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TREMFYA® (guselkumab)

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TREMFYA - Overview of the SOLSTICE Clinical Trial

Last Updated: 04/08/2026

SUMMARY

SOLSTICE (NCT04936308) is an ongoing phase 3b, multicenter, randomized, double-blind, placebo (PBO)-controlled study designed to evaluate the efficacy and safety of TREMFYA subcutaneous (SC) every 4 weeks (q4w) and every 8 weeks (q8w) compared with PBO in adult patients with active psoriatic arthritis (PsA) and an inadequate response to 1 prior tumor necrosis factor inhibitor (TNFi).¹^-⁵
At week 24, the primary endpoint of the proportion of the patients who achieved ≥20% improvement from baseline (BL) in the American College of Rheumatology criteria (ACR20) was significantly greater in both TREMFYA groups compared to PBO (ACR20: TREMFYA q4w, 58.6%, and TREMFYA q8w, 62.2%, vs PBO, 34.8%; P<0.001 and P<0.001, respectively).¹
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 PBO group.¹
- 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 PBO group.
Efficacy and safety outcomes through week 52 in the SOLSTICE study are summarized below.⁴

CLINICAL STUDY

Phase 3b Study - SOLSTICE

Ogdie et al (2025)¹, Gottlieb et al (2025)² reported results through week 24, and Gottlieb et al (2026)⁴ reported results through week 52 of a phase 3b, multicenter, randomized, double-blind, PBO-controlled study to evaluate the efficacy and safety of TREMFYA in adult patients with active PsA and an inadequate response to 1 prior TNFi.

Study Design/Methods

The study design is summarized in Figure: SOLSTICE Study Design.¹^-⁵

SOLSTICE Study Design¹^-⁵

Abbreviations: ACR, American College of Rheumatology response criteria; AS, ankylosing spondylitis; BL, baseline; CASPAR, ClASsification criteria for Psoriatic ARthritis; CRP, C-reactive protein; csDMARD, conventional synthetic disease-modifying antirheumatic drug; DBL, database lock; EE, early escape; GUS, guselkumab; JAK, Janus kinase; PBO, placebo; 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 patient who was double randomized.
^cEE: At week 16, all participants in 3 groups with <20% improvement from BL in both tender and swollen joint counts will qualify for EE 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. Final safety follow-up at week 112 is 12 weeks after final study agent administration.

Primary endpoint (multiplicity controlled)¹^-³:
- Proportion of patients achieving an ACR20 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 BL
- Proportion of patients achieving ≥90% improvement in Psoriasis Area and Severity (PASI 90) response at week 24
- Least square (LS) 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)¹:
- Proportion of patients achieving an ACR20 response at week 16
- Proportion of patients achieving an ACR50 response at week 24
- Proportion of patients achieving an ACR70 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.¹^,²
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.¹
Endpoints at week 52⁴:
- ACR20/50/70
- IGA 0/1 response: score 0 or 1 and ≥2-grade improvement
- PASI 90
- MDA

Results

Efficacy

Week 24 Efficacy Results

The results for the primary and major secondary endpoints at week 24 are summarized in the following Table: Summary of Efficacy Results at Week 24.

Summary of Efficacy Results at Week 24¹^,²

	TREMFYA 100 mg q4w	TREMFYA 100 mg q8w	PBO
Primary endpoint (multiplicity controlled)	n=150	n=151	n=150
ACR20 response at week 24,^a %	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 24,^a,b,c %	50.0	57.3	17.4
P-value	<0.001	<0.001	-
PASI 90 response at week 24,^a,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 24,^d,e	-0.42	-0.40	-0.24
P-value	0.003	0.008	-
LS mean change from BL in SF-36 PCS at week 24,^d,e	7.0	7.0	3.7
P-value	<0.001	<0.001	-
LS mean change from BL in FACIT-F at week 24,^d,e	8.4	7.8	3.9
P-value	<0.001	<0.001	-
MDA at week 24,^a %	18.8	23.9	5.4
P-value	<0.001	<0.001	-
Major secondary endpoints (weakly controlled)	n=150	n=151	n=150
ACR20 response at week 16,^a,f %	51.1	56.5	29.1
P-value	<0.001	<0.001	-
ACR50 response at week 24,^a,f %	31.4	32.1	12.2
P-value	<0.001	<0.001	-
ACR70 response at week 24,^a,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; COVID-19, coronavirus disease 2019; 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 of February 24, 2022); MDA, minimal disease activity; MI, multiple imputation; ND, natural disaster (COVID-19 site access restrictions); NRI, nonresponder 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.

Week 52 Efficacy Results

Results for endpoints at week 52 are summarized in Table: Summary of Efficacy Results at Week 52.⁴

Summary of Efficacy Results at Week 52⁴

	TREMFYA 100 mg q4w	TREMFYA 100 mg q8w	PBO→TREMFYA q4w
	n=150	n=151	n=150
ACR20 response,^a %	70.0	64.9	58.9
ACR50 response,^a %	46.9	43.7	36.7
ACR70 response,^a %	26.7	27.8	14.7
	n=92	n=89	n=86
IGA 0/1 response,^d%	72.8	66.3	64.0
PASI 90 response,^d%	73.0	66.3	61.7
	n=150	n=151	n=150
MDA, %	36.7	31.8	23.3
Abbreviations: ACR, American College of Rheumatology response criteria; BL, baseline; BSA, body surface area; IGA, Investigator's Global Assessment; MDA, minimal disease activity; PASI, Psoriasis Area and Severity Index; PBO, placebo; PsO, psoriasis; q4w, every 4 weeks; q8w, every 8 weeks. ^aPost hoc analysis (weeks 4, 8, 12, 20, and 28-52) used methods consistent with those used for primary and major secondary endpoint analysis. ^dAmong patients with ≥3% BSA and IGA score ≥2 at BL.

Safety

Week 24 Safety Results

Safety results through week 24 are summarized in Table: Summary of Safety Results at Week 24.¹^,⁴

Summary of Safety Results at Week 24¹^,⁴

	TREMFYA 100 mg q4w (n=150)	TREMFYA 100 mg q8w (n=151)	PBO (n=149)
Patients with ≥1 of the following:
AE^a	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. Note: Data reported as n (%) unless otherwise noted. ^aPatients are counted only once for any given event, regardless of the number of times they actually experienced the event.

The SOLSTICE study is blinded through week 112.¹
Serious infections were reported in 2 patients (pyelonephritis, laryngitis), malignancy (nonmelanoma skin cancer) in 1 patient, 2 venous thromboembolism events (VTE) (deep vein thrombosis [DVT] and pulmonary embolism [PE]) in 1 patient, a major adverse cardiovascular event (MACE) resulted in death in 1 patient.¹^,⁴
No cases of active tuberculosis, clinically important hepatic disorders, serum sickness reactions, or anaphylaxis were reported.¹

Week 52 Safety Results

Safety results through week 52 are summarized in Table: Summary of Safety Results at Week 52.⁴

Summary of Safety Results at Week 52⁴

	TREMFYA 100 mg q4w (n=150)	TREMFYA 100 mg q8w (n=151)	PBO→TREMFYA q4w (Week 24-52)^b (n=138)
Patients with ≥1 of the following^a:
AE	97 (64.7)	101 (66.9)	64 (46.4)
SAE	5 (3.3)	10 (6.6)	2 (1.4)
AE leading to discontinuation	1 (0.7)	2 (1.3)	2 (1.4)
Infections	50 (33.3)	63 (41.7)	39 (28.3)
Opportunistic infections	0	0	0
Injection site reactions	6 (4.0)	3 (2.0)	1 (0.7)
Abbreviations: AE, adverse event; PBO, placebo; q4w, every 4 weeks; q8w, every 8 weeks; SAE, serious adverse event. Note: Data reported as n (%) unless otherwise noted. ^aPatients are counted only once for any given event, regardless of the number of times they actually experienced the event. ^bIncludes only patients who received TREMFYA q4w following crossover at week 24.

One case of serious infection (cellulitis) was reported and there were 2 patients with malignancies (gastric cancer; colon cancer). One death was reported in the patient with colon cancer.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 19 February 2026.

References

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1	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.
2	Gottlieb AB, Merola 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.
3	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.
4	Gottlieb AB, Merola JF, Mease PJ, et al. Efficacy and safety of guselkumab in participants with active psoriatic arthritis and inadequate response/intolerance to one prior tumor necrosis factor inhibitor through 1 year of the SOLSTICE study. Poster presented at: 19th Annual Rheumatology Winter Clinical Symposium (RWCS); February 11-14, 2026; Maui, HI.
5	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 2026 March 12]. Available from: https://clinicaltrials.gov/study/NCT04936308 NLM Identifier: NCT04936308.

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