Phase III IM-UNITI study of Stelara shows continued efficacy at 3 years in Crohn's disease.- J&J Janssen Cilag.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced new three-year data from the phase III IM-UNITI study, which demonstrates the continued efficacy of Stelara (ustekinumab) in improving clinical remission rates and shows ustekinumab to be generally well-tolerated in patients with Crohn�s disease. Overall efficacy assessments at week 152 demonstrated that 60.3% of all randomised ustekinumab-treated patients who entered the long-term extension study were in clinical remission. Furthermore, 68.8% of these randomised ustekinumab treated patients had demonstrated a clinical response. The key study findings for different dosing regimens found that 61.9% of patients who were randomised to receive 90 mg ustekinumab SC every 12 weeks (q12w) and continued to receive this dose in the study extension were in clinical remission.

For those patients who were randomised to receive 90 mg ustekinumab SC in the every eight week dosing regimen group (q8w) and continued to receive this dose, 69.5% of patients were in clinical remission. The study also found that, of those patients who were naive to TNF antagonist therapy and treated with ustekinumab, 67.6% were in clinical remission at week 156. This demonstrates that patients who have not yet received TNF antagonist therapy (the most commonly prescribed class of biologic treatments) could benefit from ustekinumab treatment.

Further to this, of those ustekinumab treated patients who had previously failed (i.e. who were refractory to) or who were intolerant to TNF antagonist therapy, 48.4% were in clinical remission. Safety events (per hundred patient years) were not higher amongst all ustekinumab treated patients entering the long-term extension study compared to placebo from week 44 through to week 156. No new safety signals were observed. The data from the IM-UNITI trial, which will continue for a further two years, are being presented at the 26th United European Gastroenterology Week congress.