6/30/23, 12:06 AM UNITI-1 (fixed-dose ustekinumab) Pathway Feedback Search Clinical Topics Home Studies UNITI 1 (fixed-dose ustekinumab) UNITI 1 (fixed-dose ustekinumab) Disease Crohn's disease Trial question What is the role of fixed-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 N = 492 44.0% male 492 patients (276 female, 216 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=245 ustekinumab (an induction dose of 130 mg IV) N=247 placebo (matching placebo) Primary outcome 100-point clinical response at week 6 34.3 % 34.3 https://web.pathway.md/studies/rec4A9QkXtoKvjzpp 1/2 6/30/23, 12:06 AM UNITI-1 (fixed-dose ustekinumab) Pathway 25.7 % 21.5 17.1 % Significant increase 8.6 % NNT = 8 0.0 % Ustekinumab Placebo Significant increase in 100-point clinical response at week 6 (34.3% vs. 21.5%; AD 12.8%, 95% CI 5 to 20.7) Secondary outcomes Significant increase in clinical remission at week 8 (15.9% vs. 7.3%; AD 8.6%, 95% CI 3 to 14.2) Significant increase in 100-point clinical response at week 8 (33.5% vs. 20.2%; AD 13.2%, 95% CI 5.5 to 21) Significant increase in 70-point clinical response at week 6 (46.1% vs. 30.4%; AD 15.8%, 95% CI 7.3 to 24.2) 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. Open reference URL https://web.pathway.md/studies/rec4A9QkXtoKvjzpp 2/2