UNITI-1 (weight-based dose of ustekinumab)
Trial question
What is the role of weight-based dose ustekinumab in patients with moderately to severely active Crohn's disease?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
56.0% female
44.0% male
N = 496
496 patients (277 female, 219 male).
Inclusion criteria: patients with active moderate to severe Crohn's disease who didn't respond to to TNF antagonists or had unacceptable side effects.
Key exclusion criteria: patients with gastrointestinal conditions that might require surgery or might preclude the use of Crohn's disease activity index; infections including active tuberculosis; history of cancer.
Interventions
N=249 ustekinumab (an induction dose of approximately 6 mg/kg of body weight).
N=247 placebo (matching placebo).
Primary outcome
100-point clinical response at week 6
33.7%
21.5%
33.7 %
25.3 %
16.9 %
8.4 %
0.0 %
Ustekinumab
Placebo
Significant
increase ▲
NNT = 8
Significant increase in 100-point clinical response at week 6 (33.7% vs. 21.5%; AD 12.3%, 95% CI 4.5 to 20.1).
Secondary outcomes
Significant increase in clinical remission at week 8 (20.9% vs. 7.3%; AD 13.6%, 95% CI 7.6 to 19.6).
Significant increase in 100-point clinical response at week 8 (37.8% vs. 20.2%; AD 17.5%, 95% CI 9.7 to 25.3).
Significant increase in 70-point clinical response at week 6 (43.8% vs. 30.4%; AD 13.4%, 95% CI 3.2 to 23.6).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients with active moderate to severe Crohn's disease who didn't respond to to TNF antagonists or had unacceptable side effects, ustekinumab was superior to placebo with respect to a 100-point clinical response at week 6.
Reference
Brian G Feagan, William J Sandborn, Christopher Gasink et al. Ustekinumab as Induction and Maintenance Therapy for Crohn's Disease. N Engl J Med. 2016 Nov 17;375(20):1946-1960.
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