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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

TREMFYA® (guselkumab)

Medical Information

TREMFYA – Use in Pediatric Patients Weighing Less than 40 kg with Plaque Psoriasis

Last Updated: 10/21/2025

SUMMARY

  • The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
  • Please refer to the local labeling for information on the recommended dosing and administration of TREMFYA in pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate to severe plaque psoriasis (PsO).
  • A phase 3, multicenter, placebo (PBO)-controlled trial (PROTOSTAR) evaluated the efficacy, safety, pharmacokinetics (PK), and immunogenicity of TREMFYA in pediatric patients (≥6 to <18 years of age) with moderate to severe plaque PsO.1

CLINICAL DATA

Phase 3 Clinical Study - PROTOSTAR (Pediatric Patients with Moderate to Severe Plaque PsO)

Prajapati et al (2025)1 evaluated the efficacy, safety, PK, and immunogenicity of TREMFYA compared to PBO with an open-label reference arm (etanercept) in a phase 3, multicenter, randomized trial in pediatric patients with moderate to severe plaque PsO.

Study Design/Methods

  • Select inclusion criteria:
    • Pediatric patients (≥6 to <18 years of age) with moderate to severe plaque PsO for ≥6 months (with or without PsA)
    • IGA ≥3
    • PASI ≥12, and ≥10% body surface area (BSA) involvement, with at least 1 of the following criteria fulfilled:
      • Very thick lesions
      • Clinically relevant facial, genital, or hand/foot involvement
      • PASI ≥20 or BSA >20% or IGA=4
    • PsO inadequately controlled by phototherapy and/or topical therapy
  • Select exclusion criteria:
    • Nonplaque or drug-induced PsO
    • History of chronic/recurrent infectious diseases or lymphoproliferative diseases
    • Previous treatment with TREMFYA or etanercept
    • Anti-tumor necrosis factor (TNF)α therapies within 3 months
    • Interleukin (IL)-12/23, IL-17, or IL-23 therapies within 6 months
    • Systemic immunosuppressants within 4 weeks
    • Systemic or topical therapies affecting PsO or IGA within 2 weeks
  • Adolescents (≥12 to <18 years of age) were randomized 2:1:1 in part 1a to 1 of 3 treatment arms shown in Figure: PROTOSTAR Study Design.
  • Children (≥6 to <12 years of age) were randomized 1:1:1 in part 1b to receive TREMFYA, PBO or etanercept, which began after adolescents in part 1a completed the PBO-controlled period (weeks 0-16).
  • Dosing in part 1 was double-blinded, TREMFYA and PBO were administered as subcutaneous (SC) injections at weeks 0, 4, and 12 based on body weight (<70 kg, 1.3 mg/kg; ≥70 kg, 100 mg).
  • Etanercept was administered SC weekly (0.8 mg/kg up to 50 mg/dose) through week 15 (no statistical comparisons between the etanercept and TREMFYA arms were planned in the study).
  • Part 2 evaluated adolescents receiving TREMFYA from weeks 0-52 in an open label, single-arm design.

PROTOSTAR Study Design1

Abbreviations: E, enrollment; ETN, etanercept; GUS, guselkumab; NR, nonresponder; PASI, Psoriasis Area and Severity Index; PBO, placebo; q8w, every 8 weeks; R, randomization; SC, subcutaneous.
Part 1a: ages ≥12 to <18 years; Part 1b: ages ≥6 to <12 years.
aAt baseline, patients were randomized to receive GUS or PBO SC (1.3 mg/kg for <70 kg; 100 mg for ≥70 kg) at week 0, week 4, and week 12; or open-label ETN SC (0.8 mg/kg up to 50 mg) weekly through week 15. Patients who crossed over to GUS after randomization to PBO or ETN received their first dose of GUS at week 16 and week 20, respectively.
bInvestigators evaluating efficacy were blinded to treatment arm.
cFollowed by a long-term extension.
dThe number of patients enrolled was dependent on the number of patients randomized to GUS in part 1, ranging from ≥10 to a number sufficient to ensure ≥100 patients exposed to GUS.
eAfter completing week 52 in Parts 1 or 2, patients could continue q8w weight-based GUS in an open-label, long-term extension phase.

Results

Patient Demographics
Part 1
  • A total of 92 patients were randomized to receive TREMFYA (n=41), PBO (n=25), and etanercept (n=26).1
    • Among the randomized groups, 62 (67%) patients were adolescents and 30 (33%) were children, respectively. For baseline characteristics, see Table: Select Baseline Characteristics (Full Analysis Set).
    • Through week 52, 79 (86%) patients remained in the study.
Part 2

Select Baseline Characteristics (Full Analysis Set)1,2
Part 1
Part 2
TREMFYA (n=41)
PBO
(n=25)
Reference Arm
(Open-Label ETN; n=26)
Total
(N=92)

Open-Label TREMFYA
(n=28)
Age (years), mean (SD)
13.4 (2.9)
12.4 (3.6)
12.5 (3.3)
12.9 (3.2)
15.1 (1.6)
   ≥12 to <18
31 (76)
15 (60)
16 (62)
62 (67)
28 (100)
   ≥6 to <12
10 (24)
10 (40)
10 (38)
30 (33)
0
Sex
   Male
24 (58)
12 (48)
15 (58)
51 (55)
17 (61)
   Female
17 (41)
13 (52)
11 (42)
41 (45)
11 (39)
Weight (kg), mean (SD)
59.4 (20.3)
-
-
-
68.4 (17.3)
   <70
71%
-
-
-
57%
   ≥70
29%
-
-
-
43%
BMI (kg m-2), mean (SD)
22.0 (5.0)
22.6 (7.8)
22.6 (5.2)
22.3 (5.9)
23.1 (4.6)
Disease duration at diagnosis (years), mean (SD)
5.0 (3.1)
4.5 (2.9)
4.8 (3.6)
4.8 (3.2)
6.2 (3.1)
PsA
2 (5)
1 (4)
0
3 (3)
0
BSA involvement (%), mean (SD)
25.9 (16.8)
23.4 (9.8)
22.7 (10.4)
24.3 (13.5)
28.8 (14.1)
IGA score (0-4)
   Moderate (3)
31 (76)
20 (80)
21 (81)
72 (78)
15 (54)
   Severe (4)
10 (24)
5 (20)
5 (19)
20 (22)
13 (46)
PASI score (0-72), mean (SD)
19.9 (7.0)
18.0 (4.4)
17.9 (5.9)
18.8 (6.1)
21.2 (8.5)
CDLQI score (0-30), mean (SD)
9.4 (6.99)
9.3 (6.57)
9.6 (6.56)
9.4 (6.68)
8.3 (7.27)
Data shown are n (%) unless otherwise specified.
Abbreviations: BMI, body mass index; BSA, body surface area; CDLQI, Children’s Dermatology Life Quality Index; ETN, etanercept; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PBO, placebo; PsA, psoriatic arthritis; SD, standard deviation.
Efficacy
Part 1: PBO-Controlled Period (Weeks 0-16) - TREMFYA vs PBO

Co-Primary and Major Secondary Endpoints at Week 163 
TREMFYA
PBO
Using Multiple Imputation After Applying Treatment Failure Rules and Rescue Treatment Rules
Full analysis set, N
41
25
IGA 0/1 (co-primary endpoint)
27 (66)
4 (16)
   Treatment differencea (95% CI)
49.9 (25.9, 69.4)
P-valueb
<0.001
PASI 75 (co-primary endpoint)
31 (76)
5 (20)
   Treatment differencea (95% CI)
55.6 (32.1, 74.0)
P-valueb
<0.001
PASI 90 (US-FDA required co-primary endpoint)
23 (56)
4 (16)
   Treatment difference (95% CI)
40.1 (15.6, 61.3)
P-valueb
0.003
IGA 0
16 (39)
1 (4)
   Treatment difference (95% CI)
35.0 (10.5, 56.8)
P-valueb
0.004
PASI 100
14 (34)
0
   Treatment difference (95% CI)
34.1 (9.7, 56.1)
P-value
0.002
LS mean change in CDLQI (95% CI)
-7.27 (-8.81, -5.72)
-1.88 (-3.74, -0.02)
   LS mean (95% CI)
<0.001
Data shown are n (%) unless otherwise specified.
Abbreviations: CDLQI, Children’s Dermatology Life Quality Index; CI, confidence interval; IGA, Investigator’s Global Assessment; LS, least squares; PASI, Psoriasis Area and Severity Index; PBO, placebo; US-FDA, United States Food and Drug Administration.
aTreatment difference and 95% CI were calculated adjusting for pooled geographic region and age group using Mantel-Haenszel weight.
bP-values represent the comparisons with PBO and are based on Cochran-Mantel-Haenszel chi-square test stratified by age group and geographic region (pooled).

Clinical Response Rates at Week 16 by Age Group1
Children (≥6 to <12 years)
Adolescents (≥12 to <18 years)
TREMFYA
PBO
TREMFYA
PBO
Full analysis set
10
10
31
15
IGA 0/1
5 (50)
3 (30)
22 (71)
1 (7)
IGA 0
3 (30)
1 (10)
13 (42)
0
PASI 75
6 (60)
3 (30)
25 (81)
2 (13)
PASI 90
5 (50)
3 (30)
18 (58)
1 (7)
PASI 100
3 (30)
0
11 (35)
0
CDLQI change from BL, mean (SD)
-3.00 (5.96)
-4.40 (7.26)
-8.45 (7.72)
0.13 (5.08)
Data shown are n (%) unless specified otherwise.
Abbreviations: BL, baseline; CDLQI, Children’s Dermatology Life Quality Index; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PBO, placebo; SD, standard deviation.
Part 1: Open-Label Reference Arm (Etanercept)
  • At week 16, 69%, 69% and 54% of patients receiving open-label etanercept achieved IGA 0/1, PASI 75 and PASI 90, respectively.1
Part 1 (Weeks 16-52) - Crossover to TREMFYA
  • A total of 80% (20/25) of patients randomized to the PBO group who were PASI 90 nonresponders at week 16 were crossed over to the TREMFYA group.1
    • The response rates for IGA 0/1, PASI 75 and PASI 90 were 0%, 5%, and 0%, respectively at week 16, and improved to 80%, 95%, and 65%, respectively at week 52.
  • A total of 85% (22/26) of patients randomized to receive open-label etanercept were crossed over to receive TREMFYA at week 20.1
    • The response rates for IGA 0/1, PASI 75, and PASI 90 were 64%, 55%, and 36%, respectively at week 20, and improved to 91%, 96%, and 91%, respectively at week 52.
Part 1 (Weeks 16-52) - PASI 90 Nonresponders Treated with TREMFYA
  • At week 16, 44% (18/41) of patients in the TREMFYA group who were PASI 90 nonresponders continued TREMFYA treatment, and 61% (11/18) of patients achieved PASI 90 by week 52.1
TREMFYA Withdrawal and Retreatment in PASI 90 Responders
  • Of the 41 patients randomized to receive TREMFYA, 23 (56%) patients achieved PASI 90 at week 16 and were withdrawn from TREMFYA; 30% of these patients maintained a PASI 90 response at week 52.1
  • Four patients met retreatment criteria after loss of PASI 90 response and were retreated at either week 44 or week 48. One patient regained PASI 90 response at week 52.1
Part 2: Open-Label TREMFYA (Weeks 0-52)
  • At week 16, 89%, 82%, and 64% of patients achieved IGA 0/1, PASI 75, and PASI 90, respectively; 46% and 36% of patients achieved IGA 0 and PASI 100, respectively.1
  • The response rates by week 52 for IGA 0/1, PASI 75, PASI 90, IGA 0 and PASI 100 were 86%, 93%, 82%, 75% and 54%, respectively.1
  • At week 52, the mean (standard deviation) change from baseline in the Children’s Dermatology Life Quality Index (CDLQI) score was -7.3 (6.8).1
Safety
Part 1: PBO-Controlled Period (Weeks 0-16)
  • Through week 16, 42% of patients receiving TREMFYA, 68% of patients receiving PBO and 58% of patients receiving etanercept reported AEs (see Table: AEs Occurring in Patients from Part 1 in the TREMFYA, PBO and Open-Label ETN Groups through Week 16).1
  • One patient in the PBO group discontinued treatment due to worsening PsO, compared to 0 patients in the TREMFYA group.1
  • At least 1 serious adverse event (SAE) was reported in the TREMFYA group (radius fracture) and was unrelated to study treatment.1
  • One patient in both the TREMFYA and PBO groups reported mild injection site reactions (ISRs).1
  • One patient treated with etanercept reported ISRs.1

AEs Occurring in Patients from Part 1 in the TREMFYA, PBO and Open-Label ETN Groups through Week 164 
Part 1
TREMFYA
(N=41)
PBO
(N=25)
Reference Arm: Open-Label ETN
(N=26)
Mean weeks of follow up
16.4
16.3
16.1
Mean number of administrations
3.0
2.9
14.9
Patients with ≥1 AE
   AE
42%
68%
58%
   SAE
2%a
0
0
   AE leading to discontinuation
0
4%b
0
   Infection
29%
40%
38%
   Serious infection
0
0
0
Patients are counted only once for any given event, regardless of the number of times they experienced the event. AEs are coded using MedDRA Version 26.0.
Abbreviations: AE, adverse event; ETN, etanercept; MedDRA, Medical Dictionary for Regulatory Activities; PBO, placebo; PsO, psoriasis; SAE, serious adverse event.
aRadius fracture in 1 patient receiving TREMFYA.
bWorsening PsO in 1 patient receiving PBO.
Parts 1 and 2: Through Week 52

AEs Occurring in >5% of Patients in the Total TREMFYA Group from Part 1 and 2 at Week 521 
Part 1
Part 2a
Week 16
(Double-Blind PBO-Controlled Period
Week 52
(Crossover, Withdrawal, and Retreatment Period)
Week 52 (Continuous TREMFYA)
TREMFYA
PBO
TREMFYA
(Crossover from PBO)
TREMFYAb
TREMFYA (Crossover from Open-Label ETN)
Total
TREMFYA

Open-Label TREMFYA
Safety analysis set, N
41
25
23
41
22
86
28
Weeks of follow-up (mean)
16.4
(0.6)
16.3 (1.2)
33.6
(7.1)
50.1
(6.5)
31.7
(1.8)
41.0 (10.6)
50.8
(8.0)
≥1 AE
17 (42)
17 (68)
16 (70)
33 (80)
13 (59)
62 (72)
23 (82)
Common AEs
   Nasopharyngitis
5 (12)
7 (28)
8 (35)
12 (29)
4 (18)
24 (28)
7 (25)
   Upper
   respiratory tract
   infection
4 (10)
2 (8)
0
8 (20)
3 (14)
11 (13)
2 (7)
   Headache
3 (7)
0
2 (9)
6 (15)
2 (9)
10 (12)
2 (7)
   Pharyngitis
1 (2)
0
1 (4)
3 (7)
1 (5)
5 (6)
1 (4)
≥1 AE leading to discontinuationc
0
1 (4)
0
1 (2)
0
1 (1)
1 (4)
≥1 serious AEd
1 (2)
0
1 (4)
1 (2)
0
2 (2)
1 (4)
≥1 infection
12 (29)
10 (40)
12 (52)
25 (61)
13 (59)
50 (58)
15 (54)
Active tuberculosis
0
0
0
0
0
0
0
Opportunistic infection
0
0
0
0
0
0
0
Malignancy
0
0
0
0
0
0
0
Death
0
0
0
0
0
0
0
Data shown are n (%) unless specified otherwise.
Patients are counted only once for any given event, regardless of the number of times they experienced the event. AEs are coded using MedDRA version 26.0.
Abbreviations: AE, adverse event; COVID-19, coronavirus disease 2019; ETN, etanercept; MedDRA, Medical Dictionary for Regulatory Activities; PBO, placebo.
aIn part 2, the most common AEs were nasopharyngitis (25%), COVID-19 (21%), and acne (11%).
bFor patients randomized to TREMFYA initially, data through week 52 include events experienced through week 16.
cAEs leading to discontinuation included exacerbation of psoriasis (PBO group), pregnancy (TREMFYA group), and suicidal ideation (open-label TREMFYA).
dSerious AEs included a radius fracture (TREMFYA group), chronic tonsillitis (crossover from PBO to TREMFYA), and trauma due to a fall (open-label TREMFYA).

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 01 October 2025.

 

References

Show
1 Prajapati VH, Seyger MMB, Wilsmann-Theis D, et al. Guselkumab for the treatment of moderate-to-severe plaque psoriasis in paediatric patients: results of the phase III, randomized, placebo-controlled PROTOSTAR study. Br J Dermatol. 2025;192(4):618-628.  
2 Sinha V, Crauwels H, Obianom ON, et al. Guselkumab pharmacokinetics and immunogenicity in pediatric psoriasis: phase 3 PROTOSTAR study. Presented at: SID Annual Meeting; May 7-10, 2025; San Diego, CA.  
3 Prajapati VH, Seyger MMB, Wilsmann-Theis D, et al. Supplement to: Guselkumab for the treatment of moderate-to-severe plaque psoriasis in paediatric patients: results of the phase III, randomized, placebo-controlled PROTOSTAR study. Br J Dermatol. 2025;192(4):618-628.  
4 Prajapati VH, Seyger MMB, Wilsmann-Theis D, et al. Guselkumab for the treatment of moderate-to-severe plaque psoriasis in pediatric patients: results of a phase 3, randomized, placebo-controlled study. Poster presented at: American Academy of Dermatology (AAD) Annual Meeting; March 7-11, 2025; Orlando, FL.