J&J Medical Connect
TREMFYA®

(guselkumab)

J&J Medical Connect

Connect with us

  • Products

This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

TREMFYA® (guselkumab)
Medical Information

JNJ-78934804 (Golimumab and Guselkumab) vs SIMPONI or TREMFYA Monotherapy in Crohn’s Disease

Last Updated: 06/12/2026

summary

  • The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
  • DUET-CD (NCT05242471)1,2 is an ongoing, phase 2b randomized, double-blind, active-and placebo (PBO)-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of subcutaneous (SC) guselkumab and golimumab combination therapy vs TREMFYA or golimumab monotherapy in adult patients with moderately to severely active Crohn’s disease (CD). Results through week 48 are reported below.

CLINICAL DATA

Phase 2b Study: DUET-CD

DUET-CD (NCT05242471)1 is an ongoing, phase 2b randomized, double-blind, active-and PBO-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of SC guselkumab and golimumab combination therapy vs TREMFYA or golimumab monotherapy in adult patients with moderately to severely active CD.

Study Design/Methods

  • Patients were randomized (1:2:2:2:2:2) to receive the following1,2:
    • Group 1: PBO SC
    • Experimental Groups (SC administration):
      • Group 2: TREMFYA SC
      • Group 3: Golimumab SC
      • Group 4: High-dose of SC combination therapy of guselkumab and golimumab
        (JNJ-78934804)
      • Group 5: Mid-dose of SC combination therapy of guselkumab and golimumab
        (JNJ-78934804)
      • Group 6: Low-dose of SC combination therapy of guselkumab and golimumab
        (JNJ-78934804)
  • Patients who meet inadequate response criteria will be escalated to an active treatment.
  • Patients who are eligible and willing to continue the study intervention at week 44 may enter the long-term extension.
  • The efficacy and safety outcomes to be evaluated are summarized in Table: Efficacy and Safety Outcome Measures.

Efficacy and Safety Outcome Measures1,2
Study Outcomes
Primary efficacy outcome at week 48
  • Clinical remission based on the CDAI score
  • Endoscopic response based on the SES-CD
Selected secondary efficacy outcomes at week 48
  • Endoscopic response based on the SES-CD score
  • Corticosteroid-free (60-day) clinical remission
  • Clinical remission based on the CDAI score
  • Endoscopic remission based on SES-CD score
  • Deep remission
  • PRO-2 remission based on average daily AP and SF scores
Safety will be evaluated up to week 48.
Abbreviations: AP, abdominal pain; CDAI, Crohn’s Disease Activity Index; PRO-2, patient-reported outcomes; SES-CD, Simple Endoscopic Score for Crohn’s Disease; SF, stool frequency.

Results

Patient Characteristics
  • A total of 693 patients were included in the study.2
  • At baseline, the mean (standard deviation [SD]) duration of CD was 11 (8.4) years, mean (SD) Simple Endoscopic Score for Crohn’s Disease (SES-CD) was 14 (7.9), and mean (SD) Crohn’s Disease Activity Index (CDAI) score was 323 (60.4).
  • 50% of patients had an inadequate response to ≥2 systemic therapy classes.
Efficacy
  • At week 48, in the overall population, the proportions of patients achieving the coprimary endpoints were higher with high-dose JNJ-78934804 vs golimumab (clinical remission, Δ25.7 [P<0.001]; endoscopic response, Δ18.5 [nominal P<0.001]); compared to TREMFYA, rates were greater than or similar with high-dose JNJ-78934804 (clinical remission, Δ8.5 [nominal P=0.171]; endoscopic response, Δ4.5 [nominal P=0.451]).
  • Efficacy outcomes among subpopulation refractory to 2 or more systemic therapy classes are summarized in Table: Key Primary and Secondary Endpoints at Week 48 in Patients with CD Refractory to ≥2 Systemic Therapy Classes.

Key Primary and Secondary Endpoints at Week 48 in Patients with CD Refractory to ≥2 Systemic Therapy Classes2
PBO
(N=35)
JNJ-78934804 High-Dose vs PBO
Δ (95% CI)
Golimumab
(N=65)
JNJ-78934804 High-Dose vs Golimumab
Δ (95% CI)
TREMFYA
(N=55)
JNJ-78934804 High-Dose vs TREMFYA
Δ (95% CI)
JNJ-78934804
High-Dose
(N=63)
Coprimary endpoint, n (%)
   Clinical
   remission at
   week 48a
4 (11.4)
39.4
(21.6 to 57.3)
15 (23.1)
27.3
(10.9 to 43.6)
15 (27.3)
21.2
(4.1 to 38.3)
31 (49.2)
   Endoscopic
   response at
   week 48b
1 (2.9)
35.0
(20.2 to 49.7)
8 (12.3)
21.2
(7.4 to 35.0)
11 (20.0)
11.7
(-4.3 to 27.6)
21 (33.3)
Secondary endpoints, n (%)
   Corticosteroid-
   free clinical
   remission at
   week 48c
4 (11.4)
37.2
(18.5 to 55.8)
14 (21.5)
24.8
(8.8 to 40.8)
15 (27.3)
20.1
(3.2 to 37.1)
29 (46.0)
   Endoscopic
   remission at
   week 48d
1 (2.9)
21.2
(8.0 to 34.3)
5 (7.7)
19.3
(6.7 to 31.9)
4 (7.3)
15.4
(3.0 to 27.7)
15 (23.8)
   Deep
   remission at
   week 48e
0
20.1
(8.8 to 31.4)
4 (6.2)
17.7
(6.3 to 29.1)
3 (5.5)
13.8
(2.3 to 25.3)
13 (20.6)
Abbreviations: CD, Crohn’s disease; CDAI, Crohn’s Disease Activity Index; CI, confidence interval; PBO, placebo; SES-CD, Simple Endoscopic Score for Crohn’s Disease.
aClinical remission was defined as a CDAI score of <150.
bEndoscopic response was defined as a >50% improvement from baseline in SES-CD or SES-CD ≤2, assessed by central endoscopy reading.
cCorticosteroid-free clinical remission (60-day) was defined as clinical remission with no corticosteroids received for at least 60 days.
dEndoscopic remission was defined as SES-CD ≤4, with at least a 2-point reduction from baseline and no subscore >1 on any individual component.
eDeep remission was defined as achieving both clinical remission and endoscopic remission.
Note: Δ denotes treatment difference.
Safety
  • The most common serious adverse events (AEs) across the groups were gastrointestinal, and the rate of serious infections was low.
  • AEs through week 48 are presented in Table: Treatment-Emergent AEs through Week 48.

Treatment-Emergent AEs through Week 482,a
PBO
(N=64)
Golimumab
(N=126)
TREMFYA
(N=127)
High Dose of
JNJ-78934804
(N=126)
Combined
JNJ-78934804b
(N=376)
Total patient-years of follow-up
38.5
86.0
98.6
104.3
300.5
Number of Events
Events per
100 PYs (95% CI)
Number of Events
Events per
100 PYs (95% CI)
Number of Events
Events per
100 PYs (95% CI)
Number of Events
Events per
100 PYs (95% CI)
Number of Events
Events per
100 PYs (95% CI)
AEs
249
646.8
(568.91-732.28)
519
603.2
(552.39-657.37)
553
561.0
(515.26-609.82)
518
496.4
(454.59-541.08)
1559
518.7
(493.29-545.13)
SAEs
12
31.2
(16.11-54.45)
38
44.2
(31.25-60.62)
14
14.2
(7.77-23.83)
19
18.2
(10.96-28.44)
70
23.3
(18.16-29.43)
AEs leading to discontinuation of study treatment
16
41.6
(23.75-67.49)
20
23.2
(14.20-35.90)
11
11.2
(5.57-19.97)
11
10.5
(5.26-18.86)
29
9.6
(6.46-13.86)
Infections
49
127.3
(94.16-168.26)
105
122.0
(99.81-147.72)
94
95.4
(77.07-116.71)
122
116.9
(97.09-139.60)
354
117.8
(105.83-130.72)
Serious infections
1
2.6
(0.07-14.47)
6
7.0
(2.56-15.18)
4
4.1
(1.11-10.39)
3
2.9
(0.59-
8.40)
14
4.7
(2.55-
7.82)
Abbreviations: AE, adverse event; CI, confidence interval; PBO, placebo; PY, patient-years; SAE, serious adverse event.
aInadequate responder events after treatment escalation at week 24 are excluded.
bCombined group includes patients from the JNJ-78934804 low-dose (N=127), mid-dose (N=123), and high-dose (N=126) groups.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 17 April 2026.

References

Show
1 Janssen Research & Development, LLC. A study of combination therapy with guselkumab and golimumab in participants with moderately to severely active Crohn’s disease (DUET-CD). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2026 May 08]. Available from: https://clinicaltrials.gov/study/NCT05242471 NLM Identifier: NCT05242471.  
2 Sands BE, D’Haens G, Dotan I, et al. Efficacy and safety of the first co-antibody therapy, JNJ-78934804, in patients with moderately to severely active Crohn’s disease refractory to systemic therapies. Abstract presented at: Digestive Disease Week (DDW); May 2-5, 2026; Chicago, IL.  

Would you like to clear and leave your conversation? Message history will be lost.