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(guselkumab)

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TREMFYA® (guselkumab)

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Treatment Effect of TREMFYA on Radiographic Progression in Adult Patients with Active Psoriatic Arthritis

Last Updated: 02/17/2026

Summary

  • The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
  • The effect of TREMFYA on radiographic progression in adult patients with active psoriatic arthritis (PsA) was evaluated in a randomized, double-blind, placebo-controlled, multicenter, phase 3 study (DISCOVER-2).1-6
    • In the first and second reading sessions, the least squares (LS) mean change from baseline at week 24 in the PsA-modified van der Heijde-Sharp (vdH-S) score in the TREMFYA 100 mg every 4 weeks (q4w) group vs the placebo group was 0.29 vs 0.95 (P=0.011), and in the TREMFYA 100 mg every 8 weeks (q8w) group vs the placebo group was 0.52 vs 0.95 (P=0.072).
    • The LS mean change from baseline at week 52 in the PsA-modified vdH-S score in the TREMFYA 100 mg q4w and q8w groups was 1.10 and 1.13, respectively.
    • The mean change from baseline at week 100 in the PsA-modified vdH-S score in the TREMFYA 100 mg q4w and q8w groups was 1.68 and 1.50, respectively.
    • In the third reading session, the mean change from baseline in the total PsAmodified vdH-S score in the TREMFYA 100 mg q4w and q8w groups from weeks 52 to 100 was 0.8 and 0.5, respectively.6
  • APEX was designed to evaluate the clinical, radiographic, and safety outcomes of TREMFYA in a phase 3b, randomized, double-blind, placebo-controlled study in biologic-naïve patients with active PsA and known risk factors for radiographic progression. Results are available through week 48 in this ongoing study.7-11
    • At week 24, for the major secondary endpoint of LS mean change from baseline in total PsA-modified vdH-S score, patients in both TREMFYA groups exhibited significantly less radiographic progression compared to those in the placebo group (LS mean changes in PsA-modified vdH-S score: TREMFYA q4w, 0.55 and TREMFYA q8w, 0.54, vs placebo, 1.35; P=0.002 and P<0.001, respectively).7-9
    • From week 24 to week 48, the LS mean change in PsA-modified vdH-S score was 0.24 in patients receiving TREMFYA q4w, 0.32 in patients receiving TREMFYA q8w, and 0.41 in the placebo crossover to TREMFYA q4w group.11
    • Through week 48, adverse events (AEs), serious adverse events (SAEs), infection rates, and serious infection rates were reported as follows11:
      • AEs occurred in 51% (142/280) and 55% (214/388) of patients in the TREMFYA q4w and q8w groups, respectively vs 34% (127/372) in the placebo crossover to TREMFYA q4w group.
      • SAEs occurred in 4% (10/280) and 5% (21/388) of patients in the TREMFYA q4w and q8w groups, respectively vs 4% (16/372) in the placebo crossover to TREMFYA q4w group.
      • Infection rate was 30% (84/280) and 34% (131/388) in the TREMFYA q4w and q8w groups, respectively vs 13% (50/372) in the placebo crossover to TREMFYA q4w group.
      • Serious infection rate was 1% (2/280) and 2% (6/388) in the TREMFYA q4w and q8w groups, respectively vs 1% (4/372) in the placebo crossover to TREMFYA q4w group.

CLINICAL DATA

Phase 3 Study – DISCOVER-2

Mease et al (2020)1,12, McInnes et al (2021)2, McInnes et al (2022)3, Mease et al (2024)4,13, Mease et al (2024)5, and Gottlieb et al (2023)6,14 evaluated the effect of TREMFYA on radiographic progression using the PsAmodified vdH-S score in biologic-naïve adult patients with active PsA who had inadequate response to or intolerance of standard therapies (nonbiologic disease-modifying antirheumatic drugs [DMARDs], apremilast, and nonsteroidal anti-inflammatory drugs [NSAIDs]) in a randomized, doubleblind, placebo-controlled, multicenter, phase 3 study (DISCOVER-2).

Study Design/Methods

DISCOVER-2 Study Design1,12

Abbreviations: CASPAR, Classification Criteria for Psoriatic Arthritis; cDMARD, conventional disease-modifying antirheumatic drug; CRP, Creactive protein; EE, early escape; NSAID, nonsteroidal anti-inflammatory drug; PsA, psoriatic arthritis; PsO, psoriasis; R, randomized; SC, subcutaneously; q4w, every 4 weeks; q8w, every 8 weeks.
aPatients were eligible to initiate/increase background medications if there was <5% improvement from baseline in tender and swollen joint counts at week 16.

  • The primary endpoint was the proportion of patients achieving ACR20 at week 24.
  • Secondary endpoints adjusted for multiplicity included change from baseline in PsAmodified vdH-S score at week 24.
  • Radiographs of the hands (posteroanterior) and feet (anteroposterior) were obtained at weeks 0 and 24 for the first reading session and at weeks 0, 24, and 52 for the second reading session and were evaluated independently by 2 central readers (masked to the order of radiographs and clinical data) using the PsA-modified vdH-S score. A third reader was used for adjudication and was blinded to treatment group and time point.
    • The total PsA-modified vdH-S score (range, 0-528) included addition of the following scores:
      • Joint erosion score (range 0-320; 0 for no erosions to 5 for extensive loss of bone from >50% of the articulating bone)
      • Joint space narrowing (JSN) score (range 0-208; 0 for no joint space narrowing to 4 for complete loss of joint space, bony ankylosis, or complete luxation)
    • The average of the joint erosion and the JSN scores were used in the analysis.
  • For radiographic data, treatment failure rules, including discontinued study treatment, terminated study participation, initiated or increased DMARD or oral corticosteroid doses, or initiated protocol-prohibited PsA treatment, were not applied, and missing data were assumed to be missing at random and were imputed using multiple imputations.

Results

Patient Characteristics
  • A total of 739 patients were randomized to receive TREMFYA 100 mg q8w (n=248), TREMFYA 100 mg q4w (n=245), or placebo (n=246). Of the randomized patients, 93% and 88% completed 1 year and 100 weeks of treatment, respectively.
  • Baseline demographics were generally similar between the treatment groups and are summarized in Table: Baseline Demographic and Disease Characteristics.
  • The majority of patients in the overall population (n=713; 96%), including those who received TREMFYA 100 mg q8w (n=234/248; 94%), TREMFYA 100 mg q4w (n=241/245; 98%), or placebo (n=238/246; 97%), had a PsA-modified vdH-S score >0.

Baseline Demographic and Disease Characteristics1,4,14
TREMFYA 100 mg
Placebo
(n=246)
q4w
(n=245)
q8w
(n=248)
Age, years
45.9 (11.5)
44.9 (11.9)
46.3 (11.7)
Sex, female, n (%)
103 (42)
119 (48)
129 (52)
PsA disease characteristics
   PsA duration, years (SD)
5.5 (5.9)
5.1 (5.5)
5.8 (5.6)
   SJC (0-66), mean (SD)
12.9 (7.8)
11.7 (6.8)
12.3 (6.9)
   TJC (0-68), mean (SD)
22.4 (13.5)
19.8 (11.9)
21.6 (13.1)
   Psoriatic BSA, % (0-100)
18.2 (20.0)
17.0 (21.0)
17.1 (20.0)
   IGA score of 3 or 4 (0-4), n (%)
117 (48)
108 (44)
115 (47)
   CRP, median (IQR), mg/dL
1.2 (0.6-2.3)
1.3 (0.7-2.5)
1.2 (0.5-2.6)
   DAPSA scorea, mean (SD)
49.7 (21.1)
46.3 (19.4)
48.8 (19.4)
   Patients with enthesitis, n (%)
170 (69)
158 (64)
178 (72)
      LEI score (1-6)
3.0 (1.7)
2.6 (1.5)
2.8 (1.6)
   Patients with dactylitis, n (%)
121 (49)
111 (45)
99 (40)
      DSS (1-60)
8.6 (9.6)
8.0 (9.6)
8.4 (9.3)
   PASI score (0-72), mean (SD)
10.8 (11.7)
9.7 (11.7)
9.3 (9.8)
   HAQ-DI score (0-3), mean (SD)
1.2 (0.6)
1.3 (0.6)
1.3 (0.6)
   SF-36 PCS score (0-100), mean (SD)
33.3 (7.1)
32.6 (7.9)
32.4 (7.0)
   SF-36 MCS score (0-100), mean (SD)
48.4 (11.0)
47.4 (10.8)
47.2 (12.0)
   PsA-modified vdH-S score (0-528),
   mean (SD)
27.2 (42.3)
23.0 (37.7)
23.8 (37.8)
Abbreviations: BSA, body surface area; CRP, C-reactive protein; DAPSA, Disease Activity Index for PsA; DSS, Dactylitis Severity score; HAQ-DI, Health Assessment Questionnaire-Disability Index; IGA, Investigator’s global assessment; IQR, interquartile range; LEI, Leeds Enthesitis Index; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; q4w, every 4 weeks; q8w, every 8 weeks; SD, standard deviation; SF-36 PCS/MCS, 36-Item Short Form Health Survey physical component summary/mental component summary; SJC, swollen joint count; TJC, total joint count; vdH-S, van der Heijde-Sharp.
Efficacy in Radiographic Reading
  • A significantly greater proportion of patients achieved ACR20 at week 24 in the TREMFYA 100 mg q4w (64%) and q8w (64%) groups vs the placebo (33%) group (P<0.0001 for both TREMFYA groups).
  • At week 24, significantly less progression of structural damage, as reflected by smaller changes from baseline in the PsA-modified vdH-S score, was observed in the TREMFYA 100 mg q4w group vs the placebo group (LS mean [95% confidence interval, CI), 0.29 [0.05 to 0.63] vs 0.95 [0.61 to 1.29]; P=0.011), whereas a nonsignificant decrease in radiographic progression was observed in the TREMFYA 100 mg q8w group vs the placebo group (LS mean [95% CI], 0.52 [0.18 to 0.86] vs 0.95 [0.61 to 1.29]; P=0.072).
  • At week 52, the estimated LS mean changes in the TREMFYA 100 mg q4w and q8w groups, respectively, were 1.10 (95% CI, 0.48-1.71) and 1.13 (95% CI, 0.52-1.73), and the LS mean differences compared with placebo were -1.06 (95% CI, -1.89 to -0.23) and -1.03 (95% CI, -1.85 to -0.20).
  • At week 100, low rates of radiographic progression were observed across both the TREMFYA 100 mg q4w (1.68) and q8w (1.50) groups. Overall, mean changes in the total PsA-modified vdH-S score showed less radiographic progression from weeks 52 to 100 compared with weeks 0-52 in the 3 groups.
  • For the third reading session, patients continuing study treatment at week 52 underwent assessments at weeks 0, 24, 52, and 100 (or at discontinuation after week 52). Readers were blinded to the treatment group and time point.6 
    • Mean changes in the total PsA-modified vdH-S score, JSN, and erosion scores were reported.
    • Among patients who did and did not achieve clinical response at week 100, changes in the total vdH-S scores from weeks 0-100 were determined by ACR20, ACR50, or ACR70, low disease activity (LDA) based on Disease Activity in PsA (DAPSA) score (≤14) or PsA Disease Activity Score (PASDAS; ≤3.2), minimal disease activity (MDA), and normalized Health Assessment Questionnaire-Disability Index (HAQ-DI) score (<0.5).
  • From weeks 0-24, the mean changes in radiographic scores indicated that the rates of radiographic progression of joint damage were numerically lower in TREMFYA-treated vs placebo-treated patient.
  • For mean changes in radiographic scores, see Table: Change in PsA-Modified vdH-S Score through Weeks 24, 52, and 100.

Change in PsA-Modified vdH-S Score through Weeks 24, 52, and 1002,6
Reading session 1a
Baseline PsA-Modified vdHS, Mean (SD)
TREMFYA q4w
(n=245)
TREMFYA q8w
(n=248)
Placebo→TREMFYA q4w (n=246)
Total
27.2 (42.3)
23.0 (37.7)
23.8 (37.8)
   Erosion
13.3 (22.4)
11.6 (20.3)
11.0 (19.1)
   JSN
13.9 (21.5)
11.5 (18.3)
12.7 (19.9)
Reading session 2b
Baseline PsA-Modified vdHS, Mean (SD)
TREMFYA q4w
(n=232)
TREMFYA q8w
(n=238)
Placebo→TREMFYA q4w (n=231)
Total
25.4 (40.2)
22.4 (37.9)
23.0 (39.5)
   Erosion
15.1 (22.2)
13.6 (20.8)
13.3 (21.4)
   JSN
10.3 (19.5)
8.8 (17.9)
9.7 (19.1)
Reading session 3c
Baseline PsA-Modified vdHS, Mean (SD)
TREMFYA q4w
(n=221)
TREMFYA q8w
(n=228)
Placebo→TREMFYA q4w (n=215)
Total
28.0 (43.6)
23.9 (40.4)
25.6 (42.4)
   Erosion
14.2 (23.3)
12.0 (21.9)
12.1 (21.9)
   JSN
13.8 (21.8)
11.9 (19.5)
13.5 (21.6)
Change in PsA-Modified vdHS, Mean (SD)
TREMFYA q4w
(n=221)
TREMFYA q8w
(n=228)
Placebo→TREMFYA q4w (n=215)
Weeks 0-24b,d
   Total
0.5 (2.7)
0.7 (2.4)
1.1 (3.8)
      Erosion
0.3 (1.9)
0.5 (2.0)
0.7 (2.2)
      JSN
0.2 (1.2)
0.2 (0.7)
0.4 (1.7)
TREMFYA q4w
(n=221)
TREMFYA q8w
(n=228)
Placebo→TREMFYA q4w (n=213)
Weeks 24-52b,d
   Total
0.6 (2.7)
0.3 (1.6)
0.3 (2.8)
      Erosion
0.4 (1.8)
0.2 (1.2)
0.2 (1.8)
      JSN
0.2 (1.1)
0.1 (0.7)
0.1 (1.1)
TREMFYA q4w
(n=229)
TREMFYA q8w
(n=235)
Placebo→TREMFYA q4w (n=230)
Weeks 0-52b,d
   Totale
1.07 (3.84)
0.97 (3.62)
1.25 (3.51)
      Erosion
0.70 (2.63)
0.67 (2.71)
0.92 (2.50)
      JSN
0.38 (1.63)
0.29 (1.27)
0.33 (1.36)
TREMFYA q4w
(n=211)
TREMFYA q8w
(n=216)
Placebo→TREMFYA q4w (n=202)
Weeks 52-100
   Total
0.8 (4.0)
0.5 (2.4)
0.1 (3.7)
      Erosion
0.4 (2.9)
0.3 (1.8)
0.1 (2.0)
      JSN
0.3 (1.3)
0.2 (0.9)
0.04 (1.9)
TREMFYA q4w
(n=211)
TREMFYA q8w
(n=216)
Placebo→TREMFYA q4w (n=204)
Weeks 0-100
   Total
1.7 (7.0)
1.5 (4.4)
1.5 (6.9)
      Erosion
1.0 (4.7)
1.0 (3.4)
1.0 (4.0)
      JSN
0.7 (2.7)
0.5 (1.4)
0.5 (3.0)
Abbreviations: ICC, intraclass correlation; JSN, joint space narrowing; PsA, psoriatic arthritis; q4w, every 4 weeks; q8w, every 8 weeks; SD, standard deviation; vdH-S, van der Heijde-Sharp.
aIncluded randomized patients who received ≥1 administration of study drug (partial or complete) and had radiographic images obtained at weeks 0 and 24 (or at discontinuation prior to week 24).
bIncluded patients continuing study treatment at week 24 with images at week 0, 24 and 52 (or at discontinuation after week 24).
cReading session 3 included patients continuing study treatment at week 52 with images at weeks 0, 24, 52 and 100 (or at discontinuation after week 52).
dICC estimates for the total PsA-modified vdH-S score at baseline, week 24, and week 52 were 0.92, 0.93, and 0.93, respectively, and ICC estimates for changes in the total PsA-modified vdH-S score during weeks 0-24, weeks 24-52, and weeks 0-52 were 0.69, 0.58, and 0.76, respectively.
eThe smallest detectable change in the total PsA-modified vdH-S score was 1.85 for weeks 0-24, 1.91 for weeks 24-52, and 2.39 for weeks 0-52.

Changes in PsA-Modified Total vdH-S Score from Baseline through Week 100 by Clinical Responses at Week 52 and Week 1006 
ACR20
ACR50
ACR70
TREMFYA
TREMFYA
TREMFYA
q4w
q8w
q4w
q8w
q4w
q8w
Clinical responders at week 52
   n
163
173
107
110
62
65
   Mean change
1.0
1.2
0.7
1.0
0.2
1.1
Clinical nonresponders at week 52
   N
47
43
103
106
148
151
   Mean change
4.1
2.8
2.8
2.0
2.3
1.7
Clinical responders at week 100
   N
176
175
134
131
85
83
   Mean change
0.8
1.2
0.4
0.9
0.3
0.8
Clinical nonresponders at week 100
   N
33
39
76
84
125
132
   Mean change
4.6
2.9
4.0
2.4
2.6
2.0
PASDAS LDA
DAPSA LDA
MDA
HAQ-DI≤0.5
TREMFYA
TREMFYA
TREMFYA
TREMFYA
q4w
q8w
q4w
q8w
q4w
q8w
q4w
q8w
Clinical responders at week 52
   n
102
99
122
119
82
72
75
56
   Mean change
1.0
1.0
0.7
0.9
0.5
0.5
0.3
0.9
Clinical nonresponders at week 52
   n
107
117
87
97
128
144
107
127
   Mean change
2.4
1.9
3.1
2.3
2.5
2.0
2.6
2.0
Clinical responders at week 100
   n
125
117
147
141
92
97
85
172
   Mean change
0.6
0.9
0.7
1.0
0.4
0.9
0.6
0.4
Clinical nonresponders at week 100
   n
84
97
62
73
118
118
97
110
   Mean change
2.5
2.2
3.0
2.5
2.7
2.0
2.6
2.5
Abbreviations: ACR20, ≥20% improvement in the American College of Rheumatology criteria; ACR50, ≥50% improvement in the American College of Rheumatology criteria; ACR70, ≥70% improvement in the American College of Rheumatology criteria; DAPSA, Disease Activity in PsA Score; HAQ-DI, Health Assessment Questionnaire-Disability Index; LDA, low disease activity; MDA, minimal disease activity; PASDAS, PsA Disease Activity Score; PsA, psoriatic arthritis; q4w, every 4 weeks; q8w, every 8 weeks; vdH-S, van der Heijde-Sharp.

Proportions of Patients Achieving MDA Components at Week 24, 52, and 100 by Treatment Groups and Progression Status6
Patients achieving MDA components (%)
MDA
SJC≤1
TJC≤1
Pain≤15
TREMFYA
TREMFYA
TREMFYA
TREMFYA
q4w
q8w
q4w
q8w
q4w
q8w
q4w
q8w
At week 24a
   Pb
12.0
14.5
36.0
32.3
16.0
11.3
16.0
11.3
   NPc
22.1
29.8
46.3
52.5
15.8
18.2
23.2
30.4
At week 52d
   Pe
23.4
20.8
53.1
58.4
20.3
20.8
20.3
29.9
   NPf
42.6
38.9
69.8
69.4
31.5
38.2
35.6
35.0
At week 100g
   Ph
31.6
33.8
61.4
64.9
28.1
26.0
29.8
36.4
   NPi
48.4
51.4
73.9
81.9
42.5
43.5
44.4
47.8
Patients achieving MDA components (%)
PtGA≤20
HAQ-DI≤0.5
LEI≤1
PASI≤1
TREMFYA
TREMFYA
TREMFYA
TREMFYA
q4w
q8w
q4w
q8w
q4w
q8w
q4w
q8w
At week 24a
   Pb
16.0
19.4
32.0
21.0
74.0
80.6
74.0
74.2
   NPc
32.6
34.3
38.4
35.9
75.3
77.9
70.2
75.0
At week 52d
   Pe
25.0
35.1
32.8
26.0
87.5
90.9
85.9
85.7
   NPf
45.4
44.6
48.5
45.2
81.5
82.8
82.7
79.0
At week 100g
   Ph
42.1
42.9
47.4
31.2
82.5
89.6
89.5
72.4
   NPi
58.2
51.4
53.6
55.8
89.5
90.6
81.0
84.1
Abbreviations: HAQ-DI, Health Assessment Questionnaire-Disability Index; LEI; Leeds Enthesitis Index; MDA, minimal disease activity; NP, nonprogressors; P, progressors; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; PtGA, patient global assessment; q4w, every 4 weeks; q8w, every 8 weeks; SJC, swollen joint count; TJC, tender joint count; vdH-S, van der Heijde-Sharp.
Note: Progression was defined as change from baseline total PsA-modified vdH-S score >0.5.
aReading session 1.
bFor q4w (n=50) and q8w (n=62).
cFor q4w (n=190) and q8w (n=181).
dReading session 2.
eFor q4w (n=64) and q8w (n=77).
fFor q4w (n=162) and q8w (n=157).
gReading session 3.
hFor q4w (n=57) and q8w (n=77).
iFor q4w (n=153) and q8w (n=138).
Correlation of Baseline PsA-Modified vdH-S Scores with Baseline PsA Parameters

Correlation Between Baseline PsA-Modified vdH-S Scores and Radiographic Progression Risk Factors4 
Parameters
Spearman’s Rho
P-Value
PsA duration
0.37
<0.0001
CRP level
0.28
<0.0001
Age
0.27
<0.0001
SJC (0-66)
0.26
<0.0001
PsO duration
0.21
<0.0001
PASI score
0.03
0.5153
Abbreviations: CRP, C-reactive protein; PASI, Psoriasis Area Severity Index; PsA, psoriatic arthritis; PsO, psoriasis; SJC, swollen joint count; vdH-S, van der Heijde-Sharp.
Impact on Total PsA-Modified vdH-S Scores through Week 100

Multivariate Associations of DAPSA Endpoints at Week 8 and Baseline Risk Factors of Radiographic Progression through Week 1004,13
Covariates
Saturated Model
Reduced Model
β
P-Value
β
P-Value
Median DAPSA improvement at week 8
-0.66
0.0405
-0.62
0.0510
   Male
0.53
0.0966
-
-
   Baseline age
-0.02
0.1401
-
-
   Baseline vdH-S score
0.02
<0.0001
0.02
<0.0001
   Baseline CRP level
0.18
0.0157
0.21
0.0039
   Baseline DAPSA score
0
0.9832
-
-
DAPSA MCID at week 8
-0.67
0.0610
-0.66
0.0647
   Male
0.52
0.0994
-
-
   Baseline age
-0.02
0.1706
-
-
   Baseline vdH-S score
0.02
<0.0001
0.02
<0.0001
   Baseline CRP level
0.18
0.0155
0.20
0.0042
   Baseline DAPSA score
0
0.8717
-
-
DAPSA LDA at week 8
-1.84
0.0154
-1.73
0.0208
DAPSA LDA at week 8*time
0.79
0.0694
0.79
0.0688
   Male
0.54
0.0899
-
-
   Baseline age
-0.02
0.2392
-
-
   Baseline vdH-S score
0.02
<0.0001
0.02
<0.0001
   Baseline CRP level
0.17
0.0241
0.18
0.0107
   Baseline DAPSA score
-0.01
0.3906
-
-
Abbreviations: CRP, C-reactive protein; DAPSA, Disease Activity Index for psoriatic arthritis; LDA, low disease activity; MCID, minimal clinically important difference; vdH-S, van der Heijde-Sharp.

Time-Averaged LS Mean Change in Total PSA-Modified vdH-S Score by DAPSA Endpoints4,13 
DAPSA Endpoints
n
Time-Averaged LS Mean Change in Total PsA-Modified vdH-S Scores
P-Value
Saturated
Model
Reduced
Model
Saturated
Model
Reduced
Model
Median DAPSA improvement
   ≥12.55
250
1.04
1.09
0.0405
-
   <12.55
190
1.70
1.71
DAPSA MCID
   ≥7.25
325
1.15
1.19
-
-
   <7.25
115
1.82
1.85
DAPSA LDA
   Yes
77
0.13
0.26
0.0151
0.0213
   No
363
1.57
1.59
DAPSA LDA
LS Mean Change in Total PsA-Modified vdH-S Scores
P-Value
Saturated
Model
Reduced
Model
Saturated
Model
Reduced
Model
Baseline to Week 52
   Yes
0.12
0.25
0.0267
0.0390
   No
1.17
1.19
Baseline to week 100
   Yes
0.14
0.26
0.0154
0.0208
   No
1.98
2.00
Abbreviations: CRP, C-reactive protein; DAPSA, Disease Activity Index for psoriatic arthritis; LDA, low disease activity; LS, least squares; MCID, minimal clinically important difference; PsA, psoriatic arthritis; vdH-S, van der Heijde-Sharp.
Note: LS mean changes in total PsA-modified vdH-S score were derived from mixed models adjusted for achievement of DAPSA endpoints at week 8 and variables selected following stepwise backward selection among the following: age, sex, baseline CRP level, baseline vdH-S score, and baseline DAPSA scores. For DAPSA LDA, the interaction of endpoint achievement with time was also included in the model.

LS Mean Change in Total PSA-Modified vdH-S Score by cDAPSA LDA/REM at Week 52 and Week 1005
cDAPSA LDA/REM
n
LS Mean Change in Total PsA-Modified vdH-S Scores
P-Value
At week 52
   Yes
77
0.14
0.028
   No
372
1.16
At week 100
   Yes
76
0.10
0.013
   No
368
1.97
Abbreviations: cDAPSA, clinical Disease Activity Index for psoriatic arthritis; LDA, low disease activity; LS, least squares; PsA, psoriatic arthritis; REM, remission; vdH-S, van der Heijde-Sharp.
Safety
  • Safety results summarized below are from patients enrolled in DISCOVER-2 and are not limited to patients with radiographic progression.
  • The safety results through week 24 are presented in Table: Summary of Safety Results through Week 24.

Summary of Safety Results through Week 241
TREMFYA 100 mg
Placebo
(n=246)
q4w
(n=245)
q8w
(n=248)
Duration of follow-up, weeks, mean
23.8
23.9
24.0
Patients with ≥1 AE, n (%)
113 (46)
114 (46)
100 (41)
AEs occurring in ≥3% of patients in any group, n (%)
   ALT increased
25 (10)
15 (6)
11 (4)
   AST increased
11 (4)
14 (6)
6 (2)
   Bronchitis
10 (4)
1 (<1)
3 (1)
   Nasopharyngitis
12 (5)
10 (4)
9 (4)
   Upper respiratory tract infection
12 (5)
6 (2)
8 (3)
Patients with ≥1 serious AE, n (%)
8 (3)b
3 (1)a
7 (3)c
AE leading to discontinuation of study treatment, n (%)
6 (2)e
2 (1)d
4 (2)f
Infectiong, n (%)
49 (20)
40 (16)
45 (18)
   Serious infection
3 (1)
1 (<1)
1 (<1)
Injection-site reaction, n (%)
3 (1)
3 (1)
1 (<1)
Suicidal ideation, n (%)
1 (<1)
0
1 (<1)
Malignancy, n (%)
0
1 (<1)
1 (<1)
Abbreviations: AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; q4w, every 4 weeks; q8w, every 8 weeks.
aOne patient each with ankle fracture, coronary artery disease, and pyrexia.
bOne patient each with acute hepatitis B, blue toe syndrome, femur fracture, influenza pneumonia, ischemic stroke, lower limb fracture and metal poisoning, oophoritis, and osteoarthritis.
cOne patient each with clear cell renal cell carcinoma, isoniazid-induced liver injury, inflammatory bowel disease (suspected), obesity, postprocedural fistula, tubulointerstitial nephritis, and unstable angina.
dOne patient each with rash and malignant melanoma in situ.
eOne patient each with acute hepatitis B (de novo); allergic dermatitis; isoniazid-induced liver injury; ischemic stroke; rhinovirus infection; and injection-site erythema, swelling, and warmth.
fOne patient each with clear cell renal cell carcinoma, isoniazid-induced liver injury, inflammatory bowel disease (suspected), and tubulointerstitial nephritis.
gEvents identified by investigators as infections.
  • From week 24 through week 52, the rate of serious infection did not increase in patients treated with TREMFYA and no additional malignancies or major cardiovascular events were reported after week 24.2
  • Through week 1123:
    • Death was reported in 1 patient from the placebo to TREMFYA q4w crossover group due to road traffic accident.
    • Opportunistic infections, including fungal esophagitis and disseminated herpes zoster, were reported in 2 patients in the TREMFYA q8w group, and listeria meningitis was reported in 1 patient from the placebo to TREMFYA q4w crossover group.
    • Patients treated with TREMFYA did not report any inflammatory bowel disease.
    • Patients did not report any anaphylactic or serum sickness reactions or active tuberculosis.

Phase 3b Study – APEX

Mease et al (2025)7-9 and Ritchlin et al (2025)11 reported the clinical, radiographic, and safety outcomes of TREMFYA compared with placebo in biologic-naïve patients with active PsA and known risk factors for radiographic progression in an ongoing phase 3b, randomized, double-blind, placebo-controlled study. Results are available through week 48 in this ongoing study.

Study Design/Methods

  • Selected inclusion criteria7-10,15:
    • Adults (≥18 years old) with a diagnosis of PsA for ≥6 months and met ClASsification criteria for Psoriatic ARthritis (CASPAR) at screening
    • Active PsA (despite previous conventional synthetic disease-modifying antirheumatic drugs [csDMARD], apremilast, and/or nonsteroidal anti-inflammatory drug [NSAID] therapy): ≥3 swollen/tender joints and CRP ≥0.3 mg/dL
    • ≥2 joints with erosions on baseline radiographs of the hands and feet
    • Active plaque psoriasis (PsO), with ≥1 psoriatic plaque of ≥2 cm diameter and/or nail changes consistent with PsO
  • Selected exclusion criteria:
    • Previous biologic or Janus kinase inhibitor therapy
    • Received the following therapies within the specified timeframe before the first study agent administration:
      • Systemic immunosuppressants (4 weeks)
      • csDMARDs (other than methotrexate [MTX], sulfasalazine, hydroxychloroquine, or leflunomide; 4 weeks)
      • Experimental antibody or biological therapy (6 months)
      • Intramuscular or intravenous corticosteroids (4 weeks)
      • Lithium (4 weeks)
  • Patients were allowed to receive concomitant stable NSAIDs, oral corticosteroids (prednisone ≤10 mg/d or equivalent), and select csDMARDs (MTX ≤25 mg/wk, sulfasalazine ≤3 g/d, hydroxychloroquine ≤400 mg/d, or leflunomide ≤20 mg/d). Patients could not receive >2 concomitant csDMARDs or MTX with leflunomide through W24.
  • The study design is summarized in Figure: APEX Study Design.

APEX Study Design7,8,10,15 

Abbreviations: EE, early escape; F/U, follow-up; GUS, guselkumab; LTE, long-term extension; Q4W, every 4 weeks; Q8W, every 8 weeks; PBO, placebo; PE, primary endpoint; R, randomization; SC, subcutaneous; vs, versus; W, week.
aPBO SC W8 then Q8W through W48 administered to maintain blinding.
bEE if <20% improvement from baseline in both tender and swollen joint counts at week 16, patients may initiate or increase the dose of permitted medication up to the maximum allowed dose, at the investigator’s discretion.
cFinal safety visit for those who do not enter LTE.
dFinal safety visit for those who entered LTE.

  • Multiplicity-controlled endpoints7-10,15:
    • Primary endpoint: ACR20 response at week 24
    • Major secondary endpoint: mean change from baseline in total PsA-modified vdH-S score at week 24.
  • Selected other endpoints at week 24 or week 48:
    • Proportion of patients achieving ACR20 at week 48, ACR50/70 at week 24, and ACR50/70 at week 48
    • LS mean change in total PsA-modified vdH-S score at week 24→week 48
    • LS mean change in erosion score and JSN score from week 0→week 24 and from week 24→week 48
    • Proportions of patients with no radiographic progression: change from baseline in PsA-modified vdH-S score of ≤0 at week 24 and week 48
  • The modified full analysis set (mFAS) was defined as all randomized patients excluding those from Ukraine sites rendered unable to support key study operations due to major disruptions (main efficacy analysis set).
  • Safety analyses included all patients who received ≥1 dose of study treatment through week 24.

Results

Patient Characteristics
  • A total of 1054 patients were enrolled and randomized.7-9
    • The mFAS included 1020 patients (TREMFYA q4w, n=273; TREMFYA q8w, n=371; PBO, n=376).
    • The safety analysis set included all 1054 patients randomized.
  • Selected baseline characteristics are summarized in Table: Selected Baseline Characteristics.

Selected Baseline Characteristics9,a
Parameter
TREMFYA
100 mg q4w
(n=273)
TREMFYA
100 mg q8w
(n=371)
PBO
(n=376)
Baseline demographic
Age, years
52.2 (13.2)
53.2 (12.9)
53.5 (13.0)
Male,b n (%)
149 (54.6)
199 (53.6)
213 (56.6)
BMI, kg/m2
29.4 (6.0)
29.0 (5.6)
28.9 (5.7)
PsA characteristic
PsA disease duration, years
7.5 (7.1)
7.2 (7.6)
7.2 (6.9)
SJC (0-66), mean (SD)
11.6 (9.4)
12.1 (8.5)
11.8 (8.9)
TJC (0-68), mean (SD)
21.2 (14.6)
20.6 (13.4)
20.5 (13.9)
CRP (mg/dL), mean (SD)
1.7 (2.9)
1.5 (2.0)
1.7 (2.5)
Enthesitis, %
57.9
58.6
58.6
Dactylitis, %
43.9
39.3
44.9
Radiographic characteristic
PsA-modified vdH-S score (0-528), mean (SD)
27.7 (47.6)
26.7 (43.4)
26.8 (42.2)
   Erosion score (0-320)
13.7 (24.3)
13.4 (21.9)
13.4 (20.7)
   JSN score (0-208)
14.0 (24.2)
13.3 (22.8)
13.4 (22.4)
Abbreviations: BMI, body mass index; CRP, C-reactive protein; JSN, joint space narrowing; PBO, placebo; PsA, psoriatic arthritis; q4w, every 4 weeks; q8w, every 8 weeks; SD, standard deviation; SJC, swollen joint count; TJC, tender joint count; vdH-S, van der Heijde-Sharp.
aBaseline characteristics are reported for the modified full analysis set, excluding 34 participants who were enrolled at 5 sites in Ukraine that could not carry out key study operations.
bParticipant sex was reported by the investigators by selecting one of the following options: female, male, unknown, or undifferentiated.
Efficacy
Week 24 Efficacy Results

Summary of Primary, Major Secondary, and Selected Other Endpoints at Week 247-9 
Endpoint
TREMFYA
100 mg q4w
(n=273)
TREMFYA
100 mg q8w
(n=371)
PBO
(n=376)
Primary endpointa,b
ACR20 response at W24, %
66.6
68.3
47.0
   Treatment difference vs PBO
   (95% CI)
19.7 (12.1, 27.2)
21.3 (14.4, 28.2)
-
P-value
<0.001
<0.001
-
Major secondary endpointb,c,e
LS mean change in total PsA-modified vdH-S score W0→W24
0.55
0.54
1.35
   Treatment difference vs PBO
   (95% CI)
-0.80 (-1.31, -0.28)
-0.80 (-1.28, -0.33)
-
P-value
0.002
<0.001
-
Selected other endpointsb
ACR50 response at W24, %
41.4
42.2
20.5
Nominal P-value
<0.001d
<0.001d
-
ACR70 response at W24, %
22.0
22.4
11.2
Nominal P-value
<0.001d
<0.001d
-
LS mean change in ES from W0→W24f,g
0.35
0.32
0.87
Nominal P-value
0.002d
<0.001d
-
LS mean change JSN scoreg,h
0.22
0.24
0.50
Nominal P-value
0.025d
0.027d
-
Change from baseline in PsA-modified vdH-S score ≤0, %
67.3
62.8
53.0
Nominal P-value
<0.001d
0.007d
-
Abbreviations: ACR, American College of Rheumatology; ANCOVA; analysis of covariance; CI, confidence interval; CMH, Cochran-Mantel-Haenszel; ES, erosion score; JSN, joint space narrowing; LS, least squares; mFAS, modified full analysis set; MI, multiple imputation; ND/MD, natural disaster/major disruption; PBO, placebo; PsA, psoriatic arthritis; q4w, every 4 weeks; q8w, every 8 weeks; vdH-S, van der Heijde-Sharp; W, week.
aThe primary endpoint P-value is multiplicity controlled using a fixed sequence testing procedure and can be used to determine statistical significance. Statistics are based on CMH across multiply imputed datasets.
bEfficacy analyses are from the mFAS, which included all randomized patients excluding those from Ukraine sites rendered unable to support key study operations due to major disruptions.
cThe major secondary endpoint P-value is multiplicity controlled using a fixed sequence testing procedure and can be used to determine statistical significance. Statistics are based on analysis of covariance across multiply imputed datasets.
dNominal P-value for TREMFYA vs PBO. These endpoints were not adjusted for multiple comparisons. Therefore, the P-values displayed are nominal, and statistical significance has not been established.
eFor changes from baseline in total PsA-modified vdH-S score at W24, data from participants with discontinuation of study agent/severe noncompliance due to ND/MD were not used, and MI was employed for all missing data; treatment failure rules were not applied.
fFor changes from baseline in erosion subscores at W24, data from participants with discontinuation of study agent/severe noncompliance due to ND/MD were not used, and MI was employed for all missing data; treatment failure rules were not applied.
gStatistics are based on ANCOVA across multiply imputed datasets.
hFor changes from baseline in JSN subscores at W24, data from participants with discontinuation of study agent/severe noncompliance due to ND/MD were not used, and MI was employed for all missing data; treatment failure rules were not applied.
Week 48 Efficacy Results

Summary of Selected Other Endpoints at Week 4811,16,a
Endpoint
TREMFYA
100 mg q4w
(n=273)
TREMFYA
100 mg q8w
(n=371)
PBO crossover to TREMFYA q4w
(n=376)
ACR20 response,b-d, %
71
74
71
ACR50 response, %b-d
51
56
48
ACR70 response, %b-d
31
35
26
LS mean change in total PsA-modified vdH-S scoreW24→W48b,e,f,g,h
0.24
0.32
0.41
LS mean change in erosion score W24→W48b,e,h,i,j
0.09
0.12
0.16
LS mean change in JSN score W24→W48b,e,h,i,j
0.15
0.21
0.25
Change from baseline in PsA-modified vdH-S score ≤0 at W48, %b,c,e,k
69.1
65.7
60.1
Abbreviations: ACR, American College of Rheumatology; ANCOVA, Analysis of Covariance; CI, confidence interval; DMARD, disease-modifying antirheumatic drug; ICE, intercurrent event; JSN, joint space narrowing; LS, least squares; mFAS, modified full analysis set; MI, multiple imputation; ND/MD, natural disaster or major disruption; NRI, nonresponder imputation; PBO, placebo; PsA, psoriatic arthritis; q4w, every 4 weeks; q8w, every 8 weeks; vdH-S, van der Heijde-Sharp; W, week.
aNo statistical testing was conducted after W24 in the APEX trial.
bEfficacy analyses are from the mFAS, which included all randomized patients excluding those from Ukraine sites rendered unable to support key study operations due to major disruptions.
cAverage proportions of patients in the mFAS with ACR20/50/70 responses across the 200 MI datasets.
dThrough W48, patients who discontinued study intervention for any reason except ND/MD were considered nonresponders. Through W24, patients who initiated/increased dose of oral corticosteroid or nonbiologic DMARD or initiated protocol-prohibited PsA therapies were considered nonresponders; after W24, these patients were not considered nonresponders. Data from patients who discontinued study intervention or had severe treatment noncompliance due to ND/MD were imputed using MI at all subsequent time points or at the next time point, respectively. Other missing data were imputed using NRI.
eReading sessions 1 and 2 were prespecified in the protocol. Session 1 included independent assessment of images by 2 blinded central readers and a blinded adjudicator from W0 to W24. Session 2 included re-reading of images by 2 blinded central readers and a blinded adjudicator from W24 to W48. The same readers were used for reading sessions 1 and 2.
fFor patients with missing W48 radiographs, W0/W24 radiographs were not re-read during reading session 2; W0/W24 data from reading session 1 were used if available.
gScore change was assessed in the mFAS according to the Adjusted Treatment Policy Estimand, irrespective of background PsA medication or adherence to study intervention. When ND/MD occurred, observed data collected after ND/MD were not used; data for visits after ND/MD and missing data were imputed using full conditional specification multiple imputation.
hLS mean change and CIs based on results from ANCOVA model (explanatory variables: baseline modified vdH-S score, treatment group, and randomization stratification level) combined across multiple imputation datasets.
iMissing Data Imputation: After applying ICE strategies, remaining missing data were imputed using MI. The corresponding n includes all patients with change data at W48 after ICE strategies and Missing Data Imputation.
jAnalysis Model: After applying ICE strategies and missing data imputation, data at W48 were analyzed using an ANCOVA model for each MI dataset. Explanatory variables included baseline modified vdH-S score, treatment group, and randomization stratification level.
kMissing Data Imputation: After applying ICE strategies, remaining missing data were imputed using MI. The corresponding n includes all subjects with change data at any post-baseline scheduled visit after ICE strategies and Missing Data Imputation.
Safety
Week 24 Safety Results

Summary of Safety Profile through Week 247,9,a
Safety through Week 24
TREMFYA
100 mg q4w
(n=280)
TREMFYA
100 mg q8w
(n=388)
PBO
(n=386)
Mean weeks of follow-up
24.0
23.9
23.8
Patients with ≥1:
AE
107 (38.2)
165 (42.5)
144 (37.3)
SAE
5 (1.8)
12 (3.1)
10 (2.6)
AE leading to study agent d/c
2 (0.7)
6 (1.5)
1 (0.3)
Infection
52 (18.6)
91 (23.5)
81 (21)
    Serious infection
2 (0.7)
5 (1.3)
1 (0.3)
    Active tuberculosis
0
0
0
    Opportunistic infection
0
0
0
Malignancyb
0
2 (0.5)
0
Venous thromboembolism event
1 (0.4)
1 (0.3)
1 (0.3)
MACEc
0
1 (0.3)
0
Anaphylactic or serum sickness reaction
0
0
0
Clinically important hepatic disorderd
0
0
0
Injection-site reactione
8 (2.9)
2 (0.5)
0
Abbreviations: AE, adverse event; d/c, discontinuation; MACE, major adverse cardiovascular event; PBO, placebo; q4w, every 4 weeks; q8w, every 8 weeks; SAE, serious adverse event.
aData are n (%) unless otherwise noted.
bTwo patients with malignancy had prostate cancer and renal cancer.
cOne patient with MACE experienced a myocardial infarction.
dClinically important hepatic disorders were prespecified as AE terms within the Medical Dictionary for Regulatory Activities category of Drug-Related Hepatic Disorders that met the criteria for an SAE or led to study agent discontinuation.
eInjection-site reactions were defined as any adverse reaction at a study intervention injection site.
  • One unvaccinated patient in the TREMFYA q4w group died due to COVID-19.
  • No new onset for inflammatory bowel disease was reported.7,9,17 
  • The most common AEs (>5%) were upper respiratory infections (TREMFYA q4w, 15 cases [5.4%]; TREMFYA q8w, 20 cases [5.2%]; PBO, 22 cases [5.7%]) and COVID-19 (TREMFYA q4w, 9 cases [3.2%]; TREMFYA q8w, 22 cases [5.7%]; PBO, 21 cases [5.4%]).9 
Week 48 Safety Results

Summary of Safety Results through Week 4811,a
TREMFYA
100 mg q4w
W0→W48
(n=280)
TREMFYA
100 mg q8w
W0→W48
(n=388)
PBO crossover to TREMFYA 100 mg q4w W24→W48b
(n=372)
Mean weeks of follow-up
47.3
46.9
23.5
Patients with ≥1:
AE
142 (51)
214 (55)
127 (34)
SAE
10 (4)
21 (5)
16 (4)
AE leading to study agent d/c
4 (1)
10 (3)
8 (2)
Infection
84 (30)
131 (34)
50 (13)
    Serious infection
2 (1)
6 (2)
4 (1)
    Active tuberculosis
0
0
0
    Opportunistic infection
0
0
0
Venous thromboembolism event
1 (0.4)
2 (0.5)
0
MACEc
0
2 (0.5)
4 (1)
Anaphylactic or serum sickness reaction
0
0
0
Clinically important hepatic disorder
1 (0.4)
0
0
Abbreviations: AE, adverse event; d/c, discontinuation; GUS, guselkumab; MACE, major adverse cardiovascular event; PBO, placebo; q4W, every 4 weeks; q8W, every 8 weeks; SAE, serious adverse event; W, week.
aData are n (%) unless otherwise noted.
bFor patients in the PBO group who received TREMFYA at W24 or another time point, only data on or after the first administration of TREMFYA are included. Data prior to the first administration of TREMFYA are not included.
cThis includes the case reported through W24.
  • Through week 48, 2 cases of major adverse cardiovascular events (MACE) were reported in the TREMFYA q8w group (this included the case reports through week 24) and 4 cases were reported in the placebo crossover to TREMFYA q4w group.16,17 

LITERATURE SEARCH

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 05 January 2026.

References

Show
1 Mease PJ, Rahman P, Gottlieb AB, et al. Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1126-1136.  
2 McInnes IB, Rahman P, Gottlieb AB, et al. Efficacy and safety of guselkumab, an interleukin‐23p19–specific monoclonal antibody, through one year in biologic‐naive patients with psoriatic arthritis. Arthritis Rheumatol. 2021;73(4):604-616.  
3 McInnes IB, Rahman P, Gottlieb AB, et al. Long-term efficacy and safety of guselkumab, a monoclonal antibody specific to the p19 subunit of interleukin-23, through two years: results from a phase 3, randomized, double-blind, placebo-controlled study conducted in biologic-naïve patients with active psoriatic arthritis. Arthritis Rheumatol. 2022;74(3):475-485.  
4 Mease PJ, Gottlieb AB, Ogdie A, et al. Earlier clinical response predicts low rates of radiographic progression in biologic-naïve patients with active psoriatic arthritis receiving guselkumab treatment. Clin Rheumatol. 2024;43(1):241-249.  
5 Mease P, Gottlieb AB, McInnes IB, et al. Effects of guselkumab on cDAPSA disease activity state and its association with long-term radiographic progression in a cohort of patients with moderately-highly active psoriatic arthritis: post hoc analyses of phase 3 randomized controlled studies. Poster presented at: American College of Rheumatology (ACR) Convergence 2024; November 14-19, 2024; Washington, DC.  
6 Gottlieb AB, McInnes IB, Rahman P, et al. Low rates of radiographic progression associated with clinical efficacy following up to 2 years of treatment with guselkumab: results from a phase 3, randomised, double-blind, placebo-controlled study of biologic-naïve patients with active psoriatic arthritis. RMD Open. 2023;9(1):e002789.  
7 Mease PJ, Ritchlin CT, Coates LC, et al. Inhibition of structural damage progression with guselkumab, a selective IL-23i, in participants with active PsA: results through week 24 of the phase 3b, randomized, double-blind, placebo-controlled APEX study. Oral Presentation presented at: European Alliance of Association for Rheumatology (EULAR); June 11-14, 2025; Barcelona, Spain.  
8 Mease PJ, Ritchlin CT, Coates LC, et al. Inhibition of structural damage progression with guselkumab, a selective IL-23i, in participants with active PsA: results through week 24 of the phase 3b, randomized, double-blind, placebo-controlled APEX study. Abstract presented at: European Alliance of Association for Rheumatology (EULAR); June 11-14, 2025; Barcelona, Spain.  
9 Mease PJ, Ritchlin CT, Coates LC, et al. Inhibition of structural damage progression with the selective interleukin-23 inhibitor guselkumab in participants with active PsA: results through week 24 of the phase 3b, randomised, double-blind, placebo-controlled APEX study. Ann Rheum Dis. 2025;84(12):1983-1994.  
10 Ritchlin CT, Coates LC, Mease PJ, et al. The effect of guselkumab on inhibiting radiographic progression in patients with active psoriatic arthritis: study protocol for APEX, a phase 3b, multicenter, randomized, doubleblind, placebocontrolled trial. Trials. 2023;24(1):22.  
11 Ritchlin CT, Mease PJ, Coates LC, et al. Durable inhibition of structural damage progression and improvements in joint disease activity with guselkumab in active and erosive psoriatic arthritis: week 48 results from APEX. Oral Presentation presented at: 6th Inflammatory Skin Disease Summit (ISDS); November 12-15, 2025; New York, NY.  
12 Mease PJ, Rahman P, Gottlieb AB, et al. Supplement to: Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1126-1136.  
13 Mease PJ, Gottlieb AB, Ogdie A, et al. Supplement to: Earlier clinical response predicts low rates of radiographic progression in biologic-naïve patients with active psoriatic arthritis receiving guselkumab treatment. Clin Rheumatol. 2024;43(1):241-249.  
14 Gottlieb AB, McInnes IB, Rahman P, et al. Supplement to: Low rates of radiographic progression associated with clinical efficacy following up to 2 years of treatment with guselkumab: results from a phase 3, randomised, double-blind, placebo-controlled study of biologic-naïve patients with active psoriatic arthritis. RMD Open. 2023;9(1):e002789.  
15 Janssen Research & Development, LLC. A study of guselkumab in participants with active psoriatic arthritis (APEX). In: ClinicalTrial.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2026 February 13]. Available from: https://clinicaltrials.gov/study/NCT04882098 NLM Identifier: NCT04882098.  
16 Data on File. Guselkumab. APEX Week 48 Clinical Study Report CNTO1959PSA3004. Janssen Research & Development, LLC. EDMS-RIM-1576499; 2025.  
17 Data on File. Guselkumab. APEX Week 24 Clinical Study Report CNTO1959PSA3004. Janssen Research & Development, LLC. EDMS-RIM-1362747 v1; 2025.