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TREMFYA® (guselkumab)
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TREMFYA - Comparison to TNF Inhibitors in the Treatment of Adult Patients with Active Psoriatic Arthritis
Last Updated: 11/06/2025
SUMMARY
- The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
- Results from an ongoing ambispective observational cohort study comparing the effectiveness, persistence, and tolerability of second-line TREMFYA versus (vs) tumor necrosis factor inhibitors (TNFis) in adult patients with psoriatic arthritis (PsA) after a first-line TNFi are summarized below.1
, 2 - Results from a real-world retrospective study comparing the on-label treatment persistence in adult patients with PsA treated with TREMFYA vs TNFis using the IQVIATM
database are summarized below.3 ,4 - A Bayesian network meta-analysis (NMA) indirectly compared the treatment effect of TREMFYA to other targeted therapies, including TNFis (golimumab, infliximab, adalimumab, etanercept, and certolizumab pegol), on joint and skin efficacy outcomes and safety in adults with active PsA.5
,6
CLINICAL DATA
Ambispective Studies
MANHATTAN Study
González-Molina et al (2024)1 evaluated an ongoing, ambispective, observational cohort study (MANHATTAN) comparing the effectiveness, persistence, and tolerability results between subcutaneous (SC) TREMFYA vs a second TNFi through week 24 in adult patients with PsA.
Study Design/Methods
- An interim analysis was conducted 10 months after the first patient was included in the study.
- Data of 69 patients (SC TREMFYA, n=36; TNFi, n=33) were available at week 12, and data of 39 patients (SC TREMFYA, n=25; TNFi, n=14) were available at week 24. The maximum follow-up period was 24 weeks.
Results
- The proportion of patients achieving Disease Activity in Psoriatic Arthritis (DAPSA) low disease activity (LDA) or remission (≤14) increased with time in both groups (see Table: DAPSA LDA or Remission (≤14) at Week 0, 12, and 24).
| SC TREMFYA Second Line | TNFi Second Line | |
|---|---|---|
| Week 0 | 23% | 33% |
| Week 12 | 50% | 65% |
| Week 24 | 78% | 69% |
| Abbreviations: DAPSA, Disease Activity in Psoriatic Arthritis; LDA, low disease activity; SC, subcutaneous; TNFi, tumor necrosis factor inhibitor. | ||
- After 24 weeks, 95.7% of patients continued treatment with SC TREMFYA (1 patient discontinued due to patient desire), and 78.3% of patients continued treatment with TNFi (3 patients discontinued due to adverse events [AEs] and 1 patient discontinued due to primary failure).
- One patient from the SC TREMFYA group reported headache and 4 patients from the TNFi group reported upper respiratory tract infection, syncope, alopecia, and skin reaction. No severe adverse drug reactions were reported.
Joven-Ibáñez et al (2025)2 reported results from MANHATTAN study comparing the persistence, effectiveness, and tolerability of SC TREMFYA vs a second TNFi through week 52 in adult patients with PsA.
Study Design/Methods
- Patients who had previously received TNFi and were switched to either SC TREMFYA or another TNFi as second-line therapy were included in the study.
- Study endpoints included as follows:
- Treatment persistence analyzed by Kaplan-Meier (KM) curves
- Percentage of patients achieving minimal disease activity (MDA)
- Psoriatic body surface area (BSA)
- Mean change in tender joint count (TJC)
- Mean change in swollen joint count (SJC)
Results
- A total of 139 patients were included (TREMFYA, n=77; TNFi, n=62). For details, see Table: Select Baseline Demographic Characteristics.
| Baseline Demographics | Second-Line TREMFYA (n=77) | Second-Line TNFi (n=62) |
|---|---|---|
| Male, n (%) | 31 (40.3) | 31 (50.0) |
| BMI (kg/m2), mean (SD) | 28.2 (6.6) | 27.3 (5.7) |
| PsA characteristics, n (%) | ||
| Age at PsA diagnosis (years), mean (SD) | 43.9 (11.9) | 44.7 (11.9) |
| Active PsO | 51 (66.2) | 29 (47.5) |
| Dactylitisa | 12 (15.8) | 11 (18.0) |
| Enthesitisa | 16 (21.1) | 23 (37.1) |
| TJC,b | 6.0 (6.1) | 5.5 (5.8) |
| SJC,b mean (SD) | 3.5 (4.8) | 2.9 (4.0) |
| DAPSA,c | 23.0 (13.2) | 21.2 (12.3) |
| BSA, mean (SD) | 4.0 (5.2) | 1.9 (4.1) |
| Abbreviations: BSA, body surface area; DAPSA, Disease Activity in Psoriatic Arthritis; PsA, psoriatic arthritis; PsO, psoriasis; SD, standard deviation; SJC, swollen joint count; TJC, tender joint count, TNFi, tumor necrosis factor inhibitor. aOf a total of 76 patients in the TREMFYA group and 61 in the TNFi group. bOf a total of 60 patients in the TREMFYA group and 50 patients in the TNFi group. cOf a total of 51 patients in the TREMFYA group and 39 patients in the TNFi group. | ||
- The most common second-line TNFi was etanercept (46.8%) followed by adalimumab (25.8%).
- The use of concomitant conventional disease-modifying antirheumatic drug (DMARDs) was reported in 41.6% and 41.9% of patients in the second-line TREMFYA and second-line TNFi groups, respectively.
- Persistence at week 52 was higher in the TREMFYA group (85.3%) compared to TNFi group (73.5%); see Figure: KM Plot of Second-Line Treatment (TREMFYA or TNFi) Persistence up to Week 52.
Abbreviations: GUS, guselkumab; KM, Kaplan-Meier; TNFi, tumor necrosis factor inhibitor.
- The overall percentage of patients achieving MDA increased over time in both groups, with a slightly higher rate in the TREMFYA group at weeks 12, 24, and 52, see Figure: Percentage of Patients Achieving MDA in Second-Line Treatment (TREMFYA or TNFi) at Weeks 0, 12, 24, and 52.
Note: MDA was achieved if 5 of 7 criteria were met. The N corresponds to the total number of patients with MDA evaluation in each week.
Abbreviations: GUS, guselkumab; MDA, minimal disease activity; TNFi, tumor necrosis factor inhibitor.
- A reduction was observed in TJC and SJC over time in both groups, see Table: TJC and SJC in Second-Line Treatment (TREMFYA or TNFi) at Weeks 12, 24, and 52.
| Endpoints | TREMFYA | TNFi |
|---|---|---|
| TJC | ||
| Week 12 | -2.7 | -2.2 |
| Week 24 | -3.3 | -3.5 |
| Week 52 | -3.2 | -3.8 |
| SJC | ||
| Week 12 | -2.0 | -1.6 |
| Week 24 | -1.9 | -2.4 |
| Week 52 | -2.2 | -3.1 |
| Abbreviations: SJC, swollen joint count; TJC, tender joint count, TNFi, tumor necrosis factor inhibitor. | ||
Retrospective Studies
Walsh et al (2024)3 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®
Study Design/Methods
- Inclusion criteria:
- Adult patients with PsA who received index biologic (ie SC TREMFYA 100 mg at baseline, week 4, and Q8W or first SC TNFi [adalimumab, certolizumab pegol, etanercept, or golimumab]) between 14 July 2020 and 31 March 2022 were included.
- The index date was defined as the date of first claim for SC TREMFYA or SC TNFi.
- The baseline period was defined as 12 months before the index date in which the patient had 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 biologic DMARD (bDMARD) use (other than SC TREMFYA, SC TNFi, or intravenous [IV] TNFi) during the 12-month baseline period.
- Exclusion criteria:
- Patients had received ≥1 claim for any of the studied drugs at any time during the period of continuous eligibility before the index date.
- Patients initiated >1 index biologic on the index date or had ≥1 diagnosis for other potentially confounding rheumatic diseases (as listed by the authors) in 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 an SC TNFi) or any dose escalation/reduction during follow-up.
- Sensitivity analyses were done for on-label persistence, defined as follows:
- 1st
sensitivity analysis: absence of treatment discontinuation based on a gap of 56 days for SC TREMFYA or 28 days for an SC TNFi. - 2nd
sensitivity analysis: absence of treatment discontinuation for a fixed 112 days to evaluate persistence based on the same gap definition for all index biologics.
- 1st
- Cox proportional hazard 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
- In the SC TREMFYA group (N=526), 48.5% were biologic naive and in the SC TNFi group (N=1953: adalimumab, n=1339; etanercept, n=400; certolizumab pegol, n=159; golimumab, n=55), 87.9% were biologic-naive 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% in the SC TREMFYA vs 16.7% in the SC TNFi cohort]) across the SC TREMFYA and SC TNFi groups. See Table: Select Demographics and Baseline Characteristics for Weighted Cohort in the 12-Month Baseline Period.
| Characteristic | SC TREMFYA (n=526) | SC TNFi (n=1953) | Standardized Difference, % |
|---|---|---|---|
| Age at index date, years, mean±SD; median | 49.8±11.7; 50.7 | 49.2±11.6; 50.3 | 5.2 |
| Time between latest observed PsA diagnosis and 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 |
| Any prior PsA treatment, n (%) | 385 (73.2) | 1012 (51.8) | 45.3 |
| bDMARDsb | 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 |
| csDMARDsc | 118 (22.4) | 471 (24.1) | 4.0 |
| tsDMARDsd | 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 Tlymphocyte associated antigen 4; ICD-10, International Classification of Disease, Tenth 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; US, United States. 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 hazard models. bIL-17A inhibitors (secukinumab and ixekizumab), IL-12/23 inhibitor (ustekinumab), anti-CTLA-4 agent (abatacept), and IL-23p19-subunit inhibitor (risankizumab). The proportion of patients with 1 and ≥2 bDMARDs is reported among those with any bDMARD use. cMethotrexate, leflunomide, cyclosporine, mycophenolate, and azathioprine. dApremilast, deucravacitinib, and JAK inhibitors (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 PsA patients persistent on treatment after 12 months was 72% vs 44%, respectively.
- In the primary analysis, the SC TREMFYA group was 3 times more likely to persist on treatment at 12 months compared with the SC TNFi group (hazard ratio [HR], 2.97; 95% confidence interval [CI], 2.36-3.74; P<0.001).
- The median time to discontinuation was not reached in the SC TREMFYA group and 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.
| Parameterb | SC TREMFYA (n=526) | SC TNFi (n=1953) | Hazard Ratio (95% CI) | P-Valuec |
|---|---|---|---|---|
| Primary analysis | ||||
| Patients at risk,d 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 risk,d 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 risk,d 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 hazard models. bCox proportional hazard 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 having the event are patients who have not had the event and have not been lost to follow-up at that point in time. eP values were determined by using Chi-square test. fP values were determined by using log-rank test. | ||||
- In sensitivity analysis 1, the SC TREMFYA group was 2.4 times more likely to persist on treatment at 12 months compared with the SC TNFi group (HR, 2.41; 95% CI, 1.98-2.92; P<0.001).3,8
- The median time to discontinuation was 18.4 months in the SC TREMFYA group and 6.9 months in the SC TNFi group.3
- In sensitivity analysis 2, the SC TREMFYA group was 2.4 times more likely to persist on treatment at 12 months compared with the SC TNFi group (HR, 2.35; 95% CI, 1.86-2.97; P<0.001).3,8
- The median time to discontinuation was not reached in the SC TREMFYA group and 13.8 months in the SC TNFi group.3
Study Design/Methods
- Inclusion criteria:
- Adult patients with PsA (International Classification of Disease, 10th
Revision, Clinical Modification [ICD-10-CM: L40.5]) who received the first claim of index agent (ie, SC TREMFYA or SC TNFi [adalimumab, etanercept, certolizumab pegol, or golimumab]) within the intake period (14 July 2020 to 31 December 2022) were included; see Figure: IQVIATM Health Plan Claims Data Study Design. - Patients were required to have a 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.
- Adult patients with PsA (International Classification of Disease, 10th
- 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 in the 12-month baseline period before preceding the index date.
Abbreviations: ICD-10-CM, International Classification of Disease, 10th Revision, Clinical Modification; PsA, psoriatic arthritis; SC TNFi, subcutaneous tumor necrosis factor inhibitor; US, United States.
aThe IQVIATM Health Plan Claims Data is comprised of fully adjudicated claims for inpatient and outpatient services, and outpatient prescription drugs, offering a diverse representation of geographic zones, employers, payers, providers, and therapy areas.
bA validated algorithm for identifying patients with PsA in US claims data was used: ≥2 claims with a PsA diagnosis (ICD-10-CM: L40.5x) ≥30 days apart and ≥1 prescription claim for PsA-related medications (ie, guselkumab or SC TNFi).
cPatients could be bio-naïve or bio-experienced during baseline but were naïve to treatment with guselkumab or SC TNFi agents.
dPatients in the SC TNFi cohort were newly initiated within the class.
eDiagnoses for PsA include claims on the index date.
- 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 imputation, see Table: Days of Supply Imputation Rule.
| Days of Supply Imputation Rule | SC TREMFYA | SC TNFi |
|---|---|---|
| Medical claims | ||
| 1st claim | 28 days | 28 days |
| 2nd+claims | 56 days | 28 days |
| Pharmacy claims | ||
| 1st claim | 28 days | No imputationa |
| 2nd+claims | Based on time to next claimb | No imputationa |
| Abbreviations: SC TNFi, subcutaneous tumor necrosis factor inhibitor. aPharmacy claims for SC TNFi are typically consistent with approved labeling; therefore, reported days supply was used for SC TNFi and no imputation was performed. b28 days if time to next claim is <42 days; 56 days if time to next claim is between 42-70 days; 84 days if time to next claim is >70 days; if there is no next claim, days of supply of the previous claim was carried forward or imputed as 56 days if the original value was missing or if this was the second claim; no imputation for claims with days supply 56-60 or >60. | ||
Results
Baseline Characteristics
- A total of 804 and 2490 patients were included in the SC TREMFYA group and SC TNFi group (adalimumab, n=1742; etanercept, n=528; certolizumab pegol, n=198; golimumab, n=22), respectively. See Table: Select Weighted Baseline Demographics and Characteristics.a
- Prior to the index date, 55.1% of patients in the SC TREMFYA group and 12.8% in the SC TNFi group had received ≥1 bDMARD; these values were unweighted.
| SC TREMFYA (n=804) | SC TNFi (n=2490) | |
|---|---|---|
| Demographics | ||
| Age at 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 latest observed PsA diagnosis and 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 TNFi, subcutaneous tumor necrosis factor inhibitor; SD, standard deviation; 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 anti-IL-17A (secukinumab and ixekizumab), anti-IL-12/23 (ustekinumab), anti-CTLA-4 (abatacept), and anti-IL-23 (risankizumab). dIncludes methotrexate, leflunomide, cyclosporine, mycophenolate, and azathioprine. eIncludes apremilast, deucravacitinib, and JAKi (upadacitinib, baricitinib, and tofacitinib). | ||
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% in the SC TNFi group, despite a higher prevalence of biologic-experienced patients in the SC TREMFYA vs SC TNFi group (47.6% vs 14.0%, respectively) 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 2.2 times more likely to remain persistent with on-label treatment through 24 months compared with those in the SC TNFi group (1x: HR, 1.90; fixed gap: HR, 1.80; P<0.001 for both).
- SC TREMFYA was associated a significantly higher on-label persistence when compared with SC TNFi at each time point assessed (6/12/18/24 months). See Table: Primary Analysis of On-Label Persistence through 24 Months in Weighted SC TREMFYA and SC TNFi Groups.a
| Parameters | SC TREMFYAb (n=804) | SC TNFib (n=2490) | Hazard Ratio (95% CI) | P-Value |
|---|---|---|---|---|
| Patients at risk,c 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 hazard 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 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. | ||||
Network Meta-analysis
Mease et al (2021)5 and (2023)6 conducted a Bayesian NMA to indirectly compare the treatment effect of TREMFYA with other targeted therapies for PsA, including TNFis (golimumab, infliximab, adalimumab, etanercept, and certolizumab pegol), 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 randomized controlled trials (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 DMARDs (tsDMARDs) and bDMARDs) in adults with active PsA.5
- The NMA was updated up to February 2021 and again in July 2021 to include new data and new agents.6
- The Bayesian NMA was performed to compare treatments on American College of Rheumatology (ACR) 20/50/70 response, change from baseline in van der Heijde-Sharp (vdH-S) score, Psoriasis Area and Severity Index (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 was 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 and log-odds ratio scales, respectively.
- These treatment effects were transformed to relative risks using the unweighted averages 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 and log-odds ratio scales, respectively.
- Treatments evaluated pertaining to TREMFYA 100 mg SC every 8 weeks (Q8W) compared to the following TREMFYA dosing regimen and the TNFis: 6,7
- TREMFYA 100 mg SC every 4 weeks (Q4W)
- IV TNFis (golimumab 2 mg weight-based [WT] and infliximab 5 mg WT)
- SC TNFis (adalimumab 40 mg, etanercept 25 mg, golimumab 50 mg, and certolizumab 400 mg and 200 mg)
Results
- A total of 33 trials (87 citations) evaluating all doses of tsDMARDs and bDMARDs approved by either the Food and Drug Administration (FDA) or European Medicines Agency (EMA) for the treatment of active PsA were included in the NMA.
- For results specific to multi-ACR20 response, multi-PASI 90 response, vdH-S score, and SAEs, respectively, see:
- Figure: Forest Plot with Pairwise Comparisons of TREMFYA Q8W vs Comparators for Multi-ACR20 Response.
- Figure: Forest Plot with Pairwise Comparisons of TREMFYA Q8W vs Comparators for Multi-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-23i, interleukin-23 inhibitor; IV, intravenous; Q4W, every 4 weeks; Q8W, every 8 weeks; RR, relative risk; SC, subcutaneous; TNFi, tumor necrosis factor inhibitor; WT, weight-based.
Abbreviations: Crl, credible interval; IL-23i, interleukin-23 inhibitor; IV, intravenous; PASI, Psoriasis Area and Severity Index; Q4W, every 4 weeks; Q8W, every 8 weeks; RR, relative risk; SC, subcutaneous; TNFi, tumor necrosis factor inhibitor; WT, weight-based.
Abbreviations: Crl, credible interval; IL-23i, interleukin-23 inhibitor; IV, intravenous; MD, mean difference; Q4W, every 4 weeks; Q8W, every 8 weeks; SC, subcutaneous; TNFi, tumor necrosis factor inhibitor; vdH-S, van der Heijde-Sharp; WT, weight-based.
Abbreviations: Crl, credible interval; IL-23i, interleukin-23 inhibitor; IV, intravenous; Q4W, every 4 weeks; Q8W, every 8 weeks; RR, relative risk; SAE, serious adverse event; SC, subcutaneous; TNFi, tumor necrosis factor inhibitor; WT, weight-based.
Literature Search
A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 10 October 2025.
References
| 1 | González-Molina M, Marín Huertas C, Joven-Ibáñez B, et al. Manhattan study: observational, ambispective study to describe persistence and effectiveness of a second-line guselkumab or TNF inhibitors after first-line TNF inhibitors for the treatment of active psoriatic arthritis in Spain [abstract]. Arthritis Rheumatol. 2024;76(Suppl. 9):Abstract 1469. |
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