(guselkumab)
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TREMFYA® (guselkumab)
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TREMFYA - Occurrence of Major Adverse Cardiovascular Events in Adult Patients with Crohn’s Disease or Ulcerative Colitis
Last Updated: 09/12/2024
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 data related to the major adverse cardiovascular events (MACE) from these 2 programs.1
, 2
CLINICAL DATA – CROHN’S DISEASE
Phase 3 Clinical Studies- GALAXI 2 and 3
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).
| 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 | ||||
| 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. | ||||
CLINICAL DATA – ULCERATIVE COLITIS
QUASAR Phase 3 Maintenance Study
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.
| 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 | |||
| 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. | |||
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 and Virtual. |
| 2 |