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(guselkumab)

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TREMFYA® (guselkumab)
Medical Information

TREMFYA - Efficacy Outcomes by Weight in Adult Patients with Plaque Psoriasis or Psoriatic Arthritis

Last Updated: 12/23/2025

SUMMARY

  • The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling. Please refer to the local labeling for relevant information.
  • Pooled VOYAGE 1 and VOYAGE 2 data from a subpopulation of patients defined by body weight and/or body mass index (BMI) at weeks 16, 24, 28, and 156 were measured.1-3
  • Reich et al (2022) conducted a post hoc analysis of pooled VOYAGE 1 and VOYAGE 2 data to describe baseline characteristics of weight and BMI in patients treated with TREMFYA who achieved a super response (SR) status.4
  • Constanza et al (2021) performed a post hoc analysis of the 5-year (252 week) VOYAGE 1 data to evaluate the baseline characteristics, including BMI, of patients achieving complete skin clearance Psoriasis Area and Severity Index (PASI) score of 0 for ≥156 consecutive weeks of TREMFYA treatment.5
  • Blauvelt et al (2022) showed the efficacy of TREMFYA vs secukinumab (SEC) in patients with moderate to severe plaque psoriasis (PsO), defined by subpopulations, including baseline body weight and BMI in the ECLIPSE study.6
  • Ritchlin et al (2022) conducted a post hoc analysis to evaluate the efficacy of TREMFYA through 52 weeks in subgroups of patients with psoriatic arthritis (PsA) pooled from the DISCOVER-1 and DISCOVER-2 studies.7
  • Ritchlin et al (2024) conducted a post hoc analysis of the DISCOVER-2 study to assess the efficacy of TREMFYA in Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-recommended domains across diverse baseline characteristics, including BMI, through week 100.8
  • McInnes et al (2022) conducted a post hoc analysis of the COSMOS study to assess the maintenance of TREMFYA response across disease domains through 1 year in patients with PsA and an inadequate response to tumor necrosis factor (TNF) inhibitors, defined by subgroups, including BMI.9
  • Safety outcomes by weight were not summarized because the studies either did not report safety outcomes or conclude that safety outcomes were similar to previous studies (ie, VOYAGE 1, VOYAGE 2, ECLIPSE, DISCOVER-1, DISCOVER-2, and COSMOS).1-9

CLINICAL DATA - plaque psoriasis

VOYAGE 1 and VOYAGE 2

Papp et al (2018)1 and Gordon et al (2018)2 reported results from a pooled subgroup analysis of VOYAGE 1 and VOYAGE 2 patients defined by body weight and BMI.

Methods

  • In VOYAGE 1 and VOYAGE 2, patients with plaque PsO were randomized 2:1:2 into TREMFYA 100 mg at weeks 0, 4, 12, and 20; placebo (PBO) at weeks 0, 4, and 12 followed by TREMFYA 100 mg at weeks 16 and 20; and adalimumab (ADA) 80 mg at week 0, 40 mg at week 1, and then every 2 weeks (Q2W) through week 23.
  • Coprimary endpoints were the proportions of patients treated with TREMFYA:
    • Compared to PBO achieving ≥90% improvement in PASI score (PASI 90) at week 16
    • Compared to PBO and ADA achieving Investigator’s Global Assessment (IGA 0/1 [cleared or minimal]) responses at week 16
  • Secondary endpoints were the proportions of patients treated with TREMFYA:
    • Compared to PBO and ADA achieving IGA 0/1 (cleared or minimal) responses at week 24
    • Compared to PBO and ADA achieving IGA 0 responses at week 24
    • Compared to ADA achieving PASI 90 at week 24
  • Response rates across endpoints were evaluated for predetermined subgroups such as:
    • Baseline weight (kg): ≤90, >90
    • Baseline BMI (kg/m2): normal (<25), overweight (≥25 to <30), obese (≥30)
    • Baseline weight quartiles (kg): <74.6, ≥74.6 to <86.4, ≥86.4 to <100, ≥100

Results


Pooled Baseline Demographics by Weight and BMI from VOYAGE 1 and VOYAGE 22
Characteristics
PBO
TREMFYA
ADA
Total
Patients randomized at week 0, n
422
825
582
1829
Baseline weighta
   Mean±SD, kg
88.4±21.9
89.3±20.5
89.2±21.5
89.1±21.2
   Median, kg
84.5
87.5
86.0
86.4
   ≤90 kg, n (%)
252 (59.7)
466 (56.5)
344 (59.3)
1062 (58.1)
   >90 kg, n (%)
170 (40.3)
 359 (43.5)
236 (40.7)
 765 (41.9)
Baseline BMIa
   Mean±SD, kg/m2
29.3±6.7
29.7±6.4
29.7±6.5
29.6±6.5
   Median, kg/m2
28.1
28.6
28.4
28.4
   Normal (<25), n (%)
111 (26.3)
184 (22.3)
140 (24.1)
435 (23.8)
   Overweight (25 to <30), n (%)
151 (35.8)
 308 (37.3)
198 (34.1)
657 (36.0)
   Obese (≥30), n (%)
160 (37.9)
 333 (40.4)
242 (41.7)
735 (40.2)
Abbreviations: ADA, adalimumab; BMI, body mass index; PBO, placebo; SD, standard deviation.
aBecause of missing data for weight and BMI in the ADA group n=580 and total n=1827.

Pooled VOYAGE 1 and VOYAGE 2 Subgroup Analysis Providing the Proportion of Patients at Weeks 16 and 24 that Achieved an IGA Score of 0/1 or IGA 0 by Weight1,2
 
Week 16: IGA 0/1
Week 24: IGA 0/1
Week 24: IGA 0
PBO
TREMFYA
100 mg
ADA
40 mg
TREMFYA
100 mg
ADA
40 mg
TREMFYA
100 mg
ADA
40 mg
All patients, n (%)
422
(7.8)
825 (84.5)
582 (66.7)
825 (83.8)
582 (63.1)
825 (52.1)
582 (30.2)
Baseline weight, n (%)
   ≤90 kg
252 (11.1)
466 (88.0)
344 (74.1)
466 (86.5)
344 (72.4)
466 (57.3)
344 (38.4)
   >90 kg
170
(2.9)
359 (79.9)
236 (56.4)
359 (80.2)
236 (50.0)
359 (45.4)
236 (18.6)
Baseline weight by quartile, n (%)
   <74.6 kg
121 (11.6)
192 (89.1)
141 (73.8)
192 (85.9)
141 (70.9)
192 (60.4)
141 (41.1)
   ≥74.6 to
   <86.4 kg
105 (10.5)
201 (88.6)
153 (75.8)
201 (88.1)
153 (76.5)
201 (57.2)
153 (34.0)
   ≥86.4 to
   <100 kg
82
(4.9)
225 (78.7)
131 (67.2)
225 (83.1)
131 (61.1)
225 (48.0)
131 (30.5)
   ≥100 kg
114
(3.5)
207 (82.6)
155 (51.6)
207 (78.3)
155 (45.2)
207 (44.0)
155 (16.8)
Baseline BMI, n (%)
   Normal
   (<25 kg/m2)
111 (11.7)
184 (91.3)
140 (79.3)
184 (87.5)
140 (78.6)
184 (64.1)
140 (43.6)
   Overweight
   (25 to
   <30 kg/m2)
151
(7.9)
308 (84.1)
198 (72.7)
308 (86.7)
198 (72.7)
308 (52.3)
198 (32.3)
   Obese
   (≥30 kg/m2)
160
(5.0)
333 (81.1)
242 (55.0)
333 (79.0)
242 (46.7)
333 (45.3)
242 (21.1)
Abbreviations: ADA, adalimumab; BMI, body mass index; IGA, Investigator’s Global Assessment; PBO, placebo.

Proportion of Patients in Pooled VOYAGE 1 and VOYAGE 2 Studies Achieving PASI 90 Across Weight Quartiles through Weeks 16 and 241
Week 16
Week 24
TREMFYA
100 mg
PBO
TREMFYA
100 mg
ADA
40 mg
Baseline weight quartiles, %
   <74.6 kg
76.0
5.0
79.7
62.4
   ≥74.6 to <86.4 kg
78.6
2.9
81.1
66.0
   ≥86.4 to <100 kg
66.2
1.2
75.1
52.7
   ≥100 kg
65.2
0.9
73.4
35.5
Abbreviations: ADA, adalimumab; PASI 90, 90% improvement in Psoriasis Area and Severity Index from baseline; PBO, placebo.

Blauvelt et al (2019)3 assessed the efficacy of TREMFYA for up to week 156 (3 years) across patient demographic subgroups, including those based on weight, from the pooled VOYAGE 1 and VOYAGE 2 studies.

Methods

  • In VOYAGE 1 and VOYAGE 2, patients with plaque PsO were randomized 2:1:2 into TREMFYA 100 mg at weeks 0, 4, 12, and then every 8 weeks (Q8W) thereafter; PBO at weeks 0, 4, and 12 followed by TREMFYA 100 mg at weeks 16 and 20 and then Q8W thereafter; and ADA 80 mg at week 0, 40 mg at week 1, and then Q2W through week 47 (VOYAGE 1) or week 23 (VOYAGE 2).
  • In VOYAGE 1, all patients received open-label TREMFYA 100 mg Q8W during weeks 52 to 156. VOYAGE 2 incorporated a randomized withdrawal study design, followed by open-label treatment with TREMFYA during weeks 76 to 156.
  • Data for patients receiving TREMFYA during the open-label period of VOYAGE 1 and VOYAGE 2 were combined in pooled analysis.
  • Treatment failure rules were applied for patients who discontinued due to any reason related to efficacy (loss of response, worsening of PsO, use of a prohibited PsO medication) as nonresponse.

Results


Proportion of Patients in Pooled VOYAGE 1 and VOYAGE 2 Subgroup Analysis Achieving IGA Score of 0/1 (Cleared or Minimal) Based on Weight through Week 1563
Week 100
(n=1103)
Week 156
(n=1042)
Patients receiving TREMFYA 100 mg, %
83.1
82.6
Weight, %
   ≤90 kg
86.9
88.0
   >90 kg  
78.0
75.4
Abbreviation: IGA, Investigator’s Global Assessment.

Reich et al (2022)4 conducted a post hoc analysis of pooled VOYAGE 1 and VOYAGE 2 data to describe baseline characteristics of weight and BMI in TREMFYA-treated patients achieving an SR status (100% improvement in the Psoriasis Area and Severity Index [PASI 100] at weeks 20 and 28).

Methods

  • VOYAGE 1 and VOYAGE 2 had identical study designs up to week 28.
    • In VOYAGE 1, the ADA group received ADA 40 mg Q2W through week 28.
    • In VOYAGE 2, the ADA group received ADA 40 mg Q2W through week 23 and then received no study drug until week 28.
  • Patients with an SR status were defined as those who received TREMFYA and achieved a PASI 100 (absolute PASI=0) response at weeks 20 and 28.
  • In addition to patients not achieving PASI 100 at weeks 20 and 28, nonsuper response (nSR) status also included patients who met treatment failure rules and those missing efficacy data.
  • Pooled VOYAGE 1 and VOYAGE 2 data compared baseline demographic profiles such as weight and BMI of TREMFYA-treated patients who achieved a SR vs nSR status.
  • Stepwise logistic regression analysis was performed to determine which factors were predictive of SR status.

Results


Proportion of Patients in Pooled VOYAGE 1 and VOYAGE 2 Studies Achieving Super-Response Based on Baseline Body Weight and BMI4
Treated with TREMFYA 100 mg
(N=664)
Achieved SR
(n=271)
Did Not Achieve SR (nSR)
(n=393)
Median body weight (IQR) [range], kg
84.8 (73.0 to 97.5)
[48 to 163]
90.0 (76.9 to 102.2)
[45 to 167]
   ≤90 kg, n (%)
169 (62.4)
202 (51.4)
   >90 kg, n (%)
102 (37.6)
191 (48.6)
Median BMI, kg/m2
27.8
29.1
   Normal (<25 kg/m2), n (%)
79 (29.2)
79 (20.1)
   Overweight (25 to <30 kg/m2), n (%)
96 (35.4)
136 (34.6)
   Obese (≥30 kg/m2), n (%)
96 (35.4)
178 (45.3)
Abbreviations: BMI, body mass index; IQR, interquartile range; nSR, nonsuper response; SR, super response.
  • Baseline body weight (≤90 kg vs >90 kg) was one of the few factors that suggested it was a significant predictor of SR status with an odds ratio (95% CI) of 1.42 (1.026-1.977, P=0.034).

VOYAGE 1

Constanza et al (2021)5 performed a post hoc analysis of 5-year (252 week) VOYAGE 1 data to evaluate the baseline characteristics, including BMI, of patients achieving a complete skin clearance PASI score of 0 for ≥156 consecutive weeks of treatment with TREMFYA.

Methods

  • VOYAGE 1 data from weeks 0 to 252 were included in this analysis.
  • Baseline demographics of TREMFYA-treated patients maintaining PASI=0 (complete skin clearance) for ≥156 consecutive weeks were compared to patients who never achieved PASI=0 (comparator group), utilizing descriptive statistics.

Results

  • There were 112 and 79 patients in the PASI=0 and the comparator groups, respectively.
  • Mean baseline BMI (95% CI):
    • PASI=0 group: 28.5 (27.3, 29.7) kg/m2
    • Comparator group: 30.2 (28.7, 31.7) kg/m2
  • Proportion of obese patients (BMI ≥30 kg/m2):
    • PASI=0 group: 32.1%
    • Comparator group: 48.1%

ECLIPSE

Blauvelt et al (2022)6 showed the efficacy of TREMFYA vs SEC in subpopulations, including baseline body weight and BMI, of patients with moderate to severe plaque PsO from the ECLIPSE study.

Methods

  • In the ECLIPSE study, patients with plaque PsO were randomized 1:1 to receive TREMFYA 100 mg subcutaneously (SC) at weeks 0, 4, 12 and Q8W thereafter or SEC 300 mg SC in two 150 mg injections at weeks 0, 1, 2, 3, 4, and every 4 weeks (Q4W) thereafter through week 44.
  • Efficacy endpoints for the subgroup analysis included the proportion of TREMFYA-treated patients achieving PASI 90, PASI 100, IGA 0/1, and IGA 0 at week 48 compared to the SEC group.
  • Efficacy was analyzed in baseline subpopulations, including body weight and BMI, using descriptive statistics.
  • Analyses of PASI 90 and PASI 100 at week 48 by baseline body weight were post hoc analyses.

Results


Baseline Demographics by Body Weight and BMI and Disease Characteristics in ECLIPSE Study6
TREMFYA 100 mg
SEC 300 mg
Total
Patients analyzed, N
534
514
1048
Weight, N
534
512
1046
   ≤60 kg, n (%)
40 (7.5)
26 (5.1)
66 (6.3)
   >60 to 70 kg, n (%)
67 (12.5)
55 (10.7)
122 (11.7)
   >70 to 80 kg, n (%)
92 (17.2)
92 (18.0)
184 (17.6)
   >80 to 90 kg, n (%)
98 (18.4)
119 (23.2)
217 (20.7)
   >90 to 100 kg, n (%)
97 (18.2)
96 (18.8)
193 (18.5)
   >100 to 110 kg, n (%)
61 (11.4)
63 (12.3)
124 (11.9)
   >110 kg, n (%)
79 (14.8)
61 (11.9)
140 (13.4)
BMI, kg/m2, N
533
511
1044
   Mean (SD)
29.8 (7.10)
30.0 (6.33)
29.9 (6.73)
   Median (IQR)
28.4 (25.0; 33.4)
29.2 (25.5; 33.6)
28.8 (25.1; 33.6)
   Normal (<25 kg/m2), n (%)
134 (25.1)
109 (21.3)
243 (23.3)
   Overweight (25 to <30 kg/m2),
   n (%)
176 (33.0)
177 (34.6)
353 (33.8)
   Obese (≥30 kg/m2), n (%)
223 (41.8)
225 (44.0)
448 (42.9)
Abbreviations: BMI, body mass index; IQR, interquartile range; SD, standard deviation; SEC, secukinumab.

Proportion of Patients in ECLIPSE Study Achieving PASI 90, PASI 100, IGA 0/1, and IGA 0 Based on Baseline Body Weight at Week 486
PASI 90a
PASI 100a
IGA 0/1
IGA 0
TREMFYA 100 mg
SEC 300 mg
TREMFYA 100 mg
SEC 300 mg
TREMFYA 100 mg
SEC 300 mg
TREMFYA 100 mg
SEC 300 mg
Baseline weight, %
   ≤60 kg
85.0
69.2
50.0
46.2
77.5
76.9
52.5
50.0
   >60 to
   70 kg
86.8
74.5
64.2
58.2
85.1
74.5
65.7
60.0
   >70 to
   80 kg
89.1
77.2
65.2
57.6
90.2
79.3
68.5
59.8
   >80 to
   90 kg
89.8
72.3
64.3
46.2
91.8
79.8
71.4
48.7
   >90 to
   100 kg
76.3
70.8
56.7
51.0
79.4
81.3
57.7
53.1
   >100 to
   110 kg
82.0
66.7
57.4
44.4
78.7
69.8
62.3
44.4
   >110 kg
82.3
55.7
44.3
32.8
86.1
55.7
50.6
34.4
Abbreviations: IGA, Investigator’s Global Assessment; PASI 100, 100% improvement in Psoriasis Area and Severity Index; PASI 90, 90% improvement in Psoriasis Area and Severity Index from baseline; SEC, secukinumab.
aThe analyses of PASI 90 and PASI 100 at week 48 by baseline body weight were post hoc analyses.

Proportion of Patients in ECLIPSE Study Achieving PASI 90, PASI 100, IGA 0/1, and IGA 0 Based on BMI at Week 486
PASI 90
PASI 100
IGA 0/1
IGA 0
TREMFYA 100
mg
SEC 300
mg
TREMFYA 100
mg
SEC
300
mg
TREMFYA 100
mg
SEC
300
mg
TREMFYA 100
mg
SEC 300 mg
Baseline BMI, %
   Normal
   (<25 kg/m2)
88.1
75.2
64.2
57.8
85.8
77.1
68.7
60.6
   Overweight
   (≥25 to
   <30 kg/m2)
84.1
73.4
61.4
53.7
86.9
81.9
64.2
54.2
   Obese
   (≥30 kg/m2)
82.5
65.3
52.5
40.4
83.0
69.3
57.0
43.1
Abbreviations: BMI, body mass index; IGA, Investigators Global Assessment; PASI 100, 100% improvement in Psoriasis Area and Severity Index; PASI 90, 90% improvement in Psoriasis Area and Severity Index from baseline; SEC, secukinumab.

CLINICAL DATA - PSORIATIC ARTHRITIS

DISCOVER-1 and DISCOVER-2

Ritchlin et al (2022)7 conducted a post hoc analyses to evaluate the efficacy of TREMFYA through 52 weeks in subgroups of PsA patients from the DISCOVER-1 and DISCOVER-2 studies.

Methods

  • Adults with a diagnosis of active PsA for ≥6 months per ClASsification Criteria for
  • Psoriatic ARthritis (CASPAR) and who had an inadequate response to standard therapies were enrolled into DISCOVER-1 (swollen joint count [SJC], ≥3; tender joint count [TJC], ≥3; and C-reactive protein [CRP], ≥0.3 mg/ dL) and DISCOVER-2 (SJC ≥5, TJC ≥5, CRP ≥0.6 mg/dL, and biologic-naïve). Stable doses of select nonbiologic disease-modifying antirheumatic drugs (DMARDs), low dose oral corticosteroids, or non-steroidal anti-inflammatory drugs (NSAIDs) were permitted.
  • Patients were randomized 1:1:1 to receive SC injections of TREMFYA 100 mg at weeks 0, 4 and then Q4W; TREMFYA 100 mg at weeks 0, 4, and then Q8W; or PBO Q4W with crossover to TREMFYA Q4W at week 24. Treatment continued through weeks 48 and 100 for DISCOVER-1 and DISCOVER-2, respectively.
  • Efficacy endpoints were measured at weeks 24 and 52:
    • Proportion of patients achieving an improvement of ≥20%/50%/70% in American College of Rheumatology (ACR) criteria (ACR20/50/70)
    • An improvement of ≥4-point from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score
    • PsA Disease Activity Score (PASDAS) 30 ≤3.2, indicative of low disease activity (LDA)
    • An IGA score of 0 (clear) or 1 (minimal) and ≥2-grade reduction from baseline, or an IGA score of 0 among patients with a baseline body surface area (BSA) of ≥3% who had PsO and IGA score of ≥2
    • An improvement of ≥0.35-point from baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) 29 score among patients with a baseline HAQ-DI score ≥0.35
    • Minimal disease activity (MDA)
  • Efficacy endpoint results were stratified by patient sex, BMI, SJC and TJC, PsA duration, CRP level, and conventional-synthetic nonbiologic disease-modifying antirheumatic drugs (csDMARDs) use at baseline.

Results by BMI


Proportion of Patients Achieving Joint and Skin Clearance Responses, Patient Reported Outcomes, and Composite Measures of Disease Activity at Weeks 24 and 52 Between TREMFYA Treatments and PBO Defined by Baseline BMI7
Week 24
Week 52
PBO
TREMFYA 100 mg Q4W
TREMFYA 100 mg Q8W
PBO →
TREMFYA 100 mg Q4W
TREMFYA 100 mg Q4W
TREMFYA 100 mg Q8W
ACR20a
All patients, n (%)
109 (29)
232 (62)
225 (60)
229 (62)
267 (72)
261 (70)
BMI (kg/m2), n (%)
   <25
34 (37)
65 (71)
59 (58)
57 (61)
69 (75)
70 (69)
   ≥25 to <30
34 (26)
74 (60)
76 (58)
84 (63)
92 (75)
93 (72)
   ≥30
41 (28)
93 (59)
90 (63)
88 (60)
106 (67)
98 (68)
ACR50b
All patients, n (%)
46 (12)
127 (34)
116 (31)
139 (37)
181 (48)
169 (45)
BMI (kg/m2), n (%)
   <25
12 (13)
36 (39)
33 (33)
36 (39)
45 (49)
46 (46)
   ≥25 to <30
20 (15)
42 (34)
43 (33)
53 (40)
65 (53)
59 (45)
   ≥30
14 (10)
49 (31)
40 (28)
50 (34)
71 (45)
64 (44)
ACR70c
All patients, n (%)
17 (5)
58 (16)
61 (16)
64 (17)
101 (27)
102 (27)
BMI (kg/m2), n (%)
   <25
4 (4)
21 (23)
17 (17)
18 (19)
30 (33)
27 (27)
   ≥25 to <30
9 (7)
19 (15)
26 (20)
25 (19)
36 (29)
39 (30)
   ≥30
4 (3)
18 (11)
18 (12)
21 (14)
35 (22)
36 (25)
FACIT-Fd
All patients, n (%)
156 (42)
227 (61)
218 (58)
223 (60)
236 (63)
233 (62)
BMI (kg/m2), n (%)
   <25
41 (44)
57 (62)
65 (64)
51 (55)
60 (65)
71 (70)
   ≥25 to <30
59 (44)
76 (62)
74 (57)
79 (59)
78 (63)
77 (59)
   ≥30
56 (38)
94 (60)
79 (55)
93 (64)
98 (62)
85 (59)
PASDAS LDAe
All patients, n (%)
33 (9)
104 (28)
113 (30)
137 (37)
169 (45)
157 (42)
BMI (kg/m2), n (%)
   <25
8 (9)
27 (29)
30 (30)
36 (39)
44 (48)
41 (41)
   ≥25 to <30
15 (11)
35 (28)
42 (32)
54 (41)
58 (47)
62 (48)
   ≥30
10 (7)
42 (27)
41 (28)
47 (32)
67 (42)
54 (38)
IGA 0/1f
All patients, n (%)
47 (18)
193 (71)
171 (66)
198 (76)
219 (80)
183 (71)
BMI (kg/m2), n (%)
   <25
13 (19)
46 (71)
46 (68)
53 (79)
53 (82)
48 (71)
   ≥25 to <30
17 (18)
62 (71)
60 (68)
71 (76)
71 (82)
66 (75)
   ≥30
17 (17)
85 (70)
65 (64)
74 (74)
95 (78)
69 (68)
IGA 0g
All patients, n (%)
20 (8)
141 (52)
119 (46)
158 (60)
174 (64)
142 (55)
BMI (kg/m2), n (%)
   <25
5 (8)
31 (48)
33 (48)
43 (64)
40 (62)
38 (56)
   ≥25 to <30
8 (8)
52 (60)
44 (50)
56 (60)
64 (74)
48 (54)
   ≥30
7 (7)
58 (48)
42 (41)
59 (59)
70 (58)
56 (55)
HAQ-DIh
All patients, n (%)
106 (31)
191 (56)
171 (50)
162 (47)
208 (62)
189 (56)
BMI (kg/m2), n (%)
   <25
31 (36)
52 (63)
47 (51)
46 (53)
58 (70)
49 (53)
   ≥25 to <30
39 (32)
62 (55)
57 (50)
61 (50)
67 (60)
65 (58)
   ≥30
36 (26)
77 (54)
67 (50)
55 (40)
83 (58)
75 (56)
MDAi
All patients, n (%)
29 (8)
85 (23)
91 (24)
105 (28)
134 (36)
115 (31)
BMI (kg/m2), n (%)
   <25
7 (8)
23 (25)
25 (25)
29 (31)
34 (37)
33 (33)
   ≥25 to <30
12 (9)
28 (23)
38 (29)
39 (29)
47 (38)
43 (33)
   ≥30
10 (7)
34 (22)
28 (19)
37 (25)
53 (34)
39 (27)
Abbreviations: ACR20/50/70, American College of Rheumatology 20/50/70% improvement; BMI, body mass index; BSA, body surface area; CRP, C-reactive protein; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; HAQ-DI, Health Assessment Questionnaire Disability Index; IGA, Investigator’s Global Assessment; LDA, low disease activity; MDA, minimal disease activity; PASDAS, PsA Disease Activity Score; PASI, Psoriasis Area and Severity Index; PBO, placebo; PsA, psoriatic arthritis; Q4W/Q8W, every 4 weeks/every 8 weeks.
a,b,c≥20%, ≥50%, and ≥70%, respectively, improvement from baseline in both tender joint count (68 joints) and swollen joint count (66 joints), and ≥20%, ≥50%, and ≥70%, respectively, improvement from baseline in at least 3 of the 5 assessments: patient’s assessment of pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, HAQ-DI, and CRP.
dAn improvement of ≥4-point in FACIT-F score from baseline. The FACIT-F score is calculated based on the FACIT-F questionnaire that comprises of 13 questions, with each question graded on a 5-point scale (0-4).  The FACIT-F scores can range from 0 to 52 with higher scores indicating less fatigue.
ePASDAS score ≤3.2. The PASDAS score is calculated from a combination of the tender and swollen joint counts, Physical Component Summary Short Form-36 score, physician’s global assessment of disease activity, patient’s global assessment of disease activity (arthritis and psoriasis), enthesitis, dactylitis count, and CRP.
fIGA psoriasis score of 0 (cleared) or 1 (minimal) and ≥2-grade reduction from baseline in the IGA psoriasis score among patients with ≥3% BSA with psoriasis & IGA ≥2 at baseline.
gIGA psoriasis score of 0 and ≥2-grade reduction from baseline in the IGA psoriasis score among patients with ≥3% BSA with psoriasis and IGA ≥2 at baseline.
hAn improvement of ≥0.35-point in HAQ-DI score from baseline among patients with a HAQ-DI score ≥0.35 at baseline. The score is the average of the computed categories scores (dressing, arising, eating, walking, hygiene, gripping, and daily living). Lower scores are indicative of better functioning.
i5/7 MDA criteria are met (tender joint count ≤1, swollen joint count ≤1, PASI ≤1, patient’s assessment of pain ≤15, patient’s global assessment of disease activity ≤20, HAQ-DI score ≤ 0.5, tender entheseal points ≤1).

DISCOVER-2

Ritchlin et al (2024)8 conducted a post hoc analysis to assess the efficacy of TREMFYA in GRAPPA-recommended domains across diverse baseline characteristics from the DISCOVER-2 study.

Methods

  • Adults who were biologic naïve with active PsA were enrolled in DISCOVER-2 (SJC ≥5; TJC ≥5; CRP ≥0.6 mg/dL).
  • Patients were randomized 1:1:1 to receive TREMFYA 100 mg Q4W (n=245); TREMFYA 100 mg at weeks 0 and 4 and then Q8W (n=248); or PBO crossover to TREMFYA Q4W at week 24 (n=246). Treatment was continued through week 100.
  • The following efficacy endpoints were measured at weeks 24, 52, and 100:
    • Proportion of patients who achieved ACR50/70
    • FACIT-F (≥4-point improvement from baseline)
    • PASDAS LDA
    • IGA score of 0 (clear) among patients with ≥3% BSA affected by PsO and an IGA score of ≥2 at baseline
    • HAQ-DI (≥0.35-point improvement from baseline)
    • MDA
    • Resolution of dactylitis among patients affected at baseline per the Dactylitis Severity Score (DSS)
    • Resolution of enthesitis among patients affected at baseline per the Leeds Enthesitis Index (LEI)
    • PASI 100
  • Efficacy endpoint results were stratified by patient sex, BMI, SJC and TJC, PsA duration, CRP level, BSA, PASI, concomitant csDMARD use, and concomitant methotrexate use at baseline.
  • Response rates at week 100 were determined using nonresponder imputation for data missing due to patient discontinuation.

Results by BMI


Proportion of Patients in the DISCOVER-2 Study Achieving ACR50, ACR70, FACIT-F,PASDAS LDA, IGA 0, HAQ-DI, MDA, and Dactylitis and Enthesitis Resolution Response Based on BMI at Week 100 (NRI)8
BMI (kg/m2), n (%)
TREMFYA 100 mg Q4W
TREMFYA 100 mg Q8W
ACR50
(n=245)
(n=248)
   <25
66 (57.6)
74 (60.8)
   ≥25 to <30
83 (57.8)
82 (54.9)
   ≥30
96 (53.1)
92 (50.0)
ACR70
   <25
66 (34.8)
74 (41.9)
   ≥25 to <30
83 (39.8)
82 (32.9)
   ≥30
96 (30.2)
92 (32.6)
(n=239)
(n=247)
FACIT-F (NRI)
   <25
65 (69.2)
74 (68.9)
   ≥25 to <30
81 (71.6)
82 (68.3)
   ≥30
93 (64.5)
91 (61.5)
(n=245)
(n=248)
PASDAS LDA
   <25
66 (50.0)
74 (51.4)
   ≥25 to <30
83 (51.8)
82 (53.7)
   ≥30
96 (52.1)
92 (43.5)
(n=184)
(n=176)
IGA 0
   <25
48 (66.7)
50 (48.0)
   ≥25 to <30
61 (70.5)
57 (56.1)
   ≥30
75 (52.0)
69 (59.4)
(n=228)
(n=228)
HAQ-DI (NRI)
   <25
61 (68.9)
70 (58.6)
   ≥25 to <30
78 (61.5)
74 (71.6)
   ≥30
89 (59.6)
84 (60.7)
(n=245)
(n=248)
MDAa
   <25
66 (37.9)
74 (41.9)
   ≥25 to <30
83 (42.2)
82 (41.5)
   ≥30
96 (35.4)
92 (38.0)
(n=184)
(n=176)
PASI 100
   <25
48 (60.4)
50 (48.0)
   ≥25 to <30
61 (68.9)
57 (54.4)
   ≥30
75 (50.7)
69 (56.5)
(n=121)
(n=111)
Dactylitis resolution
   <25
35 (68.6)
34 (79.4)
   ≥25 to <30
35 (65.7)
40 (82.5)
   ≥30
51 (78.4)
37 (86.5)
(n=170)
(n=158)
Enthesitis resolution
   <25
47 (66.0)
50 (68.0)
   ≥25 to <30
55 (69.1)
49 (85.7)
   ≥30
68 (52.9)
59 (57.6)
Abbreviations: ACR50/70, American College of Rheumatology 50/70% improvement; BMI, body mass index; FACIT, Functional Assessment of Chronic Illness Therapy; HAQ-DI, Health Assessment Questionnaire Disability Index; IGA, Investigator’s Global Assessment; LDA, low disease activity; MDA, minimal disease activity; NRI, nonresponder imputation; PASDAS, Psoriatic Arthritis Disease Activity Score; PASI, Psoriasis Area and Severity Index; PsO, psoriasis; Q4W/Q8W, every 4 weeks/every 8 weeks; VAS, visual analog scale.
aMDA is defined as the fulfillment of ≥5 of the 7 criteria: Tender and swollen joint counts ≤1, PASI ≤1, patient pain VAS ≤15, patient global disease activity VAS ≤20 (arthritis and PsO), HAQ-DI score ≤0.5, and/or ≤1 tender entheseal points.

COSMOS

McInnes et al (2022)9 conducted a post hoc analysis to evaluate the maintenance of response to TREMFYA across disease domains through 1 year in subgroups of patients with PsA who had an inadequate response to TNF inhibitors in the COSMOS study.

Methods

  • Select inclusion criteria: patients ≥18 years old with active PsA, SJC ≥3 and TJC ≥3, active or documented history of plaque PsO or current nail PsO, and an inadequate response or intolerance to 1-2 TNF inhibitors.10,11
  • The study comprised PBO-controlled (weeks 0-24) and active treatment (weeks 24-48) periods, with the final intervention at week 44.10
  • Patients were randomized 2:1 to receive either TREMFYA 100 mg SC or PBO SC at weeks 0 and 4 and Q8W thereafter through week 44.10
  • At week 16, patients from either group who experienced <5% improvement from baseline in both SJC and TJC were eligible for early escape (EE) to initiate/increase one of the permitted concomitant medications at the investigator’s discretion. Patients in the TREMFYA group continued the randomized treatment and received PBO at week 16 to maintain blinding, and patients in the PBO group who qualified for EE crossed over to TREMFYA.9,10
    • Patients who discontinued and/or met the EE criteria prior to week 24 were imputed as nonresponders.
    • At week 48, response rates were assessed for the sustainability of responses over time in each patient subgroup by imputing missing data as no response.
  • At week 24, all remaining randomized patients treated with PBO were crossed over to receive TREMFYA 100 mg at weeks 24, 28, 36, and 44.11
  • The primary endpoint was the proportion of patients who achieved an ACR20 response at week 24.10
  • The efficacy of TREMFYA in subgroups of patients with an inadequate response to TNF inhibitors was evaluated at weeks 24 and 48 using joint (ACR20/50 responses), skin (PASI 90/100 responses), and multidomain (MDA response) outcome measures.
    • Subgroups were defined by BMI, sex, SJC, TJC, PsA duration, proportion of BSA with PsO, and csDMARD use at baseline.
  • Safety was assessed through week 56.

Results by BMI


Proportion of Patients Achieving Joint, Skin, and MDA Responses at Weeks 24 and 48 Between TREMFYA Treatment and PBO Defined by Baseline BMI (NRI)9
n/N (%)
Week 24
Week 48
PBO
TREMFYA
100 mg Q8W
TREMFYA
100 mg Q8W
ACR20
All patients
27/96 (28)
95/189 (50)
109/189 (58)
BMI (kg/m2)
   <30
17/52 (33)
64/115 (56)
65/115 (57)
   ≥30
10/43 (23)
31/74 (42)
44/74 (59)
ACR50
All patients
8/96 (8)
43/189 (23)
74/189 (39)
BMI (kg/m2)
   <30
5/52 (10)
31/115 (27)
53/115 (46)
   ≥30
3/43 (7)
12/74 (16)
21/74 (28)
PASI 90a
All patients
6/53 (11)
77/133 (58)
89/133 (67)
BMI (kg/m2)
   <30
4/29 (14)
50/81 (62)
57/81 (70)
   ≥30
2/24 (8)
27/52 (52)
32/52 (62)
PASI 100a
All patients
4/53 (8)
47/133 (35)
71/133 (53)
BMI (kg/m2)
   <30
3/29 (10)
30/81 (37)
47/81 (58)
   ≥30
1/24 (4)
17/52 (33)
24/52 (46)
MDA
All patients
4/96 (4)
32/189 (17)
51/189 (27)
BMI (kg/m2)
   <30
3/52 (6)
23/115 (20)
39/115 (34)
   ≥30
1/43 (2)
9/74 (12)
12/74 (16)
Abbreviations: ACR20/50, American College of Rheumatology 20/50% improvement; BMI, body mass index; BSA, body surface area; IGA, Investigator’s Global Assessment; MDA, minimal disease activity; NRI, nonresponder imputation; PASI 90/100, ≥90%/100% improvement in Psoriasis Area and Severity Index; PBO, placebo; Q8W, every 8 weeks.
aPASI 90/100 was assessed in the subgroup of patients with ≥3% BSA psoriatic involvement and a mild IGA score of ≥2 at baseline (PBO, n=53; TREMFYA, n=133).

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 28 October 2025.

Data included in this response are from the following phase 3 clinical trials of TREMFYA in adult patients with plaque PsO or PsA: VOYAGE 1, VOYAGE 2, ECLIPSE, DISCOVER-1, DISCOVER-2, and COSMOS.

References

Show
1 Papp K, Crowley J, Rubel D, et al. Consistency of response by weight across subgroups of patients with psoriasis treated with guselkumab: results from the VOYAGE 1 and VOYAGE 2 trials [abstract]. J Am Acad Dermatol. 2018;79(3):AB87. Abstract 6729.  
2 Gordon KB, Blauvelt A, Foley P, et al. Efficacy of guselkumab in subpopulations of patients with moderate‐to‐severe plaque psoriasis: a pooled analysis of the phase III VOYAGE 1 and VOYAGE 2 studies. Br J Dermatol. 2018;178(1):132-139.  
3 Blauvelt A, Reich K, Spelman L, et al. Consistency of response maintained across demographic sub-groups of psoriasis patients treated with guselkumab for up to 3 years in the VOYAGE 1 and 2 trials [abstract]. J Am Acad Dermatol. 2019;81(4):AB38. Abstract 10072.  
4 Reich K, Gordon KB, Strober B, et al. Super-response to guselkumab treatment in patients with moderate-to-severe psoriasis: age, body weight, baseline Psoriasis Area and Severity Index, and baseline Investigator’s Global Assessment scores predict complete skin clearance. J Eur Acad Dermatol Venereol. 2022;36(12):2393-2400.  
5 Costanzo A, Conrad C, Gramiccia T, et al. Maintenance of complete skin clearance throughout 3 years of continuous guselkumab treatment in patients with moderate-to-severe psoriasis: a post hoc analysis of 5-year data from the VOYAGE 1 trial [abstract]. J Am Acad Dermatol. 2021;85(3):AB108. Abstract 26581.  
6 Blauvelt A, Armstrong AW, Langley RG, et al. Efficacy of guselkumab versus secukinumab in subpopulations of patients with moderate-to-severe plaque psoriasis: results from the ECLIPSE study. J Dermatolog Treat. 2022;33(4):2317-2324.  
7 Ritchlin CT, Mease PJ, Boehncke WH, et al. Sustained and improved guselkumab response in patients with active psoriatic arthritis regardless of baseline demographic and disease characteristics: pooled results through week 52 of two phase III, randomised, placebo-controlled studies. RMD Open. 2022;8(1):e002195.  
8 Ritchlin CT, Mease PJ, Boehncke WH, et al. Durable control of psoriatic arthritis with guselkumab across domains and patient characteristics: post hoc analysis of a phase 3 study. Clin Rheumatol. 2024;43(8):2551-2563.  
9 McInnes IB, Sewerin P, Sharaf M, et al. Sustained response to guselkumab regardless of baseline demographic, disease, and medication characteristics in patients with active psoriatic arthritis and an inadequate response to TNF inhibitors: results from a phase 3b trial. Poster presented at: American College of Rheumatology (ACR) Convergence; November 10-14, 2022; Philadelphia, PA.  
10 Coates LC, Gossec L, Theander E, et al. Efficacy and safety of guselkumab in patients with active psoriatic arthritis who are inadequate responders to tumour necrosis factor inhibitors: results through one year of a phase IIIb, randomised, controlled study (COSMOS). Ann Rheum Dis. 2022;81(3):359-369.  
11 Coates L, Gossec L, Theander E, et al. Efficacy and safety of guselkumab in patients with active psoriatic arthritis who demonstrated inadequate response to tumor necrosis factor inhibition: results of a phase 3b, randomized, controlled study. Oral Presentation presented at: European League Against Rheumatism (EULAR); June 2-5, 2021; Virtual Congress.  

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