P143 Real-world multicentre evaluation of liver function monitoring in patients with idiopathic or progressive pulmonary fibrosis receiving anti-fibrotic therapy in the United Kingdom

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As per Summary of Product Characteristics (SpC) there is a requirement to regularly monitor liver function tests (LFT) in patients receiving nintedanib or pirfenidone. Providing this service is placing unsustainable strain on the NHS both financially and in clinical time. This service evaluation aimed to determine the timing of LFT abnormalities (Bilirubin or ALT/AST or ALP) above the SpC defined threshold of ‘three times the upper limit of normal’ (3 x ULN) and whether patients were symptomatic of these abnormalities. Thirty-one anti-fibrotic prescribing centres were contacted across the UK. Ten centres participated. Participating centres confirmed adherence to the SpC recommendation. Retrospective LFT data were collected on all patients started on anti-fibrotic therapy between 01/01/2022 and 01/06/2023. The monitoring period ended 01/01/2024. LFT abnormalities were recorded in relation to 1. anti-fibrotic start date and 2. whether the patients were ‘symptomatic’ - defined by one or more of: jaundice, abdominal pain, nausea, vomiting. 1482 patients were included in the analysis. 67 of the 1482 (4.5%) patients developed LFT abnormalities > 3xULN. 58 of the 1172 patients who commenced nintedanib experienced LFT abnormalities > 3xULN (4.95%); 17 (29%) were symptomatic of their liver abnormalities. 52 of the 58 patients who experienced LFT abnormality >3xULN did so within the first 12 months of therapy. Of those patients monitored beyond 12 months, 6 encountered an LFT abnormality > 3xULN after 12 months of treatment. 9 of the 310 patients commenced on pirfenidone experienced LFT abnormalities > 3xULN (2.9%). 3 of the 9 patients (33.3%) were symptomatic. 7 of the 9 patients who experienced LFT abnormalities > 3xULN did so within 12 months of monitoring. Of those patients monitored beyond 12 months, 2 developed LFT abnormalities > 3xULN after 12 months of treatment. Within the limitations of this service evaluation, we demonstrate that rates of LFT abnormality > 3xULN are low beyond 12 months of therapy. Around 30% of patients are symptomatic of their LFT abnormalities, based on current definition. This work should encourage discussion around the practicalities, safety, service and financial implications of long term LFT monitoring in patients receiving anti-fibrotic therapy.

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