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

Last Updated: 01/22/2025

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.
  • Summarized in this response are the available data from real-world studies that evaluated TREMFYA in the treatment of adult patients with PsA.
    • 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 are described below.1-4
  • An ongoing, prospective, observational study (PsABIOnd [NCT05049798]) is being conducted to evaluate the long-term effectiveness and safety of TREMFYA or interleukin-17 inhibitors (IL-17is) in routine clinical practice in adult patients with active PsA.5,6

Real-world Evidence


Summary of Prospective, Retrospective, and Registry-Based Real-World Studies in Adult Patients with Active PsA1-7 
Prospective Studies
Ruscitti et al (2024)1 conducted a real-life, prospective, multicenter cohort study that evaluated the 6-month effectiveness, DRR, impact of comorbidities, and patient clinical characteristics, in a collective 18-month follow-up of TREMFYA in patients with PsA.
Study Design/Methods
  • The study enrolled patients with moderate-to-active PsA who met the CASPAR criteria from December 2021 to September 2023.
  • Patients with moderate-to-active PsA and treated with SC TREMFYA for at least 6 months were evaluated in this study.
  • The study included two TREMFYA dosing regimens: 100 mg SC q8w and q4w.
    • DAPSA was calculated at baseline and after 3 and 6 months, and the achievement of DAPSA ≤14 was also recorded.
    • The disease activity was further assessed by analyzing LEI, BASDAI, tender and swollen joints, and CRP.
    • VAS, PGA, and Patient Global Assessment were evaluated before and after the administration of SC TREMFYA.
  • After the 6 months of therapy, the DRR of SC TREMFYA was evaluated by assessing the months of therapy and the impact of selected clinical manifestations such as sex, disease duration, presence of comorbidity, obesity, and prior and concomitant therapies on DRR was also evaluated.
  • Reasons for discontinuation of SC TREMFYA due to inefficacy and/or AEs were also recorded in the cumulative 18-month follow-up.

Results
Baseline Clinical Characteristics

Efficacy
  • A significant reduction in DAPSA was observed in patients after 6 months of follow-up (P<0.001).
  • A significant overall 6-month reduction in DAPSA (β, -15.47; 95% CI, -23.15 to -9.79; P=0.001) was observed after adjusting the linear mixed model for age and male sex.
  • The percentage of patients who achieved DAPSA ≤14 at 3- and 6-month assessments was 29.7% and 39.6%, respectively.
  • The predictive role of selected clinical variables in 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, significant reductions 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) were reported.
  • At the end of 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 time of administration of 9.8±4.1 months (median IQR, 9.0 [5.0] months).
    • No influence was observed on SC TREMFYA DRR due to patient clinical characteristics (male sex [P=0.941], disease duration ≥5 years [P=0.959], comorbidities, considering any concomitant disorder [P=0.824], obesity [P=0.444], and concomitant therapy with csDMARDs [P=0.854] or prior bDMARDs [P=0.293]).

Safety
  • No life-threatening events were observed, and 4.5% of patients discontinued SC TREMFYA due to AEs.
    • Discontinuation was mainly due to gastrointestinal features, such as diarrhea and dyspepsia, and respiratory tract infections that needed antibiotic therapies. However, these reactions were resolved with no long-term consequences.
  • Minor transient AEs were reported during the study, mainly injection-site reactions, which did not lead to discontinuation of the drug.

Note: Click on Abbreviations to view all abbreviations.
Siebert et al (2023)5,6 are conducting an ongoing, prospective, international, observational study (PsABIOnd [NCT05049798]) to evaluate the long-term effectiveness and safety of TREMFYA or
IL-17i in routine clinical practice in adult patients with active PsA.

  • The study plans to enroll ~1300 patients (TREMFYA ~650; IL-17i ~650). A total of 1314 patients were enrolled in the study as of September 2024.
  • The primary objective is to evaluate the treatment persistence with TREMFYA and IL-17i initiated at enrollment in the PsABIOnd study.
  • The secondary objectives include evaluation of effectiveness, potential predictors of response, patient-reported outcomes, treatment patterns for different biologic treatments, presence of clinical features of concomitant disease and comorbidities, and safety.

Note: Click on Abbreviations to view all abbreviations.

Select Characteristics of Patients with PsA1
Clinical Characteristic
TREMFYA
(N=111)

Demographic characteristics
   Age, years, mean±SD
56.8±9.9
   Sex, male, %
20.7
   Weight, kg, mean±SD
72.2±12.6
   Height, m, mean±SD
1.7±0.4
   BMI, mean±SD
25.5±5.1
Disease characteristics
   Peripheral involvement, %
86.5
   Skin and/or nail involvement, %
75.9
   Axial movement, %
64.3
   Enthesis involvement, %
51.4
   Dactylitis features, %
29.7
   Extra-articular manifestations, %
8.9
   Disease duration, years, median (IQR)
6.0 (7.0)
   Disease duration ≥5 years, %
55.9
   DAPSA, median (IQR)
25.6 (15.2)
   LEI, median (IQR)
2.0 (3.0)
   Tender joints, median (IQR)
9.0 (5.0)
   Swollen joints, median (IQR)
1.0 (2.0)
   VAS pain, median (IQR)
7.0 (6.0)
   PGA, median (IQR)
6.0 (6.0)
   CRP, mg/dL, median (IQR)
0.7 (1.9)
   BASDAI, median (IQR)
5.8 (4.6)
TREMFYA features
   Ongoing at the last observation, %
71.2
   Discontinuation due to inefficacy, %
24.3
   Discontinuation due to side effects, %
4.5
   Previous therapy with bDMARDs, %
78.4
   Previous therapy with TNF inhibitors, %
63.5
   Concomitant therapy with csDMARDs, %
60.4
   Concomitant therapy with MTX, %
52.3
   Concomitant therapy with NSAIDs, %
45.9
   Concomitant therapy with GCs, %
12.8
Abbreviations: BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; bDMARD, biologic disease-modifying antirheumatic drug; BMI, body mass index; CRP, C-reactive protein; csDMARD, conventional synthetic disease-modifying antirheumatic drug; DAPSA, Disease Activity Index for Psoriatic Arthritis; GC, glucocorticoids; IQR, interquartile range; LEI, Leeds Enthesitis Index; MTX, methotrexate; NSAID, nonsteroidal anti-inflammatory drug; PGA, Physician Global Assessment; PsA, psoriatic arthritis; SD, standard deviation; TNF, tumor necrosis factor; VAS, visual analog scale.

Multivariate Regression Analyses of Clinical Variables for Achievement of DAPSA ≤141
Clinical Variables
Odds Ratio (95% CI)
P-Value
Achievement of DAPSA ≤14
   Multivariate analysis
      Age
0.97 (0.92-1.02)
0.289
      Male sex
2.81 (0.75-10.52)
0.996
      Axial disease
0.44 (0.16-1.17)
0.100
      Enthesitis
1.23 (0.47-3.62)
0.617
      Dactylitis
1.32 (0.45-3.92)
0.611
   Multivariate analysis
      Age
0.98 (0.93-1.03)
0.549
      Male sex
2.86 (0.80-10.30)
0.106
      Disease duration ≥5 years
0.91 (0.34-2.44)
0.856
      csDMARDs
0.92 (0.35-3.56)
0.719
      Previous bDMARDs
0.65 (0.18-2.21)
0.623
   Multivariate analysis
      Age
0.96 (0.91-1.02)
0.224
      Male sex
2.01 (0.51-8.03)
0.313
      Obesity
0.46 (0.13-1.16)
0.461
      Comorbidity
1.58 (0.46-5.41)
0.924
Note: P<0.05 is considered statistically significant.
Abbreviations:
bDMARD, biologic disease-modifying antirheumatic drug; CI, confidence interval; csDMARD, conventional synthetic disease-modifying antirheumatic drug; DAPSA, Disease Activity Index for Psoriatic Arthritis.

Retrospective Studies
Mease et al (2024)2 evaluated treatment persistence in a real-world setting in patients with PsA who were newly initiated on SC TREMFYA vs SC IL-17Ai.
Study Design/Methods
  • Inclusion criteria:
    • Adult patients (aged ≥18 years) with PsA who were initiated on SC TREMFYA or SC IL-17Ai using IQVIATM Health Plan Claims Data.
    • The index date was defined as the first date on which SC TREMFYA or the SC IL-17Ai (ixekizumab or secukinumab) was initiated between July 14, 2020, and June 30, 2022.
    • Patients who had ≥12 months of continuous health insurance eligibility before the index date.
    • 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 who had received >1 claim for any of the studied drugs at any time during the period of continuous eligibility before the index date.
    • 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) in the 12-month baseline period before the index date.
  • 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 IL-17Ai) with approved dosing regimens as per FDA label.
    • The primary analysis was conducted based on 2 times of 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 of 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 84 days.
  • Weighted Cox proportional hazard models were used to compare the on-label persistence through 12 months post-index between the SMR-weighted SC TREMFYA and SC IL-17Ai groups.

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

Treatment Persistence
  • In the primary analysis, the SC TREMFYA group was significantly (~2 times) more likely to persist on treatment at 12 months as compared with the SC IL-17Ai group (HR, 1.85; 95% CI, 1.60-2.13; P<0.001).
    • In the SC TREMFYA vs SC IL-17Ai group, the on-label persistence at 12 months was 67% vs 50%.
    • The median time to discontinuation was not reached in the SC TREMFYA group and 12.3 months in the SC IL-17Ai group.
  • In sensitivity analysis 1, the SC TREMFYA group was ~1.7 times more likely to persist with on-label treatment at 12 months as compared with the SC IL-17Ai group (HR, 1.72; P<0.001).
  • In sensitivity analysis 2, the SC TREMFYA group was ~1.2 times more likely to persist with on-label treatment at 12 months as compared with the SC IL-17Ai group (HR, 1.21; P=0.0113).
  • On-label persistence at 3, 6, 9, and 12 months is summarized in Table: Primary Analysis (2x Duration) of On-Label Persistence through 12 Months in Weighted SC TREMFYA and SC IL-17Ai Groups.
Walsh et al (2024)3,7 evaluated treatment persistence in a real-world setting in patients with PsA treated with SC TREMFYA vs SC TNFi using IQVIA PharMetrics® Plus.
Study Design/Methods
  • Inclusion criteria:
    • Adult patients with PsA who received SC TREMFYA 100 mg at baseline, week 4, and q8w and those initiating treatment with SC TNFi were included in the study.
    • The index date was defined as the date SC TREMFYA or first SC TNFi (adalimumab, certolizumab pegol, etanercept, or golimumab) was initiated between July 14, 2020, and March 31, 2022.
    • 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 could be biologic naïve or biologic experienced during a 12-month baseline but naïve to treatment with SC TREMFYA or a SC or IV TNFi.
  • 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 (such as, ankylosing spondylitis, other inflammatory arthritides, calcium pyrophosphate dihydrate crystal deposition disease, nonradiographic axial SpA, postinfectious and reactive arthritis, other spondyloarthropathies, rheumatoid arthritis, systemic connective tissue disorders, relapsing polychondritis, or unclassified connective tissue disease) 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 analysis of on-label persistence was assessed (sensitivity analysis 1: on-label treatment persistence was defined as the absence of treatment discontinuation based on a gap of 56 days for SC TREMFYA or 28 days for an SC TNFi; sensitivity analysis 2: on-label treatment persistence was defined as the absence of treatment discontinuation for a fixed 112 days to evaluate persistence based on the same gap definition for all index biologics).
  • Cox proportional hazard models were used to compare the risk of discontinuation between the SMR-weighted SC TREMFYA and SC TNFi groups.

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

Treatment Persistence
  • In the SC TREMFYA vs SC TNFi group, the mean follow-up time was 12.3 vs 12.4 months and the proportion of patients with PsA persistent on treatment at 12 months was 72% vs 44%.
  • 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 (HR, 2.97; 95% CI, 2.36-3.74; P<0.001).
    • The median time to discontinuation was not reached in the SC TREMFYA group and 8.9 months in the SC TNFir group.
  • On-label persistence at 3, 6, 9, and 12 months is summarized in Table: Analysis of On-Label Persistence through 12 Months in Weighted SC TREMFYA and SC TNFi Group.
  • 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).3,7
    • The median time to discontinuation was 18.4 months in the SC TREMFYA group and 6.9 months in the SC TNFi group.
  • In sensitivity analysis 2, the SC TREMFYA group was 2.4 times more likely to persist on treatment at 12 months compared with the SC TNFi group (HR, 2.35; 95% CI, 1.86-2.97; P<0.001).3,7
    • The median time to discontinuation was not reached in the SC TREMFYA group and 13.8 months in the SC TNFi group.

Note: Click on Abbreviations to view all abbreviations.

Select Baseline Demographics and Clinical Characteristics2a
Characteristic
SC TREMFYA
(n=910)

SC IL-17Ai
(n=2740)

Age at the index date, years, mean±SD (median)
50.4±11.1 (52.0)
50.2±11.3 (51.0)
Female, %
60.4
59.4
Time between the latest observed PsA diagnosis and the index date, months, mean±SD (median)
1.3±1.6 (1.0)
1.3±1.5 (1.0)
Quan-CCI score, mean±SD (median)
0.6±1.2 (0.0)
0.6±1.3 (0.0)
Psoriasis, %
86.5
87.6
Any prior PsA treatment, %
75.9
52.5
   bDMARDsc
51.9
52.5
      0
48.1
47.5
      1
43.6
44.0
      ≥2
8.2
8.5
   csDMARDsd
30.0
31.0
   tsDMARDse
22.5
18.1
Corticosteroids, %
43.1
44.2
Abbreviations: bDMARD, biologic disease-modifying antirheumatic drug; csDMARD, conventional synthetic disease-modifying antirheumatic drug; CTLA-4, cytotoxic T lymphocyte-associated antigen 4; IBD, inflammatory bowel disease; IL, interleukin; IL-17Ai, interleukin 17A inhibitor; IV, intravenous; JAK, Janus kinase; PsA, psoriatic arthritis; Quan-CCI, Quan-Charlson comorbidity index; SC, subcutaneous; SD, standard deviation; TNFi, tumor necrosis factor inhibitor; tsDMARD, targeted synthetic disease-modifying antirheumatic drug.
aPropensity score weighting based on the standardized mortality ratio weighting approach was used to adjust for differences in baseline characteristics between the SC TREMFYA and SC IL-17Ai groups. Weights were estimated using a multivariable logistic regression model. Baseline covariates included all demographic and clinical characteristics.
bUnclassified IBD, Crohn’s disease, and ulcerative colitis.
cIncludes IL-12/23 inhibitor (ie, ustekinumab), anti-CTLA-4 agent (ie, abatacept), IL-23 inhibitor (ie, risankizumab), SC TNF inhibitors (ie, adalimumab, certolizumab pegol, etanercept, and golimumab), and IV TNF inhibitors (ie, infliximab, infliximab biosimilars, and IV golimumab).
dIncludes methotrexate, leflunomide, cyclosporine, mycophenolate, and azathioprine.
eIncludes apremilast, deucravacitinib, and JAK inhibitors (ie, upadacitinib, baricitinib, and tofacitinib).


Primary Analysis (2x Duration) of On-Label Persistence through 12 Months in Weighted SC TREMFYA and SC IL-17Ai Groups2a
Cox Proportional Hazards Modelb
SC TREMFYA
(n=910)

SC IL-17Ai
(n=2740)

Hazard Ratio (95% CI)
P-Value
Patients at risk,c n (%)
   3 months
665 (73.1)
1065 (38.9)
1.36 (1.18-1.58)
<0.001d
   6 months
484 (53.2)
807 (29.5)
1.62 (1.41-1.88)
<0.001d
   9 months
333 (36.6)
599 (21.9)
1.75 (1.52-2.02)
<0.001d
   12 months
201 (22.1)
358 (13.1)
1.85 (1.60-2.13)
<0.001d
KM persistence, % (95% CI)
   3 months
89.8 (84.2-93.5)
81.2 (76.7-84.8)
-
<0.001e
   6 months
80.0 (74.9-84.3)
67.1 (61.5-72.0)
-
<0.001e
   9 months
71.3 (65.9-76.0)
57.5 (51.0-63.4)
-
<0.001e
   12 months
66.8 (61.1-71.8)
50.1 (42.6-57.2)
-
<0.001e
Abbreviations: CI, confidence interval; IL-17Ai, interleukin 17A inhibitor; KM, Kaplan-Meier; SC, subcutaneous; 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 IL-17Ai groups. Weights were estimated using a multivariable logistic regression model. Baseline covariates included all demographic and clinical characteristics.
bWeighted Cox 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 having the event are patients who have not had the event and have not been lost to follow-up at that point in time.
dP-values were determined using a Chi-square test.
eP-values were determined using a log-rank test.


Select Demographics and Baseline Characteristics in the 12-Month Baseline Period3a
Characteristic
TREMFYA
(N=526)
SC TNFis
(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
Female, n (%)
322 (61.2)
1193 (61.1)
0.3
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
Psoriasis,d n (%)
470 (89.4)
1718 (88.0)
4.4
Any prior PsA treatment, n (%)
385 (73.2)
1012 (51.8)
45.3
   bDMARDse
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
   csDMARDsf
118 (22.4)
471 (24.1)
4.0
   tsDMARDsg
95 (18.1)
359 (18.4)
0.8
Abbreviations: bDMARD, biologic disease-modifying antirheumatic drug; csDMARD, conventional synthetic disease-modifying antirheumatic drug; CTLA-4, cytotoxic T-lymphocyte associated antigen 4; IBD, inflammatory bowel disease; ICD-10, International Classification of Disease, Tenth Revision; IL, interleukin; IV, intravenous; JAK, Janus kinase; PsA, psoriatic arthritis; Quan-CCI, Quan-Charlson comorbidity index; SC, subcutaneous; SD, standard deviation; TNFi, tumor necrosis factor inhibitor; tsDMARD, targeted synthetic disease-modifying antirheumatic drug.
aPropensity score weighting based on the standardized mortality ratio weighting approach was used to adjust for differences in baseline characteristics between the SC TREMFYA and SC TNFi groups. Weights were estimated using a multivariable logistic regression model. Baseline covariates included all demographic and clinical characteristics reported in this table with the exception of baseline use of bDMARDs, which was included in the adjusted Cox proportional hazard models.
bPoint-of-service, consumer directed healthcare, indemnity/traditional, and unknown plan type.
cUnclassified IBD, Crohn’s disease, and ulcerative colitis.
dDefined based on the ICD-10 code L40.x (excluding L40.5).
eIL-17A inhibitors (i.e., secukinumab and ixekizumab), IL-12/23 inhibitor (i.e., ustekinumab), anti-CTLA-4 agent (i.e., abatacept), and IL-23p19-subunit inhibitor (i.e., risankizumab). The proportion of patients with 1 and ≥2 bDMARDs is reported among those with any bDMARD use.
fMethotrexate, leflunomide, cyclosporine, mycophenolate, and azathioprine.
gApremilast, deucravacitinib, and JAK inhibitors (i.e., upadacitinib, baricitinib, and tofacitinib).


Analysis of On-Label Persistence through 12 Months in Weighted SC TREMFYA and SC TNFi Group3,7,a
Cox Proportional Hazards Modelb
TREMFYA
(N=526)
SC TNFis
(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 using Chi-square test.
fP values were determined using log-rank test.

Registry-Based Studies
Mease et al (2023)4 evaluated the effectiveness of persistent use of SC TREMFYA through 6 months in adult patients with active PsA using real-world data from the CorEvitas PsA/SpA registry.
Study Design/Methods
  • The CorEvitas PsA/SpA registry is a US, prospective, multicenter, observational registry of patients with active PsA or SpA under rheumatologists’ care.
  • The study population included registry participants who initiated SC TREMFYA on/after October 20, 2018, and had a 6-month follow-up visit on/before March 31, 2023.
  • The primary analysis population was defined as patients with active PsA who received SC TREMFYA at a dose of 100 mg administered subcutaneously at weeks 0, 4, and every 8 weeks thereafter and were persistent on therapy through the 6-month visit (on-label persisters).
  • The primary outcome was a mean (95% CI) change in clinical DAPSA score from baseline to 6 months.
  • Secondary outcomes (in order of multiplicity-controlled testing) were changes in PGA of arthritis and PsO, patient-reported pain, and percent of body surface area among patients with a history of PsO from baseline at 6 months.

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

Effectiveness

Note: Click on Abbreviations to view all abbreviations.

Select Demographics and Baseline Characteristics4
Characteristic
Primary Analysis: On-Label Persisters
(N=90)
Age, years, mean±SD
55.2±12.5
Female, n (%)
62 (69.7)
(n=89)

PsA symptom onset, years, mean±SD
13.6±11.2
(n=87)

PsA diagnosis, years, mean±SD
8.9±7.9
(n=89)

PsO (yes, current or history), n (%)a
85 (94.4)
BSA with PsO, %, mean±SDb
7.6±12.6
(n=85)

Tender joint count (0-68), mean±SD
8.7±11.7
(n=87)

Swollen joint count (0-66), mean±SD
2.4±4.0
(n=87)

PGA of arthritis (VAS, 0-100), mean±SD
34.2±22.7
(n=89)

PGA of arthritis and PsO (VAS, 0-100), mean±SDb
42.3±23.7
(n=85)

Patient-reported pain (VAS, 0-100), mean±SD
57.0±24.6
(n=89)

Dactylitis count (0-20), mean±SD
0.3±1.1
Leeds Enthesitis Index (0-6), mean±SD
0.7±1.3
(n=87)

SPARCC Enthesitis Index (0-16), mean±SD
1.3±2.4
cDAPSA, mean±SD
22.0±15.1
(n=85)

Prior csDMARD, n (%)c,d
   1
35 (38.9)
   ≥2
21 (23.3)
Prior b/tsDMARD, n (%)c,d
   1
17 (18.9)
   ≥2
66 (73.3)
Abbreviations: b/tsDMARD, biologic/targeted synthetic disease-modifying antirheumatic drug; BSA, body surface area; cDAPSA, clinical Disease Activity Index for Psoriatic Arthritis; csDMARD, conventional synthetic disease-modifying antirheumatic drug; PGA, Physician Global Assessment; PsA, psoriatic arthritis; PsO, psoriasis; SD, standard deviation; SPARCC, Spondyloarthritis Research Consortium of Canada; TNF, tumor necrosis factor; VAS, visual analog scale.
aDefined as a personal history of PsO or evidence of current PsO
bAmong patients with prior or current PsO.
c
Prior therapy count does not include patient’s current therapy.
dGroups are not mutually exclusive; TNFi: adalimumab, certolizumab pegol, etanercept, etanercept-szzs, golimumab, infliximab, infliximab-dyyb; non-TNFi: abatacept, anakinra, ixekizumab, rituximab, secukinumab, tocilizumab, ustekinumab, risankizumab-rzaa; tsDMARD: apremilast, tofacitinib, and upadacitinib.


Primary and Major Secondary Outcomes of SC TREMFYA Among On-Label Persisters at 6 Months4
Baseline
At 6 Months
Mean Change (95% CI)
P-Value
Mean cDAPSA scorea
21.6
(n=75)

16.1
(n=75)

-5.4 (-8.5 to -2.3)
<0.001
Mean PGA of arthritis and PsO score (VAS, 0-100)b,c
41.3
(n=82)

22.4
(n=82)

-19.0 (-24.2 to -13.8)
<0.001
Mean patient-reported pain score (VAS, 0-100)d
58.1
(n=87)

48.9
(n=87)

-9.1 (-14.4 to -3.8)
<0.001
Mean BSA with PsO (%)c
8.0
(n=79)

2.9
(n=79)

-5.1 (-7.6 to -2.7)
<0.001
Abbreviations: BSA, body surface area; cDAPSA, clinical Disease Activity Index for Psoriatic Arthritis; CI, confidence interval; PGA, Physician Global Assessment; PsO, psoriasis; VAS visual analog scale.
aRemission, cDAPSA ≤4; low disease activity, cDAPSA >4 to ≤13; moderate disease activity, cDAPSA >13 to ≤27; high disease activity, cDAPSA >27.
bPGA ≤20 mm (0-100 VAS) considered minimal disease activity.
cAmong patients with prior or current PsO. Mild, BSA <3%; moderate, BSA ≥3% to ≤10%; severe, BSA >10%.
dPatient-reported pain score ≤15 mm (0-100 VAS) considered minimal pain; minimally important improvement=improvement ≥10 mm (VAS).

Abbreviations: AE, adverse event; BASDAI, bath ankylosing spondylitis Disease Activity Index; bDMARD, biologic disease-modifying antirheumatic drug; CASPAR, Classification Criteria for Psoriatic Arthritis; CI, confidence interval; CRP, C-reactive protein; csDMARD, conventional synthetic disease-modifying antirheumatic drug; DAPSA, Disease Activity Index for Psoriatic Arthritis; DRR, drug retention rate; FDA, Food and Drug Administration; HR, hazard ratio; IL-17Ai, interleukin 17A inhibitor; IQR, interquartile range; LEI, Leeds Enthesitis Index; PGA, Physician Global Assessment; PsO, psoriasis; q4w, every 4 weeks; q8w, every 8 weeks; SC, subcutaneous; SMR, standardized mortality ratio; SpA, spondyloarthritis; TNFi, tumor necrosis factor inhibitor; VAS, visual analog scale.

LITERATURE SEARCH

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, DERWENT® (and/or other resources, including internal/external databases) was conducted on 08 December 2024.

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

 

References

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2 Mease PJ, Zhao R, Ferrante S, et al. Comparing on-label treatment persistence in real-world patients with psoriatic arthritis receiving guselkumab versus subcutaneous IL-17A inhibitors. Poster presented at: Congress of Clinical Rheumatology-West (CCR-W); September 26-29, 2024; San Diego, CA.  
3 Walsh JA, Lin I, Zhao R, et al. Comparison of real-world on-label treatment persistence in patients with psoriatic arthritis receiving guselkumab versus subcutaneous tumor necrosis factor inhibitors. Drugs Real World Outcomes. 2024;11(3):487-499.  
4 Mease PJ, Ogdie A, Tesser J, et al. Six-month persistence and multi-domain effectiveness of guselkumab in adults with psoriatic arthritis: real-world data from the CorEvitas Psoriatic Arthritis/Spondyloarthritis registry. Rheumatol Ther. 2023;10(6):1479-1501.  
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7 Walsh JA, Lin I, Zhao R, et al. Supplement to: Comparison of real-world on-label treatment persistence in patients with psoriatic arthritis receiving guselkumab versus subcutaneous tumor necrosis factor inhibitors. Drugs Real World Outcomes. 2024;11(3):487-499.