SUMMARY

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• Please refer to local labeling for relevant information regarding TREMFYA and human immunodeficiency virus (HIV) infection.
• Two randomized, double-blind, placebo-controlled, multicenter, phase 3 studies (VOYAGE 1 and VOYAGE 2) for the treatment of adult patients with moderate to severe plaque psoriasis (PsO) excluded patients who were HIV positive.¹
• Two randomized, double-blind, placebo-controlled, multicenter, phase 3 studies (DISCOVER-1 and DISCOVER-2) for the treatment of adult patients with active psoriatic arthritis (PsA) excluded patients who were infected with HIV (a confirmed positive serology for HIV antibody).^2,3
• Case reports have described the use of TREMFYA in HIV-positive patients with PsO or plaque PsO.^4,5

Company Core data sheet

• TREMFYA may increase the risk of infection.⁶
• Infections have been observed in clinical trials in plaque PsO (23% vs 21% for placebo; ≤0.2% serious infections in both groups) and PsA (21% in both TREMFYA and placebo groups; ≤0.8% serious infections in both groups).⁶
• Treatment with TREMFYA should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.⁶
• Instruct patients treated with TREMFYA to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur.⁶
• If a patient develops a clinically important or serious infection or is not responding to standard therapy, monitor the patient closely and discontinue TREMFYA until the infection resolves.⁶

Case report

Qiu et al (2025)⁵ described the case of a 39-year-old HIV-positive Chinese male with a
23-year history of PsO.

• Before the patient was diagnosed with HIV, his PsO symptoms were managed with topical therapies (calcipotriol and corticosteroid ointment) and phototherapy, achieving 95% symptom improvement.
• The patient's antiretroviral therapy for his HIV began to lose its efficacy, which resulted in papulosquamous plaques covering 43% body surface area (BSA) and the patient began receiving apremilast, which was later shown to be ineffective.
• After ruling out tumors, hepatitis B, and tuberculosis, the patient was administered TREMFYA 100 mg subcutaneous (SC) at weeks 0 and 4, and every 8 weeks (q8w) thereafter.
• Improvement in itching and a reduction in Psoriasis Area and Severity Index (PASI) score from 35.1-20.6 was observed within 2 weeks and over an 8-month period, the patient’s skin lesions were almost completely resolved, his HIV infection was well managed, and no adverse effects were observed.
• To date, the patient has remained on TREMFYA 100 mg every 8-12 weeks and has maintained complete clearance.
• For clinical symptom improvement during TREMFYA treatment, see Table: Clinical Symptom and Clinical Indicator Improvement through Week 34.

Bartos et al (2018)⁴ described the case of a 51-year-old HIV-positive male who received TREMFYA for his poorly controlled plaque PsO.

• The patient’s plaque PsO was initially managed with topical corticosteroids, calcipotriene, and phototherapy, which were inadequate despite his adherence to treatment and Highly Active Antiretroviral Therapy (HAART).
• The patient developed erythrodermic PsO with concurrent infection and required prolonged hospitalization.
• Treatment was escalated using oral acitretin and apremilast, which provided temporary benefit.
• The patient’s disease was recalcitrant and covered 30% of his BSA and he was started on TREMFYA 100 mg SC at week 0, week 4, and q8w thereafter.
• Complete clearance was achieved on TREMFYA without continued use of topical therapies.
• The patient’s CD4 counts remained stable with no significant episodes of abscesses or bacteremia in the intervening 6 months.
• No adverse outcomes were noted in the patient’s 12 months of TREMFYA treatment.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 21 March 2025.