Adherence, Persistence, and Effectiveness in Real Life. Multicenter Long-Term Study on the Use of Pirfenidone and Nintedanib in the Treatment of Idiopathic Pulmonary Fibrosis

Abstract

Background: In the treatment of idiopathic pulmonary fibrosis (IPF), nintedanib and pirfenidone, with their different mechanisms of action, lead to a reduction in the rate of progression of the fibrosis process measured by the reduction of functional decline, and, in particular, the decrease in forced vital capacity (FVC) and of the diffusion capacity of the lungs for carbon monoxide (DLCO). The objective of this study was to analyze real-life adherence, persistence and efficacy in the use of pirfenidone and nintedanib in the treatment of IPF. Methods: A non-interventional multicenter retrospective observational pharmacological study in real-life treat-ment at 1 and 2 years was conducted. Furthermore, we analyzed the levels of FVC and DLCO at 6 and 12 months, respectively, from the start of treatment. Results: We identified 144 patients in the period between January 2013 and April 2019. From the point of view of adherence, there is no difference between the two drugs, even though patients who used pirfenidone had increasingly higher values: 0.90 vs 0.89, in the first year, and 0.91 vs 0.84, in the second year. In the first year of treatment, the percentage of persistent patients was 67% and 76%, while in the second year, it dropped to 47% and 53% for pirfenidone and nintedanib, respectively. Conclusion: The stratification of the adherence values as a function of the response to treatment in terms of FVC at 12 months for both study drugs showed that patients with optimal response scored adherence of more than 90%.

Electronically monitored medication adherence in idiopathic pulmonary fibrosis: prevalence, predictors and outcomes

“…In fact, several doses per day are required, the medication has to be taken over a long period of time and there may be burdensome medication side-effects [8,9]. Prior studies primarily evaluated discontinuation rates (ranging between 21 and 58%) cross-sectionally or retrospectively, and used adherence measures, such as self-reporting or pharmacy refill data, which are known to underestimate adherence problems [10][11][12][13]. To investigate adherence to complex pharmacological regimens one needs accurate measurement methods.…”

Clinical course of mild-to-moderate idiopathic pulmonary fibrosis during therapy with pirfenidone: Results of the non-interventional study AERplus

“…Our results should be interpreted with caution due to the declining numbers of patients over the course of the study. This is not uncommon in real-life and reflects the poor treatment persistence generally observed in IPF patients [34,35]. The strength of this study is represented by objective measurements of pulmonary function and the use of validated scores to assess severity of dyspnea [21], quality of life in chronic cough [20], and staging of IPF [19].…”

Association between nintedanib adherence trajectory and healthcare use among idiopathic pulmonary fibrosis patients

“…We are aware of only one study that examined the association between nintedanib adherence and outcomes. Santoleri et al reported a positive association between nintedanib adherence and FVC response one year after initiation among 144 nintedanib users in Italy during 2013–2019 [ 23 ]. Although a small number of studies examine the association of medication adherence and health and healthcare outcomes using the GBTM methodology, they vary greatly in their selected indications, outcomes and findings [ 30 – 37 ].…”

“…A few recent studies have documented nintedanib adherence in the United States using administrative claims data [ 20 – 22 ]. A small observational cohort study from Italy reported a positive association between levels of adherence to nintedanib and lung function response [ 23 ]. To date, however, no studies have examined the association between non-adherence to nintedanib and healthcare use and spending in patients with IPF.…”