Long-term data from two Phase 3 clinical trials show that adults with Crohn's disease treated with Tremfya (guselkumab) achieved clinical remission rates of up to 94% over three years, according to Johnson & Johnson (JNJ.US).
Participants in the GALAXI 2 and GALAXI 3 trials first received induction therapy with Tremfya, followed by maintenance dosing of either 100 mg every eight weeks or 200 mg every four weeks. The remission rate was 94% in the eight-week regimen group and 91% in the four-week regimen group.
In addition, 52% of patients in the eight-week regimen group achieved endoscopic remission, compared with 61% in the four-week regimen group. Meanwhile, 88% of patients in both groups achieved 90-day corticosteroid-free clinical remission.
Johnson & Johnson also said that results from the Phase 3 FUZION study showed that Tremfya can achieve sustained fistula remission in specific Crohn's disease subgroups. Overall, 28% of patients in the eight-week (q8w) regimen group and 27% in the four-week (q4w) regimen group reached the composite endpoint of comprehensive fistula remission at week 24, compared with 10% in the placebo group.
However, among patients with higher baseline luminal disease activity, the remission rates were 30% and 21% in the q8w and q4w groups, respectively, versus 0% in the placebo group. Among patients previously treated with biologics, as well as those with or without proctitis at baseline, fistula remission was also significantly better with Tremfya than with placebo.