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

Croitoru et al (2022)² described the case of a 43-year-old male patient with a history of fistulizing CD and who was referred for suspected Hidradenitis Suppurativa (HS).

• 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 initially with loop ileostomy, but his perianal disease continued to persist.
• Over the next year, the patient was treated with ustekinumab but developed pancolitis. This led to initiation of methylprednisolone treatment, bridged to a modified total proctocolectomy with end ileostomy. Perianal dissection was foregone, and a small stump was left in place.
• Over the following months, the patient was put on steroid taper and later treated with a TNF inhibitor. Addition of sulfasalazine, methotrexate, hyperbaric oxygen, and concurrent intralesional steroids minimally benefited.
• The arrangement of draining tract and inflammation nodules led to suspicion for concomitant HS and the patient was referred to dermatology clinical for evaluation and management.
  • 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, without fever, and abdominal pain and minimal change in stoma output.
  • Given the patient's history of fistulizing CD and extensive wounds, it was suspected that he had ongoing occult inflammation intestinal disease and fistulation to skin. MRI of the pelvis showed an intramural abscess in the most superior aspect of the rectal stump and multiple emanating fistulas.
  • Treatment with ertapenem drastically reduced perianal pain and discharge and the patient was subsequently started on TREMFYA 100 mg every 8 weeks.
  • Within 6 months of initiating TREMFYA, the patient experienced near complete resolution of all inflammatory nodules and abscesses with significant weight gain and improvement of the bilateral perineal ulcerative to near resolution. His serum C-reactive protein levels decreased from baseline (60 to 8.3).
  • Repeated MRI of the pelvis and abdomen showed interval resolution and improvement of multiple intestinal fistulas with reduction in size of intramural abscess. The patient underwent multidisciplinary re-evaluation for surgical candidacy to remove the remaining portion of his rectal stump.

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.