Ustekinumab Intravenous Reinduction after Secondary Loss of Response in Patients with Crohn's Disease.

ABSTRACT:

Background

The POWER study (NCT03782376) evaluated efficacy and safety of a single ustekinumab intravenous (IV) reinduction dose versus placebo under continued ustekinumab subcutaneous (SC) treatment in adult patients with moderately to severely active Crohn's disease who demonstrated a secondary loss of response to ustekinumab every 8 weeks (q8w) maintenance therapy.

Methods

Patients were randomly assigned 1:1 at Week 0 to ustekinumab IV reinduction (ustekinumab ∼6 mg/kg and SC placebo) or continuous maintenance (IV placebo and SC ustekinumab 90 mg q8w). Clinical and biomarker assessments occurred at Weeks 0, 8, 16, and 24 with optional ileocolonoscopy at Weeks 0 and16. The primary endpoint was clinical response (≥100-point decrease from baseline Crohn's Disease Activity In

SUBMITTER: Schreiber S 

PROVIDER: S-EPMC12688074 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature