SUMMARY  

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• A phase 3 randomized clinical trial is ongoing to evaluate the efficacy and safety of TREMFYA in fistulizing, perianal Crohn's disease (CD). Key study description is provided below and additional details are available at clinicaltrials.gov: NCT05347095¹ 
• A case report of an adult patient with perianal fistulizing CD treated with TREMFYA is described below.² 

clinical data

Fistulizing, Perianal Crohn’s Disease (FUZION CD): The efficacy and safety of TREMFYA are currently being evaluated in adult patients with fistulizing, perianal CD in a phase 3, randomized, placebo-controlled, parallel-group, multicenter study.¹ 

Study Design/Methods

• Please refer to clinicaltrials.gov (NCT05347095) for inclusion and exclusion criteria.

Treatment Arms

Group 1

• TREMFYA intravenous (IV) infusion dose 1  subcutaneous (SC) dose 2.

Group 2

• TREMFYA intravenous IV infusion dose 1  SC dose 3.
• At week 24, TREMFYA SC dose 3 non-responders will switch to receive TREMFYA SC dose 2.

Group 3

• Placebo IV infusion  placebo SC.
• At week 24, placebo non-responders will continue to receive TREMFYA dose 4  TREMFYA SC dose 2.

Primary outcome

• Combined fistula remission at week 24.
  • Combined fistula remission is defined as 100 % closure of all treated external openings without development of new fistulas or abscesses and without any drainage by the external openings and absence of collections >2 cm of the perianal fistulas in at least two of three dimensions, confirmed by a blinded central review of the magnetic resonance imaging (MRI) results.

Case Report

Napolitano et al (2022)² described the case of a 43-year-old male patient with a history of fistulizing CD.

• The patient was diagnosed with CD due to a 5-year presentation of weight loss and diarrhea, confirmed by endoscopic assessment. His CD progressed to pancolitis involving the rectum with multiple draining fistulas.
• After failing multiple treatments, including antibiotics, mesalamine, azathioprine, and various tumor necrosis factor (TNF) inhibitors, he underwent surgical intervention with loop ileostomy and later, a total proctocolectomy with end ileostomy, but his perianal disease continued to persist.
  • Upon further examinations, there were deep ulcerated fissures in the bilateral groin with linear sinuses with peripheral erosions and fibrinoid changes at the wound. There were also many tender and deep nodules and subcutaneous abscesses adjacent ulcers, which extended perianally. The patient described ongoing weight loss, fever, and abdominal pain. MRI demonstrated intramural abscess in the rectum and multiple fistulas.
• After treatment with antibiotics, he was started on TREMFYA 100 mg every 8 weeks.
  • Within 6 months of initiating TREMFYA, the patient experienced near complete resolution of inflammatory nodules and abscesses with significant weight gain and improvement of the bilateral perineal ulcerative to near resolution.
  • There was improvement in bilateral perineal ulceration, and notable weight gain. His serum C-reactive protein levels decreased from baseline (60 to 8.3).
  • Repeat MRI revealed resolution and improvement of several intestinal fistulas with decreased size of intramural abscess.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, DERWENT^® (and/or other resources, including internal/external databases) was conducted on 10 April 2025.