TREMFYA - Use in Adult Patients with Plaque Psoriasis or Psoriatic Arthritis with Comorbid HIV Infection

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 (PBO)-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.^1,2
• Two randomized, double-blind, PBO-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
• A case series has described the use of TREMFYA in HIV-positive patients with PsO.⁵
• Case reports have described the use of TREMFYA in HIV-positive patients with PsO or plaque PsO.^6,7

Company Core data sheet

• TREMFYA may increase the risk of infection.⁸
• Infections have been observed in clinical trials in plaque PsO (23% vs 21% for PBO; ≤0.2% serious infections in both groups) and PsA (21% in both TREMFYA and PBO groups; ≤0.8% serious infections in both groups).⁸
• Treatment with TREMFYA should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.⁸
• Instruct patients treated with TREMFYA to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur.⁸
• 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.⁸

CASE SERIES

Maione et al (2025)⁵ reported the clinical outcomes of TREMFYA and risankizumab treatment in 9 patients from 4 leading centers in Italy.

• The Psoriasis Area and Severity Index (PASI) score, drug durability, HIV replication rate, and cluster of differentiation 4 (CD4) count before and after treatment with TREMFYA and risankizumab at week 16 were analyzed.
• Of the 9 patients enrolled, 6 were men and 3 were women; the mean age was 50.89±7.18 years.
• Among 7 patients, the date of HIV diagnosis was available for 5 patients, with a mean duration since diagnosis of 11.60±7.80 years.
• Overall, 33% of patients received TREMFYA and 67% of patients received risankizumab.
• Most commonly prescribed treatments prior to initiating anti-IL-23 therapy included acitretin (44%), ultraviolet light therapy (33%), tumor necrosis factor alpha (TNFα) inhibitors (22%) and interleukin (IL)-12/23 inhibitors (11%).
• At week 16, a significant reduction in PASI score was observed with a median score of 0 (interquartile range [IQR], 0-3); this reduction was sustained until week 28 (median score, 0 [IQR, 0-1]).
• At week 16, 55.56% and 88.89% of patients achieved PASI 100 and PASI 90, respectively. By week 28, 77.78% and 100% of patients achieved PASI 100 and PASI 90, respectively.
• The median drug survival for TREMFYA was 11 months (IQR, 6-35).
• No difference was observed in the viral replication rate and CD4 count before and after treatment with TREMFYA.
• No adverse events were reported with TREMFYA treatment.

Case report

Qiu et al (2025)⁷ 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 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)⁶ 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 20 February 2026.