Janssen announced new long-term data from the Phase 3 IM-UNITI study which showed that treatment with Stelara (ustekinumab) lowered the risk of Crohn’s disease (CD)-related hospitalization, surgery, and the need for alternative biologic therapy in patients with moderate-to-severe CD when compared with placebo. The full findings were presented at Digestive Disease Week (DDW) 2018 in Washington, DC.
The new analysis pooled patients from the UNITI-1 and UNITI-2 trials who had clinical response after a single intravenous (IV) dose of ustekinumab and entered a 5-year follow-up period. Patients were randomized to either placebo, subcutaneous (SC) ustekinumab 90mq every 8 weeks (q8w) or 90mg every 12 weeks (q12w). Rates of hospitalization, surgery, or initiation of an alternate biologic (TNF-antagonist or anti-integrin therapy) were evaluated at week 96.
At 2 years, results showed that patients in the ustekinumab q12w group were 52% less likely to be hospitalized or require surgery vs patients in the placebo group (hazard ratio [HR] 0.477; 95% CI, 0.238, 0.957; P =.033). Patients in the ustekinumab q8w group were 40% less likely to be hospitalized or require surgery (HR 0.601; 95% CI, 0.411, 0.879; P =.006). Moreover, pooled data on quality of life outcomes showed that by week 8, patients receiving ustekinumab had significant improvements in quality of life factors (eg, fatigue, sleep, loose stools, emotional/social effects) vs placebo.
With regard to alternative treatment, patients in the ustekinumab q8w group were 53% less likely to switch to another biologic when compared with placebo (HR 0.473; 95% CI, 0.215, 1.040; P =.042); patients receiving the study drug every 12 weeks saw a risk reduction of 33% but it was not considered statistically significant (HR 0.667; 95% CI, 0.223, 1.999; P =.467).
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