Real-life comparison of pirfenidone and nintedanib in patients with idiopathic pulmonary fibrosis: A 24-month assessment

Abstract

Background: Real-life data on the use of pirfenidone and nintedanib to treat patients with idiopathic pulmonary fibrosis (IPF) are still scarce. Methods: We compared the efficacy of either pirfenidone (n=78) or nintedanib (n=28) delivered over a 24-month period in patients with IPF, followed at two regional clinic centers in Italy, with a group of patients who refused the treatment (n=36), and who were considered to be controls. All patients completed regular visits at 1-to 3-month intervals, where primary [forced vital capacity (FVC) and diffusing capacity of the lungs for carbon monoxide (DLCO)] and secondary outcomes (side effects, treatment compliance, and mortality) were recorded. Results: Over time, the decline in FVC and DLCO was significantly higher (p=0.0053 and p=0.037, respectively) in controls when compared with the combined treated group, with no significant difference between the two treated groups. Compared to patients with less advanced disease (GAP (Gender, Age, Physiology) stage I), those in GAP stages II and III showed a significantly higher decline in both FVC and DLCO irrespective of the drug taken. Side effects were similarly reported in patients receiving pirfenidone and nintedanib (5% and 7%, respectively), whereas mortality did not differ among the three groups. Conclusion: This real-life study demonstrated that both pirfenidone and nintedanib were equally effective in reducing the decline of FVC and DLCO versus non-treated patients after 24 months of treatment; however, patients with more advanced disease were likely to show a more rapid decline in respiratory function.Dear Editor, dear Reviewers, Thank you for the thoughtful and constructive review of our paper. We carefully read your comments and suggestions, and we modified the manuscript accordingly.Please find enclosed a point-by-point response as well as a marked and clean copy of the revised manuscript.While we hope that you will find the revised version of the manuscript acceptable for publication as "Original Article" in Respiratory Medicine we will be happy to respond to outstanding comments and questions, should they occur.Best regards, Prof. Enrico Clini Reviewer 1We thank the Reviewer for the precise reviewing process of our work. We have welcomed all of her/his comments and we have tried to emend the manuscript accordingly. Major comments Reviewer 1's comment 1Did the authors calculate the power of the study (e.g. number of patients needed to respond to the main aim) before its start? This does not seem to be mentioned along the paper.

Long-Term Follow-Up of Patients With Idiopathic Pulmonary Fibrosis Treated With Pirfenidone or Nintedanib: A Real-Life Comparison Study

“…Although our data may be influenced by demographic discrepancies between the two groups, our results suggest that the two drugs have substantially the same performance in preventing functional deterioration and reducing mortality. These assumptions are in line with a recent paper by Cerri et al (2019) , although our study considered a larger cohort of patients (including those with advanced disease) and a much longer follow-up, further underlining the reliability of both antifibrotic drugs in the treatment of IPF.…”

“…A metanalysis published in 2016 failed to find any significant differences in safety or concerning progression between the two drugs, whereas nintedanib appeared to be more effective in reducing acute exacerbations and mortality risk ( Rogliani et al, 2016 ). Two other retrospective observational studies confirmed the substantial similarity of the two antifibrotic drugs in terms of effectiveness and tolerability, albeit with a relatively short follow-up ( Bargagli et al, 2019 ; Cerri et al, 2019 ).…”

Patient expectations, experiences and satisfaction with nintedanib and pirfenidone in idiopathic pulmonary fibrosis: a quantitative study

“…Previous studies have shown that nintedanib and pirfenidone have a similar effect on lung function decline. Furthermore, no significant differences in all-cause mortality and frequency of side-effects were found between the two drugs [2,3,5,21]. However, these studies did not compare patient experiences and satisfaction between both antifibrotic drugs.…”

“…These drugs slow down disease progression, may reduce the rate of acute exacerbations, and seem to prolong survival [ 2 – 4 ]. The decision to prescribe either nintedanib or pirfenidone is usually based on the specific side-effect profiles, comorbidities, co-medication, and a patient’s preferences [ 5 , 6 ]. The prevalence of adverse events has been reported in randomized controlled trials and registries with real-world data.…”

Radix Astragali and Radix Angelicae Sinensis in the Treatment of Idiopathic Pulmonary Fibrosis: A Systematic Review and Meta-analysis

“…IPF cannot be cured at present. The purpose of treatment is to delay disease progress, improve quality of life and prolong survival (Cerri et al, 2019). IPF has poor prognosis, median survival time after diagnosis is about 2 to 3 years.…”