SUMMARY

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• TREMFYA was evaluated in a randomized, double-blind, placebo-controlled phase 2b/3 clinical trial program in adult patients with moderately to severely active UC (QUASAR).¹
• The phase 3 clinical trial program consisted of a 12-week intravenous induction study followed by a 44-week subcutaneous randomized withdrawal maintenance study.¹
• Patients were required to have an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine), biologic therapy (tumor necrosis factor [TNF] antagonists, vedolizumab), and/or Janus kinase (JAK) inhibitors.¹
• In the QUASAR program following medications/therapies must have been discontinued before the first dose of study intervention:
  • Vedolizumab for at least 12 weeks.¹
  • Tofacitinib and other inhibitors of JAK for at least 2 weeks or 5 half-lives, whichever is longer.¹
  • TNFα-antagonist therapy (eg, infliximab, adalimumab, or golimumab [or approved biosimilars for these therapies]) for at least 8 weeks.¹
• Patients treated with biologic therapy targeted at interleukin (IL)-12 and/or IL-23 (eg, ustekinumab, briakinumab, TREMFYA, mirikizumab, tildrakizumab, brazikumab, or risankizumab) were excluded.¹

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 14 September 2024.