Guselkumab Efficacious for Moderately to Severely Active Crohn Disease in Adults
THURSDAY, July 24, 2025 -- Intravenous induction followed by subcutaneous maintenance therapy with guselkumab is efficacious for adults with moderately to severely active Crohn disease, according to a study published online July 17 in The Lancet.
Remo Panaccione, M.D., from the University of Calgary in Alberta, Canada, and colleagues examined the efficacy and safety of intravenous induction followed by subcutaneous maintenance therapy with guselkumab over 48 weeks in adults with moderately to severely active Crohn disease based on results from two phase 3 trials (GALAXI-2 [508 participants] and GALAXI-3 [513 participants]). Adults with moderately to severely active Crohn disease were enrolled at 257 sites across 40 countries and assigned to guselkumab 200 mg, guselkumab 100 mg, ustekinumab, or placebo.
The researchers found that compared with placebo, both guselkumab regimens were superior for the coprimary composite end point of clinical response at week 12 and clinical remission at week 48 in GALAXI-2 (adjusted treatment difference, 43 and 38 percent in the guselkumab 200-mg and 100-mg groups, respectively) and in GALAXI-3 (corresponding adjusted treatment difference, 35 and 34 percent, respectively). Compared with placebo, both guselkumab regimens were superior for the coprimary composite end point of clinical response at week 12 and endoscopic response at week 48 in GALAXI-2 (adjusted treatment difference, 33 and 34 percent, respectively) and in GALAXI-3 (adjusted treatment difference, 31 and 28 percent, respectively).
"Patients receiving guselkumab showed significantly higher rates of endoscopic healing and deep remission, critical indicators linked to fewer disease flares, hospitalizations, and long-term complications," senior author Bruce E. Sands, M.D., from the Icahn School of Medicine at Mount Sinai in New York City, said in a statement.
Several authors disclosed ties to biopharmaceutical companies, including Johnson & Johnson, which manufactures guselkumab and funded the study.
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