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

Gastroenterology Feb 12, 2022

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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