Guselkumab promising for Crohn’s disease

In Crohn’s disease patients with inadequate response or intolerance to conventional or biologic therapy, guselkumab, a selective p19 interleukin (IL)-23 antagonist, appears effective by yielding better clinical and endoscopic improvements than placebo, a recent study has found.

The present analysis reported induction results from the phase II GALAXI-1 study, which enrolled 309 patients randomly assigned 1:1:1:1 to 200-, 600-, or 1,200-mg intravenous guselkumab or placebo. Guselkumab was given at weeks 0, 4, and 8, after which the Crohn’s Disease Activity Index (CDAI) score was determined.

At week 12, reductions in CDAI score were significantly greater in the 200-, 600-, and 1,200-mg guselkumab dose groups than placebo controls (–160.4, –138.9, and –144.9 vs –36.2, respectively; p<0.05). No dose-response relationship was reported.

Moreover, clinical remission was significantly better in the combined guselkumab vs placebo group, with 53.0 percent and 16.4 percent of patients, respectively, achieving such an endpoint by week 12 (p<0.05). Similarly, 65.9 percent in the combined guselkumab arm showed 12-week clinical response, as opposed to only 24.9 percent in the placebo arm (nominal p<0.05).

The safety analysis included 360 patients. The proportion of patients who experienced at least one adverse event (AE) throughout the 12-week follow-up was comparable across all treatment groups. Guselkumab dose was not associated with AE incidence. Serious AEs were rare and likewise occurred at comparable frequencies across groups.

“The results from this 12-week study of guselkumab further substantiate the clinical relevance of targeting IL-23 in the treatment of Crohn’s disease. Phase III studies evaluating the efficacy and safety of guselkumab for the treatment of Crohn’s disease are currently underway,” the researchers said.