Tremfya (guselkumab) demonstrates superiority versus Steklara (ustekinumab) in phase III Crohn’s disease program

Data showed that both maintenance doses of Tremfya met the composite co-primary endpoints compared to placebo in each individual study. In results versus ustekinumab, both doses of Tremfya demonstrated statistically significant and clinically meaningful differences on all prespecified pooled endoscopic endpoints. These findings were featured as a late-breaking oral presentation (Abstract #1057b) at Digestive Disease Week (DDW) 2024.

The GALAXI 2 (n=508) and GALAXI 3 (n=513) studies were the first-ever double-blind registrational head-to-head clinical trials to demonstrate superiority versus ustekinumab in CD.

The studies tested two doses of Tremfya – 200mg every four weeks and 100mg every eight weeks. Both doses met statistical significance for endoscopic response compared with Stelara, with the monthly dose yielding a response in 52.7% of patients (p<0.001) and the every-two-months dose producing response in 47.9% of patients (p="0.009)," compared to 37.1% of patients given stelara. for endoscopic remission, the monthly dose yielded a 37.2% remission rate (p><0.001) and the less-frequent dose a 33.2% rate (p="0.024)," compared to 24.7% for stelara. both study drug doses also met statistical superiority on deep remission as measured by endoscopy. on a combined endpoint of clinical remission and endoscopic response, the monthly dose produced a 47.3% response rate (p><0.001) and the every-two-months dose a rate of 41.6% (p="0.049)," compared with a 33.7% rate for stelara. however, on a separate endpoint of clinical remission, the tremfya doses showed a numerical trend but did not meet statistical significance versus stelara.

Tremfya has a well-studied safety profile and years of patient experience in approved indications and earlier inflammatory bowel disease trials. In the GALAXI program, the safety profile was consistent with that of the currently approved indications. Through Week 48, the number of patients with at least one or more ( greater than 1) adverse events (AE), greater than 1 serious AEs, and AEs leading to discontinuation were similar across patients who received Tremfya, placebo, or ustekinumab. The proportions of patients with serious infections and AEs of interest were low.

Editors Notes; i. Endoscopic response is defined as greater than 50 percent improvement from baseline in the Simple Endoscopic Score in Crohn’s disease (SES-CD) (primary efficacy analysis set (nonresponder imputation)).ii. Endoscopic remission is defined as SES-CD less than 4 and greater than 2-point reduction from baseline and no subscore greater than 1 in any individual component. iii. Deep remission endpoint consists of clinical remission and endoscopic remission together. iv. Clinical remission is defined as a Crohn’s Disease Activity Index (CDAI) score of less than 150 (primary efficacy analysis set (nonresponder imputation)).