GALAXI 2 & 3: Guselkumab proves efficacy in Crohn’s disease

Guselkumab, a monoclonal antibody targeting the IL-23p19 subunit, demonstrated superior short- and long-term clinical and endoscopic outcomes compared with ustekinumab and placebo in participants with moderate-to-severe Crohn’s disease (CD), according to the results from the GALAXI 2 & 3 trials at weeks 12 and 48.

Dr Remo Panaccione (University of Calgary, Canada) presented the findings of the identical GALAXI 2 & 3 trials (NCT03466411) [1]. In total, 508 and 513 participants were randomised 2:2:2:1 to receive guselkumab 200 mg intravenous (IV) every 4 weeks for 12 weeks, followed by 200 mg subcutaneous (SC) every 4 weeks, or 100 mg SC every 8 weeks, ustekinumab 6 mg/kg IV once followed by 90 mg SC every 8 weeks, or a placebo. Participants in the placebo group who did not achieve clinical response at week 12 were switched to ustekinumab IV followed by 90 mg SC every 8 weeks. The primary endpoints were clinical response at week 12 and clinical remission or endoscopic response at week 48.

At week 12, significantly more participants receiving guselkumab 200 mg IV achieved clinical remission (47.1% in both trials) compared with placebo (22.4% and 15.3%; P<0.001). Endoscopic response rates were also higher with guselkumab (37.7% and 36.2%) than with placebo (10.5% and 13.9%; P<0.001).

In both trials, a pooled analysis at week 48 showed guselkumab’s superiority over ustekinumab for endoscopic response (Δ10.6%; P=0.009 and Δ15.6%; P<0.001), endoscopic remission (Δ8.5%; P=0.024 and Δ12.3%; P=0.001), clinical remission plus endoscopic response (Δ7.8%; P=0.049 and Δ13.6%; P<0.001), and deep remission (Δ7.4%; P=0.40 and Δ11.3%; P=0.002).

Safety profiles were similar across guselkumab, ustekinumab, and placebo groups, with no differences in the proportion of participants with serious infections or with adverse events leading to discontinuation. No unexpected safety issues were reported.

“GALAXI 2 & 3 trials independently established the short- and long-term efficacy of guselkumab compared with placebo, and its statistical superiority to ustekinumab across multiple endpoints at week 48,” concluded Dr Panaccione.

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   1. Panaccione R, et al. Efficacy and safety of guselkumab therapy in patients with moderately to severely active Crohn’s disease: results of the GALAXI 2 & 3 phase 3 studies. 1057b, DDW 2024, 18–21 May, Washington DC, USA.

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Posted on 11 July 202424 July 2024