TREMFYA®
(guselkumab)
Medical inquiries
This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.
TREMFYA® (guselkumab)
Medical Information
TREMFYA - Retreatment of Ulcerative Colitis after a Drug Free Interval
Last Updated: 09/11/2024
SUMMARY
- The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
- The efficacy and safety of TREMFYA were evaluated in adult patients with moderately to severely active ulcerative colitis through a phase 3, randomized, double-blind, placebo-controlled clinical trial program.1
- During the induction study, patients were randomized to receive TREMFYA 200 mg intravenous (IV) or placebo at weeks 0, 4, and 8. At week 12, patients who had a clinical response to TREMFYA IV induction therapy were re-randomized to receive TREMFYA 200 mg subcutaneous (SC) every 4 weeks (q4w), TREMFYA 100 mg every 8 weeks (q8w), or placebo.2
- Patients who were randomized to placebo SC in the maintenance study who met the loss of response criteria were eligible for a dose adjustment to TREMFYA 200 mg SC q4w between week 8 and week 32 of the maintenance study.2
- Loss of clinical response was defined as patients who no longer satisfied the definition of clinical response, defined as a decrease from induction baseline in the modified Mayo score by ≥30% and ≥2 points, with either a ≥1 point decrease from induction baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.1
- For the symptomatic response and remission rates following a treatment interruption, See Table: Symptomatic Response and Symptomatic Remission Rates through 12 Weeks After Resuming TREMFYA.
| Weeks After Dose Adjustment | Placebo→TREMFYA 200 mg SC Q4W |
|---|---|
| Symptomatic responseb | |
| Week 0 | 8/69 (11.6) |
| Week 4 | 49/69 (71) |
| Week 8 | 57/69 (82.6) |
| Week 12 | 62/69 (89.9) |
| Symptomatic remissionc | |
| Week 0 | 2/69 (2.9) |
| Week 4 | 26/69(37.7) |
| Week 8 | 40/69(58) |
| Week 12 | 44/69(63.8) |
| Abbreviations: SC, subcutaneous; Q4W, every 4 weeks. aIncludes only patients with a modified Mayo score of 5-9 at induction baseline. bSymptomatic response is defined as a decrease from induction baseline in the symptomatic Mayo score by ≥30% and ≥1 point, with either a ≥1 point decrease from induction baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. cSymptomatic remission is defined as a stool frequency subscore of 0 or 1 and not increased from induction baseline, a rectal bleeding subscore of 0. | |
Literature Search
A literature search of MEDLINE®
References
| 1 | Data on File. Guselkumab. Clinical Study Report (44-Week) CNTO1959UCO3001. Janssen Research & Development, LLC. EDMS-RIM-799057; 2024. |
| 2 |