai et al (2023)¹⁵^,¹⁷conducted 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

Of total 1829 patients randomized in VOYAGE 1 and VOYAGE 2, 153, 106, and 76 in the TREMFYA, adalimumab, and placebo groups, respectively, self-reported having PsA (pooled PsA cohort).
Baseline characteristics were comparable across the treatment groups,¹⁷ see Table: Select Baseline Demographics and Clinical Characteristics of Patients with Self-Reported PsA in the Pooled Analysis.

Select Baseline Demographics and Clinical Characteristics of Patients with Self-Reported PsA in the Pooled Analysis¹⁷

	TREMFYA (n=153)	Placebo (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; 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

The proportion of patients achieving ss-IGA 0/1 (clear/very mild) and ss-IGA 0 at weeks 16 and 24 is given in Table: Proportion of Patients Achieving an ss-IGA 0/1 and ss-IGA 0 at Week 16 and Week 24.

Proportion of Patients Achieving an ss-IGA 0/1 and ss-IGA 0 at Week 16 and Week 24¹⁵

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

Safety

For the summary of AEs in patients with moderate-to-severe psoriasis and self-reported PsA, see Table: AEs Through Week 28 in VOYAGE 1 and 2.

AEs Through Week 28 in VOYAGE 1 and 2¹⁷

	Placebo-Controlled Period (Weeks 0-16)			Active-Comparator Period (Weeks 0-28)
	TREMFYA (n=153)	Placebo (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
Malignancies^a	0	0	0	0	0
MACE^b	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; SAEs, serious adverse events; TB, tuberculosis. ^aExcludes NMSC ^bIncludes sudden cardiac death, MI, and stroke.

Jo et al (2023)¹⁶ 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 placebo group at week 16, and the active treatment groups (TREMFYA vs adalimumab) were compared at week 24. Patients who crossed over from placebo 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

Among the 1829 patients randomized in VOYAGE 1 and VOYAGE 2, 257 were Asian patients of which, 199 were eligible for inclusion in this study.
Baseline demographics and disease characteristics are summarized in Table: Select Baseline Demographics and Disease Characteristics of Randomized Asian Patients.

Select Baseline Demographics and Disease Characteristics of Randomized Asian Patients¹⁶

	TREMFYA (n=94)	Placebo (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; 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

The proportion of Asian patients achieving ss-IGA 0/1 (clear/very mild) and ss-IGA 0 at weeks 16 and 24 is given in Table: Proportion of Asian Patients Achieving an ss-IGA 0/1 and ss-IGA 0 for Regional PsO at Weeks 16 and 24.

Proportion of Asian Patients Achieving an ss-IGA 0/1 and ss-IGA 0 for Regional PsO at Weeks 16 and 24¹⁶

	TREMFYA	Placebo	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: PsO, psoriasis; ss-IGA, scalp-specific Investigator’s Global Assessment. ^aNominal P-value <0.001 for placebo 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 placebo 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 placebo 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 placebo experiencing ≥1 AEs through week 28 was 60.6%, 40.0%, 50.0%, respectively.¹⁶
- 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 16 December 2024.

References

Show

1	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.
2	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.
3	Alexis A, Rodriguez G, 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.
4	Alexis A, Rodriguez A, Yadav G. VISIBLE cohort A: guselkumab demonstrates significant scalp clearance at 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.
5	Janssen Research & Development, LLC. Study of guselkumab in skin of color participants with moderate-to-severe plaque and/or scalp psoriasis (VISIBLE). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2024 December 16]. https://clinicaltrials.gov/ct2/show/NCT05272150 NLM Identifier: NCT05272150.
6	Alexis A, Bhutani T, McMichael A, et al. Study design of a phase 3b, multicenter, randomized, double-blind, placebo-controlled trial of guselkumab in patients with skin of color who have moderate to severe plaque and/or scalp psoriasis (VISIBLE). Poster presented at: Society for Investigative Dermatology; May 18-21, 2022; Portland, OR.
7	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.
8	Gold LS, Strober B, Armstrong A, et al. SPECTREM: guselkumab demonstrates consistent significant clearance at week 16 across the full range of low body surface area, moderate psoriasis with special sites involvement. Poster presented at: Fall Clinical Dermatology Conference; October 24-27, 2024; Las Vegas, Nevada.
9	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, Nevada.
10	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, Nevada.
11	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 2024 December 16]. Available from: https://clinicaltrials.gov/study/NCT06039189
12	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.
13	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.
14	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.
15	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.
16	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.
17	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.