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TREMFYA® (guselkumab)

Medical Information

TREMFYA - Occurrence of Tuberculosis in Adult Patients with Crohn’s Disease or Ulcerative Colitis

Last Updated: 09/04/2025

SUMMARY

  • Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with TREMFYA. Initiate treatment of latent TB prior to administering TREMFYA. Patients receiving TREMFYA should be monitored for signs and symptoms of active TB during and after treatment. Do not administer TREMFYA to patients with active TB infection. Consider anti-TB therapy prior to initiating TREMFYA in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.1 
  • The efficacy and safety of TREMFYA was assessed in adult patients with moderately to severely active Crohn's disease (CD) in the phase 3 GALAXI 2 and 3 trials. GALAXI 2 and 3 were 2 identically designed, randomized, double-blind, active comparator, placebo-controlled treat-through trials. Patients who completed evaluations at week 48, and in the opinion of the investigator would benefit from treatment, were eligible to enter the long-term extension (LTE) and continue to receive TREMFYA.2-4
    • Active TB was reported during treatment with TREMFYA in 1 patient in GALAXI through week 48 and 1 patient in the open-label LTE (both from endemic regions).2,3
  • Additionally, TREMFYA was assessed in a double-blind, placebo-controlled, treat-through GRAVITI study which assessed the efficacy and safety of subcutaneous (SC) TREMFYA from induction through week 24. At week 24, all patients entered the extension phase receiving the same treatment until week 48. After evaluations were complete at week 48, the study was unblinded and patients who in the opinion of the investigator were benefitting from TREMFYA will continue on treatment through Week 248.4,5
    • Through 96 weeks of treatment with TREMFYA in the GRAVITI study, no cases of active TB were reported.5,6
  • The safety of TREMFYA was evaluated in adult patients with moderately to severely active ulcerative colitis (UC) through two phase 3 clinical studies, including a 12-week induction study and a 44-week maintenance study. Patients who completed the maintenance study, including the week 44 visit and in the opinion of the investigator may benefit from continued study intervention, could enter the long-term extension and continue their current treatment with TREMFYA.7-9
    • Through 92 weeks of treatment with TREMFYA, there were no reports of active TB.7,8
  • The safety of TREMFYA, including the occurrence of TB, was evaluated for up to 1 year through a pooled safety analysis of phase 2/3 clinical trials of TREMFYA in patients with moderately to severely active CD or UC.2

Clinical data

GALAXI Phase 3 Studies – Crohn’s Disease

  • In the GALAXI clinical program and open-label LTE, one case of active extrapulmonary TB was reported between Weeks 12-48 and one case of active pulmonary TB was reported after Week 48. Both patients had negative baseline screenings and resided in TB-endemic regions.2-4,10-12

GRAVITI Phase 3 Study – Crohn’s Disease

  • In the GRAVITI clinical study and open-label LTE, no cases of active TB were reported through week 96.5,6,13

QUASAR Phase 3 Studies – Ulcerative Colitis

In the QUASAR clinical program and open-label LTE, no cases of active TB were reported in patients receiving TREMFYA through week 92.7-9

Pooled Safety Analysis of Phase 2/3 Studies in Crohn's Disease and Ulcerative Colitis 

  • Patients with moderately to severely active CD or UC through up to 1 year were included:2
    • UC: n=1514 from QUASAR induction study 1, 2 and the maintenance study
    • CD: n=1492 from GALAXI 1,2 and 3; GRAVITI (SC induction therapy with TREMFYA).
    • UC: VEGA study (Guselkumab plus golimumab combination therapy versus TREMFYA or golimumab monotherapy [VEGA]).
  • TREMFYA studies were pooled for the induction period (GALAXI, GRAVITI, & QUASAR; Weeks 0-12 [VEGA excluded due to no PBO control]) and through 1 year (GALAXI, GRAVITI, QUASAR, & VEGA).
  • In this pooled analysis, safety events were normalized to 100 patient-years (PY) of follow-up with corresponding confidence intervals.
  • In the TREMFYA treated patients, please see Table: Total Patient Years of Follow Up and Occurrence of Active Tuberculosis per 100 Patient Year. 

Total Patient Years of Follow Up and Occurrence of Active Tuberculosis per 100 Patient Years2 
Pooled IBD
Induction Period (Weeks 0-12)a
Through 1 year
Placebo (n=743)
TREMFYA
(n=1703)
Placebob (n=886)
TREMFYAc
(n=2057)
Total PYs of follow-up
171.6
399.9
447.4
1752.1
Events/100 PY (95% CI)d
Active TB
0.00
(0.00, 1.75)
0.00
(0.00, 0.75)
0.00
(0.00, 0.67)
0.06
(0.00, 0.32)
Abbreviations: CI, confidence interval; IBD, inflammatory bowel disease; PY, participant-years; TB, tuberculosis.Note:  Includes all patients who were treated.Note: Patients are counted only once for any given event, regardless of the number of times they actually experienced the event. Adverse events are coded using MedDRA version 26.aUlcerative colitis: (0-12 weeks) CNTO1959UCO3001 QUASAR Induction Study 1 and Induction Study 2 (VEGA not included due to no PBO control); Crohn's disease (0-12 weeks): CNTO1959CRD3001 GALAXI 1, GALAXI 2, GALAXI 3 and CNTO1959CRD3004 GRAVITI. bUlcerative colitis: includes data up to the first dose of TREMFYA for participants who were initially treated with placebo; includes data at or after 12 weeks from the last induction dose of TREMFYA for participants who were treated with TREMFYA in induction and were rerandomized to placebo in the maintenance study, up to the dose adjustment for participants who had a dose adjustment. Crohn's disease: includes data up to the time of rescue or crossover. cUlcerative colitis: CNTO1959UCO3001 QUASAR (through induction week 20 for participants who did not enter the maintenance study and did not receive treatment at induction week 12; through induction Week 32 for participants who did not enter the maintenance study and received treatment at induction week 12; through maintenance week 44 for participants who entered the maintenance study); CNTO1959UCO2002 VEGA through week 38 (TREMFYA monotherapy arm only); includes all TREMFYA data and data up to 12 weeks from the last induction dose of TREMFYA for participants who were randomized to placebo in the maintenance study. Crohn's disease: CNTO1959CRD3001 GALAXI 1, GALAXI 2 and GALAXI 3, and CNTO1959CRD3004 GRAVITI through week 48; includes data from the first dose of TREMFYA onward for participants who were rescued or crossed over from placebo. dConfidence interval based on an exact method assuming that the observed number of events follows a Poisson distribution.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 05 June 2025.

 

References

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1 Data on File. Guselkumab Company Core Data Sheet (CCDS) v022. Janssen Research & Development, LLC. EDMS-ERI-111962822; 2025.  
2 Sands BE, Panaccione R, Danese S, et al. Safety of guselkumab in inflammatory bowel disease up to 1 year: integrated safety analysis of phase 2 and 3 studies in Crohn’s disease and ulcerative colitis. Abstract presented at: 20th Congress of European Crohn’s and Colitis Organisation (ECCO); February 19-22, 2025; Berlin, Germany.  
3 Data on File. TSFAESIP01A. Summary Table for Treatment-Emergent Adverse Events of Special Interest from Week 48 Through Week 96; LTE Safety Analysis Set (Pooled CNTO1959CRD3001 GALAXI 2 and GALAXI 3). Janssen Research & Development, LLC; 2024.  
4 Data on File. Clinical Protocol CNTO1959CRD3001. Janssen Research and Development, LLC. EDMS-ERI-136754231; 2024.  
5 Hart A, Panaccione R, Steinwurz F, et al. Efficacy and safety of guselkumab subcutaneous induction and maintenance in participants with moderately to severely active Crohn’s disease: results from the phase 3 GRAVITI study. [published online ahead of print March 18, 2025]. Gastroenterology. doi:10.1053/j.gastro.2025.02.033.  
6 Data on File. TSFAE20e: Number of subjects with treatment-emergent adverse events of interest (including special interest) per hundred subject-years follow-up through week 96. Janssen Research and Development, LLC; 2025.  
7 Rubin D, Allegretti J, Panés J, et al. Guselkumab in patients with moderately to severely active ulcerative colitis (QUASAR): phase 3 double-blind, randomised, placebo-controlled induction and maintenance studies. Lancet. 2025;405(10472):33-49.  
8 Lichtenstein G, Allegretti J, Rubin D, et al. Efficacy and safety of guselkumab for ulcerative colitis through week 92 of the QUASAR long-term extension study. Abstract presented at: Digestive Disease Week (DDW); May 3-6, 2025; San Diego, CA.  
9 Data on File. Clinical Protocol CNTO1959UCO3001. Janssen Research and Development, LLC. EDMS-ERI-164743339; 2024.  
10 Data on File. GALAXI 3 Week 48 Clinical Trial Participant Narrative. CNTO1959CRD3001. Janssen Research & Development, LLC; 2023.  
11 Data on File. GALAXI 3 90-Day Safety Update. CNTO19593001. Janssen Research & Development, LLC; 2024.  
12 Data on File. Tuberculosis Clinical Trial Participant Narrative Details. CNTO1959. Janssen Research & Development, LLC; 2025.  
13 Data on File. Clinical Protocol CNTO1959CRD3004. Janssen Research & Development, LLC. EDMS-RIM-163296; 2025.