TREMFYA - Use of TREMFYA in Adult Patients with Proctitis

SUMMARY

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• The use of TREMFYA in adult patients with proctitis has been reported in a case report summarized below.¹

CASE REPORT

Kunisaki et al (2026)¹ reported a case of ulcerative colitis (UC) refractory to multiple advanced therapies (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 flare-ups.
• Two years after onset, his UC severity progressed to moderate and steroid-resistant pancolitis.
• ADTs (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 intravenous [IV] doses followed by 200 mg subcutaneous [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 interleukin [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 26 May 2026.