5PSQ-103 Experience of antifibrotic agents in the treatment of idiopathic pulmonary fibrosis

Background and importance Antifibrotics are an important alternative for the treatment of idiopathic pulmonary fibrosis (IPF) but long term follow-up studies of their effectiveness and safety are required. Aim and objectives To assess the safety and efficacy of pirfenidone and nintedanib in patients with IPF. Material and methods A retrospective observational study was conducted in all patients treated with pirfenidone and nintedanib for >3 months. Variables collected were age, sex, forced vital capacity (FVC) at baseline, at 6 and 12 months, and at the end of treatment, duration of treatment, disease progression (absolute decline in%FVC >10%), exacerbations and deaths due to IPF, hospitalisations due to respiratory causes and adverse drug reactions (ADR). Results Ninety-four patients were included, 57 received pirfenidone and 37 nintedanib. Mean age was 67 years (79.8% men). The mean baseline%FVC was 69.9% (SD 16.98) for pirfenidone and 68.1% (SD 14.33) for nintedanib. Median duration of pirfenidone and nintedanib treatment was 31.1 months (0.8–56.3) and 16.2 months (5.8–36.8), respectively. Twenty-nine per cent of patients treated with pirfenidone had exceeded 2 years of treatment (2.5–4.7 years) and%FVC was stable at the present time compared with 18.9% in the nintedanib group. Of the patients treated with pirfenidone, 45.6% discontinued (33.3% in the first year) due to ADR (17.5%), disease progression (14.0%) or death (7.0% IPF related and 12.3% in total). For nintedanib, 62.2% discontinued (35.1% in the first year) due to ADR (18.2%), disease progression (21.6%) or death (5.4%, all IPF related). IPF related exacerbations per year of treatment rate was 0.19 for pirfenidone and 0.47 for nintedanib; hospitalisations per year of treatment rate was 0.21 for pirfenidone and 0.45 for nintedanib. The average ADR/patient was 1.0 for pirfenidone (19.2% ADR grade 2, 5.1% grade 3) and 0.97 for nintedanib (45% grade 2, 2.7% grade 3). The most frequent ADR in pirfenidone treated patients were gastrointestinal (24.1%), asthenia (22.4%), cutaneous reactions (18.9%), cough (15.5%) and myalgia (8.6%); for nintendanib, the most frequent ADR were gastrointestinal (73.53%, mainly diarrhoea), liver enzyme alteration (11.8%) and bleeding (8.8%). Conclusion and relevance Both drugs had moderate efficacy and high toxicity. Although it was not a comparative study, pirfenidone showed better tolerance than nintedanib and patients had longer courses of treatment with stable disease. References and/or acknowledgements No conflict of interest.