TREMFYA - Comparison to IL-17A Inhibitors in the Treatment of Adult Patients with Active Psoriatic Arthritis

SUMMARY

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• PsABIOnd, an ongoing, prospective, observational, international study was designed to evaluate the treatment persistence, effectiveness, and safety outcomes in patients with psoriatic arthritis (PsA) who initiated subcutaneous (SC) TREMFYA or SC interleukin-17 inhibitors (IL-17i). Results are available through 12 months.^1,2
• Real-world retrospective studies comparing treatment persistence in patients with active PsA initiating on-label SC TREMFYA dosing regimen vs SC IL-17Ai using IQVIAPharMetrics^® Plus database through 24 months are summarized below.³
• A matching-adjusted indirect comparison (MAIC) was performed to evaluate the relative efficacy of SC TREMFYA vs SC secukinumab on joint and skin outcomes over 52 weeks in a mixed population of biologic-naïve and biologic-experienced adult patients with active PsA.⁴
• A Bayesian network meta-analysis (NMA) indirectly compared the relative treatment effect of SC TREMFYA to other targeted therapies for PsA, including SC IL-17Ai (ie, ixekizumab and secukinumab), on joint and skin efficacy outcomes and safety in adults with active PsA.^5,6
• BIOPURE registry-based study evaluated the effectiveness and drug survival of SC TREMFYA vs adalimumab and SC IL-17Ai in patients with PsA using real-world data.⁷

CLINICAL DATA

Prospective Study

PsABIOnd

Gossec et al (2026)¹ conducted a 12-month analysis of an ongoing, prospective, observational, international study (PsABIOnd) to evaluate treatment persistence, treatment effectiveness, patient-reported outcomes, and safety outcomes in patients with PsA who initiated SC TREMFYA or SC IL-17i.

Study Design/Methods

• Adult patients with a confirmed diagnosis of PsA initiating treatment with TREMFYA or an IL-17i as first- to fourth-line biologic therapy (as monotherapy or in combination with other agents) per standard of care were included in the study.
• The study enrollment was completed in May 2024 with 1314 patients across 19 countries.  
• The study visit schedule is summarized in Figure: PsABIOnd Visit Schedule.

• At the 12-month visit, the study evaluated the following outcomes:
  • Treatment persistence between TREMFYA and IL-17i:
    • Persistence with TREMFYA and IL-17i over 12 months was evaluated using Kaplan-Meier (KM) analysis and defined as the time from the date of the first treatment administration to the date of the last treatment dose of the initial treatment line administration plus 1 dosing interval or until start of subsequent treatment.
    • A propensity score (PS)-adjusted analysis estimated the hazard ratio (HR) for discontinuation or switching of TREMFYA vs IL-17i prior to the 12-month visit, adjusting for baseline variable imbalances across cohorts.
  • Treatment effectiveness between TREMFYA and IL-17i:
    • Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA; score ≤13 among patients with baseline scores >cutoff)
    • Disease Activity Index for Psoriatic Arthritis (DAPSA; score ≤14 among patients with baseline score >cutoff)
    • Minimal disease activity (MDA) achieving 5/7 criteria. Among non-MDA achievers at baseline, the criteria included tender joint count ≤1, swollen joint count ≤1, body surface area (BSA) <3%, patient pain ≤15mm, patient global disease activity (PtGA) ≤20mm, health assessment questionnaire-disability index
      (HAQ-DI) ≤0.5, and total pain/tenderness enthesitis score ≤1 (or no enthesitis)
    • Mild PsO: BSA ≤3% in patients with BSA ≥3
    • Mean change from baseline to 12 months in the Leeds Enthesitis Index (LEI)
    • Mean change from baseline in number of digits affected by dactylitis
    • Psoriatic Arthritis Impact of Disease-12 (PsAID-12) minimal clinically important improvement (MCII) decrease ≥1.4
    • Mean at baseline and 12 months in PsAID-12 item scores
    • Achievement of Dermatology Life Quality Index (DLQI) 0/1 in patients with BSA ≥3
  • Safety was evaluated by assessing the number and percentage of patients experiencing ≥1 AE, as well as exposure-adjusted event rates (events per 100 patient-years [PY]).

Results

Baseline Characteristics

• A total of 1141 patients were analyzed at the 12-month visit. For baseline characteristics, see Table: Selected Baseline Characteristics of the PsABIOnd Analysis Groups.¹

Treatment Persistence

• At the 12-month visit, treatment persistence was high for both TREMFYA and IL-17i (76% vs 77%).¹
  • The PS-adjusted HR for stop or switch of treatment with TREMFYA vs IL-17i was 0.89 (95% confidence interval [CI], 0.73-1.08), adjusted for potential baseline confounders, including the initial biologic disease-modifying antirheumatic drug (bDMARD) treatment line.¹
• At the 12-month visit, treatment effectiveness was similar between TREMFYA and IL-17i across PsA clinical outcomes; see Table: Treatment Effectiveness of TREMFYA and IL-17i at the 12-Month Visit.

• Reasons for treatment discontinuation were comparable between TREMFYA and IL-17i (primary failure: 11.7% vs 9.8% and AEs: 7.3% vs 9.2%).

AEs

• Through 12 months, exposure-adjusted AE rates were comparable between TREMFYA and IL-17i.
• For details of AEs, see Table: Overall Summary of AEs through 12 months.

• There were no cases of active tuberculosis in either of the cohorts.
• The rates of special interest AEs in TREMFYA/IL-17i groups were Candida infection/candidiasis (<1%/2%), fungal infection (including candidiasis) (1%/4%), other fungal infection (unspecified) (<1%/2%), and uveitis (<1%/<1%), respectively.

Retrospective Studies

Mease et al (2026)³ 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 TREMFYA or IL-17Ai who were identified using IQVIAPharMetrics^® Plus databasewere included.
  • The index date was defined as the first date on which TREMFYA or 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 TREMFYA or 56 days for 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 TREMFYA or 28 days for 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.
• 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 TREMFYA group and 2601 patients in the 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 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 TREMFYA group vs 35.0% of patients in the IL-17Ai group (P<0.001).
• The median time to discontinuation in the TREMFYA vs IL-17Ai group was 20.9 vs 12.2 months, respectively.
• In both sensitivity analyses, patients in the TREMFYA group were 1.49 times more likely to remain persistent with on-label treatment through 24 months compared with those in the 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).⁸
• TREMFYA was associated with a significantly higher on-label persistence compared with 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 TREMFYA and IL-17Ai Groups.

Indirect Comparison

Comparison of TREMFYA and Secukinumab

van Sanden et al (2025)⁴ conducted an MAIC to evaluate the relative efficacy of SC TREMFYA vs SC secukinumab for joint and skin outcomes over 52 weeks in a mixed population of biologic-naïve and biologic-experienced adult patients with active PsA.

Study Design/Methods

• A structured literature review was conducted to identify randomized controlled trials (RCTs) that evaluated TREMFYA 100 mg every 8 weeks (Q8W) and every 4 weeks (Q4W) and secukinumab 150 mg and 300 mg at weeks 0, 1, 2, 3, and 4, followed by monthly maintenance dosing (Q4W) in adult patients with active PsA.⁴
• The study design is summarized in Figure: A Flow Diagram Outlining the Primary, Sensitivity, and Scenario Analyses.

• Primary outcomes included American College of Rheumatology (ACR)20 and Psoriasis Area and Severity Index (PASI) 90 through 52 weeks.
• For the mixed population, TREMFYA Q8W and Q4W data were pooled from DISCOVER-1, DISCOVER-2 (only included biologic-naive patients), and COSMOS (only included patients with inadequate response to tumor necrosis factor inhibitors [TNFi]). COSMOS was only included in TREMFYA Q8W analyses due to a lack of TREMFYA Q4W studied group.
• The biologic-naïve population secukinumab trial EXCEED was excluded from the primary analysis as it included only secukinumab 300 mg dosage, ACR20 endpoint, and a week-52 time point.

Results

Patient Population

• A total of 1970 patients were included in the study (TREMFYA 100 mg Q8W, n=564; TREMFYA 100 mg Q4W, n=373; secukinumab 150 mg Q4W, n=572; secukinumab 300 mg Q4W, n=461). For details, see Table: Baseline Characteristics for the Mixed Population.

Primary Analysis (Mixed Population)

• For details on ACR20 and PASI 90 responses, see Table: Comparison of ACR20 and PASI 90 Responses for TREMFYA vs Secukinumab at Week 52.

Network Meta-analysis

Mease et al (2021)⁵ and (2023)^6,10 conducted a Bayesian NMA to indirectly compare the relative treatment effect of SC TREMFYA to other targeted therapies for PsA, including SC IL-17Ai like ixekizumab and secukinumab, on joint and skin efficacy outcomes and safety in adults (≥18 years of age) with active PsA.

Study Design/Methods

• A systematic literature review was conducted to identify (RCTs; the original search was conducted in October 2018 and subsequently updated in January 2020 to expand the comparator scope) assessing the use of targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs) and bDMARDs in adults with active PsA.⁵
• The NMA was updated up to February 2021 and an additional hand-search was conducted in July 2021 to include new data and new agents.⁶
• The Bayesian NMA was performed to compare treatments on ACR20/50/70 response, change from baseline in van der Heijde-Sharp (vdH-S) score, PASI 75/90/100 response, and serious adverse events (SAEs).
  • From the primary assessment timepoint of each trial, ACR and PASI data were included, which varied from 12 to 24 weeks.
  • vdH-S data were included from the 24-week timepoint.
  • Regarding SAEs, the latest placebo-controlled timepoint was utilized in this analysis (up to 24 weeks).
• A multinomial probit NMA model for ordinal outcomes was used to compare interventions for ACR and PASI, dichotomous outcomes were used for SAEs, and continuous outcomes were used for vdH-S score.
  • Treatment effects for ordinal and dichotomous outcomes were modeled on the probit scale and log-odds ratio scale, respectively.
    • These treatment effects were transformed to relative risks using the unweighted average of trial placebo responses.
  • For continuous outcomes, treatment effects were modeled and reported on the mean difference scale.
• TREMFYA 100 mg Q8W and comparators (TREMFYA 100 mg Q4W and IL-17Ai like ixekizumab 80 mg [every 2 weeks (Q2W), Q4W, and Q4W/Q2W], secukinumab 300 mg, secukinumab 150 mg, and secukinumab 150 mg with no loading dose) were evaluated.^6,10

Results

• A total of 33 trials (87 citations) evaluating all doses of tsDMARDs and bDMARDs approved by either the FDA or European Medicines Agency for treatment of active PsA were included in the NMA analysis.⁶
• For results specific to ACR20 response, PASI 90, vdH-S score, and SAEs, see:
  • Figure: Forest Plot with Pairwise Comparisons of TREMFYA Q8W vs Comparators for ACR20 Response
  • Figure: Forest Plot with Pairwise Comparisons of TREMFYA Q8W vs Comparators for PASI 90 Response
  • Figure: Forest Plot with Pairwise Comparisons of TREMFYA Q8W vs Comparators for vdH-S Score
  • Figure: Forest Plot with Pairwise Comparisons of TREMFYA Q8W vs Comparators for SAEs

Registry-Based Study

Rotondo et al (2025)⁷ evaluated the effectiveness and drug survival of SC TREMFYA vs SC adalimumab and SC 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 15 June 2026.