METHODS: Thirty consecutive IPF cases, which discontinued
pirfenidone because of a decline in forced vital capacity (FVC) or intolerable adverse event (AE), and newly started
nintedanib (150 mg twice daily) from September 2015 to August 2017 (switch-group) were retrospectively reviewed. Subsequently, we compared the characteristics, treatment status, and AEs between the switch-group and other 64 IPF patients newly started
nintedanib during the same period without any prior anti-fibrotic treatment (
pirfenidone-naïve group).
RESULTS: In the switch group, median age,
body weight, body mass index (BMI), and %FVC were 72 years old, 54.9 kg, 21.0 kg/m2, and 52.9%, respectively. Most common AE of
nintedanib was
aspartate aminotransferase/
alanine aminotransferase elevation (71.9%), followed by
anorexia (46.7%) and
diarrhea (46.7%); whereas,
anorexia (63.3%) and ≥ 5%
weight loss from baseline (56.7%) were common during
pirfenidone administration. Sixteen patients (53.3%) discontinued
nintedanib within 6 months (early termination). Multivariate logistic regression analysis revealed a significant association between low BMI and early
nintedanib termination in the switch-group (p = 0.0239).
Nintedanib suppressed FVC decline as compared with that during administration period of
pirfenidone in 70% of the patients who could undergo lung function before and after switching to
nintedanib. The incidence of early termination of
nintedanib was higher in the switch-group than in the
pirfenidone-naïve group, whereas
body-weight, BMI, absolute FVC values, and %FVC were significantly lower in the switch-group (just before
nintedanib initiation) than in the
pirfenidone-naïve group.
Nintedanib-induced
anorexia was more frequent and severer in the switch-group than in the
pirfenidone-naïve group, but no significant differences were observed in terms of other AEs.
CONCLUSIONS: