SUMMARY

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• Please refer to the local labeling for relevant information regarding switching from other biologics to STELARA in ulcerative colitis.
• STELARA was evaluated in a randomized, double-blind, placebo-controlled phase 3 clinical trial program in adult patients with moderately to severely active ulcerative colitis (UNIFI). The clinical trial program consisted of an 8-week intravenous induction study followed by a 44-week subcutaneous randomized withdrawal maintenance study for a total of 52 weeks of therapy.¹
  • UNIFI eligible patients were required to have had an inadequate response to or unacceptable side effects from tumor necrosis factor (TNF) blockers, vedolizumab, or conventional (ie, nonbiologic) therapy.
  • At baseline in the induction study, among 51.1% (491/961) of randomly assigned patients who had previous treatment failure with biologic agents, a total of 98.8% (485/491) had failed at least one TNF blocker, 32.6% (160/491) had failed both a TNF blocker and vedolizumab, and 1.2% (6/491) had failed vedolizumab only. Among patients who did not have previous treatment failure with biologics, 94.3% (443/470) had not received biologics and 5.7% (27/470) had received biologics but did not have documented treatment failure.
  • For UNIFI clinical trial program entry, previous treatment with interleukin-12 or interleukin-23 antagonists was prohibited. Additionally, previous TNF blocker therapy was discontinued at least 8 weeks before trial entry, and vedolizumab was discontinued at least 4 months before trial entry.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 13 September 2024.