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(guselkumab)

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TREMFYA® (guselkumab)
Medical Information

Use of TREMFYA in Patients with Active Psoriatic Arthritis and Imaging-Confirmed Sacroiliitis

Last Updated: 02/09/2026

Summary

  • The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
  • Please refer to local labeling for relevant information regarding the use of TREMFYA in patients with active psoriatic arthritis (PsA).
  • In a post hoc analysis of pooled data from DISCOVER1 and DISCOVER2, the efficacy of TREMFYA in patients with PsA and imaging confirmed axial inflammation consistent with sacroiliitis at baseline was evaluated at week 24 and week 52.1,2
    • Of the 1120 (DISCOVER-1, N=381; DISCOVER-2, N=739) patients enrolled in both studies, 312 patients had axial inflammation consistent with sacroiliitis at baseline (every 8 weeks [q8w] group n=91, every 4 weeks [q4w] group n=103, placebo group n=118).2
    • At week 24, patients in the TREMFYA treatment groups had greater least squares (LS) mean changes from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), spinal pain, modified BASDAI (mBASDAI), and Ankylosing Spondylitis Disease Activity Score (ASDAS) compared with patients in the placebo group.2
    • At week 24, the proportion of patients who achieved at least 50% improvement in BASDAI (BASDAI50), ASDAS responses of inactive disease (<1.3), major improvement (decrease ≥2.0), and clinically important improvement (decrease ≥1.1) was greater in the TREMFYA treatment groups versus placebo.1,2
    • Improvements observed at week 24 in patients treated with TREMFYA compared with placebo were maintained through week 52.2
  • A post hoc analysis of the DISCOVER-2 study in biologic-naïve patients with active PsA and imaging-confirmed sacroiliitis treated with TREMFYA reported improvements in axial symptoms as measured by ASDAS and BASDAI endpoints at week 100.3

CLINICAL DATA

DISCOVER-1 and DISCOVER-2 Pooled Analysis

Helliwell et al (2020)1 and Mease et al (2020 and 2021)2,4 evaluated the efficacy of TREMFYA in patients with PsA and axial inflammation consistent with sacroiliitis at baseline in a post hoc pooled analysis from DISCOVER-1 and DISCOVER-2 (2 phase 3 studies) at week 24 and week 52.

Study Design/Methods

  • Adult patients with active PsA despite standard therapies (ie, disease-modifying antirheumatic drugs, nonsteroidal anti-inflammatory drugs, or apremilast) with ≥3 swollen joints, ≥3 tender joints, C-reactive protein (CRP) ≥0.3 mg/dL with or without tumor necrosis factor inhibitors [TNFi] experience were enrolled in DISCOVER-1 (N=381).
    • Approximately 30% of patients previously received ≤2 TNFi.
  • Adult patients with active PsA, despite standard therapies with ≥5 swollen joints, ≥5 tender joints, CRP≥0.6 mg/dL, naïve to biologic agents and Janus kinase [JAK] inhibitors, were enrolled in DISCOVER-2 (N=739).
  • Patients were randomized (1:1:1) to TREMFYA 100 mg dosed at week 0 then q4w or at weeks 0, 4 then q8w or placebo.
  • Investigators confirmed patients to have sacroiliitis based on documented prior imaging (DISCOVER-1 and DISCOVER-2) or pelvic radiograph at screening (DISCOVER2 only).
  • The following efficacy endpoints were assessed at weeks 24 and 52: LS mean changes in BASDAI score, mBASDAI (excluded question on peripheral joint pain to reduce the effect of peripheral joint disease on the total score) and ASDAS, and proportion of patients achieving BASDAI50 and ASDAS responses of inactive disease (score <1.3), major improvement (decrease of ≥2.0), and clinically important improvement (decrease of ≥1.1).
  • The change in BASDAI score, proportion of patients with a BASDAI50 response, and the imputation rules for missing data were prespecified in each study. The mBASDAI and ASDAS endpoints were calculated post hoc.
  • For weeks 0-24
    • For response variables, patients with missing data and patients meeting treatment failure criteria were considered nonresponders from that point onward.
    • For continuous endpoints, patients meeting the treatment failure criteria were assigned a change of 0 from baseline for subsequent timepoints.
  • After week 24
    • Patients with missing data were considered nonresponders.
    • Patients with early discontinuation of the study agent (before week 48 for DISCOVER-1 and before week 52 for DISCOVER-2) for any reason were assigned a change of 0 for subsequent timepoints.
  • No treatment groups comparisons were done after week 24 due to placebo crossover.

Results

Patient Characteristics
  • Overall, 312 patients (q8w n=91, q4w n=103, and placebo n=118) were assessed as PsA patients with imaging confirmed axial inflammation consistent with sacroiliitis at baseline. Of these patients, 214 patients received concomitant methotrexate therapy.
  • Baseline demographics and disease characteristics of patients from the post hoc analysis of pooled data from DISCOVER-1 and DISCOVER-2 are summarized in Table: Summary of Patient Baseline Demographics and Disease Characteristics.

Summary of Patient Baseline Demographics and Disease Characteristics1,5
Analysis Seta
Placebo
n=118
TREMFYA 100 mg
Total
N=312
q8w
n=91
q4w
n=103
PsA disease duration, years
6.7 (6.4)
4.8 (5.0)
5.5 (5.5)
5.7 (5.8)
Male, n (%)
69 (58.5)
54 (59.3)
68 (66.0)
191 (61.2)
Female, n (%)
49 (42.0)
37 (41.0)
35 (34.0)
121 (39.0)
BMI (kg/m2)
28.5 (6.2)
27.6 (6.5)
28.0 (6.1)
28.1 (6.3)
CRP (mg/dL)
2.4 (2.9)
2.7 (3.4)
2.3 (2.9)
2.5 (3.0)
BASDAI
   Patients, n
110
84
95
289
   Score
6.6 (1.5)
6.5 (1.8)
6.4 (1.7)
6.5 (1.7)
Modified BASDAI (excluded Q3)b
6.5 (1.6)
6.5 (1.9)
6.4 (1.8)
6.5 (1.7)
BASDAI Q2c (spinal pain)
6.7 (2.0)
6.5 (2.3)
6.6 (2.1)
6.6 (2.10)
ASDAS
   Patients, n
110
84
95
289
   Score
4.0 (0.8)
3.9 (1.1)
3.9 (0.8)
3.9 (0.9)
HLA-B27 status available, N
71
56
63
190
   HLA-B27 positive, n
18
17
22
57 (30.0)
   HLA-B27 negative, n
53
39
41
133 (70.0)
Data presented are mean (SD) unless otherwise specified.
Abbreviations: AS, ankylosing spondylitis; ASDAS, Ankylosing Spondylitis Disease Activity Score; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BMI, body mass index; CRP, Creactive protein; HLA-B27, human leukocyte antigen B27; PsA, psoriatic arthritis; q4w, every 4 weeks; q8w, every 8 weeks; Q2, question 2; Q3, question 3; SD, standard deviation.
aPatients with spondylitis and peripheral arthritis at baseline and either a history of imaging confirmation (DISCOVER-1 and -2) or pelvic radiograph at screening (DISCOVER 2).
bExcluded Q3 of the BASDAI (How would you describe the overall level of pain/swelling in joints other than neck, back, hips you have had?).
cQ2 of the BASDAI (How would you describe the overall level of AS neck, back, or hip pain you have had?).
Efficacy
  • At week 24, improvements in axial symptoms as measured by ASDAS and BASDAI related endpoints, irrespective of human leukocyte antigen B27 (HLA-B27) status, were observed in patients treated with TREMFYA compared with placebo; these improvements were maintained through week 52. (Table: Summary of Efficacy Results at Week 24 and Week 52).

Summary of Efficacy Results at Week 24 and Week 521,2,4,5,a
BASDAI Related Endpoints
Week 24
Week 52
PBO
TREMFYA 100 mg
PBO to TREMFYA
100 mg q4wb
TREMFYA 100 mg
q8w
q4w
q8w
q4w
n=110
n=83
n=95
n=110
n=82
n=95
LS mean change from baseline in BASDAIi
-1.3
-2.7c
-2.7c
-2.9
-2.8
-3.1
LS mean change from baseline in spinal paind
-1.2
-2.7c
-2.5k
-2.7
-2.7
-3.0
LS mean change from baseline in mBASDAIe
-1.4
-2.7c
-2.6c
-2.8
-2.7
-3.1
LS mean change from baseline in ASDAS
-0.7
-1.4
-1.4
-1.6
-1.6
-1.7
n=110
n=84
n=95
n=110
n=84
n=95
BASDAI50f, %
19
40g
38g
49
43
48
BASDAI Related Endpoints Based on HLA-B27 Status
LS mean change in HLA-B27 (+)
n=17
n=16
n=20
n=17
n=15
n=20
   BASDAI
-2.5
-3.7
-3.4
-4.1
-3.3
-4.0
   mBASDAIe
-2.5
-3.7
-3.2
-4.0
-3.4
-3.9
   ASDAS
-1.1
-1.8
-1.8
-2.3
-1.7
-2.0
LS mean change in HLA-B27 (-)
n=48
n=33
n=36
n=48
n=34
n=36
   BASDAI
-1.1
-2.6g
-2.5g
-2.9
-2.6
-2.9
   mBASDAIe
-1.1
-2.6g
-2.5g
-2.8
-2.6
-2.8
   ASDAS
-0.6
-1.2h
-1.3g
-1.5
-1.4
-1.5
ASDAS Related Endpoints
n=118
n=91
n=103
n=118
n=91
n=103
Clinically important improvement ≥1.1, (%)
28
51g
55c
59
53
58
Major improvement ≥2.0, (%)
9
26g
29c
34
31
36
Inactive disease <1.3, (%)
2
17c
13g
14
20
20
Abbreviations: AS, ankylosing spondylitis; ASDAS, Ankylosing Spondylitis Disease Activity Score; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASDAI50, ≥50% improvement in BASDAI; HLA-B27, human leukocyte antigen B27; LS, least squares; mBASDAI, modified BASDAI; PBO, placebo; q4w, every 4 weeks; q8w, every 8 weeks.
aPatients with axial involvement consistent with sacroiliitis at baseline and either a history of imaging confirmation of pelvic x-ray at screening (pooled data from DISCOVER-1 and DISCOVER-2).
bAt week 24, patients in the PBO group crossed over to TREMFYA 100 mg q4w.
cDifferences between the TREMFYA groups and placebo were evaluated on the basis of nominal P values. P values vs PBO: P<0.001.
dQuestion 2 of the BASDAI (How would you describe the overall level of AS neck, back, or hip pain you have had?).
eExcluded the question on peripheral joint pain to reduce the effect of peripheral joint disease on the total score
fPatients with BASDAI>0 at baseline.
gDifferences between the TREMFYA groups and placebo were evaluated on the basis of nominal P values. P values vs PBO: P<0.01.
hDifferences between the TREMFYA groups and placebo were evaluated on the basis of nominal P values. P values vs PBO: P<0.05.
iLS mean changes for BASDAI endpoints were calculated using mixed-effect repeated measures where the number of patients included in the model: n=95 for TREMFYA q4w, n=83 for TREMFYA q8w, and n=110 for PBO.
jLS mean changes for ASDAS scores were calculated using mixed-effect repeated measures where the number of patients included in the model: n=95 for TREMFYA q4w, n=82 for TREMFYA q8w, and n=110 for PBO.
kDifferences between the TREMFYA group and placebo were evaluated on the basis of nominal P values. P values vs PBO: P=0.002.

DISCOVER-2 Post Hoc Analysis

Mease et al (2023)3 conducted a post hoc analysis of the DISCOVER-2 study to evaluate the efficacy of TREMFYA in biologic-naïve patients with active PsA and imaging-confirmed sacroiliitis at week 100.

Study Design/Methods

  • Enrollment and dosing were previously described for DISCOVER-2. In addition, at week 24, patients in the placebo group began receiving TREMFYA 100 mg q4w.
  • Assessments through 2 years were defined as follows:
    • Active disease was defined by a total BASDAI score of ≥4.
    • Inactive, low, and very high disease activity was defined by an ASDAS score of <1.3, <2.1, and >3.5, respectively.
    • Clinically important and major improvements in disease were defined by ≥1.1 and ≥2.0 reductions in ASDAS scores, respectively.
  • Mean change from baseline and response rates on BASDAI and ASDAS endpoints were assessed at week 100.
  • After week 24, missing data (ie, patients who discontinued treatment early) was considered as nonresponse for binary endpoints or as no change for continuous endpoints.

Results

Patient Characteristics
  • A total of 246 patients with active PsA, axial symptoms, and sacroiliitis as confirmed by prior imaging (n=145) or pelvic radiograph (n=101) at screening were assessed.
  • Baseline demographics between the treatment groups are summarized in Table: Summary of Baseline Demographics and Disease Characteristics.

Summary of Baseline Demographics and Disease Characteristics3
Placebo
n=96
TREMFYA 100 mg
q8w
n=68
q4w
n=82
Male, n (%)
59 (62)
40 (59)
54 (66)
Age, years
44.2 (11.3)
45.0 (10.7)
44.2 (12.0)
PsA disease duration, years
5.8 (5.2)
4.9 (5.4)
5.2 (5.7)
BASDAI (0-10)
6.6 (1.6)
6.6 (1.9)
6.5 (1.6)
   Fatigue/spinal pain/joint
   pain/enthesitis scores, using the
   VAS (0-10 cm)
6.5/6.7/6.8/6.4
6.7/6.6/6.6/6.6
6.4/6.5/6.4/6.3
   Qualitative/quantitative morning
   stiffness, using the VAS (0-10 cm)
7.0/6.3
7.0/6.0
6.9/6.4
ASDAS
4.0 (0.8)
4.1 (1.0)
3.9 (0.8)
HLA-B*27+, n/N (%)
17/63 (27.0)
12/38 (31.6)
19/48 (39.6)
Data presented are mean (SD) unless otherwise specified.
Abbreviations: ASDAS, Ankylosing Spondylitis Disease Activity Score; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; HLA-B*27, human leukocyte antigen B*27; PsA, psoriatic arthritis; q4w, every 4 weeks; q8w, every 8 weeks; SD, standard deviation; VAS, visual analog scale.
Efficacy

Summary of Efficacy Results at Week 1003
Endpoints
PBO to TREMFYA
100 mg q4w
n=89
TREMFYA 100 mg
q8w
n=62
q4w
n=79
LS mean change from baseline in BASDAI
-3.3
-3.1
-3.0
Mean change from baseline in spinal painb
-3.0
-3.1
-2.8
Mean change from baseline in mBASDAI
-3.3
-3.1
-3.0
BASDAI50, %
54
53
49
Mean change from baseline in ASDAS
-1.6
-1.7
-1.6
   Clinically important improvement
   (decrease ≥1.1), %
66
61
60
   Major improvement (decrease
   ≥2.0), %
39
39
39
   Inactive disease (<1.3), %
16
24
20
Abbreviations: ASDAS, Ankylosing Spondylitis Disease Activity Score; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASDAI50, 50% improvement in BASDAI; LS, least squares; mBASDAI, modified BASDAI excluding Q3 (peripheral joint pain); PBO, placebo; Q2, question 2; Q3, question 3; q4w, every 4 weeks; q8w, every 8 weeks.
aNonresponder imputation analysis was reported for BASDAI50, ASDAS clinically important improvement, ASDAS major improvement, and ASDAS inactive disease.
bBASDAI Q2.

LITERATURE SEARCH

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 04 February 2026.

References

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1 Helliwell PS, Gladman DD, Poddubnyy D, et al. Efficacy of guselkumab, a monoclonal antibody that specifically binds to the p-19 subunit of IL-23, on endpoints related to axial involvement in patients with active psoriatic arthritis with imaging confirmed sacroiliitis: week 24 results from two phase 3, randomized, double-blind, placebo-controlled studies. Poster presented at: European League Against Rheumatism; June 3-6, 2020; E-congress.  
2 Mease PJ, Helliwell PS, Gladman DD, et al. Efficacy of guselkumab on axial involvement in patients with active psoriatic arthritis and sacroiliitis: a post-hoc analysis of the phase 3 DISCOVER-1 and DISCOVER-2 studies. Lancet Rheumatol. 2021;3(10):e715-e723.  
3 Mease PJ, Gladman DD, Poddubnyy D, et al. Efficacy of guselkumab on axial-related symptoms through up to 2 years in adults with active psoriatic arthritis in the phase 3, randomized, placebo-controlled DISCOVER-2 study. Rheumatol Ther. 2023;10(6):1637-1653.  
4 Mease PJ, Helliwell PS, Gladman DD, et al. Efficacy of guselkumab, a monoclonal antibody that specifically binds to the p19 subunit of IL-23, on axial-related endpoints in patients with active PsA with imaging-confirmed sacroliitis: week-52 results from two phase 3, randomized, double-blind, placebo-controlled studies. Oral Presentation presented at: American College of Rheumatology (ACR); November 5-9, 2020; E-congress.  
5 Mease PJ, Helliwell PS, Gladman DD, et al. Supplement to: Efficacy of guselkumab on axial involvement in patients with active psoriatic arthritis and sacroiliitis: a post-hoc analysis of the phase 3 DISCOVER-1 and DISCOVER-2 studies. Lancet Rheumatol. 2021;3(10):e715-e723.   

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