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(guselkumab)

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TREMFYA® (guselkumab)

Medical Information

TREMFYA - Overview of the SOLSTICE Clinical Trial

Last Updated: 10/06/2025

SUMMARY

  • SOLSTICE (NCT04936308) is an ongoing phase 3b, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of TREMFYA subcutaneous (SC) every 4 weeks (q4w) and every 8 weeks (q8w) compared with placebo in adult patients with active psoriatic arthritis (PsA) and an inadequate response to 1 prior tumor necrosis factor inhibitor (TNFi).1-4
  • At week 24, the primary endpoint of the proportion of the patients who achieved ≥20% improvement from baseline in the American College of Rheumatology criteria (ACR20) was significantly greater in both TREMFYA groups compared to placebo (ACR20: TREMFYA q4w, 58.6%, and TREMFYA q8w, 62.2%, vs placebo, 34.8%; P<0.001 and P<0.001, respectively).2  
  • Through week 24, adverse events (AEs) occurred in 46.7% (70/150) and 53.6% (81/151) of patients in the TREMFYA q4w and q8w groups, respectively, vs 48.3% (72/149) in the placebo group.2    
    • Serious adverse events (SAEs) occurred in 1.3% (2/150) and 2.6% (4/151) of patients in the TREMFYA q4w and q8w groups, respectively, vs 4.0% (6/149) in the placebo group.

CLINICAL STUDY

Phase 3b Study - SOLSTICE

Ogdie et al (2025)2 and Gottlieb et al (2025)3 reported results through week 24 of a phase 3b, multicenter, randomized, double-blind, placebocontrolled study to evaluate the efficacy and safety of TREMFYA compared with placebo in patients with active PsA with inadequate response to 1 prior TNFi.

Study Design/Methods

SOLSTICE Study Design1-4

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Abbreviations: AS, ankylosing spondylitis; BL, baseline; csDMARD, conventional synthetic disease-modifying antirheumatic drug; DBL, database lock; EE, early escape; GUS, guselkumab; JAK, Janus kinase; MDA, minimal disease activity; PBO, placebo; PK pharmacokinetics; PsA, psoriatic arthritis; q4w, every 4 weeks; q8w, every 8 weeks; R, randomization; RA, rheumatoid arthritis; SC, subcutaneous; TNFi, tumor necrosis factor inhibitor.
aRandomization was stratified by BL use of csDMARDs.
bTotal number randomized=453, the full analysis set of 451 excludes 1 pt who was double randomized.
cEarly escape: At week 16, all participants in 3 groups with <20% improvement from baseline in both tender and swollen joint counts will qualify for early escape and will be allowed to initiate or increase the dose of one of the permitted concomitant medications up to the maximum allowed dose, as selected by the investigator.
dCrossover period, the first DBL will occur when all randomized participants have either completed the week 24 assessments or terminated study participation prior to the week 24 visit.
eThe second DBL will occur when all randomized participants have either completed the week 52 assessments or terminated study participation prior to the week 52 visit.
fThe third DBL will occur when all participants have either completed their final safety visit or have terminated study participation.

  • Primary endpoint (multiplicity controlled):1-3
    • Proportion of patients achieving an ACR 20 response at week 24 
  • Major secondary endpoints (multiplicity controlled):
    • Proportion of patients achieving Investigator’s Global Assessment (IGA) 0/1 response at week 24
      • IGA 0 or 1 and ≥2-grade reduction from baseline (BL)
    • Proportion of patients achieving ≥90% improvement in Psoriasis Area and Severity Index (PASI 90) response at week 24
    • LS (least square) mean change from BL in Health Assessment Questionnaire-Disability Index (HAQ-DI) at week 24 (physical function)
    • LS mean change from BL in 36-item Short-Form Health Survey Physical Component Summary (SF-36 PCS) at week 24 (health-related quality of life)
    • LS mean change from BL in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at week 24 (fatigue)
    • Minimal Disease Activity (MDA) at week 24
  • Major secondary endpoints (weakly controlled):2
    • Proportion of patients achieving an ACR 20 response at week 16
    • Proportion of patients achieving an ACR 50 response at week 24
    • Proportion of patients achieving an ACR 70 response at week 24
  • Weakly-controlled endpoints were not included in the sequential testing procedures; however, they were prespecified to be tested upon achieving statistical significance of the strongly controlled primary endpoint (ACR20 response at week 24). P-values are not considered nominal.
  • Efficacy analysis set included all randomized patients. One patient was randomized into 2 treatment groups simultaneously and was excluded from all analyses.
  • Safety analysis set included all patients who received ≥1 dose of any study intervention. One patient was randomized into 2 treatment groups simultaneously and was excluded from all analyses.

Results

Efficacy

Summary of Primary and Major Secondary Endpoints2,3 
TREMFYA 100 mg q4w
TREMFYA 100 mg q8w
PBO
Primary endpoint
(multiplicity controlled)
n=150
n=151
n=150
ACR 20 response at week 24a, %
58.6
62.2
34.8
P-value
<0.001
<0.001
-
Major secondary endpoints
(multiplicity controlled)
n=92
n=89
n=86
IGA 0/1 response at week 24a,b,c, %
50.0
57.3
17.4
P-value
<0.001
<0.001
-
PASI 90 response at week 24a,b, %
49.4
45.5
12.0
P-value
<0.001
<0.001
-
n=150
n=151
n=150
LS mean change from BL in HAQ-DI at week 24d,e
-0.42
-0.40
-0.24
P-value
0.003
0.008
-
LS mean change from BL in SF-36 PCS at week 24d,e
7.0
7.0
3.7
P-value
<0.001
<0.001
-
LS mean change from BL in FACIT-F at week 24d,e
8.4
7.8
3.9
P-value
<0.001
<0.001
-
MDA at week 24a, %
18.8
23.9
5.4
P-value
<0.001
<0.001
-
Major secondary endpoints
(weakly controlled)
n=150
n=151
n=150
ACR 20 response at week 16a,f, %
51.1
56.5
29.1
P-value
<0.001
<0.001
-
ACR 50 response at week 24a,f, %
31.4
32.1
12.2
P-value
<0.001
<0.001
-
ACR 70 response at week 24a,f, %
17.5
17.3
2.0
P-value
<0.001
<0.001
-
Abbreviations: ACR, American College of Rheumatology response criteria; BL, baseline; BSA, body surface area; FACIT-F, functional assessment of chronic illness therapy-fatigue; HAQ-DI, health assessment questionnaire disability index; IGA=Investigator's Global Assessment; LS, least square; MD, major disruption (Ukraine and neighboring countries/territories beginning 24 February 2022); MDA, minimal disease activity; MI, multiple imputation; ND, natural disaster (COVID-19 site access restrictions); NRI, non-responder imputation; PASI, Psoriasis Area and Severity Index; PBO, placebo; PsO, psoriasis; q4w, every 4 weeks; q8w, every 8 weeks; SF-36 PCS, 36-item short-form health survey physical component summary.
aAfter applying treatment failure rules (no change from BL or nonresponder), data impacted by ND/MD were imputed using MI; other missing data were imputed using NRI.
bAmong patients with ≥3% BSA affected by PsO and ≥2 IGA at BL.
cIGA 0 or 1 and ≥2-grade reduction from BL
dAfter applying treatment failure rules (no change from BL or nonresponder), data impacted by ND/MD were not used; other missing data were imputed using MI for continuous endpoints and NRI for binary endpoints.
eMajor secondary endpoints are multiplicity controlled; P-values were based on analysis of covariance for continuous endpoints and generalized linear mixed models for binary endpoints.
fWeakly-controlled endpoints were not included in the sequential testing procedures; however, they were prespecified to be tested upon achieving statistical significance of the strongly controlled primary endpoint (ACR20 response at week 24). P-values are not considered nominal.
Safety

Summary of Safety Results Through Week 24.2,a 
n (%)
TREMFYA 100 mg q4w
(n=150)
TREMFYA 100 mg q8w
(n=151)
PBO
(n=149)
Patients with ≥1 of the following:
AE
70 (46.7)
81 (53.6)
72 (48.3)
SAE
2 (1.3)
4 (2.6)
6 (4.0)
AE leading to discontinuation
1 (0.7)
2 (1.3)
3 (2.0)
Infections
35 (23.3)
43 (28.5)
44 (29.5)
Opportunistic infections
0
0
0
Injection site reactions
1 (0.7)
2 (1.3)
1 (0.7)
Abbreviations: AE, adverse event; PBO, placebo; q4w, every 4 weeks; q8w, every 8 weeks; SAE, serious adverse event.aPatients are counted only once for any given event, regardless of the number of times they actually experienced the event.
  • The SOLSTICE study remains blinded through week 112.2  
  • Serious infections were reported in 2 patients, malignancy (non-melanoma skin cancer) in 1 patient, venous thromboembolism event (VTE) in 1 patient, a major adverse cardiovascular event (MACE) resulted in death in 1 patient.
  • No cases of active tuberculosis, clinically important hepatic disorders, serum sickness reactions, or anaphylaxis were reported.

LITERATURE SEARCH

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 10 September 2025.

 

References

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1 Ogdie A, Merola JF, Mease PJ, et al. Efficacy and safety of guselkumab in patients with active psoriatic arthritis who had inadequate efficacy and/or intolerance to one prior tumor necrosis factor inhibitor: study protocol for SOLSTICE, a phase 3B, multicenter, randomized, double-blind, placebo-controlled study. BMC Rheumatol. 2024;8(1):20.  
2 Ogdie A, Merola JF, Mease PJ, et al. Efficacy and safety of guselkumab in participants with active psoriatic arthritis and inadequate response and/or intolerance to one prior tumor necrosis factor inhibitor. Poster presented at: CCR-West; September 18-21, 2025; Huntington Beach, CA.  
3 Gottlieb AB, Merola2 JF, Mease PJ, et al. Improvements in patient-reported outcomes through 24 weeks of guselkumab treatment in participants with active psoriatic arthritis and inadequate response and/or intolerance to one  prior tumor necrosis factor inhibitor. Poster presented at: CCR-West; September 18-21, 2025; Huntington Beach, CA.  
4 Janssen Research & Development, LLC. Guselkumab in active psoriatic arthritis participants with inadequate response/intolerance to one prior anti-TNF alpha agent (SOLSTICE). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 September 12]. Available from: https://clinicaltrials.gov/study/NCT04936308 NLM Identifier: NCT04936308.