TREMFYA - Switching from Other Biologics or Small Molecules to TREMFYA in Ulcerative Colitis

SUMMARY

• The safety and efficacy of TREMFYA were evaluated through 2 randomized, double-blind, placebo-controlled phase 3 studies in adult patients with moderately to severely active ulcerative colitis (UC):
  • QUASAR consisted of a 12-week, phase 2b induction study and a 12-week, phase 3 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, azathioprine, or corticosteroids) or advanced therapy (ADT; ie, tumor necrosis factor alpha [TNFα] antagonists, vedolizumab, or tofacitinib). Additionally, the ASTRO program 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 programs, following ADTs must have been discontinued before the first dose of study intervention:
  • Vedolizumab for ≥12 weeks^1,2
  • Janus kinase inhibitors for ≥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 ≥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 ≥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
• A real-world study evaluating the efficacy and safety of TREMFYA in patients with moderate to severe UC and prior ustekinumab (UST) exposure is summarized below.³
• Additionally, a case report of a patient with refractory UC who switched from mirikizumab to TREMFYA is reported below.⁴

CLINICAL DATA

PROSPECTIVE, OBSERVATIONAL STUDY

Shafrir et al (2026)³ reported the real-world effectiveness and safety of TREMFYA in adult patients with moderate to severe UC at a large tertiary inflammatory bowel disease (IBD) center.

Study Design/Methods

• Patients receiving TREMFYA were prospectively evaluated at weeks 0, 2, 4, 8, and 12.
• Data on the following parameters were collected at baseline and at weeks 4, 8, and 12:
  • Disease activity (Simple Clinical Colitis Index [SCCAI])
  • Corticosteroid use
  • Adverse events
  • Laboratory markers
• Patients were included if they had ≥12 weeks of follow-up.

Results

• Of the 59 patients included in this analysis, 23.7% (14) had prior exposure to UST.
• At week 12, 97% (N=59) of patients continued receiving TREMFYA.
• The proportion of patients with prior UST exposure who achieved clinical remission through week 12 is shown in Figure: Proportion of Patients with Prior UST Exposure Achieving Clinical Remission through Week 12.

• At weeks 8 or 12, age, sex, and prior TNFα or UST therapy was not associated with steroid-free remission in an univariate analysis.

Safety

• No treatment-related serious adverse events were reported.

CASE REPORT

Kunisaki et al (2026)⁴ reported a case of UC refractory to multiple ADTs, including mirikizumab.

• A male patient in his 40s with ulcerative proctitis was treated with oral
  5-aminosalicylates and showed improvement with oral prednisolone during flareups.
• Two years after onset, his UC severity progressed to moderate and steroid-resistant pancolitis.
• ADT therapies (eg, adalimumab, infliximab, vedolizumab, ustekinumab, and upadacitinib) in combination with oral thiopurine failed to induce a response.
• Clinical features included bloody diarrhea (10-20 times/day), fecal urgency, and incontinence. Endoscopy revealed severe inflammation, and blood tests showed anemia (hemoglobin, 6.7-11.0 g/dL), albumin levels ranging from 2.0-3.5 g/dL, and elevated C-reactive protein (CRP, 5.0-30 g/dL).
• The patient declined colectomy since his UC was stable at onset, which was proposed by the attending physician.
• Treatment was switched to mirikizumab (three 300 mg IV doses followed by 200 mg SC every 4 weeks [Q4W]), which was administered for over a year. No clinical or serological improvements were observed. Endoscopy demonstrated partial but inadequate improvement, with persistent severe inflammation.
• The patient requested to be switched to TREMFYA after being presented with these options: colectomy, switching to a sphingosine-1-phosphate receptor modulator, or another IL-23p19 inhibitor.
• After the first IV infusion of TREMFYA 200 mg, bowel movements decreased by approximately 50%, with resolution of bloody stools and fecal incontinence occurred within days. Blood tests revealed CRP levels within normal limits, with improvements in hemoglobin and albumin levels.
• Following 3 IV TREMFYA doses Q4W, colonoscopy demonstrated marked improvement in inflammation.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 27 March 2026.