VIDEO: Subcutaneous guselkumab induction achieves clinical remission in Crohn’s disease
Click Here to Manage Email Alerts
Key takeaways:
- At the end of induction, 56% of patients treated with subcutaneous guselkumab vs. 21% on placebo achieved clinical remission.
- Endoscopic response was achieved by 41% vs. 21%, respectively.
PHILADELPHIA — Subcutaneous guselkumab outperformed placebo and, as with IV administration, appears to have “profound induction effects” on both clinical remission and endoscopic response in Crohn’s disease, a presenter told Healio.
“Back at DDW, we presented the results of the GALAXI 2 and 3 study comparing guselkumab to not only placebo but to ustekinumab,” Remo Panaccione, MD, FRCPC, professor of medicine and director of the Inflammatory Bowel Disease Unit at the University of Calgary, said. “The objective of GRAVITI was to evaluate the efficacy and safety of guselkumab subcutaneous induction, and then maintenance, in patients with moderate to severe Crohn’s disease.”
In the phase 3, treat-through GRAVITI study, Panaccione and colleagues enrolled approximately 350 patients (mean age, 37.5 years) who were randomly assigned subcutaneous guselkumab 400 mg induction followed by 200 mg maintenance or 400 mg induction followed by 100 mg maintenance or placebo.
The co-primary endpoints were clinical remission and endoscopic response at week 12.
According to Panaccione, 56% of guselkumab-treated patients vs. 21% of placebo-treated patients achieved clinical remission and 41% vs. 21%, respectively, achieved endoscopic response, both of which were “highly statistically significant.”
In addition, the maintenance doses were also “highly effective and statistically significantly better” compared with placebo.
“The most important part of the trial is that it looks like you can either give subcutaneous or IV guselkumab and have profound induction effects both for clinical remission and for endoscopic response,” Panaccione said.
Collapse
Panaccione R, et al. Efficacy and safety of subcutaneous guselkumab induction therapy in patients with moderately to severely active Crohn’s disease: Results through week 48 from the phase 3 GRAVITI study. Presented at: ACG Annual Scientific Meeting; Oct. 25-30, 2024; Philadelphia (hybrid meeting).
Read more about
Click Here to Manage Email Alerts