TREMFYA®
(guselkumab)
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TREMFYA® (guselkumab)
Medical Information
TREMFYA - Occurrence of Infections in Adult Patients with Crohn’s Disease or Ulcerative Colitis
Last Updated: 02/26/2025
SUMMARY
- The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
- The safety and efficacy of TREMFYA in adults with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) were evaluated in the QUASAR and GALAXI clinical trial program, respectively. Summarized below is infection data from these 2 programs.1
- 3 - The safety of TREMFYA, including the occurrence of infections, 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.4
CLINICAL DATA
Phase 3 Clinical Studies- GALAXI 2 and 3 – Crohn’s Disease
Panaccione et al (2024)1 reported the safety of TREMFYA in adult patients with moderately to severely active CD through GALAXI 2 and 3. GALAXI 2 and 3 were 2 identically designed, randomized, double-blind, active comparator, placebo-controlled treat-through trials.
For the occurrence of infections, please see Table: Occurrence of Tuberculosis, Opportunistic Infections, And Serious Infections Through Week 48 of GALAXI 2 And 3 (Pooled Results).
| TREMFYA 200 mg IV Q4W→100 mg SC Q8W | TREMFYA 200 mg IV Q4W→200 mg SC Q4W | Ustekinumab ~6 mg/kg IV→90 mg SC Q8W | Placebo IV→SCa | |
|---|---|---|---|---|
| All-treated safety analysis set, N | 296 | 299 | 300 | 153 |
| Average duration of follow-up (weeks) | 46.2 | 46.7 | 45.5 | 21.8 |
| Participants with ≥1b | ||||
| Tuberculosis, n (%) | 1 (0.3) | 0 | 0 | 0 |
| OIs, n (%) | 1 (0.3) | 2 (0.7) | 0 | 1 (0.7) |
| Serious Infectionc | 1 (0.3) | 3 (1) | 12 (4) | 2 (1.3) |
| Abbreviation: IV, intravenous; MedDRA, Medical Dictionary for Regulatory Activities; OI, opportunistic infection; Q4W, every 4 weeks; Q8W, every 8 weeks; SC, subcutaneous. aEvents attributed to participants randomized to placebo, except where a participant is randomized to placebo and cross over to ustekinumab (events occurring after receiving ustekinumab are not counted). bParticipants are counted only once for any given event, regardless of the number of times they experienced the event. Adverse events are coded using the MedDRA 26.0. cInfections defined as any adverse event coded to MeDRA organ class “Infections and infestations”. | ||||
- Through Week 48 of the GALAXI 2 and 3 studies, COVID-19 and upper respiratory tract infection were among the 5 most frequently reported adverse events in patients receiving TREMFYA.
QUASAR Phase 3 Studies – Ulcerative Colitis
The safety of TREMFYA was evaluated through 2 phase 3, randomized, double-blind, placebo-controlled, studies in adult patients with moderately to severely active UC (QUASAR). This included a 12-week induction study and a 44-week randomized, withdrawal maintenance study.2
For the occurrence of infections in TREMFYA-and placebo placebo-treated patients in the induction study, please see Table: Occurrence of Infections in the QUASAR Induction Study.
| TREMFYA 200 mg IV | Placebo IV | |
|---|---|---|
| Safety analysis set, N | 421 | 280 |
| Participants with ≥1 | ||
| Infectionsa, n (%) | 66 (15.7) | 43 (15.4) |
| Serious infectionsa, n (%) | 3 (0.7) | 1 (0.4) |
| Abbreviation: IV, intravenous; MedDRA, Medical Dictionary for Regulatory Activities. aInfections were defined as any adverse event that was coded to the MedDRA system organ class ‘Infections and infestations.’ | ||
- Through week 12 of the induction study, COVID-19 was one of the most common adverse events among TREMFYA-treated patients (5%, TREMFYA vs 4.3%, placebo).
For the occurrence of infections through the 44-week maintenance study, please see Table: Occurrence of Tuberculosis, Infections, Serious Infections, And Opportunistic Infections Through Week 44 of the QUASAR Maintenance Study.
| Randomized TREMFYA | Randomized Placebo (TREMFYA Withdrawal) | ||
|---|---|---|---|
| 100 mg Q8W | 200 mg Q4W | ||
| Randomized safety analysis set, N | 186 | 190 | 192 |
| Average duration of follow-up (weeks) | 40.5 | 39.2 | 34 |
| Participants with ≥1 | |||
| Tuberculosis | 0 | 0 | 0 |
| Infectionsa, n (%) | 59 (31.7) | 59 (31.1) | 63 (32.8) |
| Serious infectionsa, n (%) | 1 (0.5) | 2 (1.1) | 0 |
| Opportunistic infectionsa,b | 0 | 0 | 0 |
| Abbreviation: Q4W, every 4 weeks; Q8W, every 8 weeks. aIncludes only patients with modified Mayo score 5-9 at induction baseline who are randomized in the maintenance study and data up to the time of dose adjustment for patients who underwent dose adjustment. bPatients were counted only once for any given document. | |||
- Through week 44 of the maintenance study, COVID-19 was one of the most common adverse events among TREMFYA-treated patients (11.2%, TREMFYA vs 14.1%, placebo).
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:4
- 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.
- For the rates of infections through 1 year, see Table: Total Patient Years of Follow-up and Occurrence of Infections per 100 Patient Years.
Total Patient Years of Follow
| 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 | ||||
| Opportunistic infections | 1.75 (0.36, 5.11) | 0.50 (0.06, 1.81) | 0.67 (0.14, 1.96) | 0.23 (0.06, 0.58) |
| Serious infections | 1.17 | 1.50 | 1.56 | 1.66 |
| 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 | Panaccione R, Danese S, Feagan B, et al. Efficacy and safety of guselkumab therapy in patients with moderately to severely active Crohn’s disease: results of the GALAXI 2 & 3 phase 3 studies. Oral Presentation presented at: Digestive Disease Week (DDW); May 18-21, 2024; Washington, DC & Virtual. |
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