- Ustekinumab improves health-related QoL (HRQoL) in patients with moderate-to-severe Crohn's disease who have failed TNF-blocker and conventional therapies.
Why this matters
- Ustekinumab is a good treatment option for patients who have failed other therapies.
- Phase 3, randomized, placebo-controlled trial studying 2 groups: UNITI-1 (n=741; failed TNF-blockers) and UNITI-2 (n=627; failed conventional therapies).
- Both groups were randomly assigned to a single intravenous infusion of 130 mg ustekinumab, 6 mg/kg ustekinumab, or placebo and studied for HRQoL at 8 weeks.
- At 8 weeks, ustekinumab responders were rerandomized to subcutaneous placebo or ustekinumab 90 mg every 12 weeks or every 8 weeks.
- HRQoL was assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ) and the physical component score (PCS) and mental component score (MCS) of the Short-Form 36.
- Funding: Janssen Research & Development, LLC.
- At week 8, both groups improved on the IBDQ:
- UNITI-1: 54.8% receiving 6 mg/kg and 46.9% receiving 130 mg had clinically meaningful improvement vs 36.5% on placebo (all P<.05>
- UNITI-2: 68.1% and 58.7% vs 41.1%, respectively (all P<.05>
- None identified.