TREMFYA®
(guselkumab)
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TREMFYA® (guselkumab)
Medical Information
TREMFYA – Dose Escalation During TREMFYA Maintenance Therapy in Ulcerative Colitis
Last Updated: 01/09/2025
SUMMARY
- The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
- The safety and efficacy of TREMFYA were evaluated in adult patients with moderately to severely active ulcerative colitis in a phase 3, randomized, double-blind, placebo-controlled, multicenter clinical program (QUASAR). The program consisted of a 12-week intravenous (IV) induction study and a 44-week subcutaneous (SC) maintenance study.1
- During the induction study, patients were randomized 3:2 to receive either TREMFYA 200 mg or placebo by IV infusion at Week 0, 4, and 8. During the maintenance study, patients who achieved clinical response 12 weeks following the IV administration of TREMFYA were re-randomized to receive a SC maintenance regimen of either TREMFYA 100 mg every 8 weeks (q8w), TREMFYA 200 mg every 4 weeks (q4w) or placebo for up to 44 weeks.1
- Patients who were rerandomized in the maintenance study and met criteria for loss of clinical response were eligible to receive a single-blinded dose adjustment as described below:
- Loss of clinical response was defined as no longer satisfies the definition of clinical response, which is a decrease from induction baseline in the modified Mayo score by ≥30% and ≥2 points, with either a ≥1 point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1, which included endoscopic assessment.2
CLINICAL DATA
QUASAR Study
In a phase 3 maintenance study, the proportion of patients with symptomatic response and remission through 12 weeks after dose adjustment is presented in Table: Patients in Symptomatic Response and Remission through 12 Weeks After Dose Adjustment.
| Dose Escalation | Randomized Placebo SCa | TREMFYA 100 mg SC q8w→TREMFYA 200 mg SC q4w | TREMFYA 200 mg SC q4w→TREMFYA 200 mg SC q4w |
|---|---|---|---|
| Analysis set: dose adjustment, N | 69 | 19 | 30 |
| Patients in symptomatic responseb | |||
| At the time of dose adjustmentc 95% CI for treatment proportiond | 8 (11.6) (5.1-21.6) | 1 (5.3) (0.1-26.0) | 9 (30.0) (14.7-49.4) |
| 4 weeks after dose adjustmente 95% CI for treatment proportiond, (%) | 49 (71.0) (58.8-81.3) | 10 (52.6) (28.9-75.6) | 18 (60.0) (40.6-77.3) |
| 8 weeks after dose adjustmente, n (%) 95% CI for treatment proportiond, (%) | 57 (82.6) (71.6-90.7) | 11 (57.9) (33.5-79.8) | 17 (56.7) (37.4-74.5) |
| 12 weeks after dose adjustmente, n (%) 95% CI for treatment proportiond, (%) | 62 (89.9) (80.2-95.8) | 11 (57.9) (33.5-79.8) | 22 (73.3) (54.1-87.7) |
| Patients in symptomatic remissionf | |||
| At the time of dose adjustmentc, n (%) 95% CI for treatment proportiond, (%) | 2 (2.9) (0.4-10.1) | 0 (0.0-17.7) | 5 (16.7) (5.6-34.7) |
| 4 weeks after dose adjustmente, n (%) 95% CI for treatment proportiond, (%) | 26 (37.7) (26.3-50.2) | 3 (15.8) (3.4-39.6) | 9 (30.0) (14.7-49.4) |
| 8 weeks after dose adjustmente, n (%) 95% CI for treatment proportiond, (%) | 40 (58.0) (45.5-69.8) | 4 (21.1) (6.1-45.6) | 11 (36.7) (19.9-56.1) |
| 12 weeks after dose adjustmente, n (%) 95% CI for treatment proportiond, (%) | 44 (63.8) (51.3-75.0) | 5 (26.3) (9.2-51.2) | 12 (40.0) (22.7-59.4) |
| Note: This data is not controlled for multiplicity. Note: Includes only subjects with modified Mayo score 5-9 at induction baseline. The symptomatic Mayo score is defined as the sum of the stool frequency and the rectal bleeding subscore. Abbreviations: CI, confidence interval; q4w, every 4 weeks; q8w, every 8 weeks; SC, subcutaneous. aSubjects who were in clinical response to TREMFYA IV induction dosing and were randomized to placebo SC on entry into this maintenance study. 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. cIncludes the closest nonmissing status at or prior to the dose adjustment. Subjects with data were considered not to be in symptomatic response or remission. dThe CIs for the proportion of subjects meeting endpoint in each treatment group were based on the exact confidence limits. eNonresponder imputation for missing data: Subjects who were missing one or more Mayo subscore pertaining to this endpoint (stool frequency and /or rectal bleeding) at the designed timepoint were considered not to be in symptomatic response or remission.fSymptomatic remission is defined as a stool frequency subscore 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline. | |||
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. [published online ahead of print December 17, 2024]. Lancet. doi:10.1016/s0140-6736(24)01927-5. |
| 2 |