TREMFYA - Treatment of Pyoderma Gangrenosum

SUMMARY

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• A retrospective study and case reports describing the use of TREMFYA in patients with pyoderma gangrenosum (PG) are detailed below.^1-5

RETROSPECTIVE STUDY

Bettolini et al (2026)¹ conducted a multicenter, retrospective pilot study to evaluate the efficacy, safety, steroid-sparing potential, and predictors of response to selective interleukin (IL)-23 inhibitors in patients with conventional treatment-refractory PG.

Study Design/Methods

• Adults with a diagnosis of PG (based on clinical features, histopathological findings, and a PARACELSUS diagnostic score ≥10) and refractory disease (defined as failure, intolerance, or contraindication to conventional systemic treatments, including systemic corticosteroids and/or immunosuppressive agents) were included.
• Selective IL-23 inhibitors (TREMFYA, risankizumab, or tildrakizumab) were used off-label at standard dose regimens approved for inflammatory skin conditions or at dose/ frequency-intensified regimens. Concomitant systemic corticosteroids were tapered or withdrawn when clinically feasible.
• Clinical assessments were conducted at baseline and at approximately 1, 3, 6, and 12 months (±15 days), as well as at the final follow-up visit.

Results

• Overall, 18 patients with PG were treated with selective IL-23 inhibitors.
• All patients had prior exposure to systemic corticosteroids. Use of conventional immunosuppressants and biologics was common, particularly cyclosporine and anti-tumor necrosis factor-alpha (TNF-α) agents. Other baseline characteristics are presented in Table: Select Baseline Demographic and Clinical Characteristics of Patients with PG.

• A median (range) percentage reduction in ulcer area of -99.2% (-100% to 0%) was observed in patients receiving TREMFYA, compared with -79.2% (-100% to 5%) in those receiving risankizumab.¹ 
• No statistically significant difference between the 2 groups was observed (P=0.182). For more details, see Table: Comparison Between TREMFYA and Risankizumab in Percentage Ulcer Area Reduction.

Case reports

Nikzad et al (2025)² described the use of TREMFYA in a 64-year-old female patient with perianal fistulizing Crohn’s disease (CD), who was subsequently diagnosed with concomitant cutaneous CD and PG.

• The patient presented with 2 months of worsening wounds in the groin, gluteal cleft, and peristomal skin. She had been diagnosed 3 years earlier with severe perianal CD with fistulas and abscesses, without luminal disease.
• Prior treatments included infliximab and adalimumab (discontinued due to anti‑TNF antibodies), followed by vedolizumab and upadacitinib, with continued disease progression.
• Colonoscopy revealed severe active colitis with extensive ulceration from the rectum to the hepatic flexure. Due to inadequate symptomatic response to corticosteroids and upadacitinib, colectomy was recommended.
• Six months after surgery, systemic therapy was stopped due to low recurrence risk. The patient subsequently underwent proctectomy and developed worsening skin lesions over 2 months, including linear ulcerations in the groin/gluteal cleft and peristomal PG.
• Biopsy of a gluteal ulcer confirmed cutaneous CD, showing neutrophilic infiltration, epithelioid granulomas, and mixed dermal inflammation.
• She was initiated on oral corticosteroids but had persistent symptoms requiring hospitalization. During this period, she received an induction dose of TREMFYA 400 mg and 5 days of methylprednisolone 40 mg. She transitioned to prednisone 60 mg daily, along with antimicrobials (rifabutin 150 mg, clarithromycin 250 mg, and ciprofloxacin 500 mg) and topical therapy (clobetasol 0.05% ointment for topical cutaneous CD and triamcinolone 0.1% paste for peristomal PG).
• After discharge, the patient received TREMFYA 200 mg every 4 weeks (Q4W), with a prednisone taper and a 30-day antimicrobial course (self-discontinued) while continuing topical clobetasol therapy.
• At 2 months follow up, marked improvement in pain, drainage, and size in groin and gluteal wounds was observed, with resolution of the peristomal wound. After approximately 4 months of therapy and 3 total TREMFYA doses, continued improvement in groin and gluteal wounds was observed.

Botvid et al (2025)³ described the use of TREMFYA in 2 cases of treatment-resistant PG.

Case 1:

• A 39-year-old woman with a history of ulcerative colitis (UC), colectomy with ileostomy, polychondritis, arthritis, and facial rosacea developed PG at the external stoma site following abdominal surgery.
• Examination revealed a painful, deep necrotic peristomal ulcer (5 × 6 cm) with thick fibrin deposits and irregular erythematous borders.
• Prior treatment included topical and systemic corticosteroids (prednisolone) and biological therapy (infliximab and adalimumab), with insufficient results and several adverse events (AEs).
• The patient received off-label TREMFYA 100 mg every 6 weeks (Q6W). Following clinical improvement within 6 months; the dosing interval was extended to every 7 weeks (Q7W).^3,7
• The stoma was relocated from the left to the right lower abdomen, and PG was completely healed after approximately 1 year of therapy with TREMFYA.
• No TREMFYA-related AEs were reported.

Case 2:

• A 35-year-old female patient with a history of UC and obesity presented with a deep necrotic ulcer, with thick fibrin deposits, hemorrhagic bullae, and several peripheral petechiae and purpura elements.³
• Prior treatment included topical and systemic corticosteroids (prednisolone), immunomodulating therapy (ciclosporin), and biological therapy (infliximab, adalimumab, and certolizumab), with insufficient results and several AEs.
• The patient received off-label TREMFYA 100 mg every 8 weeks (Q8W). Following clinical improvement within 6 months, the dosing interval was extended to Q7W.
• After approximately 1 year of treatment, PG was remarkably healed.
• No TREMFYA-related AEs were reported.

Reese et al (2022)⁴ described the use of TREMFYA at a modified dose in a 49-year-old female patient with recalcitrant PG.

• The patient had a medical history of well-controlled type 2 diabetes mellitus and presented with a nonhealing ulcer in the left lower extremity (LLE).
• The ulcer was misdiagnosed as a vascular ulcer and treated with oral antibiotics.
• The patient developed 2 episodes of LLE deep vein thrombosis (DVT), and rivaroxaban was initiated.
• Upon diagnosis of PG following dermatology referral, the patient was treated with cyclosporine, prednisone, adalimumab, Epifix biologic dressing, dapsone, and intralesional corticosteroids, but the ulcer did not show improvement.
• TREMFYA was initiated at a dose of 200 mg subcutaneously, and within 2 weeks, response to treatment was evident by a reduction in the size of the ulcer and the amount of drainage.
• Following a diagnosis of Escherichia coli bacteremia, the patient was hospitalized.
• After discharge from the hospital, the second dose of TREMFYA 100 mg was administered 4 weeks after the initial dose.
• A diagnosis of sepsis secondary to cellulitis and another episode of LLE DVT led to rehospitalization, and intravenous (IV) antibiotics along with continued rivaroxaban were administered.
• The third and fourth doses of TREMFYA 100 mg were administered at 6-week intervals.
• Complete healing was achieved with 4 doses of TREMFYA.
• A right lower extremity (RLE) ulcer, which developed about 7 months after the development of LLE ulcer, also healed.
• The authors anticipated that the patient would continue TREMFYA dosed at 100 mg Q6W for 1 year.

Baier et al (2021)⁵ described the use of TREMFYA in a 60-year-old female patient with recalcitrant PG.

• The patient had a history of monoclonal gammopathy of undetermined significance (MGUS) and type 2 diabetes mellitus and presented to the clinic with a 1-year history of lower leg ulcers.
• The ulcer did not respond to topical or systemic treatment, including intralesional steroids.
• Treatment with ustekinumab was initiated.
• The ulcer deepened, leading to exposure of tendons, ligaments, and muscle.
• A Pseudomonas superinfection was identified, and IV antibiotics were administered.
• Ustekinumab was discontinued temporarily and restarted once stabilization was achieved.
• The ulcer improved rapidly, with nearly complete re-epithelialization. However, despite the ongoing ustekinumab treatment, the ulcer relapsed.
• Development of neutralizing autoantibodies against ustekinumab was suspected, and TNF-α inhibitors (adalimumab and infliximab) were administered; however, the ulcer expanded further.
• Following ulcer expansion, the patient received IV immunoglobulin (IVIG) and prednisone, and the progression of the ulcer halted.
• Considering the previous response to ustekinumab and failure of 2 TNF-α inhibitors, treatment with TREMFYA was started at 100 mg monthly dosing.
• The ulcer bed began receding within weeks and was virtually nonexistent within 3 months of initiating TREMFYA, with >95% re-epithelialization achieved over time.
• The patient continued to be in remission after 15 months of initiating treatment with TREMFYA.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 12 May 2026.