Positive Results Reported for Nintedanib (Ofev) in Pulmonary Fibrosis Patients

Kinase inhibitor improves forced vital capacity

A new analysis of data from the phase 3 INPULSIS trials of nintedanib (Ofev, Boehringer Ingelheim) in patients with idiopathic pulmonary fibrosis (IPF) has shown that disease progression is similar in patients with IPF identified using a broader diagnostic definition compared with the current diagnostic guidelines. The post-hoc analysis was published in the American Journal of Respiratory and Critical Care Medicine.

The INPULSIS studies included patients with a classic diagnosis of IPF as well as those with a clinical diagnosis of IPF who, in the absence of a surgical lung biopsy and honeycombing on high-resolution computed tomography (HRCT), had a possible usual interstitial pneumonia (UIP) pattern and the presence of traction bronchiectasis. Traction bronchiectasis is recognized as one of the most relevant computed tomography signs of lung fibrosis. The analysis also showed that nintedanib was effective in slowing disease progression in both diagnostic subgroups.

A total of 1,061 patients were included in the post-hoc analysis by diagnostic criteria of pooled data from the INPULSIS trials. All of the patients had a diagnosis of IPF established in clinical practice for no more than five years before randomization. For the purpose of the subgroup analysis, 32% of the patients were classified as having a possible UIP pattern with traction bronchiectasis on HRCT and had not undergone a surgical lung biopsy, and 68% of the patients were classified as having either a UIP pattern on HRCT and/or a surgical lung biopsy confirming a UIP pattern (the diagnosis of IPF according to current international guidelines).

The subgroup analysis showed that:

  • In patients with a confirmed UIP pattern, including honeycombing and/or biopsy, the adjusted annual rates of decline in the forced vital capacity (FVC) was −108.7 mL/year in the nintedanib group and –225.7 mL/year in the placebo group.
  • In patients with HRCT features of a possible UIP pattern, with no honeycombing and no biopsy but the presence of traction bronchiectasis, the adjusted annual rates of decline in the FVC were −122.0 mL/year in the nintedanib group and –221.0 mL/year in the placebo group.
  • The treatment-by-subgroup interaction P value was not significant (P = 0.8139), indicating that the treatment effect of nintedanib was not different between the two subgroups.
  • Adverse events were similar between the two subgroups.

The FDA approved nintedanib for the treatment of patients with IPF in October 2014. Nintedanib is the only kinase inhibitor approved for this indication.

Source: Boehringer Ingelheim; June 27, 2016.