SUMMARY

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• Case reports describing the use of TREMFYA in patients with pyoderma gangrenosum (PG) are detailed below.^1,2

Case reports

Reese et al (2022)¹ 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 after 4 weeks from 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 every 6 weeks for 1 year.

Baier et al (2021)² 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 tumor necrosis factor (TNF)-alpha 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-alpha 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 23 July 2024.