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.