5PSQ-055 Effectiveness, safety, and monitoring of pirfenidone and nintedanib in idiopathic pulmonary fibrosis

<h3>Background and Importance</h3> Idiopathic Pulmonary Fibrosis (IPF) is a rare and progressive disease. Current treatments, pirfenidone and nintedanib, aim to slow disease progression in mild to moderate cases. The Therapeutic Positioning Report (TPR) guides treatment monitoring, recommending discontinuation if Forced Vital Capacity (FVC) decreases by over 10% or Diffusing Capacity for Carbon Monoxide (DLCO) drops by 15% annually. This study compares the effectiveness, safety, and adherence to TPR guidelines for both drugs. <h3>Aim and Objectives</h3> The study’s objective is to evaluate the real-world effectiveness and safety of pirfenidone and nintedanib in IPF treatment, assessing patient response rates and treatment discontinuation reasons in accordance with TPR criteria. <h3>Material and Methods</h3> This retrospective study analysed data from IPF patients treated with antifibrotics up to December 2023. Patient information, including demographics, FVC, DLCO, adverse events (AEs), and treatment adherence, was collected from electronic records. The effectiveness analysis excluded patients treated for less than six months, and statistical analysis was conducted using Chi-square tests for categorical data. <h3>Results</h3> Thirty-one patients were recruited (54.84% female, mean age 71 ± 9.53 years); of these, five received only pirfenidone, 21 received nintedanib, and five received both sequentially. One patient on pirfenidone and one on nintedanib did not meet TPR initiation criteria. The responder rate for pirfenidone was 70% (95% CI: 38.7%–89.2%) compared to 45.8% (95% CI: 28.9%–62.9%) for nintedanib (p=0.2). One patient on pirfenidone and five on nintedanib exhibited reductions in FVC and/or DLCO beyond TPR limits. Adverse events were reported in 57% of pirfenidone patients (95% CI: 40.1%–75.2%) versus 85% on nintedanib (95% CI: 68.5%–94.3%, p=0.02). Discontinuations among pirfenidone users included one due to AEs and one death, while nintedanib had seven discontinuations: five due to AEs, one due to death, and one due to disease progression. <h3>Conclusion and Relevance</h3> The study found no significant difference in response rates between pirfenidone and nintedanib, although AEs were more frequent with nintedanib. Some patients did not meet TPR criteria, highlighting the need for stringent monitoring to optimise economic resources and minimise unnecessary toxicity. The findings underscore the importance of careful patient evaluation by pulmonologists and pharmacists to ensure treatment adherence and efficacy. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest