SUMMARY

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• Please refer to the local labeling for relevant information regarding tuberculosis (TB) infection.
• Retrospective studies reported the risk of TB reactivation in patients with comorbid latent tuberculosis infection (LTBI) without prophylaxis who received TREMFYA for the treatment of psoriasis (PsO).^1,2 

CLINICAL DATA

Retrospective Studies

Manzanares et al (2024)¹ evaluated a retrospective multicenter study assessing the risk of TB reactivation in patients with PsO who had initiated a biologic despite having untreated LTBI.

Study Design/Methods

• Inclusion criteria: patients with moderate to severe PsO who started biologic therapy despite untreated LTBI with a minimum of 6-month follow-up.

Results

• A total of 35 patients were included in the study. There were 21 males and 14 females with an average age of 59.5±16.7 years.
  • In the total population, 25 patients (71.4%) had no prior exposure to biologics.
• The initiated biologic therapies were risankizumab (n=21), tildrakizumab (n=5), TREMFYA (n=5), ixekizumab (n=2), brodalumab (n=1), and secukinumab (n=1).
• No cases of TB reactivation were reported, including patients receiving TREMFYA.

Yuan et al (2023)² performed a retrospective patients’ chart review evaluating the incidence and the relative risk of TB reactivation in patients with PsO and comorbid LTBI, who received biological therapy, with vs without prior anti-TB therapy.

Study Design/Methods

• LTBI was defined as a positive for interferon-gamma release assay (IGRA) with no indications of active TB infection according to chest X-rays or computed tomographies (CTs), and clinical symptoms.
• Diagnosis of TB reactivation was based on findings of chest CTs or X-rays, and clinical symptoms.

Results

• A total of 1208 patients with moderate to severe PsO who underwent TB screening before starting biological therapy were included in the study. There were 881 males and 327 females with an average age of 39±11.4 years.
• In the total population, 180 patients were LTBI, positive for IGRA without evidence of active TB infection at baseline, indicating prior recovery from TB infection.
  • Of 180 patients with LTBI, 111 patients received no TB prophylaxis.
  • Of 111 patients with no TB prophylaxis, 37 patients received biologic therapy (secukinumab [n=18], ixekizumab [n=10], adalimumab [n=6], TREMFYA [n=2], ustekinumab [n=1]).
  • Among the 37 patients who were exposed to biologic therapy, 11 patients completed 24 weeks of follow-up (TREMFYA, n=1).
• At the end of week 24, one case of TB reactivation was observed in a patient with LTBI who did not receive prophylaxis and was treated 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 09 May 2025.