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.
• A case report described the use of TREMFYA in a HIV-positive patient with plaque psoriasis (PsO).¹
• 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 PsO excluded patients who were HIV positive.²
• 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).^3,4

Company Core data sheet

• TREMFYA may increase the risk of infection.⁵
• 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).
• Treatment with TREMFYA should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.
• Instruct patients treated with TREMFYA to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur.
• 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.

Case report

Bartos et al (2018)¹ 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 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 body surface area (BSA) and he was started on TREMFYA 100 mg subcutaneously (SC) at week 0, week 4, and every 8 weeks thereafter.
• Complete clearance was achieved on TREMFYA without continued use of topical therapies.
• The patient’s cluster of differentiation 4 (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 26 April 2024.