TREMFYA®
(guselkumab)
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TREMFYA® (guselkumab)
Medical Information
TREMFYA - Occurrence of Tuberculosis in Adult Patients with Crohn’s Disease or Ulcerative Colitis
Last Updated: 04/10/2025
SUMMARY
- Evaluate patients for tuberculosis (TB) infection prior to initiating TREMFYA treatment. Do not administer TREMFYA to patients with active TB infection. Initiate treatment of latent TB prior to administering TREMFYA. 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. Monitor all patients for signs and symptoms of active TB during and after TREMFYA treatment.
- The safety of TREMFYA was assessed in adult patients with moderately to severely active Crohn's disease (CD) through GALAXI 2 and 3. GALAXI 2 and 3 were 2 identically designed, randomized, double-blind, active comparator, placebo-controlled treat-through trials.
- Active TB was reported in 2 patients during treatment with TREMFYA.1
- Active TB was reported in 2 patients during treatment with TREMFYA.1
- 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.
- Through 56 weeks of treatment with TREMFYA, there were no reports of active tuberculosis.2
- Through 56 weeks of treatment with TREMFYA, there were no reports of active tuberculosis.2
- The safety of TREMFYA, including the occurrence of tuberculosis, 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.3
Clinical data
GALAXI Phase 3 Studies – Crohn’s Disease
- In the GALAXI clinical program, 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.1
QUASAR Phase 3 Studies – Ulcerative Colitis
Rubin et al (2024)2 evaluated the efficacy and safety of TREMFYA as maintenance therapy in a phase 3, randomized-withdrawal, double-blind, placebo-controlled study (QUASAR maintenance study) through week 44 in adult patients with moderately to severely active UC who achieved clinical response to TREMFYA IV induction.
- Among patients included in the randomized safety analysis set (TREMFYA 100 mg SC q8w [n=186]; TREMFYA 200 mg SC q4w [n=190]; placebo [TREMFYA withdrawal, n=192]), no cases of active tuberculosis were reported in any of the study groups.
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:3
- UC: n=1514 from QUASAR induction study 1, 2 and the maintenance study
- CD: n=1492 from GALAXI 1,2 and 3; GRAVITI (subcutaneous 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
| Pooled IBD | ||||
|---|---|---|---|---|
| Induction Period (Weeks 0-12)a | Through 1 year | |||
| Placebo (n=743) | TREMFYA (n=1703) | Placebob | 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®
References
| 1 | TREMFYA (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.;https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf |
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