The Food and Drug Administration (FDA) has approved Tremfya ® (guselkumab) for the treatment of adults with moderately to severely active Crohn disease (CD).

The failure comes after Zeposia achieved clinical remission – defined as a CDAI score of less than 150 – in 39% of Crohn’s patients in the phase 2 STEPSTONE trial at 12 weeks, with 16% also ...

However, when results were analyzed by Crohn's Disease Activity Index (CDAI), the 200-mg dose only appeared to show a benefit for clinical remission in the induction and maintenance phases.

The widespread use of 5-ASA in active Crohn's disease has, however, been founded on a single controlled, randomized 16-week study of 310 patients with an average CDAI score of 260 points (range ...

Patients with moderate to severe Crohn’s disease who did not achieve clinical response to IV induction with Skyrizi ...

p< 0.01 (adaliumumab vs placebo). † Clinical response was defined as a reduction of 100 points or more in Crohn's disease activity index (CDAI) score. ‡ Clinical response was defined as a ...

In VIVID-1, 45.4% of mirikizumab-treated patients showed a response to treatment at 12 weeks and clinical remission defined as a score below 150 on the Crohn’s Disease Activity Index (CDAI ...

included patients who had been in remission (Crohn Disease Activity Index (CDAI) score <150 points) for 3–12 months. EPIC-2 enrolled patients with active Crohn disease who were treated with ...

“This trial did not meet the primary endpoint of change from baseline in the Crohn’s disease activity index, or CDAI (symptomatic outcome), likely due to a higher-than-expected placebo respons ...