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

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.
• A prospective study that evaluated the effectiveness of TREMFYA in adult patients with PsA is summarized below.¹
• Real-world retrospective studies comparing treatment persistence through 12 and 24 months in patients with active PsA initiated on an on-label subcutaneous (SC) TREMFYA dosing regimen, TREMFYA vs SC interleukin-17A inhibitors (IL-17Ai) or tumor necrosis factor inhibitor (TNFi) regimens or targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs) are summarized below.^2-7
• Real-world registry-based studies that evaluated the use of TREMFYA in adult patients with PsA are summarized below.^8-10

Real-world Evidence

Prospective Study

Ruscitti et al (2024)¹ conducted a real-life, prospective, multicenter cohort study of TREMFYA in adult patients with PsA that evaluated the 6-month effectiveness, drug retention rate (DRR), impact of comorbidities, and patient clinical characteristics over a collective 18-month follow-up.

Study Design/Methods

• The study enrolled adult 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.
  • Disease Activity Index for Psoriatic Arthritis (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 Leeds Enthesitis Index (LEI), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), tender joint count (TJC) and swollen joint count (SJC), and C-reactive protein (CRP).
  • Assessments using the Visual Analog Scale (VAS), Physician Global Assessment (PGA), and Patient Global Assessment (PtGA) 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.
• 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

• A total of 111 patients were evaluated in the study. For clinical characteristics, see Table: Selected Characteristics of Patients with PsA.

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% confidence interval [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.

• 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 (SD) time of administration of 9.8±4.1 months (median [interquartile range (IQR)], 9.0 [5.0] months).

Safety

• Minor transient AEs were reported during the study, mainly injection-site reactions, which did not lead to discontinuation of the drug.
• 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.
  • A total of 4.5% of patients discontinued SC TREMFYA due to AEs.

Retrospective Studies

TREMFYA

Becciolini et al (2025)² evaluated the 2-year retention rate of TREMFYA and identified factors influencing the clinical outcome in a real-world setting in adult patients with PsA.

Study Design/Methods

• Patients with PsA fulfilling the CASPAR criteria and prior exposure to TREMFYA with a complete dataset were included in the study.
• The evaluated parameters at baseline and follow-up visits included SJC, TJC, LEI, DAPSA, PtGA, dactylitis count, BASDAI, CRP, and 10-point VAS for pain.
• Reasons for discontinuation of TREMFYA, such as due to inefficacy, infections, malignancies, or AEs, were recorded during the follow-up

Results

Baseline Characteristics

• A total of 278 patients were enrolled. The median observation period was 10.7 months (IQR 5.3-15.9), corresponding to 3332.6 patient-months of follow-up. The selected baseline characteristics are summarized in Table: Selected Baseline Demographics and Clinical Characteristics.

TREMFYA Retention Rates and Treatment Persistence

• The retention rates of TREMFYA at 6, 12, and 24 months were 90.4%, 80.0%, and 67.8%, respectively.
• Factors significantly associated with longer TREMFYA retention included male sex (hazard ratio [HR], 0.44; 95% CI, 0.23-0.85; P=0.015), axial involvement (HR, 0.50; 95% CI, 0.27-0.95; P=0.034), and enthesitis (HR, 0.27; 95% CI, 0.14-0.51; P<0.001); while current smoking (HR, 2.27; 95% CI, 1.17-4.40; P=0.016), more recent TREMFYA prescription (HR, 1.44; 95% CI, 1.03-2.03; P=0.035), and concomitant use of csDMARDs (MTX: HR, 1.97; 95% CI, 1.06-3.67; P=0.032; other: HR, 3.11; 95% CI, 1.15-8.40; P=0.026) or steroid use (HR, 2.27; 95% CI, 1.22-4.21; P=0.010) were associated with shorter retention.

Laíño Pinerio et al (2025)³ evaluated treatment persistence in adult patients with PsA receiving TREMFYA who had an earlier treatment failure with multiple treatments in a retrospective, multicenter, observational study.

Study Design/Methods

• Patients with moderate to severe PsA who met the European Alliance of Associations for Rheumatology (EULAR) and American College of Rheumatology (ACR) criteria for PsA, receiving ≥1 dose of TREMFYA (100 mg Q8W) for up to 165 weeks, were enrolled.
• The data were derived from DISCOVER-1, DISCOVER-2, and COSMOS trials.

Results

Baseline Characteristics

• A total of 112 patients were included in the study, and the maximum follow-up period was 3 years. See Table: Selected Baseline Demographics and Clinical Characteristics for additional details.

TREMFYA Efficacy and Survival Rates

• The survival rate for TREMFYA was 84.31% for the first year of treatment and 66.46% for the second and third years of treatment.
• Of the 112 patients, 83 remained on treatment, of whom 72 had exceeded 52 weeks of TREMFYA therapy.
• No TREMFYA discontinuations were associated with AEs or the drug safety profile.

Comparison of IL-17 Inhibitors

Mease et al (2026)⁴ 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

• Inclusion criteria:
  • Adult patients with PsA initiated on SC TREMFYA or SC IL-17Ai who were identified using IQVIAPharmMetrics^® Plus databasewere 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 December 31, 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 112 days.
• Kaplan-Meier (KM) rates were used to assess the proportion of patients remaining persistent on treatment in biologic-naïve and biologic-experienced subgroup analyses.

Results

Baseline Characteristics

• A total of 849 patients in the SC TREMFYA group and 2601 patients in the SC IL-17Ai group (secukinumab, n=1668; ixekizumab, n=933) were included in the study.
  • Among the TREMFYA cohort, 362 (42.6%) and 487 (57.4%) of the patients were biologic naïve and biologic experienced, respectively. In the SC IL-17Ai cohort, 845 (32.5%) and 1756 (67.5%) of the patients were biologic naïve and biologic experienced, respectively.
• The selected baseline demographics and characteristics are summarized in Table: Selected Weighted Baseline Demographics and Characteristics.

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 (P<0.001).
• 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 1.49 times more likely to remain persistent with on-label treatment through 24 months compared with those in the SC IL-17Ai group (overall analyses: HR, 1.49; 95% CI, 1.29-1.72; P<0.001 vs 1× FDA maintenance gap: HR, 1.54; 95% CI, 1.36-1.75; P<0.001 vs fixed gap: HR, 1.09; 95% CI, 0.94-1.27; P=0.252).⁵
• 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.

Comparison of TNFis

Mease et al (2026)⁶ compared the on-label treatment persistence over 24 months among adult patients with active PsA initiating TREMFYA vs SC TNFi in real-world clinical practice.

Study Design/Methods

• Data from the IQVIA PharMetrics^® plus United States (US) claims database between January 2011 and June 2023 were utilized.
• Adults with active PsA were identified from US claims data based on initiation of a single index therapy during the intake period, ≥12 months of continuous health plan eligibility before the index date, and ≥2 PsA diagnosis claims ≥30 days apart during baseline or on the index date.
• Patients 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]) were included in the study.
• Patients should not have a baseline diagnosis indicating alternative inflammatory conditions to ensure treatment use for PsA.
• Patients received only 1 index agent on the index date and had not received any diagnosis for other potentially confounding rheumatic diseases (as listed by the authors) during the baseline period.
• 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:
  • Therapy exposure gap utilized the FDA-approved dosing regimen for each index agent (a gap of 56 days for SC TREMFYA and 28 days for SC TNFis).
  • Fixed therapy exposure gap utilized a fixed gap of 112 days to define discontinuation for all index agents.

Results

Baseline Characteristics

• A total of 804 and 2490 patients were included in the TREMFYA and SC TNFi cohorts respectively. In the TREMFYA cohort, 361 (44.9%) and 443 (55.1%) patients were biologic naïve and biologic experienced, respectively. In the SC TNFi cohort, 2171 (87.2%) and 319 (12.8%) patients were biologic naïve and biologic experienced, respectively.
• The mean follow-up duration was 15.4 months and 15.2 months in the TREMFYA and SC TNFi cohorts, respectively.
• The selected baseline characteristics are summarized in Table: Selected Weighted Baseline Demographics and Clinical Characteristics.

Treatment Persistence

• At 24 months, persistence with on-label treatment was observed in 45.5% of patients in the SC TREMFYA group vs 28.5% of patients in the SC TNFi group (P<0.001).
• The median time to discontinuation in the TREMFYA vs SC TNFi group was 22.0 vs 9.2 months, respectively.
• In the overall cohort, patients in the TREMFYA group were 2.24 times more likely to remain persistent with on-label treatment through 24 months compared with those in the SC TNFi group (Overall cohort: HR, 2.24; 95% CI, 1.90-2.64; P<0.001 vs therapy exposure gap: HR, 1.90; 95% CI, 1.65-2.19; P<0.001 vs fixed gap: HR, 1.80; 95% CI, 1.52-2.13; P<0.001).
• On-label treatment persistence is summarized in Table: Primary Analysis of On-Label Persistence in Weighted TREMFYA and SC TNFi Cohort

Comparison to tsDMARDs

Mease et al (2026)⁷ assessed onlabel treatment persistence in adult patients with PsA who were newly initiated on TREMFYA or a tsDMARD (apremilast or a Janus kinase inhibitor [JAKi; tofacitinib or upadacitinib]), including biologic-naïve and biologic-experienced patients, in real-world clinical practice through 24 months.

Study Design/Methods

• The data from IQVIA PharMetrics^® plus database (July 2019-December 2024) was utilized.
• Adults with active PsA were identified from claims data ≥12 months of continuous health plan eligibility before the index date, and ≥ 2 PsA diagnosis claims ≥30 days apart during baseline or on the index date.
• Patients should not have a baseline diagnosis indicating confounding conditions (as listed by the authors).
• The study outcome included the assessment of treatment persistence, considering no discontinuation or dose change, with subgroup analyses comparing TREMFYA vs apremilast and JAKi.
• The details of days between administration or refill among the different treatment groups are discussed in Table: Days between Administration or Refill of Primary and Sensitivity Analyses.

Results

Baseline Characteristics

• The TREMFYA group included 924 patients (biologic-naïve, n=185; biologic-experienced, n=739) and the tsDMARD group included 1750 patients (biologic-naïve, n=796;
  bio-experienced, n=954).
• The selected baseline characteristics are summarized in Table: Selected Weighted Baseline Demographics and Clinical Characteristics.

Treatment Persistence

• At 24 months, persistence with on-label treatment was observed in 41.6% of patients in the TREMFYA group and 22.7% of patients in the tsDMARD group.
• The median time to discontinuation in the TREMFYA vs tsDMARD group was 15.9 and 7.2 months, respectively.
• In both biologic naïve and biologic-experienced patients, TREMFYA was associated with a significantly higher on-label persistence compared with tsDMARDs at each time point assessed (12, 18, and 24 months).
• The treatment persistence in TREMFYA and tsDMARDs, TREMFYA and JAKi are discussed in Tables below:
  • Primary Analysis of On-Label Persistence in Weighted TREMFYA and tsDMARDs Cohort
  • Primary Analysis of On-Label Persistence in Weighted TREMFYA vs Apremilast or JAKi Cohort.

Registry-Based Studies

Mease et al (2026)⁸ evaluated the effectiveness of persistent use of SC TREMFYA through 12 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 analysis included adult patients with active PsA who received SC TREMFYA at a dose of 100 mg administered at weeks 0 and 4 and Q8W thereafter and who were persistent with therapy through the 12-month visit (on-label persisters).
• The primary outcome was mean change (95% CI) in the clinical DAPSA score from baseline to 12 months.
• Secondary outcomes (in order of multiplicity-controlled testing) were mean changes (95% CI) in PGA of arthritis and psoriasis (PsO; 0-100), patient-reported pain (0-100), and percentage of body surface area (BSA) from baseline to 12 months among patients with a history of PsO (0-100%).

Results

Baseline Characteristics

• Among 599 patients with active PsA who were initiated on SC TREMFYA at or after enrollment in the CorEvitas PsA/SpA Registry
  • 160 had eligible baseline and 12-month follow-up visits.
  • Of these 160 patients, 90 (56%) had persistent use of SC TREMFYA at 12 months (on-label persisters).
• For baseline patient characteristics, see Table: Selected Demographics and Baseline Characteristics.

Effectiveness

• For the primary and secondary analyses of effectiveness among on-label persisters at 12 months, see Table: Primary and Secondary Outcomes of SC TREMFYA Among On-Label Persisters at 12 Months.

Atzeni et al (2025)⁹ conducted a multicentric cohort study to evaluate the 12-month efficacy and safety, DRR, reasons for discontinuation of TREMFYA, the impact of comorbidities and previous bDMARD treatment lines on achievement of minimal disease activity (MDA) in adult patients with PsA.

Study Design/Methods

• Data from GISEA registry was utilized and the inclusion criteria were as follows:
  • Patients aged ≥18 years with PsA fulfilling the CASPAR criteria
  • Patients initiated TREMFYA and were biologic-naïve or had an inadequate treatment response to biologics

Results

Baseline Characteristics

• A total of 170 patients treated with TREMFYA were enrolled, and the selected baseline characteristics are summarized in Table: Selected Baseline Demographics and Clinical Characteristics.

Clinical Response to TREMFYA and Predictors of Efficacy

• Details of ACR and MDA responses in biologic nonresponders and patients who were biologic naïve are discussed in Table: ACR and MDA Responses in Patients Treated with TREMFYA.

Retention Rates of TREMFYA at 12 Months and AEs

• The retention rate of TREMFYA at the 12-month follow-up was 76%, with a mean survival time (MST) of 10.5±0.2 months (95% CI, 10-10.9).
• No significant differences were reported in the survival time among the stratifying TREMFYA groups (P=0.912).
• Reasons for discontinuation were as follows:
  • No response: both 17% of patients in the 1 bDMARD and ≥2 bDMARDs groups, respectively.
  • AEs (all defined as minor AEs): 4% of patients

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 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.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 24 March 2026.

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.