SUMMARY

• The safety and efficacy of TREMFYA was evaluated through two randomized, double-blind, placebo-controlled phase 3 studies in adult patients with moderately to severely active ulcerative colitis (UC):
  • QUASAR consisted of a phase 2b 12-week induction study and a phase 3 12-week intravenous (IV) induction study followed by a 44-week subcutaneous (SC) randomized withdrawal maintenance study.¹
  • ASTRO consisted of a 48-week treat through study that assessed the efficacy and safety of SC induction followed by SC maintenance therapy with TREMFYA.² 
• In both QUASAR and ASTRO trials, patients were required to have an inadequate response, loss of response, or intolerance to conventional (ie, 6-mercaptopurine [6-MP], azathioprine [AZA], or corticosteroids) or advanced therapy (ADT; ie, tumor necrosis factor alpha [TNFα] antagonists, vedolizumab, or tofacitinib). Additionally, the ASTRO program also included patients who failed or were intolerant to filgotinib, upadacitinib, and ozanimod, a sphingosine-1-phosphate receptor modulator (S1PRM).^1,2
• In the QUASAR and ASTRO program following advanced therapies must have been discontinued before the first dose of study intervention:
  • Vedolizumab for at least 12 weeks.^1,2
  • Janus kinase (JAK) inhibitors for at least 2 weeks or 5 half-lives, whichever is longer.^1,2
  • TNFα-antagonist therapy (eg, infliximab, adalimumab, or golimumab [or approved biosimilars for these therapies]) for at least 8 weeks.^1,2
• Additionally, in the ASTRO program, if a patient was receiving ozanimod or another S1PRM, they were required to be discontinued for at least 4 weeks or 5 half-lives, whichever was longer.²
• In both QUASAR and ASTRO trials, 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.^1,2

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 27 August 2025.