J&J Medical Connect
TREMFYA®

(guselkumab)

J&J Medical Connect

Connect with us

  • Products

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 - Treatment of Adult Patients with Psoriatic Arthritis - Real-world Evidence

Last Updated: 01/29/2026

Summary

  • The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
  • Please refer to the local labeling for clinical data on the use of TREMFYA in adult patients with active psoriatic arthritis (PsA) from phase 3 clinical studies.
  • PsABIOnd, an ongoing, prospective, observational, international study, was designed to evaluate treatment persistence, efficacy, and safety outcomes in patients with PsA who were initiated on subcutaneous (SC) TREMFYA or SC interleukin-17A inhibitors (IL-17Ais). Results are available through 6 months.1-3
  • A prospective study that evaluated the effectiveness and drug retention rate (DRR) of TREMFYA in adult patients with PsA is summarized below.4 
  • Real-world retrospective studies comparing treatment persistence through 12 and 24 months in patients with active PsA initiated on an on-label SC TREMFYA dosing regimen vs an SC IL-17Ai or tumor necrosis factor inhibitor (TNFi) regimen who were identified using IQVIATM health plan claims data are summarized below.5-9 
  • Real-world registry-based studies that evaluated the use of TREMFYA in adult patients with PsA are summarized below.10,11

Real-world Evidence

Prospective Studies

Gossec et al (2024)2 and Siebert et al (2024)3 conducted a 6-month interim analysis of an ongoing, prospective, observational, international study (PsABIOnd) to evaluate treatment persistence and treatment effectiveness in patients with PsA initiating treatment with either SC TREMFYA or SC interleukin-17 inhibitor (IL-17i).

Study Design/Methods

  • Adult patients with a confirmed diagnosis of PsA initiating SC TREMFYA or SC IL-17i as the first- to fourth-line biologic therapy (monotherapy or in combination with other agents) between March 2023 and January 2024 per the standard of care were included in the study.2,3 
  • The study evaluated the following outcomes:
    • Treatment persistence with SC TREMFYA vs SC IL-17i2:
      • Evaluated over 6 months using a Kaplan-Meier analysis and defined as the time from the first administration of the initial treatment line to the date of the last dose plus 1 dosing interval or until initiation of a subsequent treatment. 
    • Treatment effectiveness with SC TREMFYA vs SC IL-17i2,3:
      • Evaluated using Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA; score ≤13)/DAPSA score ≤14) as defined for patients with polyarticular PsA at baseline, minimal disease activity (MDA); achieving 5/7 criteria, mild psoriasis (PsO) body surface area (BSA; <3%), Dermatology Life Quality Index 0/1 (achieving a score of 0/1), dactylitis resolution (number of affected digits: 0), and Leeds Enthesitis Index (LEI) resolution (LEI score 0).
      • Evaluated using electronic patient-reported outcomes, including the Psoriatic Arthritis Impact of Disease-12 score.

Results

Baseline Characteristics

Select Baseline Characteristics of the PsABIOnd Interim Analysis Groups2,3 
SC TREMFYA
SC IL-17i
Demographics
n=360
n=326
   Age, years
52.0 (13.1)
53.6 (11.9)
   Female
62%
61%
Characteristics
n=355
n=325
   PsA disease duration, years
7.6 (7.7)
7.6 (8.9)
   cDAPSA score
   (0-154; ModDA, 13-27, HDA >27)
n=312
n=286
24.5 (14.5)
27.6 (17.7)
n=349
n=315
   Enthesitis
49%
53%
   Dactylitis
18%
20%
   Psoriatic BSA
n=325
n=295
      <3%
51%
61%
      3-10%
36%
31%
      >10%
13%
8%
bDMARD treatment line
n=362
n=328
   First
37%
36%
   Second
26%
35%
   Third
20%
19%
   Fourth
17%
9%
Abbreviations: bDMARD, biologic disease-modifying antirheumatic drug; BSA, body surface area; cDAPSA, Clinical Disease Activity Index for Psoriatic Arthritis; HDA, high disease activity; IL-17i, interleukin-17 inhibitor; ModDA, moderate disease activity; PsA, psoriatic arthritis; SC, subcutaneous; SD, standard deviation.
Note: Data shown are mean (SD) unless otherwise indicated. Baseline characteristics were summarized among all patients in the effectiveness analysis set.
Treatment Persistence
  • At the 6-month visit, persistence on treatment was approximately 94% with both SC TREMFYA and SC IL-17i.2,3 
    • The propensity score-adjusted hazard ratio (HR) for stopping or switching treatment with SC TREMFYA vs SC IL-17i was 0.87 (95% confidence interval [CI], 0.47-1.61), adjusted for potential baseline confounders, including the initial biologic disease-modifying antirheumatic drug (bDMARD) treatment line.2 
  • At the 6-month visit, treatment effectiveness was similar with SC TREMFYA and SC IL-17i across PsA clinical outcomes2; see Table: Treatment Effectiveness of SC TREMFYA and SC IL-17i at the 6-Month Visit.

Treatment Effectiveness of SC TREMFYA and SC IL-17i at the 6-Month Visit2
SC TREMFYA
SC IL-17i
Composite outcome measures, n (%)
   cDAPSA LDA/REM
174 (40)
178 (34)
   DAPSA LDA/REM
142 (38)
149 (39)
   MDA achievement
304 (24)
268 (29)
Skin domain, n (%)
   BSA <3%a
154 (72)
108 (83)
   DLQI 0/1
153 (46)
110 (44)
LEI and dactylitis resolution, n (%)
   LEI resolution
175 (45)
171 (48)
   Dactylitis resolution
63 (60)
64 (66)
Abbreviations: BSA, body surface area; cDAPSA, Clinical Disease Activity Index for Psoriatic Arthritis; DAPSA, Disease Activity Index for Psoriatic Arthritis; DLQI, Dermatology Life Quality Index; IL-17i, interleukin-17 inhibitor; LDA, low disease activity; LEI, Leeds Enthesitis Index; MDA, minimal disease activity; REM, remission; SC, subcutaneous.
Note: The number of participants (n) corresponds to the number of participants included in each respective analysis.
aReported proportions were corrected after submission of the abstract.

Reasons for Treatment Discontinuation2 
Reason, n (%)a
SC TREMFYA
(n=360)
SC IL-17i
(n=326)
AEs
5 (1.4)
5 (1.5)
Primary failure
8 (2.2)
9 (2.8)
Drug holiday
1 (0.3)
0 (0)
Others
2 (0.6)
1 (0.3)
Abbreviations: AE, adverse event; IL-17i, interleukin-17 inhibitor; SC, subcutaneous.
Note: An additional 7 patients from each group discontinued their initial treatment without reporting a reason.
aMore than 1 reason for treatment discontinuation could be reported per event.

Ruscitti et al (2024)4 conducted a real-life, prospective, multicenter cohort study of TREMFYA in patients with PsA that evaluated the 6-month effectiveness, DRR, impact of comorbidities, and patient clinical characteristics over a collective 18-month follow-up.

Study Design/Methods

  • From December 2021 to September 2023, the study enrolled patients with moderate to active PsA who met the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria.
  • Patients with moderate to active PsA who were treated with SC TREMFYA for at least 6 months were evaluated in this study.
  • The study involved the following 2 TREMFYA dosing regimens: 100 mg SC every 8 weeks (Q8W) and every 4 weeks.
    • DAPSA was calculated at baseline and after 3 and 6 months; achievement of DAPSA ≤14 was also recorded.
    • The disease activity was further assessed by analyzing LEI, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), tender and swollen joints, and C-reactive protein (CRP).
    • Assessments using the Visual Analog Scale (VAS), Physician Global Assessment (PGA), and Patient Global Assessment were performed before and after administration of SC TREMFYA.
  • After 6 months of therapy, DRR of SC TREMFYA was evaluated by assessing the months of therapy; the impact of selected clinical manifestations (such as sex, disease duration, presence of comorbidity, obesity, and prior and concomitant therapies) on DRR was also evaluated.
  • Reasons for discontinuation of SC TREMFYA due to inefficacy and/or adverse events (AEs) were also recorded during the cumulative 18-month follow-up.

Results

Baseline Clinical Characteristics

Select Characteristics of Patients with PsA4
Clinical Characteristic
TREMFYA
(N=111)
Demographic characteristics
   Age, years, mean±SD
56.8±9.9
   Sex, male, %
20.7
   Weight, kg, mean±SD
72.2±12.6
   Height, m, mean±SD
1.7±0.4
   BMI, kg/m2, mean±SD
25.5±5.1
Disease characteristics
   Peripheral involvement, %
86.5
   Skin and/or nail involvement, %
75.9
   Axial movement, %
64.3
   Enthesis involvement, %
51.4
   Dactylitis features, %
29.7
   Extra-articular manifestations, %
8.9
   Disease duration, years, median (IQR)
6.0 (7.0)
   Disease duration ≥5 years, %
55.9
   DAPSA, median (IQR)
25.6 (15.2)
   LEI, median (IQR)
2.0 (3.0)
   Tender joints, median (IQR)
9.0 (5.0)
   Swollen joints, median (IQR)
1.0 (2.0)
   VAS pain, median (IQR)
7.0 (6.0)
   PGA, median (IQR)
6.0 (6.0)
   CRP, mg/dL, median (IQR)
0.7 (1.9)
   BASDAI, median (IQR)
5.8 (4.6)
TREMFYA features
   Ongoing at the last observation, %
71.2
   Discontinuation due to inefficacy, %
24.3
   Discontinuation due to side effects, %
4.5
   Previous therapy with bDMARDs, %
78.4
   Previous therapy with TNF inhibitors, %
63.5
   Concomitant therapy with csDMARDs, %
60.4
   Concomitant therapy with MTX, %
52.3
   Concomitant therapy with NSAIDs, %
45.9
   Concomitant therapy with GCs, %
12.8
Abbreviations: BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; bDMARD, biologic disease-modifying antirheumatic drug; BMI, body mass index; CRP, C-reactive protein; csDMARD, conventional synthetic disease-modifying antirheumatic drug; DAPSA, Disease Activity Index for Psoriatic Arthritis; GC, glucocorticoid; IQR, interquartile range; LEI, Leeds Enthesitis Index; MTX, methotrexate; NSAID, nonsteroidal anti-inflammatory drug; PGA, Physician Global Assessment; PsA, psoriatic arthritis; SD, standard deviation; TNF, tumor necrosis factor; VAS, Visual Analog Scale.
Efficacy
  • A significant reduction in DAPSA was observed in patients after 6 months of follow-up (P<0.001).
  • A significant overall 6-month reduction in DAPSA (β, -15.47; 95% CI, -23.15 to -9.79; P=0.001) was observed after adjusting the linear mixed model for age and male sex.
  • The percentage of patients who achieved DAPSA ≤14 at the 3- and 6-month assessments was 29.7% and 39.6%, respectively.
  • The predictive role of selected clinical variables for achievement of DAPSA ≤14 after administration of SC TREMFYA is presented in Table: Multivariate Regression Analyses of Clinical Variables for Achievement of DAPSA ≤14.

Multivariate Regression Analyses of Clinical Variables for Achievement of DAPSA ≤144
Clinical Variable
Odds Ratio (95% CI)
P-Value
Achievement of DAPSA ≤14
   Multivariate analysis
      Age
0.97 (0.92-1.02)
0.289
      Male sex
2.81 (0.75-10.52)
0.996
      Axial disease
0.44 (0.16-1.17)
0.100
      Enthesitis
1.23 (0.47-3.62)
0.617
      Dactylitis
1.32 (0.45-3.92)
0.611
   Multivariate analysis
      Age
0.98 (0.93-1.03)
0.549
      Male sex
2.86 (0.80-10.30)
0.106
      Disease duration ≥5 years
0.91 (0.34-2.44)
0.856
      csDMARDs
0.92 (0.35-3.56)
0.719
      Previous bDMARDs
0.65 (0.18-2.21)
0.623
   Multivariate analysis
      Age
0.96 (0.91-1.02)
0.224
      Male sex
2.01 (0.51-8.03)
0.313
      Obesity
0.46 (0.13-1.16)
0.461
      Comorbidity
1.58 (0.46-5.41)
0.924
Abbreviations: bDMARD, biologic disease-modifying antirheumatic drug; CI, confidence interval; csDMARD, conventional synthetic disease-modifying antirheumatic drug; DAPSA, Disease Activity Index for Psoriatic Arthritis.
Note: P<0.05 is considered statistically significant.
  • During the 6-month follow-up period after SC TREMFYA administration, a significant reduction in LEI (P<0.001), BASDAI (P<0.001), tender joints (P<0.001), swollen joints (P<0.001), CRP (P=0.002), VAS pain (P<0.001), PGA (P<0.001), and Patient Global Disease Assessment (P<0.001) was reported.
  • At the end of the 18-month follow-up, 71.2% of patients were still treated with SC TREMFYA, 24.3% of patients discontinued due to inefficacy, and 4.5% of patients discontinued due to side effects.
    • The cumulative 18-month DRR of SC TREMFYA was 66.7%, estimated with a mean±standard deviation time of administration of 9.8±4.1 months (median [interquartile range], 9.0 [5.0] months).
    • No influence of the following patient clinical characteristics was observed on SC TREMFYA DRR: male sex (P=0.941); disease duration ≥5 years (P=0.959); comorbidities, considering any concomitant disorder (P=0.824); obesity (P=0.444); and concomitant therapy with conventional synthetic disease-modifying antirheumatic drugs (P=0.854) or prior bDMARDs (P=0.293).
Safety
  • No life-threatening events were observed, and 4.5% of patients discontinued SC TREMFYA due to AEs.
    • Discontinuation was mainly due to gastrointestinal features, such as diarrhea and dyspepsia, and respiratory tract infections that needed antibiotic therapies. However, these reactions were resolved with no long-term consequences.
  • Minor transient AEs were reported during the study, mainly injection-site reactions, which did not lead to discontinuation of the drug.

Retrospective Studies

Mease et al (2025)5 evaluated treatment persistence in a real-world setting in patients with PsA who were newly initiated on SC TREMFYA vs SC IL-17Ai through 12 months.

Study Design/Methods

  • Inclusion criteria:
    • Adult patients (aged ≥18 years) with PsA initiated on SC TREMFYA or SC IL-17Ai who were identified using IQVIATM Health Plan Claims Data were included.
    • The index date was defined as the first date on which SC TREMFYA or SC IL-17Ai (ixekizumab or secukinumab) was initiated between July 14, 2020, and June 30, 2022.
    • Patients who had ≥12 months of continuous health insurance eligibility before the index date were included.
    • The baseline period was defined as 12 months before the index date on which the patient was diagnosed with PsA based on ≥2 claims for PsA ≥30 days apart and ≥1 prescription claim for a PsA-related medication.
  • Exclusion criteria:
    • Patients with >1 claim for any of the studied drugs at any time during the period of continuous eligibility before the index date were excluded.
    • Patients with potentially confounding rheumatic diseases (eg, ankylosing spondylitis, other inflammatory arthritides, spondyloarthropathies, rheumatoid arthritis, systemic connective tissue disorders, relapsing polychondritis, or unclassified connective tissue disease) during the 12-month baseline period before the index date were excluded.
  • In the primary analysis, on-label treatment persistence was defined as the absence of treatment discontinuation (based on a gap of 112 days for SC TREMFYA or 56 days for SC IL-17Ai), with approved dosing regimens per the Food and Drug Administration (FDA) label.
  • The primary analysis was conducted based on 2 times the FDA maintenance interval between administrations per label after induction.
  • Sensitivity analyses of on-label treatment persistence were performed.
    • In sensitivity analysis 1, on-label treatment persistence was defined as the absence of treatment discontinuation based on 1 time the FDA maintenance interval between administrations per label after induction (a gap of 56 days for SC TREMFYA or 28 days for SC IL-17Ai).
    • In sensitivity analysis 2 (fixed gap), on-label treatment persistence was defined as the absence of treatment discontinuation for a fixed 84 days.
  • Weighted Cox proportional hazards models were used to compare on-label persistence through 12 months after the index date between the standardized mortality ratio-weighted SC TREMFYA and SC IL-17Ai groups.

Results

Baseline Characteristics
  • The SC TREMFYA group (n=910) and the SC IL-17Ai group (n=2743; ixekizumab, n=1010; secukinumab, n=1733) were evaluated during the 12-month baseline period.
  • For baseline demographics and clinical characteristics across the SC TREMFYA and SC IL-17Ai groups after implementation of treatment weighting, see Table: Select Baseline Demographics and Clinical Characteristics.

Select Baseline Demographics and Clinical Characteristics5,a
Characteristic
SC TREMFYA
(n=910)
SC IL-17Ai
(n=2740)
Age at the index date, years, mean±SD (median)
50.4±11.1 (52.0)
50.2±11.3 (51.0)
Female, %
60.4
59.4
Time between the latest observed PsA diagnosis and the index date, months, mean±SD (median)
1.3±1.6 (1.0)
1.3±1.5 (1.0)
Quan-CCI score, mean±SD (median)
0.6±1.2 (0.0)
0.6±1.3 (0.0)
Psoriasis, %
86.5
87.6
Any prior PsA treatment, %
75.9
52.5
   bDMARDsb
51.9
52.5
      0
48.1
47.5
      1
43.6
44.0
      ≥2
8.2
8.5
   csDMARDsc
30.0
31.0
   tsDMARDsd
22.5
18.1
Corticosteroids, %
43.1
44.2
Abbreviations: bDMARD, biologic disease-modifying antirheumatic drug; csDMARD, conventional synthetic disease-modifying antirheumatic drug; CTLA-4, cytotoxic T lymphocyte-associated antigen 4; IBD, inflammatory bowel disease; IL, interleukin; IL-17Ai, interleukin-17A inhibitor; IV, intravenous; JAK, Janus kinase; PsA, psoriatic arthritis; Quan-CCI, Quan-Charlson comorbidity index; SC, subcutaneous; SD, standard deviation; TNF, tumor necrosis factor; tsDMARD, targeted synthetic disease-modifying antirheumatic drug.
aPropensity score weighting based on the standardized mortality ratio-weighting approach was used to adjust for differences in baseline characteristics between the SC TREMFYA and SC IL-17Ai groups. Weights were estimated using a multivariable logistic regression model. Baseline covariates included all demographic and clinical characteristics.
bIncludes an IL-12/23 inhibitor (ie, ustekinumab), an anti-CTLA-4 agent (ie, abatacept), an IL-23 inhibitor (ie, risankizumab), SC TNF inhibitors (ie, adalimumab, certolizumab pegol, etanercept, and golimumab), and IV TNF inhibitors (ie, infliximab, infliximab biosimilars, and IV golimumab).
cIncludes methotrexate, leflunomide, cyclosporine, mycophenolate, and azathioprine.
dIncludes apremilast, deucravacitinib, and JAK inhibitors (ie, upadacitinib, baricitinib, and tofacitinib).
Treatment Persistence
  • In the primary analysis, the SC TREMFYA group was significantly (~2 times) more likely to persist with treatment at 12 months as compared with the SC IL-17Ai group (HR, 1.85; 95% CI, 1.60-2.13; P<0.001).
  • In the SC TREMFYA vs SC IL-17Ai group, on-label persistence at 12 months was 67% vs 50%.
  • The median time to discontinuation was not reached in the SC TREMFYA group and was 12.3 months in the SC IL-17Ai group.
  • In sensitivity analysis 1, the SC TREMFYA group was ~1.7 times more likely to persist with on-label treatment at 12 months as compared with the SC IL-17Ai group (HR, 1.72; P<0.001).
  • In sensitivity analysis 2, the SC TREMFYA group was ~1.2 times more likely to persist with on-label treatment at 12 months as compared with the SC IL-17Ai group (HR, 1.21; P=0.0113).
  • On-label persistence at 3, 6, 9, and 12 months is summarized in Table: Primary Analysis (2× Duration) of On-Label Persistence through 12 Months in the Weighted SC TREMFYA and SC IL-17Ai Groups.

Primary Analysis (2× Duration) of On-Label Persistence through 12 Months in the Weighted SC TREMFYA and SC IL-17Ai Groups5,a
Cox Proportional Hazards Modelb
SC TREMFYA
(n=910)
SC IL-17Ai
(n=2740)
Hazard Ratio (95% CI)
P-Value
Patients at riskc,n (%)
   3 months
665 (73.1)
1065 (38.9)
1.36 (1.18-1.58)
<0.001d
   6 months
484 (53.2)
807 (29.5)
1.62 (1.41-1.88)
<0.001d
   9 months
333 (36.6)
599 (21.9)
1.75 (1.52-2.02)
<0.001d
   12 months
201 (22.1)
358 (13.1)
1.85 (1.60-2.13)
<0.001d
KM persistence, % (95% CI)
   3 months
89.8 (84.2-93.5)
81.2 (76.7-84.8)
-
<0.001e
   6 months
80.0 (74.9-84.3)
67.1 (61.5-72.0)
-
<0.001e
   9 months
71.3 (65.9-76.0)
57.5 (51.0-63.4)
-
<0.001e
   12 months
66.8 (61.1-71.8)
50.1 (42.6-57.2)
-
<0.001e
Abbreviations: CI, confidence interval; IL-17Ai, interleukin-17A inhibitor; KM, Kaplan-Meier; SC, subcutaneous.
aPropensity score weighting based on the standardized mortality ratio-weighting approach was used to adjust for differences in baseline characteristics between the SC TREMFYA and SC IL-17Ai groups. Weights were estimated using a multivariable logistic regression model. Baseline covariates included all demographic and clinical characteristics.
bWeighted Cox proportional hazards models were used to compare the risk of discontinuation between the weighted SC TREMFYA and SC IL-17Ai groups.
cPatients at risk of experiencing the event were those who had not experienced the event and were not lost to follow-up at that point in time.
dP-values were determined using a Chi-square test.
eP-values were determined using a log-rank test.

Mease et al (2025)6 compared treatment persistence in a real-world setting in patients with active PsA initiated on an on-label SC TREMFYA dosing regimen vs an SC IL-17Ai regimen through 24 months.

Study Design/Methods

  • Adult patients with PsA who received the first claim of index biologic agents (ie, SC TREMFYA 100 mg at baseline, week 4, and Q8W thereafter or SC IL-17Ai [secukinumab or ixekizumab]) and were identified using IQVIATM health plan claims data between July 14, 2020, and December 31, 2022, were included.
  • For details on eligibility criteria, see: Inclusion criteria and Exclusion criteria.

Results

Baseline Characteristics

Select Weighted Baseline Demographics and Characteristics6
SC TREMFYA
(n=849)
SC IL-17Ai
(n=2601)
Demographics
   Age at the index date, years, mean±SD (median)
49.7±11.0 (50.9)
49.6±11.3 (50.8)
   Female
59.4
59.4
Characteristics
   Months between the latest observed PsA diagnosis
   and the index date, mean±SD (median)
1.3±1.6 (0.7)
1.3±1.4 (0.8)
   Quan-CCI score, mean±SD (median)
0.6±1.3 (0.0)
0.6±1.3 (0.0)
   Psoriasis
84.5
84.5
Medicationsb
   bDMARDsc
50.5
50.5
      0
49.5
49.5
      1
44.0
43.7
      ≥2
6.6
6.8
   csDMARDsd
25.7
27.0
   tsDMARDse
21.9
21.9
   Corticosteroids
72.5
71.5
Abbreviations: bDMARD, biologic disease-modifying antirheumatic drug; csDMARD, conventional synthetic disease-modifying antirheumatic drug; CTLA-4, cytotoxic T-lymphocyte-associated protein 4; IL-12/23i, interleukin-12/23 inhibitor; IL-23i, interleukin-23 inhibitor; IL-17Ai, interleukin-17A inhibitor; IV, intravenous; JAKi, Janus kinase inhibitor; PsA, psoriatic arthritis; Quan-CCI, Quan Charlson comorbidity index; SC, subcutaneous; SD, standard deviation; TNFi, tumor necrosis factor inhibitor; tsDMARD, targeted synthetic disease-modifying antirheumatic drug.
Note: Data are % unless otherwise noted.
aPropensity score using overlap weighting.
bDuring 12 months before the index date.
cIncludes an IL-12/23i (ie, ustekinumab), an anti-CTLA-4 agent (ie, abatacept), an IL-23i (ie, risankizumab), SC TNFis (ie, adalimumab, certolizumab pegol, etanercept, and golimumab), and IV TNFis (ie, infliximab, infliximab biosimilars, and IV golimumab).
dIncludes methotrexate, leflunomide, cyclosporine, mycophenolate, and azathioprine.
eIncludes apremilast, deucravacitinib, and JAKis (upadacitinib, baricitinib, and tofacitinib).
Treatment Persistence
  • At 24 months, persistence with on-label treatment was observed in 44.9% of patients in the SC TREMFYA group vs 35.0% of patients in the SC IL-17Ai group.
  • The median time to discontinuation in the SC TREMFYA vs SC IL-17Ai group was 20.9 vs 12.2 months, respectively.
  • In both sensitivity analyses, patients in the SC TREMFYA group were 1.5 times more likely to remain persistent with on-label treatment through 24 months compared with those in the SC IL-17Ai group (1× FDA maintenance gap: HR, 1.54 [95% CI, 1.36-1.75] [P<0.001]; vs fixed gap [112 days]: HR, 1.09 [95% CI, 0.94-1.27] [P=0.252]).
  • SC TREMFYA was associated with a significantly higher on-label persistence compared with SC IL-17Ai at each time point assessed (6, 12, 18, and 24 months). See Table: Primary Analysis of On-Label Persistence through 24 Months in the Weighted SC TREMFYA and SC IL-17Ai Groups.

Primary Analysis of On-Label Persistence through 24 Months in the Weighted SC TREMFYA and SC IL-17Ai Groups6
Parameter
SC TREMFYAb
(n=849)
SC IL-17Aib
(n=2601)
Hazard Ratio
(95% CI)
P-Value
Patients at riskc, n (%)
   6 months
440 (51.8)
980 (37.7)
1.75 (1.45-2.12)
<0.001d
   12 months
179 (21.1)
460 (17.7)
1.50 (1.29-1.75)
<0.001d
   18 months
80 (9.5)
225 (8.6)
1.53 (1.32-1.77)
<0.001d
   24 months
26 (3.1)
106 (4.1)
1.49 (1.29-1.72)
<0.001d
KM persistence, % (95% CI)
   6 months
80.3 (74.8-84.8)
68.0 (64.3-71.4)
-
<0.001e
   12 months
61.9 (55.4-67.7)
50.5 (45.9-55.0)
-
<0.001e
   18 months
55.7 (47.8-62.9)
41.5 (35.7-47.1)
-
<0.001e
   24 months
44.9 (30.2-58.6)
35.0 (27.6-42.6)
-
<0.001e
Abbreviations: CI, confidence interval; IL-17Ai, interleukin-17A inhibitor; KM, Kaplan-Meier; SC, subcutaneous.
aPropensity score weights were used to obtain a balanced sample. Weights were estimated using a multivariable logistic regression model. Baseline covariates included several demographic and clinical characteristics.
bWeighted Cox proportional hazards models were used to compare the risk of discontinuation between the SC TREMFYA and SC IL-17Ai groups.
cPatients at risk of experiencing the event were those who had not experienced the event and were not lost to follow-up at that point in time.
dP-values were determined using a Chi-square test.
eP-values were determined using a log-rank test.

Walsh et al (2024)7,8 compared the on-label treatment persistence in a real-world setting in patients with PsA treated with SC TREMFYA vs SC TNFi using the IQVIA PharMetrics® Plus database through 12 months.

Study Design/Methods

  • Inclusion criteria:
    • Adult patients with PsA who received an index biologic (ie, SC TREMFYA 100 mg at baseline, week 4, and Q8W or the first SC TNFi [adalimumab, certolizumab pegol, etanercept, or golimumab]) between July 14, 2020, and March 31, 2022, were included.
    • The index date was defined as the date of the first claim for SC TREMFYA or SC TNFi.
    • The baseline period was defined as 12 months before the index date during which the patient received a diagnosis for PsA based on ≥2 claims for PsA ≥30 days apart and ≥1 prescription claim for a PsA-related medication.
    • Patients were identified as either biologic naïve or biologic experienced based on prior bDMARD use (other than SC TREMFYA, SC TNFi, or intravenous TNFi) during the 12-month baseline period.
  • Exclusion criteria:
    • Patients who had received ≥1 claim for any of the studied drugs at any time during the period of continuous eligibility before the index date were excluded.
    • Patients who were initiated on >1 index biologic on the index date or had received ≥1 diagnosis for other potentially confounding rheumatic diseases (as listed by the authors) during the baseline period were excluded.
  • In the primary analysis, on-label treatment persistence was defined as the absence of treatment discontinuation (based on a gap of 112 days for SC TREMFYA or 56 days for SC TNFi) or any dose escalation/reduction during follow-up.
  • Sensitivity analyses were performed for on-label persistence, which was defined as follows:
    • First sensitivity analysis: absence of treatment discontinuation based on a gap of 56 days for SC TREMFYA or 28 days for SC TNFi
    • Second sensitivity analysis: absence of treatment discontinuation for a fixed 112 days to evaluate persistence based on the same gap definition for all index biologics
  • Cox proportional hazards models were used to compare the risk of discontinuation between the standardized mortality ratio-weighted treatment cohorts (SC TREMFYA and SC TNFi groups).

Results

Baseline Characteristics
  • The SC TREMFYA group (n=526), 48.5% were biologic naïve and the SC TNFi group (N=1953: adalimumab, n=1339; etanercept, n=400; certolizumab pegol, n=159; SC golimumab, n=55), 87.9% were biologic naïve during the 12-month baseline period.
  • After implementation of treatment weighting, baseline demographic and clinical characteristics were comparable (except for prior bDMARD use during the baseline period [51.5% vs 16.7% in the SC TREMFYA vs SC TNFi group]) across the SC TREMFYA and SC TNFi groups. See Table: Select Demographics and Baseline Characteristics During the 12-Month Baseline Period.

Select Demographics and Baseline Characteristics During the 12-Month Baseline Period7,a
Characteristic
TREMFYA
(n=526)
SC TNFis
(N=1953)
Standardized Difference, %
Age at the index date, years, mean±SD (median)
49.8±11.7 (50.7)
49.2±11.6 (50.3)
5.2
Female, n (%)
322 (61.2)
1193 (61.1)
0.3
Time between the latest observed PsA diagnosis and the index date, months, mean±SD (median)
1.4±1.7 (0.8)
1.2±1.6 (0.7)
9.6
Baseline Quan-CCI score, mean±SD (median)
0.6±1.4 (0.0)
0.6±1.4 (0.0)
0.6
Psoriasisb, n (%)
470 (89.4)
1718 (88.0)
4.4
Any prior PsA treatment, n (%)
385 (73.2)
1012 (51.8)
45.3
   bDMARDsc
271 (51.5)
327 (16.7)
78.9
      1
228 (84.1)
302 (92.4)
64.3
      ≥2
43 (15.9)
25 (7.6)
34.3
   csDMARDsd
118 (22.4)
471 (24.1)
4.0
   tsDMARDse
95 (18.1)
359 (18.4)
0.8
Abbreviations: bDMARD, biologic disease-modifying antirheumatic drug; csDMARD, conventional synthetic disease-modifying antirheumatic drug; CTLA-4, cytotoxic T-lymphocyte-associated antigen 4; IBD, inflammatory bowel disease; ICD-10, International Classification of Diseases, 10th Revision; IL, interleukin; JAK, Janus kinase; PsA, psoriatic arthritis; Quan-CCI, Quan-Charlson comorbidity index; SC, subcutaneous; SD, standard deviation; TNFi, tumor necrosis factor inhibitor; tsDMARD, targeted synthetic disease-modifying antirheumatic drug.
aPropensity score weighting based on the standardized mortality ratio weighting-approach was used to adjust for differences in baseline characteristics between the SC TREMFYA and SC TNFi groups. Weights were estimated using a multivariable logistic regression model. Baseline covariates included all demographic and clinical characteristics reported in this table, with the exception of baseline use of bDMARDs, which was included in the adjusted Cox proportional hazards models.
bDefined based on the ICD-10 code L40.x (excluding L40.5).
cIL-17A inhibitors (ie, secukinumab and ixekizumab), an IL-12/23 inhibitor (ie, ustekinumab), an anti-CTLA-4 agent (ie, abatacept), and IL-23p19-subunit inhibitor (ie, risankizumab). The proportion of patients taking 1 and ≥2 bDMARDs has been reported among those with any bDMARD use.
dMethotrexate, leflunomide, cyclosporine, mycophenolate, and azathioprine.
eApremilast, deucravacitinib, and JAK inhibitors (ie, upadacitinib, baricitinib, and tofacitinib).
Treatment Persistence
  • In the SC TREMFYA vs SC TNFi group, the mean follow-up time was 12.3 vs 12.4 months, and the proportion of patients with PsA who were persistent with treatment at 12 months was 72% vs 44%.
  • In the primary analysis, the SC TREMFYA group was 3 times more likely to persist with treatment at 12 months compared with the SC TNFi group (HR, 2.97; 95% CI, 2.36-3.74; P<0.001).
    • The median time to discontinuation was not reached in the SC TREMFYA group and was 8.9 months in the SC TNFi group.
  • On-label persistence at 3, 6, 9, and 12 months is summarized in Table: Analysis of On-Label Persistence through 12 Months in the Weighted SC TREMFYA and SC TNFi Groups.

Analysis of On-Label Persistence through 12 Months in the Weighted SC TREMFYA and SC TNFi Groups7,8,a
Cox Proportional Hazards Modelb
TREMFYA
(n=526)
SC TNFis
(N=1953)
Hazard Ratio
(95% CI)
P-Valuec
Primary analysis
   Patients at riskd, n (%)
      3 months
368 (70.0)
1051 (53.8)
3.41 (2.41-4.80)
<0.001e
      6 months
263 (50.0)
744 (38.1)
3.30 (2.51-4.33)
<0.001e
      9 months
155 (29.5)
452 (23.1)
3.06 (2.41-3.88)
<0.001e
      12 months
84 (16.0)
299 (15.3)
2.97 (2.36-3.74)
<0.001e
   KM persistence, % (95% CI)
      3 months
91.2 (82.8-95.6)
77.3 (73.1-80.9)
-
<0.001f
      6 months
84.1 (76.7-89.4)
61.6 (56.8-66.1)
-
<0.001f
      9 months
75.9 (68.3-81.9)
50.0 (44.4-55.3)
-
<0.001f
      12 months
71.5 (63.2-78.3)
43.7 (37.3-49.8)
-
<0.001f
Sensitivity analysis 1
   Patients at riskd, n (%)
      3 months
352 (66.9)
996 (51.0)
2.73 (2.04-3.65)
<0.001e
      6 months
251 (47.7)
685 (35.1)
2.49 (1.98-3.13)
<0.001e
      9 months
144 (27.4)
388 (19.9)
2.51 (2.04-3.07)
<0.001e
      12 months
76 (14.4)
242 (12.4)
2.41 (1.98-2.92)
<0.001e
   KM persistence, % (95% CI)
      3 months
87.1 (79.6-92.0)
72.3 (67.9-76.1)
-
<0.001f
      6 months
76.4 (69.3-82.0)
55.0 (49.9-59.7)
-
<0.001f
      9 months
66.7 (59.2-73.2)
41.5 (35.6-47.3)
-
<0.001f
      12 months
59.2 (50.4-67.0)
33.5 (26.6-40.4)
-
<0.001f
Sensitivity analysis 2
   Patients at riskd, n (%)
      3 months
368 (70.0)
1106 (56.6)
2.55 (1.79-3.63)
<0.001e
      6 months
263 (50.0)
803 (41.1)
2.54 (1.92-3.35)
<0.001e
      9 months
155 (29.5)
493 (25.2)
2.38 (1.86-3.03)
<0.001e
      12 months
84 (16.0)
329 (16.8)
2.35 (1.86-2.97)
<0.001e
   KM persistence, % (95% CI)
      3 months
91.2 (82.8-95.6)
82.6 (78.5-86.0)
-
<0.001f
      6 months
84.1 (76.7-89.4)
68.7 (64.1-72.9)
-
<0.001f
      9 months
75.9 (68.3-81.9)
58.9 (53.6-63.8)
-
<0.001f
      12 months
71.5 (63.2-78.3)
52.1 (46.0-57.8)
-
<0.001f
Abbreviations: bDMARD, biologic disease-modifying antirheumatic drug; CI, confidence interval; KM, Kaplan-Meier; SC, subcutaneous; TNFi, tumor necrosis factor inhibitor.
aPropensity score weighting based on the standardized mortality ratio-weighting approach was used to adjust for differences in baseline characteristics between the SC TREMFYA and SC TNFi groups. Weights were estimated using a multivariable logistic regression model. Baseline covariates included all demographic and clinical characteristics, with the exception of baseline use of bDMARDs, which was included in the adjusted Cox proportional hazards models.
bCox proportional hazards models were used to compare the risk of discontinuation between the weighted SC TREMFYA and SC TNFi groups. Models were adjusted for baseline use of bDMARDs.
cDenotes statistical significance based on a threshold of P<0.05.
dPatients at risk of experiencing the event were those who had not experienced the event and were not lost to follow-up at that point in time.
eP-values were determined using a Chi-square test.
fP-values were determined using a log-rank test.
  • In sensitivity analysis 1, the SC TREMFYA group was 2.4 times more likely to persist with treatment at 12 months compared with the SC TNFi group (HR, 2.41; 95% CI, 1.98-2.92; P<0.001).7,8
    • The median time to discontinuation was 18.4 months in the SC TREMFYA group and 6.9 months in the SC TNFi group.
  • In sensitivity analysis 2, the SC TREMFYA group was 2.4 times more likely to persist with treatment at 12 months compared with the SC TNFi group (HR, 2.35; 95% CI, 1.86-2.97; P<0.001).7,8
    • The median time to discontinuation was not reached in the SC TREMFYA group and was 13.8 months in the SC TNFi group.

Mease et al (2025)9 compared treatment persistence in a real-world setting in patients with active PsA initiating on-label SC TREMFYA dosing regimen vs SC TNFi using IQVIATM health plan claims data through 24 months.

Study Design/Methods

  • Inclusion criteria:
    • Adult patients with PsA (International Classification of Disease, 10th Revision, Clinical Modification code: L40.5x) who received the first claim of the index agent (ie, SC TREMFYA or SC TNFi [adalimumab, etanercept, certolizumab pegol, or golimumab]) within the intake period (July 14, 2020, to December 31, 2022) were included.
    • Patients were required to have continuous health insurance eligibility for ≥12 months before the index date, with no claims for SC TREMFYA or SC TNFi approved conditions or potentially confounding diseases.
  • Exclusion criteria:
    • Patients who received a claim for ankylosis spondylitis, other inflammatory arthritides, other spondylopathies, rheumatoid arthritis, systemic connective tissue disorders, relapsing polychondritis, unclassified connective tissue disease, hidradenitis suppurativa, inflammatory bowel disease, or uveitis during the 12-month baseline period preceding the index date were excluded.
  • Censoring was defined as the earliest occurrence of either a first off-label claim or the last day of index agent supply preceding the end of the follow-up period if discontinuation was not observed.

Results

Baseline Characteristics

Select Weighted Baseline Demographics and Characterstics9
SC TREMFYA
(n=804)
SC TNFi
(n=2490)
Demographics
   Age at the index date, years, mean±SD (median)
49.4±11.2 (50.3)
49.5±11.2 (51.0)
   Female
60.3
60.3
Characteristics
   Months between the latest observed PsA diagnosis and the
   index date, mean±SD (median)
1.2±1.4 (0.7)
1.2±1.6 (0.7)
   Quan-CCI score, mean±SD (median)
0.6±1.3 (0.0)
0.6±1.2 (0.0)
   Psoriasis
86.3
86.3
Medicationsb
   bDMARDsc
47.6
14.0
      0
52.4
86.0
      1
41.2
12.6
      ≥2
6.4
1.4
   csDMARDsd
22.4
48.3
   tsDMARDse
21.1
23.4
   Corticosteroids
68.9
67.9
Abbreviations: bDMARD, biologic disease-modifying antirheumatic drug; csDMARD, conventional synthetic disease-modifying antirheumatic drug; CTLA-4, cytotoxic T-lymphocyte-associated protein 4; IL, interleukin; JAKi, Janus kinase inhibitor; PsA, psoriatic arthritis; Quan-CCI, Quan Charlson comorbidity index; SC, subcutaneous; SD, standard deviation; TNFi, tumor necrosis factor inhibitor; tsDMARD, targeted synthetic disease-modifying antirheumatic drug.
Note: Data are % unless otherwise noted.
aPropensity score using overlap weighting.
bDuring 12 months before the index date.
cIncludes anti IL-17A agents (secukinumab and ixekizumab), an anti-IL-12/23 (ustekinumab), anti-CTLA- 4 (abatacept), and an anti-IL-23 (risankizumab).
dIncludes methotrexate, leflunomide, cyclosporine, mycophenolate, and azathioprine.
eIncludes apremilast, deucravacitinib, and JAKis (upadacitinib, baricitinib, and tofacitinib).
  • Prior to the index date, 55.1% of patients in the SC TREMFYA group and 12.8% of patients in the SC TNFi group had received ≥1 bDMARD; these values were unweighted.
Treatment Persistence
  • Persistence with on-label treatment at 24 months was observed in 45.5% of patients in the SC TREMFYA group compared with 28.5% of patients in the SC TNFi group, despite a higher proportion of biologic-experienced patients in the SC TREMFYA vs SC TNFi group (47.6% vs 14.0%) during the 12-month baseline period.
  • The median time to discontinuation in the SC TREMFYA vs SC TNFi group was 22.0 and 9.2 months, respectively.
  • In both sensitivity analyses, patients in the SC TREMFYA group were approximately 2 times more likely to remain persistent with on-label treatment through 24 months compared with those in the SC TNFi group (1×: HR, 1.90; fixed gap: HR, 1.80; P<0.001 for both).
  • SC TREMFYA was associated with a significantly higher on-label persistence compared with SC TNFi at each time point assessed (6, 12, 18, and 24 months). See Table: Primary Analysis of On-Label Persistence through 24 Months in the Weighted SC TREMFYA and SC TNFi Groups.

Primary Analysis of On-Label Persistence through 24 Months in the Weighted SC TREMFYA and SC TNFi Groups9
Parameter
SC TREMFYAb
(n=804)
SC TNFib
(n=2490)
Hazard Ratio
(95% CI)
P-Value
Patients at riskc, n (%)
   6 months
420 (52.2)
1068 (42.9)
2.61 (2.10-3.24)
<0.001d
   12 months
166 (20.6)
479 (19.3)
2.34 (1.96-2.79)
<0.001d
   18 months
74 (9.2)
234 (9.4)
2.29 (1.94-2.71)
<0.001d
   24 months
25 (3.1)
114 (4.6)
2.24 (1.90-2.64)
<0.001d
KM persistence, % (95% CI)
   6 months
82.1 (76.3-86.6)
63.8 (60.1-67.3)
-
<0.001e
   12 months
65.9 (59.2-71.8)
43.8 (39.3-48.2)
-
<0.001e
   18 months
58.1 (49.5-65.7)
35.4 (30.0-40.8)
-
<0.001e
   24 months
45.5 (26.9-62.1)
28.5 (21.5-35.9)
-
<0.001e
Abbreviations: bDMARD, biologic disease-modifying antirheumatic drug; CI, confidence interval; csDMARD, conventional synthetic disease-modifying antirheumatic drug; KM, Kaplan-Meier; SC, subcutaneous; TNFi, tumor necrosis factor inhibitor.
aPropensity score weights were used to obtain a balanced sample. Weights were estimated using a multivariable logistic regression model. Baseline covariates included several demographic and clinical characteristics.
bWeighted Cox proportional hazards models were used to compare the risk of discontinuation between the SC TREMFYA and SC TNFi groups. Models were adjusted for baseline use of bDMARDs and csDMARDs.
cPatients at risk of experiencing the event were those who had not experienced the event and were not lost to follow-up at that point in time.
dP-values were determined using a Chi-square test.
eP-values were determined using a log-rank test.

Registry-Based Studies

Rotondo et al (2025)10 evaluated the effectiveness and drug survival of TREMFYA vs adalimumab and IL-17Ai in patients with PsA using real-world data from the BIOPURE registry.

Study Design/Methods

  • PsA patients initiating TREMFYA or adalimumab or IL-17Ai were included in the study.
  • The comparative analysis between TREMFYA vs adalimumab and TREMFYA vs IL-17Ai was performed at 6, 12, and 24 months of follow-up.
  • Efficacy was assessed based on achievement of remission or low disease activity according to the DAPSA score and attainment of MDA.

Results

Baseline Characteristics
  • Among 1339 patients, 112 received TREMFYA, 558 received adalimumab, and 669 received IL-17Ai.
  • Baseline demographic and clinical characteristics were comparable between the treatment groups, except a higher rate of bDMARD use was observed in patients receiving TREMFYA (35.7%) vs adalimumab (20.3%; P=0.0001).
Effectiveness
  • DAPSA improved progressively and continuously across all 3 groups studied, without significant differences, at various study time points.
  • The rate of DAPSA remission in patients receiving TREMFYA vs IL-17Ai was 32% vs 16% (P=0.004) at 6 months and 36% vs 18% (P=0.005) at 12 months.
  • At 6 months, MDA was 22% in patients receiving TREMFYA vs 9% in patients receiving IL-17Ai (P=0.037).
  • At 6 and 12 months, the proportion of corticosteroid users among patients receiving TREMFYA was 8% and 6%, respectively, compared to patients receiving adalimumab (17% [P=0.011] and 15% [P=0.012], respectively) and IL-17Ai (18% [P=0.009] and 13%[P=0.035], respectively).
  • At 24 months, no difference in the DAPSA remission, MDA, and the rate of corticosteroid users was observed among the treatment groups.

Mease et al (2023)11 evaluated the effectiveness of persistent use of SC TREMFYA through 6 months in adult patients with active PsA using real-world data from the CorEvitas PsA/ Spondyloarthritis (SpA) Registry.

Study Design/Methods

  • The CorEvitas PsA/SpA Registry is a US-based, prospective, multicenter, observational registry of patients with active PsA or SpA under rheumatologists’ care.
  • The study population included registry participants who were initiated on SC TREMFYA on/after October 20, 2018, and had a 6-month follow-up visit on/before March 31, 2023.
  • The primary analysis population comprised patients with active PsA who received SC TREMFYA at a dose of 100 mg administered at weeks 0 and 4 and Q8W thereafter and were persistent with therapy through the 6-month visit (on-label persisters).
  • The primary outcome was mean (95% CI) change in the clinical DAPSA score from baseline to 6 months.
  • Secondary outcomes (in order of multiplicity-controlled testing) were changes in PGA of arthritis and PsO, patient-reported pain, and percentage of BSA among patients with a history of PsO from baseline to 6 months.

Results

Baseline Characteristics
  • Among 329 patients with active PsA who were initiated on SC TREMFYA at or after enrollment in the CorEvitas PsA/SpA Registry, 133 had eligible baseline and 6-month follow-up visits and 196 did not. Of the 133 patients, 114 received on-label FDA-approved dosing of SC TREMFYA for active PsA.
  • Of these 114 patients, 90 (78.9%) had persistent use of SC TREMFYA at 6 months (on-label persisters).
  • For baseline patient characteristics, see Table: Select Demographics and Baseline Characteristics.

Select Demographics and Baseline Characteristics11
Characteristic
Primary Analysis: On-Label Persisters
(N=90)
Age, years, mean±SD
55.2±12.5
Female, n (%)
62 (69.7)
(n=89)
PsA symptom onset, years, mean±SD
13.6±11.2
(n=87)
PsA diagnosis, years, mean±SD
8.9±7.9
(n=89)
PsO (yes, current or history), n (%)a
85 (94.4)
BSA with PsO, %, mean±SDb
7.6±12.6
(n=85)
Tender joint count (0-68), mean±SD
8.7±11.7
(n=87)
Swollen joint count (0-66), mean±SD
2.4±4.0
(n=87)
PGA of arthritis (VAS, 0-100), mean±SD
34.2±22.7
(n=89)
PGA of arthritis and PsO (VAS, 0-100), mean±SDb
42.3±23.7
(n=85)
Patient-reported pain (VAS, 0-100), mean±SD
57.0±24.6
(n=89)
Dactylitis count (0-20), mean±SD
0.3±1.1
Leeds Enthesitis Index (0-6), mean±SD
0.7±1.3
(n=87)
SPARCC Enthesitis Index (0-16), mean±SD
1.3±2.4
cDAPSA, mean±SD
22.0±15.1
(n=85)
Prior csDMARD, n (%)c,d
   1
35 (38.9)
   ≥2
21 (23.3)
Prior b/tsDMARD, n (%)c,d
   1
17 (18.9)
   ≥2
66 (73.3)
Abbreviations: b/tsDMARD, biologic/targeted synthetic disease-modifying antirheumatic drug; BSA, body surface area; cDAPSA, clinical Disease Activity Index for Psoriatic Arthritis; csDMARD, conventional synthetic disease-modifying antirheumatic drug; PGA, Physician Global Assessment; PsA, psoriatic arthritis; PsO, psoriasis; SD, standard deviation; SPARCC, Spondyloarthritis Research Consortium of Canada; TNFi, tumor necrosis factor inhibitor; VAS, Visual Analog Scale.
aDefined as a personal history of PsO or evidence of current PsO.
bAmong patients with prior or current PsO.
cPrior therapy count does not include patient’s current therapy.
dGroups are not mutually exclusive. TNFi: adalimumab, certolizumab pegol, etanercept, etanercept-szzs, golimumab, infliximab, and infliximab-dyyb; non-TNFi: abatacept, anakinra, ixekizumab, rituximab, secukinumab, tocilizumab, ustekinumab, and risankizumab-rzaa; and tsDMARD: apremilast, tofacitinib, and upadacitinib.
Effectiveness

Primary and Major Secondary Outcomes of SC TREMFYA Among On-Label Persisters at 6 Months11
Baseline
At 6 Months
Mean Change (95% CI)
P-Value
Mean cDAPSA scorea
21.6
(n=75)
16.1
(n=75)
-5.4 (-8.5 to -2.3)
<0.001
Mean PGA of arthritis and PsO score (VAS, 0-100)b,c
41.3
(n=82)
22.4
(n=82)
-19.0 (-24.2 to -13.8)
<0.001
Mean patient-reported pain score (VAS, 0-100)d
58.1
(n=87)
48.9
(n=87)
-9.1 (-14.4 to -3.8)
<0.001
Mean BSA with PsO (%)c
8.0
(n=79)
2.9
(n=79)
-5.1 (-7.6 to -2.7)
<0.001
Abbreviations: BSA, body surface area; cDAPSA, Clinical Disease Activity Index for Psoriatic Arthritis; CI, confidence interval; PGA, Physician Global Assessment; PsO, psoriasis; SC, subcutaneous; VAS, Visual Analog Scale.
aRemission, cDAPSA ≤4; low disease activity, cDAPSA >4 to ≤13; moderate disease activity, cDAPSA >13 to ≤27; and high disease activity, cDAPSA >27.
bPGA ≤20 mm (0-100 VAS) was considered minimal disease activity.
cAmong patients with prior or current PsO. Mild, BSA <3%; moderate, BSA ≥3% to ≤10%; and severe, BSA >10%.
dPatient-reported pain score ≤15 mm (0-100 VAS) was considered minimal pain; minimally important improvement=improvement ≥10 mm (VAS).

LITERATURE SEARCH

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 18 September 2025.

Summarized in this response are PsA-specific data available from real-world prospective and retrospective (≥100 patients and a follow-up duration of ≥1 year) and registry-based studies that evaluated the use of TREMFYA in adult patients with PsA.

References

Show
1 Janssen Research & Development, LLC. A study of guselkumab and interleukin-17 (IL-17) inhibitor therapies in participants with psoriatic arthritis in routine clinical practice (PsABIOnd). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 December 24]. Available from: https://clinicaltrials.gov/study/NCT05049798 NLM Identifier: NCT05049798.  
2 Gossec L, Sharaf M, Baraliakos X, et al. Guselkumab and IL-17 inhibitors show comparable treatment persistence and effectiveness in psoriatic arthritis: 6-month interim results of the PsABIOnd observational cohort study. Poster presented at: ACR Convergence; November 14-19, 2024; Washington, DC.  
3 Siebert S, Sharaf M, Selmi C, et al. Guselkumab and IL-17 inhibitors improve patient-perceived impact of psoriatic arthritis similarly: 6-month interim results of the PsABIOnd observational cohort study. Oral Presentation presented at: ACR Convergence; November 14-19, 2024; Washington, DC.  
4 Ruscitti P, Cataldi G, Gentile M, et al. The evaluation of effectiveness and safety of guselkumab in patients with psoriatic arthritis in a prospective multicentre “real-life” cohort study. Rheumatol Ther. 2024;11(3):539-551.  
5 Mease PJ, Ferrante SA, Shiff NJ, et al. Comparison of on-label treatment persistence in real-world patients with psoriatic arthritis receiving guselkumab versus subcutaneous IL-17A inhibitors. Adv Ther. 2025;42(2):734-751.  
6 Mease PJ, Walsh J, Fitzgerald TP, et al. On-label persistence through 24 months in patients with psoriatic arthritis using guselkumab or subcutaneous interleukin-17A inhibitors. Poster presented at: Congress of Clinical Rheumatology - East (CCR-East); May 1-4, 2025; Destin, FL.  
7 Walsh JA, Lin I, Zhao R, et al. Comparison of real-world on-label treatment persistence in patients with psoriatic arthritis receiving guselkumab versus subcutaneous tumor necrosis factor inhibitors. Drugs Real World Outcomes. 2024;11(3):487-499.  
8 Walsh JA, Lin I, Zhao R, et al. Supplement to: Comparison of real-world on-label treatment persistence in patients with psoriatic arthritis receiving guselkumab versus subcutaneous tumor necrosis factor inhibitors. Drugs Real World Outcomes. 2024;11(3):487-499.  
9 Mease PJ, Walsh J, Fitzgerald TP, et al. On-label persistence through 24 months among patients with psoriatic arthritis initiating guselkumab or subcutaneous TNF inhibitors. Poster presented at: European Alliance of Associations for Rheumatology (EULAR); June 11-14, 2025; Barcelona, Spain.  
10 Rotondo C, Perniola S, Carlino G, et al. Guselkumab efficacy in psoriatic arthritis: a real-world evidence comparison study with adalimumab and IL-17A inhibitors from the multicenter prospective biologic apulian registry (BIOPURE) [abstract]. Ann Rheum Dis. 2025;84(1):1878. Abstract ABS0781.  
11 Mease PJ, Ogdie A, Tesser J, et al. Six-month persistence and multi-domain effectiveness of guselkumab in adults with psoriatic arthritis: real-world data from the CorEvitas Psoriatic Arthritis/Spondyloarthritis registry. Rheumatol Ther. 2023;10(6):1479-1501.