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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 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 patients with hepatic impairment are available.2,3
RELEVANT INCLUSION/EXCLUSION CRITERIA FROM CLINICAL TRIALS
The safety and efficacy of TREMFYA in 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.
1 | Data on File. Guselkumab Company Core Data Sheet v017. Janssen Research & Development, LLC. EDMS-ERI-111962822. US-SRSM-4830. 2024. |
2 | Nam H, Noh S, Lim B, et al. A case of the safety and efficacy of guselkumab in psoriasis with alcoholic liver cirrhosis. Ann Dermatol. 2021;33(1):88-90. |
3 | F Messina, F Peccerillo, G Odorici, et al. Efficacy and safety of guselkumab in two psoriatic patients with hepatitis B and C virus infection. [published online ahead of print January 03, 2022]. Dermatol Ther. 2022;35(3):e15281. |
4 | Clinical Protocol CNTO1959PSO3003. Janssen Research & Development, LLC. EDMS-ERI-79233319; 2015. |
5 | Livshits G, Kalinkovich A. Hierarchical, imbalanced pro-inflammatory cytokine networks govern the pathogenesis of chronic arthropathies. Osteoarthr Cartil. 2018;26(1):7-17. |
6 | Clinical Protocol TMC114FD2HTX3001 (AMBER). Janssen Research & Development, LLC. EDMS-ERI-97893189. |
7 | Deodhar A, Helliwell P, Boencke WH. Supplement to: Guselkumab in patients with activepsoriatic arthritis who were biologic-naïve or had previously received TNFα inhibitor treatment (DISCOVER-1): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1115-1125. |
8 | Mease PJ, Rahman P, Gottlieb AB. Supplement to: Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1126-1136. |