Comparative Evaluation of Liver Function Tests in Patients with Refractory Psoriasis Treated with Tofacitinib & Apremilast: A Retrospective Cohort Study

Abstract

Introduction: Psoriasis is a chronic inflammatory skin disorder often requiring long-term systemic therapy. Tofacitinib and apremilast are oral agents increasingly used in refractory cases; however, their impact on liver function remains a concern.

Aim & Objective: To compare the hepatic safety of tofacitinib and apremilast in patients with refractory moderate-to-severe psoriasis over 12 months.

Materials & Methods: A retrospective cohort study was conducted among 130 adult patients with refractory moderate to severe psoriasis receiving either tofacitinib (n=65) or apremilast (n=65) for 12 months. Liver function tests (ALT, AST, ALP, and bilirubin) were assessed at baseline, 3, 6, and 12 months. Changes in liver enzymes, incidence of elevations (>2× upper limit of normal), and treatment modifications were analyzed using appropriate statistical tests.

Results: Baseline demographic and liver function parameters were comparable between the two groups (p>0.05). The tofacitinib group demonstrated a significant progressive increase in ALT and AST levels at all follow-up points compared to the apremilast group (p<0.001). Mean ALT increased from 26.3 ± 7.6 U/L to 42.1 ± 11.2 U/L, and AST from 22.9 ± 6.8 U/L to 35.5 ± 9.6 U/L. In contrast, apremilast showed minimal changes. The incidence of ALT and AST elevations (>2× ULN) was significantly higher with tofacitinib (24.6% and 20.0%) compared to apremilast (6.2% and 4.6%) (p<0.01). ALP and bilirubin remained stable in both groups. Two patients on tofacitinib required dose adjustment, while none in the apremilast group required modification.

Conclusions: Tofacitinib is associated with significant liver enzyme elevations, whereas apremilast demonstrates a favorable hepatic safety profile. Regular monitoring is essential, and apremilast may be preferred in patients at risk of liver dysfunction.

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