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TREMFYA - Exposure-Response Relationships in Crohn's Disease Clinical Programs - GALAXI and GRAVITI
Last Updated: 10/18/2026
SUMMARY
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- Pooled analyses from the GALAXI and GRAVITI trials demonstrated positive exposure-response relationships between serum guselkumab concentrations and selected efficacy endpoints. No association was observed between guselkumab concentrations and the incidence of infections, serious infections, serious adverse events, or abnormal liver function tests.1
CLINICAL DATA
Sands et al (2026)1 evaluated the pharmacokinetics (PK) and exposure-response (E-R) of TREMFYA subcutaneous (SC) maintenance regimens in the GALAXI and GRAVITI trials.
Study Design/Methods
- The phase 2 GALAXI 1 trial, phase 3 GALAXI 2 and 3 trials, and phase 3 GRAVITI trial used a treat-through design with identical TREMFYA SC maintenance regimens (100 mg every 8 weeks [q8w] or 200 mg every 4 weeks [q4w]) in patients with Crohn’s disease (CD).
- Population PK modeling was performed using pooled data from the GALAXI (through week 48) and GRAVITI (through week 24) programs.
- E-R efficacy relationships at week 48 and the covariate impacts were evaluated using descriptive analyses and modeling approaches; associations between exposure and safety were also analyzed.
- The analysis included patients who received ≥1 TREMFYA dose, had a Simple Endoscopic Score for Crohn’s Disease (SES-CD) score of ≥6 (or ≥4 for patients with isolated ileal CD), and had ≥1 postbaseline PK value.
Results
- Positive E-R trends were observed between steady-state guselkumab concentrations and efficacy outcomes at week 48 and were maintained after accounting for clearance or half-life; see Figure: E-R Trends at Week 48 During Maintenance Treatment.
Abbreviations: Cave, week 40-48, average concentration from week 40 to week 48; Ctrough, week 48, trough concentration at week 48; E-R, exposure-response; GUS, guselkumab; IV, intravenous; PBO, placebo; q4w, every 4 weeks; SC, subcutaneous.
- Exposures with TREMFYA 200 mg SC q4w were at the plateau of E-R curves, suggesting possible maximal response with this regimen.
- Baseline SES-CD or a clinical remission/endoscopic response at week 12 were associated with clinical remission or endoscopic response at week 48 in the PK model; see Table: Model-Predicted Week 48 Response Rates for SC Maintenance Treatment Groups, Stratified by Covariates.
| Response Variable at Week 48 | Covariates | Response Rate, % (95% CI) | ||
|---|---|---|---|---|
| Endoscopic response | Baseline SES-CD >12 | Endoscopic Response at Week 12 | TREMFYA 100 mg SC q8w | TREMFYA 200 mg SC q4w |
| Yes | Yes | 77.9 (68.0-85.4) | 86.8 (79.8-91.6) | |
| Yes | No | 42.6 (31.8-54.2) | 58.0 (46.6-68.6) | |
| No | Yes | 58.9 (48.0-68.9) | 69.2 (59.4-77.5) | |
| No | No | 23.2 (16.9-30.8) | 32.1 (24.6-40.7) | |
| Clinical remission | Clinical Remission at Week 12 | Endoscopic Response at Week 12 | TREMFYA 100 mg SC q8w | TREMFYA 200 mg SC q4w |
| Yes | No | 88.6 (83.2-92.4) | 92.3 (88.3-95.1) | |
| Yes | Yes | 94.6 (91.1-96.7) | 96.8 (94.6-98.2) | |
| No | No | 55.3 (46.4-63.9) | 65.8 (57.3-73.4) | |
| No | Yes | 73.5 (63.6-81.5) | 83.1 (75.1-88.9) | |
| Abbreviations: CI, confidence interval; Ctrough, trough concentration; q4w, every 4 weeks; q8w, every 8 weeks; SC, subcutaneous; SES-CD, Simple Endoscopic Score for Crohn’s Disease. Note: Response rates were calculated using the model-predicted median week 48 Ctrough value of 0.84 μg/mL for the 100 mg SC q8w regimen and 7.60 μg/mL for the 200 mg SC q4w regimen. | ||||
- There were no associations observed between guselkumab concentrations and infections, serious infections, serious adverse events, or abnormal liver function tests.
Literature Search
A literature search of MEDLINE®
References
| 1 | Sands BE, D’Haens GR, Adedokun OJ, et al. Pharmacokinetics and exposure-response relationships of subcutaneous guselkumab maintenance in participants with moderately to severely active Crohn’s disease. Abstract presented at: American College of Gastroenterology (ACG); October 9-14, 2026; Nashville, TN. |
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