GALAXI 1: Continued subcutaneous Tremfya benefits IV induction non-responders with Crohn’s
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Key takeaways:
- At week 48, 58.7% of guselkumab IV induction non-responders achieved clinical response and 41.3% achieved remission with continued subcutaneous therapy.
- Notably, 31.7% achieved endoscopic response at this time.
VANCOUVER, British Columbia — More than 50% of patients with Crohn’s disease who did not achieve clinical response at week 12 to IV Tremfya achieved response at week 48 after continuing subcutaneous therapy, according to a presenter.
“This phase 2 GALAXI 1 study evaluated the efficacy as well as the safety of [Tremfya (guselkumab, J&J Innovative Medicines)], a human selective IL-23p19 subunit antagonist, in patients who suffered with moderate to severely active Crohn’s disease using a treat-through study design,” Anita Afzali, MD, MPH, MHCM, FACG, professor and executive vice chair for clinical operations in the department of internal medicine at the University of Cincinnati College of Medicine, told attendees at the ACG Annual Scientific Meeting.
“Previously, we reported that patients who were in clinical response after 12 weeks of IV induction had higher rates of clinical, as well as endoscopic, outcomes at week 48 than the overall study population,” Afzali continued. “In this post hoc analysis, we report the outcomes for patients who did not achieve a clinical response following that initial IV induction at week 12.”
In the GALAXI 1 study, patients in the induction phase were randomized to guselkumab 1,200 mg IV (n = 61), 600 mg IV (n = 63) or 200 mg IV (n = 61) every 4 weeks; one dose of Stelara (ustekinumab, Janssen) 6 mg/kg IV (n = 63), which was used as a reference; or placebo (n = 61). Participants transitioned to subcutaneous dosing from weeks 12 to 48 during the maintenance portion of the study.
At week 12, 34.1% of patients who received guselkumab and 33.3% of patients who received ustekinumab did not achieve clinical response based on CD Activity Index (CDAI).
Afzali noted that guselkumab induction non-responders had longer disease duration compared with the total study population (mean, 11.1 vs. 10 years), as well as a higher percentage of prior biologic failure (60.3% vs. 54.6%) and higher active severe disease based on endoscopic score (58.7% vs. 47.6%).
According to results, 46% of guselkumab non-responders achieved clinical response by week 24 and 30% achieved clinical remission.
At week 48, 58.7% of these patients achieved clinical response and 41.3% achieved clinical remission. Notably, 31.7% achieved endoscopic response at this time point.
“More than half of the patients who did not achieve a clinical response after that initial guselkumab IV induction at week 12 subsequently achieved clinical response at week 48 while continuing on with the guselkumab subcutaneous therapy,” Afzali said. “Many of these patients went on to achieve either clinical remission or endoscopic response at week 48.”
She continued, “The results from this analysis support continued treatment with subcutaneous guselkumab for patients who do not initially demonstrate a clinical response after initial IV induction.”
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Afzali A, et al. Efficacy of guselkumab in patients with moderately to severely active Crohn’s disease not in clinical response at week 12: Results from the GALAXI 1 study. Presented at: ACG Annual Scientific Meeting; Oct. 20-25, 2023; Vancouver, British Columbia (hybrid meeting).
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