Findings from a late-stage clinical trial presented at the 11th Congress of the European Crohn's and Colitis Organization showed treatment with Janssen Biotech's Stelara induced clinical response and remission in adult patients with moderate to severe Crohn's disease refractory to TNF inhibitors, according to PharmaTimes.
The 741-patient, Phase III UNITI-1 study met its primary endpoint with Stelara treatment groups demonstrating significantly higher rates of clinical response at week six when compared with the placebo group.
Here are four points:
1. At week six, 34 percent of patients receiving Stelara achieved clinical response, compared with 22 percent of patients taking a placebo.
2. At week eight, 34 percent achieved clinical response, compared with 20 percent of patients in the control arm.
3. In addition, 16 percent of patients taking the drug achieved clinical remission at week eight, compared with 7 percent on placebo.
4. Adverse events, serious adverse events and infections were reported in similar proportions across Stelara and placebo treatment groups.