Guselkumab for the treatment of Crohn disease: Induction results from the phase 2 GALAXI-1 study

GastroenterologySandborn WJ, D’Haens GR, Reinisch W, et al. | February 11, 2022

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In patients with Crohn disease, greater clinical and endoscopic improvements at week 12 were conferred by all three dose regimens of guselkumab (a selective p19 interleukin-23 antagonist) when compared with placebo, along with a favorable safety profile.

  • In a phase 2 double-blind, placebo-controlled study (GALAXI-1), patients were randomized 1:1:1:1:1 to: intravenous guselkumab 200 mg, 600 mg, or 1,200 mg at weeks 0, 4, 8; intravenous ustekinumab ∼6 mg/kg at week 0 and 90 mg subcutaneously at week 8; or placebo.

  • Participants were 309 patients, of whom nearly 50% had disease refractory to prior biologic therapy.

  • Compared to placebo, significantly greater decreases from baseline in Crohn’s Disease Activity Index and significantly greater proportions of patients had clinical remission in each guselkumab group at week 12.

  • At week 12, the proportions of patients who achieved clinical response, Patient Reported Outcomes-2 remission, clinical-biomarker response, and endoscopic response were greater with guselkumab treatment than placebo.

  • Ustekinumab was also found to be efficacious than placebo.

  • Across treatment groups, the observed safety event rates were generally similar.

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