Ustekinumab boosts health-related QoL in refractory Crohn's disease

  • Sands BE & al.
  • J Crohns Colitis
  • 3 May 2018

  • curated by Miriam Davis, PhD
  • Clinical Essentials
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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>
  • UNITI-1 and UNITI-2 had clinically meaningful improvement over placebo on the PCS and MCS.
  • At week 44, HRQoL improvements were maintained.

Limitations

  • None identified.

Please confirm your acceptance

To gain full access to GPnotebook please confirm:

By submitting here you confirm that you have accepted Terms of Use and Privacy Policy of GPnotebook.

Submit