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TREMFYA® (guselkumab)

Medical Information

TREMFYA - Occurrence of Major Adverse Cardiovascular Events in Adult Patients with Crohn’s Disease or Ulcerative Colitis

Last Updated: 03/16/2026

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 program, respectively. Summarized below is data related to the major adverse cardiovascular events (MACE) from these programs.¹^-⁶
The safety of TREMFYA, including MACE, 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.⁴^,⁷

Pooled Safety Analysis Across Crohn’s Disease and Ulcerative Colitis

Faye et al (2026)⁴ 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 of 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 occurrence of MACE specific to IBD (CD & UC) pooled population, see Table: Occurrence of MACE Among Patients 60 Years or Older Through Approximately 1 Year.

Occurrence of MACE Among Patients 60 Years or Older Through Approximately 1 Year⁴

	IBD Population^a
	PBO (N=98)^b	TREMFYA (N=238)^c
TEAE/100 PY (95% Cl)^d
Serious Adverse Events	23.0 (11.5, 41.1)	11.4 (7.0, 17.6)
MACE^e	4.2 (0.5, 15.1)	1.1 (0.1, 4.1)
Abbreviations: CD, Crohn’s disease; CI, confidence interval; IBD, inflammatory bowel disease; MACE, major adverse cardiovascular event; PBO, placebo; TEAE, treatment; UC, ulcerative colitis.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 Disease: 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. ^eMACE were identified by clinical review.

CLINICAL DATA in crohn’s disease and ulcerative colitis

Phase 3 Clinical Studies- GALAXI – 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 MACE data, please see Table: Occurrence of MACE Through Week 48 of GALAXI 2 and 3 (Pooled Results).

Occurrence of MACE Through Week 48 of GALAXI 2 and 3 (Pooled Results)¹

	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→SC^a
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 ≥1^b
MACE, n (%)	1 (0.3)	0	0	0
Abbreviations: IV, intravenous; MACE, major adverse cardiovascular events; MedDRA, Medical Dictionary for Regulatory Activities; 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 crosses 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 version 26.0. MACE were identified by clinical review.

GRAVITI Phase 3 Study – Crohn’s Disease

Hart et al (2025)⁵ reported the efficacy and safety results of SC induction therapy with TREMFYA followed by SC maintenance therapy in adults with moderately to severely active CD through week 48.

Through week 48, there were no reports of MACE in patients treated with TREMFYA.

QUASAR Phase 3 Maintenance Study – Ulcerative Colitis

The safety of TREMFYA was evaluated through phase 3, randomized, double-blind, placebo-controlled study in adult patients with moderately to severely active UC (QUASAR). This included a 44-week randomized, withdrawal maintenance study.²

For the occurrence of MACE data in randomized TREMFYA- and placebo-treated patients, please see Table: Occurrence of MACE Through Week 44 in the QUASAR Maintenance Study.

Occurrence of MACE Through Week 44 in the QUASAR Maintenance Study²

	Randomized TREMFYA		Randomized Placebo (TREMFYA Withdrawal)
	100 mg Q8W	200 mg Q4W	Randomized Placebo (TREMFYA Withdrawal)
Randomized safety analysis set, N	186	190	192
Average duration of follow-up, weeks	40.5	39.2	34
Participants with ≥1
MACE, n (%)	0	1 (0.5)	0
Abbreviations: MACE, major adverse cardiovascular events; Q4W, every 4 weeks; Q8W, every 8 weeks. ^aIncludes only patients with a modified Mayo score of 5-9 at induction baseline who were randomized in the maintenance study and data up to the time of dose adjustment for patients who underwent dose adjustment. Patients were counted only once for any given event.

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.³

Through week 24, 1 patient treated with TREMFYA had cerebral infraction.³
Through week 48, MACE was reported in 1 (0.7%) patient treated with PBO and 2 (1.4%) patients treated with TREMFYA.⁶

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:⁷
- 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.
Through 1 year, 2 deaths occurred in TREMFYA treated patients: one patient experienced acute myocardial infarction with pre-existing cardiovascular risk factors and non-suicidal gunshot wound. Please see Table: Total Patient Years of Follow-up and Occurrence of MACE per 100 Patient Years.

Total Patient Years of Follow-up and Occurrence of MACE per 100 Patient Years⁷

	Pooled IBD
	Induction Period (Weeks 0-12)^a		Through 1 year
	Placebo (n=743)	TREMFYA (n=1703)	Placebo^b(n=886)	TREMFYA^c (n=2057)
Total PYs of follow-up	171.6	399.9	447.4	1752.1
Events/100 PY (95% CI)^d
Major adverse cardiovascular events	1.17 (0.14, 4.21)	0.50 (0.06, 1.81)	0.45 (0.05, 1.61)	0.29 (0.09, 0.67)
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 22 January 2026.

References

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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.
2	Rubin DT, Allegretti JR, Panés J, et al. The efficacy and safety of guselkumab as maintenance therapy in patients with moderately to severely active ulcerative colitis: results from the phase 3 QUASAR maintenance study. Oral Presentation presented at: Digestive Disease Week (DDW); May 18-21, 2024; Washington, DC and Virtual.
3	Long M, Allegretti J, Danese S, et al. Efficacy and safety of subcutaneous guselkumab induction therapy in participants with moderately to severely active ulcerative colitis (ASTRO): a double-blind, treat-through, randomised, placebo-controlled, phase3 trial. [published online ahead of print January 13, 2026]. doi: 10.1016/S2468-1253(25)00322-X. Lancet Gastroenterol Hepatol.
4	Faye A, Sebastian S, McCaffrey V, et al. Safety of guselkumab in patients aged ≥60 years with immune-mediated inflammatory diseases: a pooled analysis of registrational trials in UC, CD, PsA and PsO [abstract]. Journal of Crohn’s and Colitis. 2026;20:(Suppl. 1). Abstract P1069.
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. Gastroenterology. 2025;169(2):308-325.
6	Allegretti JR, Peyrin-Biroulet L, Long MD, et al. Efficacy and safety of subcutaneous guselkumab induction and maintenance therapy in participants with ulcerative colitis: results through week 48 from the phase 3 ASTRO study. Oral Presentation presented at: United European Gastroenterology Week (UEGW); October 7, 2025; Berlin, Germany.
7	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. Abstract presented at: 20th Congress of European Crohn’s and Colitis Organisation (ECCO); February 19-22, 2025; Berlin, Germany.

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