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TREMFYA® (guselkumab)
Medical Information
TREMFYA - Comparison to IL-17A Inhibitors in the Treatment of Adult Patients with Active Psoriatic Arthritis
Last Updated: 11/10/2025
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, efficacy, and safety outcomes in patients with psoriatic arthritis (PsA) who initiated subcutaneous (SC) TREMFYA or SC interleukin-17A inhibitors (IL-17i). Results are available through 6 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 IQVIATM
health plan claims data through 12 and 24 months are summarized below.3 ,4 - 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.5
- 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.6
,7
CLINICAL DATA
PsABIOnd
Siebert et al (2024)1 and Gossec et al (2024)2 conducted a 6-month interim analysis of an ongoing, prospective, observational, international study (PsABIOnd) to evaluate the treatment persistence, treatment effectiveness, 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 SC TREMFYA or a 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 standard of care were included in the study.1,2
- The study visit schedule is summarized in Figure: PsABIOnd Visit Schedule.
a
- The study evaluated the following outcomes:
- Treatment persistence between SC TREMFYA and SC IL-17i
- Persistence with SC TREMFYA and SC IL-17i was evaluated over 6 months by using Kaplan-Meier (KM) analysis and was 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 the initiation of a subsequent treatment.2
- Treatment effectiveness between SC TREMFYA and SC IL-17i:1,2
- Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA; score ≤13)/ Disease Activity Index for Psoriatic Arthritis (DAPSA; score ≤14) as defined for patients with polyarticular PsA at baseline, minimal disease activity (MDA) achievement (achieving 5/7 criteria), mild PsO body surface area (BSA; <3%), Dermatology Life Quality Index (DLQI) 0/1 (achieving 0/1), dactylitis resolution (number of affected digits=0), Leeds Enthesitis Index (LEI) resolution (LEI=0)
- Electronic patient-reported outcomes (ePROs), including Psoriatic Arthritis Impact of Disease-12 (PsAID-12)
- Adverse events (AEs)
Results
Baseline Characteristics
- A total of 686 patients were analyzed at the 6-month visit. For baseline characteristics, see Table: Select Baseline Characteristics of the PsABIOnd Interim Analysis Groups.1,2
| SC TREMFYA | SC IL-17i | |
|---|---|---|
| Demographics | n=360 | n=326 |
| Age, years | 52.0 (13.1) | 53.6 (11.9) |
| Females | 62% | 61% |
| Characteristics | n=355 | n=325 |
| PsA disease duration, years | 7.6 (7.7) | 7.6 (8.9) |
| cDAPSA (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; 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 high with both SC TREMFYA and SC IL-17i.1,2
- The propensity score (PS)-adjusted hazard ratio (HR) for stop or switch of 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 drugs (bDMARD) treatment line.2
- At the 6-month visit, treatment effectiveness was similar with SC TREMFYA and SC IL-17i across PsA clinical outcomes; see Table: Treatment Effectiveness of SC TREMFYA and SC IL-17i at the 6-Month Visit.
| 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. Note: 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 discontinuation were comparable between SC TREMFYA and SC IL-17i. For details, see Table: Reasons for Treatment Discontinuation.
| 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. 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. | ||
Retrospective Studies
Mease et al (2025)3 conducted a retrospective claims-based analysis evaluating treatment persistence 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 (≥18 years of age) with PsA who were initiated on SC TREMFYA or SC IL-17Ai and were identified using the IQVIA PharMetrics®
Plus database were considered for inclusion.3 - The index date was defined as the first date on which SC TREMFYA or SC IL-17Ai (ie, ixekizumab or secukinumab) were initiated between July 14, 2020, and June 30, 2022.
- Patients who had ≥12 months of continuous health insurance eligibility before the index date were considered for inclusion.
- 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 (SC TREMFYA or SC IL-17Ai).
- Adult patients (≥18 years of age) with PsA who were initiated on SC TREMFYA or SC IL-17Ai and were identified using the IQVIA PharMetrics®
Exclusion criteria: - Patients with claims for >1 index drug on the index date or ≥1 claim for any of the index drugs during the period of continuous health insurance eligibility before the index date were excluded.
- Patients with ≥1 claim with a diagnosis for other potentially confounding rheumatic diseases (eg, ankylosing spondylitis, other inflammatory arthritides, calcium pyrophosphate dihydrate crystal deposition disease, nonradiographic axial spondyloarthritis, postinfectious and reactive arthritis, other spondylopathies, rheumatoid arthritis, systemic connective tissue disorders, relapsing polychondritis, or unspecified connective tissue disease).
- The primary outcome was the duration of on-label persistence with the index agent (SC TREMFYA or SC IL-17Ai), defined as the absence of treatment discontinuation or any dose escalation or reduction inconsistent with approved dosing regimens per the Food and Drug Administration (FDA) label.
- Treatment discontinuation was defined as twice the longest interval between administrations per the FDA-approved dosing schedule for each index agent.
- Treatment gaps were defined as 112 days (56 days, ×2) for SC TREMFYA and 56 days (28 days, ×2) for ixekizumab and secukinumab.
- 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× the FDA maintenance interval between administrations per label after induction (a gap of 56 days for SC TREMFYA or 28 days for an SC IL-17Ai).
- In sensitivity analysis 2 (fixed gap), on-label treatment persistence was defined as the absence of treatment discontinuation for a fixed gap of 84 days.
- Weighted Cox proportional hazard 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 unweighted SC TREMFYA and SC IL-17Ai groups included 910 and 2743 (ixekizumab, n=1010; secukinumab, n=1733) patients, respectively.3
- The weighted SC TREMFYA and SC IL-17Ai groups included 910 and 2740 patients, respectively.
Treatment Persistence
- The mean follow-up duration in the SC TREMFYA and SC IL-17Ai groups was 14 months and 15 months, respectively.
- At 12 months, patients in the SC TREMFYA group were 1.85 times more likely to persist with on-label treatment compared with those in the SC IL-17Ai group (HR, 1.85; 95% CI, 1.60-2.13; P<0.001).
- 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 the SC TREMFYA vs SC IL-17Ai group, on-label persistence at 12 months was 66.8% vs 50.1%.
- In sensitivity analysis 1, the weighted KM persistence rates at 3, 6, 9, and 12 months were 83.0%, 70.8%, 60.4%, and 55.5% in the SC TREMFYA group and 72.2%, 54.2%, 43.3%, and 35.0% in the SC IL-17Ai group, respectively.8
- In sensitivity analysis 2, the weighted KM persistence rates at 3, 6, 9, and 12 months were 88.0%, 76.7%, 67.1%, and 62.9% for SC TREMFYA and 83.2%, 71.2%, 62.6%, and 57.0% for SC IL-17Ai, respectively.3
- 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.3
| Cox Proportional Hazards Modelb | SC TREMFYA (n=910) | SC IL-17Ai (n=2740) | Hazard Ratio (95% CI) | P-Value |
|---|---|---|---|---|
| Patients at riskc | ||||
| 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: bDMARD, biologic disease-modifying antirheumatic drug; CI, confidence interval; ICD-10, International Classification of Diseases, Tenth Revision; IL-17Ai, interleukin-17A inhibitor; KM, Kaplan-Meier; PsA, psoriatic arthritis; 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 were age at the index date; sex; region; insurance plan type; index year and half; relationship to the primary beneficiary (eg, self, spouse, child); presence of psoriasis (ICD-10: L40.x, excluding L40.5), other autoimmune diseases (inflammatory bowel diseasef bCox proportional hazard 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 are patients who have not experienced the event and have not been lost to follow-up at that point in time. dP-values were determined by using a Chi-square test. eP-values were determined by using a log-rank test. fIncludes unclassified inflammatory bowel disease, Crohn’s disease, and ulcerative colitis. gCardiovascular disease (ie, hypertension, hyperlipidemia, coronary artery disease, cerebrovascular disease, and peripheral vascular disease), diabetes, smoking, and osteoarthritis. h i j | ||||
Mease et al (2025)4 compared treatment persistence in a real-world setting in patients with active PsA treated initiating on-label SC TREMFYA dosing regimen vs SC IL-17Ai 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 every 8 weeks (Q8W) or SC IL-17Ai cohort [secukinumab, ixekizumab]) using IQVIATM health plan claims data between July 14, 2020, and December 31, 2022, were included.
- The index date was defined as the date of first claim for SC TREMFYA or SC IL-17Ai during intake period (July 14, 2020, and December 31, 2022); patients could not have claims for >1 index agent on the index date.
- Patients were identified as either biologic-naïve or biologic-experienced during baseline but were naïve to SC TREMFYA or SC IL-17Ai.
- 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.
- For details on eligibility criteria, see: Inclusion criteria and Exclusion criteria.
Results
Baseline Characteristics
- A total of 849 patients were included 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. See Table: Select Weighted Baseline Demographics and Characteristics.
| SC TREMFYA (n=849) | SC IL-17Ai (n=2601) | |
|---|---|---|
| Demographics | ||
| Age at 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 latest observed PsA diagnosis and 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 inhibitors; tsDMARD, targeted synthetic disease-modifying antirheumatic drug. Note: Data are % unless otherwise noted. aPropensity score using overlap weighting. bDuring 12 months before index date. cIncludes IL-12/23i (ie, ustekinumab), anti-CTLA-4 (ie, abatacept), IL-23i (ie, risankizumab), SC TNFi (ie, adalimumab, certolizumab pegol, etanercept, golimumab), and IV TNFi (ie, infliximab, infliximab biosimilars, and IV golimumab). dIncludes methotrexate, leflunomide, cyclosporine, mycophenolate, and azathioprine. eIncludes apremilast, deucravacitinib, and JAKi (upadacitinib, baricitinib, and tofacitinib). | ||
Treatment Persistence
- At 24 months, persistence with on-label treatment at was observed in 44.9% of patients in the SC TREMFYA group compared with 35.0% 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 (1x 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 when 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 Weighted SC TREMFYA and SC IL-17Ai Groups.
| Parameter | SC TREMFYAb (n=849) | SC IL-17Aib (n=2601) | Hazard Ratio (95% CI) | P-Value |
|---|---|---|---|---|
| Patients at risk,c 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: bDMARD, biologic disease-modifying antirheumatic drug; CI, confidence interval; csDMARD, conventional synthetic disease-modifying antirheumatic drug; 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 hazard models were used to compare the risk of discontinuation between the SC TREMFYA and SC IL-17Ai groups. cPatients at risk of having the event were the patients who have not had the event and have not been lost to follow-up at that point in time. dP-values were determined by using Chi-square test. eP-values were determined by using log-rank test. | ||||
Indirect Comparison
Comparison of SC TREMFYA and SC Secukinumab
van Sanden et al (2025)5 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 SC TREMFYA 100 mg Q8W and every 4 weeks (Q4W) and SC 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.5
- The study design is summarized in Figure: A Flow Diagram Outlining the Primary, Sensitivity, and Scenario Analyses.
Abbreviations: ACR, American College of Rheumatology; BSA, body surface area; CRP, C-reactive protein; GUS, guselkumab; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; Q4W, every 4 weeks; Q8W, every 8 weeks; SEC, secukinumab; TNFi, tumor necrosis factor inhibitors.
Note: In the primary analysis, characteristics adjusted for included prior use of TNFi, Disease Activity Score-28, number of tender joints, number of swollen joints, enthesitis status, and psoriasis (≥3% of BSA). A sensitivity analysis included characteristics matched and adjusted from the base case as well as sex, age, dactylitis, and PsA pain, where reported in the trials. In the scenario analysis, characteristics adjusted for included Disease Activity Score-28, number of tender joints, number of swollen joints, CRP >10 mg/L, enthesitis status, psoriasis (≥3% of BSA), and baseline PASI score (in patients with BSA ≥3%).
- Primary outcomes included American College of Rheumatology (ACR)20 and Psoriasis Area and Severity Index (PASI) 90 through 52 weeks.
- For the mixed population, SC 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 [TNFis]). COSMOS was only included in SC TREMFYA Q8W analyses due to a lack of SC 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 (SC TREMFYA 100 mg Q8W, n=564; SC TREMFYA 100 mg Q4W, n=373; SC secukinumab 150 mg Q4W, n=572; SC secukinumab 300 mg Q4W, n=461). For details, see Table: Baseline Characteristics for the Mixed Population.
| Pooled SC TREMFYA 100 mg Q8W (n=564) | Pooled SC TREMFYA 100 mg Q4W (n=373) | Pooled SC SEC 150 mg Q4W (n=572) | Pooled SC SEC 300 mg Q4W (n=461) | |
|---|---|---|---|---|
| Baseline characteristics informing the primary analysis | ||||
| No prior TNFi (%) | 59 | 90 | 69 | 68 |
| ≥1 prior TNFi (%) | 41 | 10 | 31 | 32 |
| Disease Activity Score-28 (mean) | 5.0 | 5.0 | 4.7 | 4.6 |
| Number of tender joints (of 78 joints; mean)a | 23.3 | 23.9 | 22.0 | 19.9 |
| Number of swollen joints (of 76 joints; mean)a | 12.7 | 13.2 | 11.3 | 9.9 |
| Enthesitis (%) | 63 | 65 | 65 | 61 |
| Psoriasis (≥3% of BSA; %) | 78 | 81 | 53 | 47 |
| Additional characteristics included to inform the sensitivity analysis | ||||
| Sex (% female) | 50 | 44 | 52 | 51 |
| Age (mean) | 47.2 | 46.5 | 48.5 | 48.6 |
| Dactylitis (%) | 40 | 43 | 33 | 38 |
| PsA pain (mean) | 62.9 | 60.5 | - | 54.5 |
| Abbreviations: BSA, body surface area; PsA, psoriatic arthritis; Q4W, every 4 weeks; Q8W, every 8 weeks; SEC, secukinumab; TNFi, tumor necrosis factor inhibitors. Note: The first 7 characteristics were matched in the primary analysis (no prior TNFi and ≥1 prior TNFi were both included in the first match). The remaining 4 characteristics were included in the sensitivity analysis, if reported in the trial. aFor the TREMFYA trials, the mean number of tender joints was out of 68, and the mean number of swollen joints was out of 66. | ||||
Primary Analysis (Mixed Population)
- For details on ACR20 and PASI 90 responses, see Table: Comparison of ACR20 and PASI 90 Responses for SC TREMFYA vs SC Secukinumab at Week 52.
| Week 52 Response | OR | 95% CI | |
|---|---|---|---|
| Primary analysis (mixed population) | |||
| Proportion of patients with ACR20 response, % | |||
| TREMFYA Q8W vs secukinumab 150 mg | 66.0 vs 59.3 | 1.33 | 1.01-1.76 |
| TREMFYA Q8W vs secukinumab 300 mg | 64.8 vs 64.6 | 1.01 | 0.74-1.37 |
| TREMFYA Q4W vs secukinumab 150 mg | 68.3 vs 59.3 | 1.48 | 1.00-2.19 |
| TREMFYA Q4W vs secukinumab 300 mg | 68.7 vs 64.6 | 1.20 | 0.78-1.84 |
| Proportion of patients with PASI 90 response, % | |||
| TREMFYA Q8W vs secukinumab 150 mg | 71.7 vs 43.1 | 3.35 | 2.43-4.60 |
| TREMFYA Q8W vs secukinumab 300 mg | 71.0 vs 56.3 | 1.90 | 1.33-2.71 |
| TREMFYA Q4W vs secukinumab 150 mg | 75.5 vs 43.1 | 4.07 | 2.74-6.06 |
| TREMFYA Q4W vs secukinumab 300 mg | 74.9 vs 56.3 | 2.31 | 1.49-3.59 |
| Scenario analysis (biologic-naïve population) | |||
| Proportion of patients with ACR20 response, % | |||
| TREMFYA Q8W vs secukinumab 300 mg | 66.6 vs 66.9 | 0.98 | 0.67-1.44 |
| TREMFYA Q4W vs secukinumab 300 mg | 71.6 vs 66.9 | 1.25 | 0.84-1.85 |
| Abbreviations: ACR, American College of Rheumatology; PASI, Psoriasis Area and Severity Index; OR, odds ratio; CI, confidence interval; Q4W, every 4 weeks; Q8W, every 8 weeks. | |||
Network Meta-analysis
Mease et al (2021)6 and (2023)7,10
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.6
- 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.7
- 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.
- Treatment effects for ordinal and dichotomous outcomes were modeled on the probit scale and log-odds ratio scale, respectively.
- SC TREMFYA 100 mg Q8W and comparators (SC TREMFYA 100 mg Q4W and SC 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.7,10
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.7
- 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
Abbreviations: ACR, American College of Rheumatology; Crl, credible interval; IL-17Ai, interleukin-17A inhibitor; IL-23i, interleukin-23 inhibitor; LD, loading dose; Q2W, every 2 weeks; Q4W, every 4 weeks; Q8W, every 8 weeks; RR, relative risk.
Abbreviations: Crl, credible interval; IL-17Ai, interleukin-17A inhibitor; IL-23i, interleukin-23 inhibitor; LD, loading dose; PASI, Psoriasis Area and Severity Index; Q2W, every 2 weeks; Q4W, every 4 weeks; Q8W, every 8 weeks; RR, relative risk.
Abbreviations: Crl, credible interval; IL-17Ai, interleukin-17A inhibitor; IL-23i, interleukin-23 inhibitor; LD, loading dose; MD, mean difference; Q2W, every 2 weeks; Q4W, every 4 weeks; Q8W, every 8 weeks; vdH-S, van der Heijde-Sharp.
Abbreviations: Crl, credible interval; IL-17Ai, interleukin-17A inhibitor; IL-23i, interleukin-23 inhibitor; LD, loading dose; Q2W, every 2 weeks; Q4W, every 4 weeks; Q8W, every 8 weeks; RR, relative risk; SAE, serious adverse event.
Literature Search
A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 01 August 2025.
References
| 1 | 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. |
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