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TREMFYA® (guselkumab)
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TREMFYA - Occurrence of Infections in Adult Patients with Crohn’s Disease or Ulcerative Colitis
Last Updated: 02/25/2026
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/ASTRO and GALAXI/GRAVITI clinical trial programs, respectively. Summarized below is infection data from these programs.1
- 4 - The safety of TREMFYA, including infections, was evaluated for up to 1 year in a pooled phase 2/3 analysis of patients with moderately to severely active CD or UC. Additionally, a pooled analysis of 14 phase 2/3 trials in CD, UC, and psoriatic diseases for up to 1 year in patients aged ≥60 years was conducted. Results specific to CD and UC are summarized below.5
, 6
Pooled SAFETY ANALYSIS Crohn’s Disease and Ulcerative colitis
Faye et al (2026)5 analyzed pooled safety data of TREMFYA from 14 phase 2/3 trials up to 1 year in CD, UC and psoriatic diseases in patients aged ≥60 years old. Summarized below are results specific to patients with CD or UC.
- All patients included in the analysis received ≥1 dose of TREMFYA.
- Safety outcomes are presented as treatment-emergent adverse events (TEAE), per 100 patients-years (PY) with 95% confident interval (CI).
- There were 98 patients treated with placebo (PBO) with a total follow-up of 47.9 PY (mean: 25.5 weeks), and 238 patients treated with TREMFYA, with a total follow-up of 175.5 PY (mean: 38.5 weeks).
- For TEAE/100 PY specific to IBD (CD & UC) pooled population, see Table: Summary of TEAE Among Patients 60 Years or Older Through Approximately 1 Year.
| IBD Populationa | ||
|---|---|---|
| PBO (N=98)b | TREMFYA (N=238)c | |
| TEAE/100 PY (95% Cl)d | ||
| Any TEAEe | 131.5 (101.0, 168.2) | 93.5 (79.7, 108.9) |
| Serious Adverse Events | 23.0 (11.5, 41.1) | 11.4 (7.0, 17.6) |
| 56.4 (37.1, 82.0) | 39.9 (31.1, 50.4) |
| 2.1 (0.1, 11.6) | 2.3 (0.6, 5.8) |
| 0.0 | 0.0 |
| 2.1 (0.1, 11.6) | 1.1 (0.1, 4.1) |
| Abbreviations: CI, confidence interval; IBD, inflammatory bowel disease; PBO, placebo; PY, patients-year; TEAE, treatment emergent adverse events. aUC: CNTO1959UCO3001 (to Week 20, 32 or 44 depending on entry or treatment status); CNTO1959UCO2002 (to Week 38, monotherapy arm only). Crohn’s disease: CNTO1959CRD3001 GALAXI 1, GALAXI 2 and GALAXI 3 and CNTO1959CRD3004 GRAVITI (to Week 48).bUC: Data to first guselkumab dose (placebo) or ≥12 weeks after last induction (re-randomized to placebo), until dose adjustment. Crohn’s: Data to early escape/rescue/crossover.cUC: All guselkumab data and up to 12 weeks post-induction for placebo in Maintenance Study. Crohn’s Disease: Data from first guselkumab dose for early escape/crossover.dCumulative treatment duration for each study agent was calculated as the time from first to last dose across all relevant periods.eConfidence interval based on an exact method assuming that the observed number of subjects follows a Poisson distribution.fActive tuberculosis events are identified by the MedDRA HLT of 'Tuberculous infections' excluding the preferred term of 'Latent tuberculosis'.gOpportunistic infections are defined as the narrow terms in the MedDRA SMQ of 'Opportunistic Infections'. | ||
CLINICAL DATA in crohn’s disease and ulcerative coitis clinical studies
Phase 3 Clinical Studies- GALAXI 2 and 3 – Crohn’s Disease
Panaccione et al (2024)4 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, n (%) | 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.
GRAVITI Phase 3 Study – Crohn’s Disease
Hart et al (2025)3
- Through Week 48, one opportunistic infection was reported in the placebo and TREMFYA group (400 mg SC every 4 weeks followed by 200 mg SC every 4 weeks): esophageal candidiasis and fungal esophagitis, respectively.
- For occurrence of infections, see Table: Occurrence of Infections in GRAVITI Through Week 48.
| Placebo SCa | Placebo → TREMFYAb | TREMFYA 400 mg SC Q4W→100 mg SC Q8W | TREMFYA 400 mg SC Q4W→200 mg SC Q4W | |
|---|---|---|---|---|
| Safety analysis, N | 117 | 44 | 115 | 115 |
| Average duration of follow-up, week | 30.0 | 30.6 | 47 | 48 |
| Total PYs of follow-up, week | 67.3 | 25.8 | 103.5 | 105.7 |
| Most common AE, n (%) | ||||
| 12 (10.3) | 8 (18.2) | 15 (13.0) | 15 (13.0) |
| 8 (6.80 | 1 (2.3) | 11 (9.60) | 11 (9.6) |
| AEs of interests, n (%) | ||||
| 1 (0.9) | 0 | 0 | 1 (0.9)c |
| 0 | 0 | 0 | 0 |
| Abbreviations: AE, adverse event; PY, patients-year patients-years SC, subcutaneous; Q4W, every 4 weeks; Q8W, every 8 weeks.aIncludes all placebo participants excluding data after a participant is rescued with TREMFYA. bIncludes placebo participants who were rescued with TREMFYA. Data in this group occurred after a participant crossed over to TREMFYA.cRecord after database lock. | ||||
Analysis of Safety Data Through 2 Years From the Long-term Extensions of GALAXI and GRAVITI7
- All randomized patients from GALAXI 2, GALAXI 3 and GRAVITI who received ≥1 TREMFYA dose were included.
- For occurrence of infections in GALAXI 2, GALAXI 3 and GRAVITI long-term data, see Table: Occurrence of Serious Infections in GALAXI and GRAVITI Through Week 96.
| GALAXI 2 and GALAXI 3 (pooled) | GRAVITI | |||||
|---|---|---|---|---|---|---|
| Placeboab | TREMFYA 100a,b | TREMFYA 200c | Placebod | TREMFYA 100 | TREMFYA 200 | |
| Safety analysis, N | 153 | 296 | 407 | 117 | 115 | 115 |
| Average duration of follow-ups, weeks | 28.5 | 82.1 | 73.2 | 36.4 | 88.6 | 93.3 |
| Total patient-years of follow-up | 83.4 | 465.5 | 570.9 | 81.7 | 195.2 | 205.7 |
| Serious Infectionsd, n | 4 | 3 | 8 | 0 | 2 | 1 |
| Serious infection/100 patient-years follow-up | 4.8 | 0.6 | 1.4 | 0 | 1.0 | 0.5 |
| aUp to dose adjustment.bTreatment group at start of the long-term extension period. Includes events for participants who dose adjusted from week 48 up to the time point od dose adjustment, and all events from week 48 through week 96 for participants who never dose adjusted.cParticipants who were randomized to receive TREMFYA 200 mg SC q4w maintenance dosing, or had a dose adjustment (including “sham”) to TREMFYA 200 mg SC q4w dosing from all treatment groups (including those randomized to placebo and ustekinumab); for participants who has a dose adjustment, only data after their first TREMFYA 200 mg dose are included. dIncludes all placebo participants, excluding data after TREMFYA rescue. eInfections are based on MedDRA system organ class “Infections and Infestations” | ||||||
ASTRO Phase 3 Study – Ulcerative Colitis
The safety and efficacy of TREMFYA was evaluated in a phase 3, randomized, double-blind, placebo-controlled, treat-through study in adult patients with moderately to severely active UC. ASTRO consisted of a 24-week main treatment phase followed by an extension phase.2
Through Week 24
- Through week 24, 4 (1%) patients treated with TREMFYA had serious infections but did not cause study drug interruption and resolved:
- In the TREMFYA 400/100 group, one patient developed gastroenteritis.
- In the TREMFYA 400/200 group, one patient reported pilonidal disease and two were diagnosed with appendicitis.
- One participant in the TREMFYA treated group reported an opportunistic infection (cytomegalovirus colitis).
- All serious infectious infections were considered moderate in severity except for one case of severe appendicitis.
- For details on occurrence of infections in TREMFYA-treated and placebo-treated patients through week 48, see Table: Occurrence of Infections in ASTRO Through Week 48.
| Placeboa | GUS 400 mg SC → 100 mg SC q8w | GUS 400 mg SC → 200 mg SC q4w | |
|---|---|---|---|
| Safety analysis set, N | 139 | 139 | 140 |
| Most common AE (incidence >10% in either GUS group), n (%) | |||
| 5 (3.6%) | 16 (11.5%) | 13 (9.3%) |
| Events per 100 participant-years | |||
| 38.4 | 6.5 | 8.2 |
| 81.8 | 77.9 | 69.9 |
| 3.7 | 0.8 | 2.5 |
| Participants with 1 or more AEs of interest, n (%) | |||
| 0 | 1(0.7%) | 1(0.7%) |
| 0 | 0 | 0 |
| Abbreviations: AE, Adverse events; GUS, Guselkumab; Q4w, Every 4 weeks SC, Subcutaneous; aIncludes all placebo participants, excluding data after a participant is rescued with guselkumab bOpportunisitic Infections adverse events are defined as the narrow term in the MedDRA SMQ of “Opportunisitic infections”. | |||
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.1,9
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, n (%) | 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:6
- 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
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