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 the use of TREMFYA in adult patients with hepatic impairment.
• Specific studies of TREMFYA have not been conducted in patients with hepatic insufficiency.¹
• Case reports describing the use of TREMFYA in adult patients with hepatic impairment are available.^2,3

RELEVANT INCLUSION/EXCLUSION CRITERIA FROM CLINICAL TRIALS

The safety and efficacy of TREMFYA in adult patients diagnosed with moderate to severe plaque psoriasis (PsO) was evaluated in 3 phase 3 (VOYAGE 1, VOYAGE 2, NAVIGATE) multicenter, randomized, double-blind clinical studies. Patients with a history of or current signs or symptoms of severe, progressive, or uncontrolled hepatic disturbances from the 3 studies were excluded.^4-6

The safety and efficacy of TREMFYA in adult patients with active psoriatic arthritis (PsA) was evaluated in 2 phase 3 pivotal studies (DISCOVER-1 and DISCOVER-2). Patients with a history of or current signs or symptoms of severe, progressive, or uncontrolled hepatic disturbances were excluded.^7,8

Clinical data

Messina et al (2022)³ described the cases of 45- and 54-year-old male patients with chronic viral hepatitis who were receiving TREMFYA.

• Patient 1 (45 years old) presented with a medical history of both PsO and PsA for 31 years in addition to other comorbidities.
  • Human immunodeficiency virus (HIV) test results were negative; hepatitis B virus (HBV) and hepatitis C virus (HCV) test results were positive for serologic markers (anti-hepatitis B [HB] surface antigen, anti-HB core antigen, and anti-HCV), but HBV-deoxyribonucleic acid (DNA) and HCV-ribonucleic acid (RNA) were undetectable.
  • Lamivudine 100 mg/day was provided as prophylactic treatment for HBV reactivation.
  • Ultrasonography showed no signs of cirrhosis.
  • The patient had a medical history of several systemic and biologic treatment options and due to PsO relapse (Psoriasis Area and Severity Index [PASI] 28), a switch from secukinumab to TREMFYA treatment was initiated.
  • At week 12, the patient presented with complete remission of both PsO (PASI 0) and PsA, which was also present during the last follow-up presentation 20 months after the initiation of TREMFYA.
  • The patient was receiving prophylactic lamivudine during the treatment with TREMFYA.
  • Liver enzymes remained within the normal range, and no reactivation of HBV or HCV was reported.
• Patient 2 (54 years old) presented with a medical history of PsO for 27 years in addition to other comorbidities.
  • The patient tested positive for serological markers of past HBV infection and anti-HCV antibodies but negative for anti-HIV antibodies.
  • He also presented with HCV-related liver cirrhosis and in the past few years had undergone 3 successful HCV eradication therapies, but each showed signs of reinfection due to patient’s medical history of intravenous (IV) drug addiction.
  • Previous PsO treatments included narrowband ultraviolet B (NB-UVB), acitretin, ustekinumab, secukinumab, and ixekizumab.
  • TREMFYA was initiated for severe PsO relapse (PASI 23), and at the time HCV viremia was undetectable.
  • At week 12, the patient presented with PASI 6.
  • At 6 months, HCV viremia of 30,228 UI/mL was observed, and antiviral treatment with glecaprevir and pibrentasvir was administered while continuing treatment with TREMFYA.
  • HCV eradication was observed in 3 months and after 18 months of follow-up, PsO was still under control (PASI 5) with no changes in liver function detected.

Nam et al (2021)² describe the case of a 34-year-old female patient with erythematous PsO and concomitant alcoholic liver cirrhosis.

• The patient presented with an esophageal varix rupture complicated by alcoholic liver cirrhosis and a Child-Pugh score of 9 (class B).
• Skin biopsy of an erythematous scaly plaque on her right thigh was consistent with PsO.
• Prior treatment of PsO included conventional treatments such as cyclosporine and phototherapy with no improvement.
• PsO lesions persisted following topical application of calcipotriol/betamethasone dipropionate while the patient was in the intensive care unit.
• TREMFYA was initiated when the patient was transferred to the general ward. The patient’s lesions improved rapidly after initiation of TREMFYA and PASI 90 was achieved after the third dose.
• No signs or symptoms suggesting acute exacerbation of liver cirrhosis were reported.
• No opportunistic or mycobacterial infections, spontaneous bacterial peritonitis, or hepatocellular carcinoma were reported during the 20 weeks of observation.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 16 August 2024.