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TREMFYA® (guselkumab)
Medical Information
Clinical Remission through Week 12 in Crohn's Disease
Last Updated: 02/13/2026
SUMMARY
- The efficacy and safety of TREMFYA were assessed in adult patients with moderately to severely active Crohn's disease (CD) in the phase 3 GALAXI 2 and GALAXI 3 trials. Both were identically designed randomized, double-blind, active comparator, placebo (PBO)-controlled, treat-through trials.1
- Additionally, TREMFYA was evaluated in a double-blind, PBO-controlled, treat-through study (GRAVITI), which assessed the efficacy and safety of subcutaneous (SC) TREMFYA from induction through week 24 in adults with moderately to severely active CD. At week 24, all patients entered an extension phase and received the treatment until week 48.2
- Clinical remission through week 12 in the GALAXI and GRAVITI trials is reported below.3
CLINICAL DATA
Afzali et al (2025)3 evaluated clinical remission in patients with CD treated with TREMFYA intravenous (IV) or SC induction through week 12, based on data from the GALAXI and GRAVITI studies.
Study Design/Methods
- The analysis included patients from GRAVITI (N=347), GALAXI 2 (N=508), and GALAXI 3 (N=513) through week 12.
- Eligible participants had a Crohn’s Disease Activity Index (CDAI) score of 220-450 and a history of intolerance or inadequate response to oral corticosteroids, azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX), or biologic therapies (tumor necrosis factor [TNF] antagonists or vedolizumab).
- In GRAVITI, patients received induction therapy with TREMFYA 400 mg SC or PBO at weeks 0, 4, and 8.
- In GALAXI 2 and GALAXI 3, patients received induction therapy with TREMFYA 200 mg IV or PBO at weeks 0, 4, and 8.
- In all 3 treat-through studies, patients in the TREMFYA groups received SC maintenance therapy following induction therapy.
Results
For clinical remission through week 12 across GRAVITI, GALAXI 2 and 3, see Table:
Data presented in the table below are originated from separate clinical trials. Due to differences in trial designs, this is purely illustrative and should not be used for direct comparisons.
| GRAVITI | GALAXI 2 | GALAXI 3 | ||||
|---|---|---|---|---|---|---|
| TREMFYA SC Induction (n=230) | Placebo (n=117) | TREMFYA IV Induction (n=289) | Placebo (n=76) | TREMFYA IV Induction (n=293) | Placebo (n=72) | |
| Patients achieving remission, % | ||||||
| Weeks 4 | 28.7b | 17.9 | 23.9b | 13.2 | 22.9b | 11.1 |
| Weeks 8 | 43.9b | 23.1 | 39.8b | 17.1 | 33.8b | 13.9 |
| Weeks 12 | 56.1 | 21.4 | 47.1 | 22.4 | 47.1 | 15.3 |
| P<0.001c | P<0.001c | P<0.001c | ||||
| Abbreviations: CDAI, Crohn’s Disease Activity Index; IV, intravenous; SC, subcutaneous. a bClinical remission at weeks 4 and 8 was not adjusted for multiplicity. cP-value at week 12 for TREMFYA vs placebo. | ||||||
Literature Search
A literature search of MEDLINE®
References
| 1 | Panaccione R, Feagan BG, Afzali A, et al. Efficacy and safety of intravenous induction and subcutaneous maintenance therapy with guselkumab for patients with Crohn’s disease (GALAXI-2 and GALAXI-3): 48-week results from two phase 3, randomised, placebo and active comparator-controlled, double-blind, triple-dummy trials. Lancet. 2025;406(10501):358-375. |
| 2 | |
| 3 |