SUMMARY

• STELARA was evaluated in 3 randomized, double-blind, placebo-controlled clinical trials in adult patients with moderately to severely active CD. Of these trials, there were two 8-week intravenous induction studies (UNITI-1 and UNITI-2).¹
  • UNITI-1 enrolled patients who had failed or were intolerant to prior treatment with TNF blocker therapy (78.8% of patients had failed infliximab, 59.8% had failed adalimumab, and 22.1% had failed certolizumab pegol).²
  • UNITI-2 enrolled patients who had failed or were intolerant to prior treatment with conventional therapies. Of these patients, 68.6% were naïve to TNF blocker therapy and the rest of the patients previously received one or more TNF blockers but didn’t have side effects that were considered unacceptable and didn’t meet the criteria for primary or secondary non-response to treatment.¹
  • In both UNITI-1 and UNITI-2, an 8-week washout period was required for prior treatment with a TNF blocker.^3,4

CLINICAL DATA

Crohn’s Disease Phase 3 Clinical Trials

• STELARA was evaluated in 3 randomized, double-blind, placebo-controlled clinical trials in adult patients with moderately to severely active Crohn’s disease (Crohn’s Disease Activity Index [CDAI] score of 220 to 450). There were two 8-week intravenous induction studies (UNITI-1 and UNITI-2) followed by a 44-week subcutaneous randomized withdrawal maintenance study (IM-UNITI) representing 52 weeks of therapy.¹
• In UNITI-1, patients had failed or were intolerant to prior treatment with a TNF blocker: 29.2% patients had an inadequate initial response (primary non-responders), 69.3% responded but subsequently lost response (secondary non-responders), and 36.4% had unacceptable side effects. A total of 48.0% of patients had a history of one TNF blocker failure and 51.2% had failed 2 or 3 prior TNF blockers. Additionally, 78.8% of patients had failed infliximab, 59.8% had failed adalimumab, and 22.1% had failed certolizumab pegol.^1,2
• In UNITI-2, patients had failed or were intolerant to conventional therapies. Of these patients, 68.6% were naïve to TNF blocker therapy and the rest of the patients previously received one or more TNF blockers but didn’t have side effects that were considered unacceptable and didn’t meet the criteria for primary or secondary non-response to treatment.¹
• In the UNITI-1 and UNITI-2 induction trials, patients must have discontinued use of prior TNF blocker therapy at least 8 weeks before study baseline.^3,4
• Additionally, in these 2 induction trials, patients must have discontinued natalizumab, or biologic agents that deplete B or T cells at least 12 months before study baseline. Also, patients must have discontinued other immunomodulatory biologic agents for at least 12 weeks or past 5 half-lives of the agent before study baseline, whichever was longer.^3,4

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 03 June 2024.