(guselkumab)
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Last Updated: 01/04/2025
Alexis et al (2023 and 2024)4,
Cohort | Time Frame | |
---|---|---|
Co-primary Outcome Measures | ||
Percentage of patients who achieved PASI 90 response | Cohort A | Week 16 |
Percentage of patients who achieved an IGA score of cleared (0) or minimal (1) | Week 16 | |
Percentage of patients who achieved PSSI 90 response | Cohort B | Week 16 |
Percentage of patients who achieved ss-IGA score of absence of disease (0) or very mild disease (1) | Week 16 | |
Secondary Outcome Measures | ||
Percentage of patients who achieved IGA score of cleared (0) | Cohort A | Week 16 |
Percentage of patients who achieved PASI 100 response | Cohort A | Week 16 |
Change from baseline in total PASI score | Cohort A | Week 16 |
Change from baseline BSA | Cohort A | Week 16 |
Time to ≥90% reduction in PASI score | Cohort A | Week 16 |
Percentage of patients who achieved ≥4-point reduction from baseline PSSD itch score among patients with baseline PSSD itch ≥4 at baseline | Cohort A | Week 16 |
Percentage of patients who achieved ss-IGA score of absence of disease (0) | Cohort B | Week 16 |
Change from baseline SSA | Cohort B | Week 16 |
Percentage of patients who achieved PSSI 100 response | Cohort B | Week 16 |
Change from baseline in Total PSSI | Cohort B | Week 16 |
Time to ≥90% reduction in PSSI score | Cohort B | Week 16 |
Percentage of patients with ≥4-point reduction from baseline in scalp itch NRS score among patients with baseline scalp itch ≥4 at baseline | Cohort B | Week 16 |
Percentage of patients who achieved PSSD symptom score 0 among patients with baseline PSSD symptom score ≥1 | Cohort A and B | Week 16 |
Change from baseline DLQI | Cohort A and B | Week 16 |
Change from baseline PSSD symptom score | Cohort A and B | Week 16 |
Number of patients with AE | Cohort A and B | Week 116 |
Number of patients with SAEs | Cohort A and B | Week 116 |
Note: Additional detail regarding study outcome definitions can be found on clinicaltrials.gov. Abbreviations: AE, adverse event; BSA, body surface area; DLQI, dermatology life quality index; IGA, investigator’s global assessment; NRS, numerical rating scale; PASI, psoriasis area and severity index; PSSD, psoriasis symptoms and signs diary; PSSI, psoriasis scalp severity index; SAEs, serious adverse event; SSA, scalp surface area; ss-IGA, scalp-specific investigator’s global assessment. |
TREMFYA (n=77) | Placebo (n=26) | Total (N=103) | |
---|---|---|---|
Age, years, mean (SD) | 44.7 (11.80) | 42.3 (15.73) | 44.1 (12.86) |
Male, n (%) | 55 (71.4) | 19 (73.1) | 74 (71.8) |
BMI, kg/m2, mean (SD) | 32.6 (8.89) | 32.7 (8.50) | 32.6 (8.76) |
Race/Ethnicity Composition, % | |||
Hispanic or Latino | 51.9 | 46.2 | - |
Asian | 20.8 | 30.8 | - |
Black | 11.7 | 7.7 | - |
Middle Eastern | 7.8 | 7.7 | - |
Pacific Islander or Native Hawaiian | - | 3.8 | - |
Multiracial | 5.2 | 3.8 | - |
Other | 2.6 | - | - |
Fitzpatrick Skin Type, n (%) | |||
I-III | 24 (31.2) | 8 (30.8) | 32 (31.1) |
IV-VI | 53 (68.8) | 18 (69.2) | 71 (68.9) |
PsO disease duration, years, mean (SD) | 14.9 (11.04) | 14.9 (8.78) | 14.9 (10.47) |
PASI (0-72), mean (SD) | 21.2 (9.86) | 19.8 (6.17) | 20.8 (9.07) |
IGA, n (%) | |||
Moderate (3) | 57 (74.0) | 21 (80.8) | 78 (75.7) |
Severe (4) | 20 (26.0) | 5 (19.2) | 25 (24.3) |
BSA, %, mean (SD) | 27.0 (20.42) | 26.1 (15.90) | 26.8 (19.31) |
PSSD Symptom Score (0-100), mean (SD) | 66.1 (25.03) | 61.8 (26.99) | 65.0 (25.48) |
PSSD Itch Score (0-10), mean (SD) | 7.5 (2.15) | 7.6 (2.27) | 7.5 (2.17) |
Previous Treatments, n (%) | |||
Topical agents | 61 (79.2) | 19 (73.1) | 80 (77.7) |
Phototherapya | 14 (18.2) | 6 (23.1) | 20 (19.4) |
Nonbiologic systemicsb | 12 (15.6) | 6 (23.1) | 18 (17.5) |
Biologicsc | 22 (28.6) | 8 (30.8) | 30 (29.1) |
Abbreviations: BMI, body mass index; BSA, body surface area; IGA, investigator’s global assessment; PASI, psoriasis area and severity index; PsO, plaque psoriasis; PSSD, psoriasis symptoms and signs diary; PUVA, Psoralen plus ultraviolet A; UVB, ultraviolet B. aIncludes PUVA or UVB. bIncludes PUVA, methotrexate, cyclosporine, acitretin. cIncludes etanercept, infliximab, adalimumab, certolizumab, brodalumab, ixekizumab, secukinumab, ustekinumab. |
Week 16
TREMFYA | Placebo | |
---|---|---|
n=77 | n=26 | |
Patients who achieved IGA 0, % | 32.5; P<0.001 | 0 |
Patients who achieved PASI 100,a % | 29.9; P<0.01 | 0 |
n=76 | n=26 | |
Improvement from baseline (LS Mean) PASI,b % | 84.5; P<0.001 | 8.3 |
Change from baseline (LS Mean) PSSD Symptom Scoreb | -49.4; P<0.001 | -8.2 |
Change from baseline (LS Mean) PSSD Itch Scoreb | -4.7; P<0.001 | -0.7 |
n=75 | n=26 | |
Improvement from baseline (LS Mean) BSA,b % | 77.9; P<0.001 | 0.9 |
Abbreviations: CMH, Cochran-Mantel-Haenszel; BSA, body surface area; IGA, investigator’s global assessment; LS, least square; MMRM, Mixed-Effect Model Repeated Measures; PASI, psoriasis area and severity index; PsO, psoriasis; PSSD, psoriasis symptoms and signs diary. aP-values are based on CMH test stratified by Fitzpatrick Skin Type (I-III/ IV-VI). Non-responder imputation was used; patients who discontinued study agent due to lack of efficacy, worsening of PsO, or use of a prohibited PsO treatment prior to week 16, and patients with missing data were considered non-responders. bLS Means and p-value were based on MMRM. Zero change was assigned after patients discontinued study agent due to lack of efficacy/worsening of PsO or initiated a prohibited PsO treatment. Missing data was handled by MMRM under missing at random assumption. |
TREMFYA | Placebo | |
---|---|---|
Improvement from baseline (LS Mean) PSSI,b % | n=56 | n=20 |
Week 4 | 53.8; P<0.01 | 12.3 |
Week 12 | 71.6; P<0.01 | 20.7 |
Week 16 | 81.0; P<0.001 | 12.1 |
Patients who achieved ss-IGA 0,c % | n=57 | n=20 |
Week 4 | 26.3; P<0.01 | 0 |
Week 12 | 61.4; P<0.001 | 10.0 |
Week 16 | 71.9; P<0.001 | 10.0 |
Patients who achieved ss-IGA 0/1,c % | n=57 | n=20 |
Week 4 | 50.9; P<0.001 | 5.0 |
Week 12 | 73.7; P<0.001 | 15.0 |
Week 16 | 84.2; P<0.001 | 20.0 |
n=57 | n=20 | |
Mean SSA at Week 16, % | 3.1 | 17.9 |
Change from baseline (LS Mean) SSAb | -29.8; P<0.001 | -14.2 |
Change from baseline (LS Mean) Scalp Itch NRS Score at Week 16d | -4.3; P<0.001 | -1.3 |
Abbreviations: ANCOVA, Analysis of Covariance; CMH, Cochran-Mantel-Haenszel; LS, least square; MMRM, Mixed-Effect Model Repeated Measures; NRS, numeric rating scale; PsO, psoriasis; PSSI, psoriasis scalp severity index; SSA, scalp surface area; ss-IGA, scalp specific investigator’s global assessment ass-IGA≥2. bLS Means and P-value were based on MMRM. Zero change was assigned after patients discontinued study agent due to lack of efficacy/worsening of PsO or initiated a prohibited PsO treatment. Missing data was handled by MMRM under missing at random assumption. cP-values are based on CMH test stratified by Fitzpatrick Skin Type (I-III/ IV-VI). Non-responder imputation was used; participants who discontinued study agent due to lack of efficacy, worsening of PsO, or use of a prohibited PsO treatment prior to week 16 were considered non-responders. Participants with missing data were considered non-responders. dLS Means and P-value were based on ANCOVA. Zero change was assigned after participants discontinued study agent due to lack of efficacy/worsening of psoriasis or initiated a prohibited psoriasis treatment. Missing data were not explicitly imputed. |
Week 48
TREMFYA (n=76) | Placebo (n=26) | Total (N=102) | |
---|---|---|---|
Age, years, mean (SD) | 42.9 (13.9) | 41.1 (13.1) | 42.5 (13.6) |
Male, n (%) | 40 (52.6) | 18 (69.2) | 58 (56.9) |
BMI, kg/m2, mean (SD) | 31.6 (8.2) | 28.3 (6.3) | 30.8 (7.9) |
Fitzpatrick Skin Type, n (%) | |||
I-III | 28 (36.8) | 10 (38.5) | 38 (37.3) |
IV-VI | 48 (63.2) | 16 (61.5) | 64 (62.7) |
Race/Ethnicity Composition, % | |||
Hispanic or Latino | 40.8 | 30.8 | - |
Asian | 35.5 | 46.2 | - |
Black | 10.5 | 11.5 | - |
Middle Eastern | 5.3 | 3.8 | - |
Multiracial | 5.3 | 7.7 | - |
American Indian or Alaska Native | 1.3 | - | - |
Other | 1.3 | - | - |
PsO disease duration, years, mean (SD) | 11.3 (9.8) | 11.3 (12.8) | 11.3 (10.6) |
ss-IGA, n (%) | |||
Moderate (3) | 64 (84.2) | 20 (76.9) | 84 (82.4) |
Severe (4) | 12 (15.8) | 6 (23.1) | 18 (17.6) |
PSSI (0-72), mean (SD) | 34.4 (13.7) | 34.0 (11.8) | 34.3 (13.2) |
SSA, %, mean (SD) | 60.8 (27.1) | 56.6 (22.4) | 59.8 (26.0) |
IGA, n (%) | |||
Minimal (1) | 1 (1.3) | 0 | 1 (1.0) |
Mild (2) | 3 (3.9) | 0 | 3 (2.9) |
Moderate (3) | 60 (78.9) | 19 (73.1) | 79 (77.5) |
Severe (4) | 12 (15.8) | 7 (26.9) | 19 (18.6) |
PASI (0-72), mean (SD) | 13.7 (9.6) | 17.1 (8.2) | 14.6 (9.3) |
BSA, %, mean (SD) | 15.7 (15.0) | 19.1 (12.1) | 16.6 (14.4) |
Abbreviations: BMI, body mass index; BSA, body surface area; IGA, investigator’s global assessment; PASI, psoriasis area and severity index; PsO, plaque psoriasis; PSSD, psoriasis symptoms and signs diary; PSSI, psoriasis scalp severity index; ss-IGA, scalp-specific investigator’s global assessment; SSA, scalp surface area. |
Week 16
TREMFYA | Placebo | |
---|---|---|
n=75 | n=25 | |
Improvement from baseline (LS Mean) PSSI,a % | 87.6; P<0.001 | 37.8 |
n=76 | n=26 | |
Patients who achieved ss-IGA 0,b % | 57.9; P<0.001 | 3.8 |
Patients who achieved PSSI 100,b % | 59.2; P<0.001 | 3.8 |
n=75 | n=23 | |
Improvement from baseline (LS Mean) SSA,a % | 86.6; P<0.001 | 33.4 |
Abbreviations: BSA, body surface area; CMH, Cochran-Mantel-Haenszel; DLQI, dermatology life quality index; IGA, investigator’s global assessment; LS, least square; MMRM, Mixed-Effect Model Repeated Measures; PASI, psoriasis area and severity index; PsO, psoriasis; PSSD, psoriasis symptoms and signs diary. aLS Means and p-value were based on MMRM. Zero change was assigned for patients who discontinued study agent due to lack of efficacy, worsening of PsO or initiated a prohibited PsO treatment prior to week 16. Missing data was handled by MMRM under missing at random assumption. bP-values are based on CMH test stratified by Fitzpatrick Skin Type (I-III/ IV-VI). Non-responder imputation was used; patients who discontinued study agent due to lack of efficacy, worsening of PsO, or use of a prohibited PsO treatment prior to week 16, and patients with missing data were considered non-responders. |
Week 48
Cohort A – Week 16
Cohort B – Week 16
Pooled Analysis (Cohort A and Cohort B) - Placebo→TREMFYA Crossover (Weeks 16-48) 8
Pooled Analysis (Cohort A and Cohort B) - TREMFYA (Weeks 0-48)
A literature search of MEDLINE®
1 | Janssen Research & Development, LLC. Study of guselkumab in skin of color participants with moderate-to-severe plaque and/or scalp psoriasis (VISIBLE). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). https://clinicaltrials.gov/study/NCT05272150 Accessed January 25, 2024. |
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