(guselkumab)
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Last Updated: 01/22/2025
Prospective Studies |
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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
Results Baseline Clinical Characteristics
Efficacy
Safety
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.
Note: Click on Abbreviations to view all abbreviations. |
Clinical Characteristic | TREMFYA (N=111) |
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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. |
Clinical Variables | Odds Ratio (95% CI) | P-Value |
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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 |
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Mease et al (2024)2 Study Design/Methods
Results Baseline Characteristics
Treatment Persistence
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Walsh et al (2024)3 Study Design/Methods
Results Baseline Characteristics
Treatment Persistence
Note: Click on Abbreviations to view all abbreviations. |
Characteristic | SC TREMFYA (n=910) | SC IL-17Ai (n=2740) |
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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. b 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). |
Cox Proportional Hazards Modelb | SC TREMFYA (n=910) | SC IL-17Ai (n=2740) | Hazard Ratio (95% CI) | P-Value |
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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. |
Characteristic | TREMFYA (N=526) | SC TNFis (N=1953) | Standardized Difference, % |
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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). |
Cox Proportional Hazards Modelb | TREMFYA (N=526) | SC TNFis (N=1953) | Hazard Ratio (95% CI) | P-Valuec |
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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 |
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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
Results Baseline Characteristics
Effectiveness
Note: Click on Abbreviations to view all abbreviations. |
Characteristic | Primary Analysis: On-Label Persisters (N=90) |
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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. cPrior 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. |
Baseline | At 6 Months | Mean Change (95% CI) | P-Value | |
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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). |
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.
1 | Ruscitti P, Cataldi G, Gentile M, et al. The evaluation of effectiveness and safety of guselkumab in patients with psoriatic arthritis in a prospective multicentre “real-life” cohort study. Rheumatol Ther. 2024;11(3):539-551. |
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