Tolerability and safety of anti-fibrotic agents for idiopathic pulmonary fibrosis in real world

Background Recently, we became to use two anti-fibrotic agents for treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib and pirfenidone were each approved in Japan in Aug 2015 ans Dec 2008, respectively. Aim The aim of this study is to evaluate efficacy and safety of the two anti-fibrotic agents in real world cases treated in our institute. Methods: We reviewed medical records of IPF patients with Nintedanib group (N-group, n=43) and Pirfenidone group(P-group, n=133). We picked up findings of blood test, pulmonary function test(FVC, %DLco), adverse events(AEs), and outcome including survival and ocuurence of acute exacerbation(AEx). Data after treatment was collected within 52wks from baseline. We compared the decline of FVC before and after in N-group(n=27) and in P-group(n=67). We calculated the discontinuation time from AEs between two groups in GAP stageI-II using Kaplan-Meier analysis. Results Baseline characteristics (gender, age, FVC, and %DLco) and outcome(AEx and survival) were not significant between two groups. Patients number of GAP stage I-II in P-group(stageI-II/III 88/34) was significantly fewer than that of N-group(stageI-II/III 35/5)(p=0.0485). Duration of treatment was not significantly difference between two groups(N:31wks, P:35wks, p=0.3438). Decline of FVC after treatment was not significantly diffenrence between 2 groups(N:89ml/year, P:106ml/year, p=0.5011). Main AEs in N-group were diarrhea(47%), and liver disorder(37%). Avarage continuation time of two group was not significant (N:35wks, P:34wks, Log-rank test:p=0.4404). Conclusion Tolerability and safety of two anti-fibrotic agents in GAP stageI-II was not signifcantly difference in 52 wks.