Prevalence and risk factors for drug-induced liver injury among patients with rheumatic diseases treated with biological therapy: a single-center experience.

Abstract

Drug-induced liver injury (DILI) is a common event in patients with rheumatic diseases (RD) on biological therapy (BT). We aimed at evaluating the prevalence and pattern of DILI. Consecutive RD patients treated with BT were followed for 6 months. ALT and ALP >the upper limit normal (ULN) and <to 3xULN defined injury Grade 1 and >3xULN injury Grade 2. 582 liver function tests (LFTs) in 199 patients were evaluated, median age 53y, 59.3 % females, RA in 108, AS 49, and PsA 42 patients. ALT Grade 1 elevation was observed in 25.6 %, transient in 18.6 %, persisting in 7 %, Grade 2 in 1.5 %, ALP Grade 1 in 3.5 %, transient in 2 %, persisting in 1.5 %. We report no case of ALP Grade 2 or Hy´s law (ALT>3xULN, bilirubin>2xULN). Patients with persisting ALT elevation had higher BMI (28.23 vs. 25.74, p=0.016), lower DAS28 (2.22 vs. 5.28, p=0.046). ALT Grade 1 injury was more frequent with solo tocilizumab compared with other agents (27.5 % vs. 13.6 %, p=0.01). DILI was frequent, in 18.6 % transient, in 7 % persisting, Grade 2 in 1.5 %, led to treatment alteration in 0.5 %, with higher prevalence on solo tocilizumab therapy. We report no new safety signals for BT in RD.