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TREMFYA® (guselkumab)
Medical Information
TREMFYA - Retreatment of Ulcerative Colitis after a Drug Free Interval
Last Updated: 10/27/2025
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 that assessed the efficacy and safety of intravenous (IV) induction and subcutaneous (SC) maintenance (QUASAR) and a phase 3, randomized, double-blind placebo-controlled treat through study that assessed the efficacy and safety of SC induction and maintenance therapy (ASTRO).1
- 3 - During the QUASAR 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 SC every 4 weeks (q4w), TREMFYA 100 mg every 8 weeks (q8w), or placebo.1
- Patients who were randomized to placebo SC in the maintenance study who met the loss of response criteria were eligible for a blinded dose adjustment to TREMFYA 200 mg SC q4w between week 8 and week 32 of the maintenance study.1
- 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,
2
- For the symptomatic response and remission rates following a treatment interruption in the QUASAR clinical program, See Table: Symptomatic Response and Symptomatic Remission Rates through 12 Weeks After Resuming TREMFYA.2
| Weeks After Dose Adjustment | Placebo→TREMFYA 200 mg SC Q4W (N=69) |
|---|---|
| Symptomatic responseb | |
| Week 0 | 8 (12) |
| Week 4 | 49 (71) |
| Week 8 | 57 (83) |
| Week 12 | 62 (90) |
| Symptomatic remissionc | |
| Week 0 | 2 (3) |
| Week 4 | 26 (38) |
| Week 8 | 40 (58) |
| Week 12 | 44 (64) |
| Abbreviations: SC, subcutaneous; Q4W, every 4 weeks. a 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. | |
- ASTRO did not evaluate retreatment with TREMFYA after a drug free interval.3
Literature Search
A literature search of MEDLINE®
References
| 1 | Rubin D, Allegretti J, Panés J, et al. Guselkumab in patients with moderately to severely active ulcerative colitis (QUASAR): phase 3 double-blind, randomised, placebo-controlled induction and maintenance studies. Lancet. 2025;405(10472):33-49. |
| 2 | |
| 3 |