(guselkumab)
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TREMFYA® (guselkumab)
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TREMFYA - Occurrence of Hepatic-Related Adverse Events in Adult Patients with Crohn’s Disease or Ulcerative Colitis
Last Updated: 09/23/2024
SUMMARY
- The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
- Summarized below is safety information related to clinically important hepatic disorders from a pooled analysis of the phase 3 GALAXI 2 and 3 studies in adults with moderately to severely active Crohn’s disease (CD) as well as data from the phase 3 clinical trial program (QUASAR) in adults with moderately to severely active ulcerative colitis (UC).1
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CLINICAL DATA – CrohN’s Disease
GALAXI 2 and 3
Panaccione et al (2024)1 reported the results from the phase 3, randomized, double-blind, placebo- and comparator-controlled studies (GALAXI 2 and 3) that evaluated the efficacy and safety of TREMFYA in adults with moderately to severely active CD through week 48.
- Clinically important hepatic disorders were reported among patients in the TREMFYA groups. Clinically important hepatic disorders were defined as hepatic disorder adverse events (AEs) reported as serious or events leading to discontinuation of the study agent. See Table: Occurrence of Clinically Important Hepatic Disorders in GALAXI 2 and 3 Pooled Results through Week 48.
| 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 | ||||
| Clinically important hepatic disordersc | 3 (1) | 1 (0.3) | 0 | 0 |
| Abbreviations: AE, adverse event; IV, intravenous; MedDRA, Medical Dictionary for Regulatory Activities; Q4W, every 4 weeks; Q8W, every 8 weeks; SAE, serious adverse event; SC, subcutaneous; SMQ, Standardised MedDRA Query. aEvents attributed to participants randomized to placebo, except where a participant is randomized to placebo and crossover 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. AEs are coded using the MedDRA v26.0. Hepatic disorder AEs are defined as the narrow terms in the MedDRA SMQ of “Drug Related Hepatic Disorders-Comprehensive Search”. cClinically important hepatic disorders are defined as hepatic disorder AEs reported as SAEs or AEs leading to discontinuation of study intervention. | ||||
CLINICAL DATA – ULCERATIVE COLITIS
QUASAR
The safety and efficacy of TREMFYA was evaluated through the phase 3, randomized, double-blind, placebo-controlled clinical trial program (QUASAR) in adult patients with moderately to severely active UC. Through 12 weeks of induction, the majority of hepatic disorder AEs were mild or moderate and none were considered serious or led to discontinuation of the study agent.2
Through 44 weeks of maintenance therapy, the proportion of participants with hepatic disorders were similar among treatment groups in the randomized safety analysis set. No events meeting Hy’s law were reported, and no hepatic disorder adverse events were serious AEs or led to discontinuation of the study intervention.3
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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