Effect of Nintedanib in Subgroups of Idiopathic Pulmonary Fibrosis by Diagnostic Criteria.

Abstract

RATIONALE:

In the absence of a surgical lung biopsy, patients diagnosed with idiopathic pulmonary fibrosis (IPF) in clinical practice could participate in the INPULSIS trials of nintedanib if they had honeycombing and/or traction bronchiectasis plus reticulation, without atypical features of usual interstitial pneumonia (UIP), on high-resolution computed tomography (HRCT). Thus, the patients in these trials represented patients with definite UIP and a large subgroup of patients with possible UIP.

OBJECTIVES:

To investigate the potential impact of diagnostic subgroups on the progression of IPF and the effect of nintedanib.

METHODS:

We conducted a post hoc subgroup analysis of patients with honeycombing on HRCT and/or confirmation of UIP by biopsy versus patients without either, using pooled data from the INPULSIS trials.

MEASUREMENTS AND MAIN RESULTS:

Seven hundred twenty-three (68.1%) patients had honeycombing and/or biopsy, and 338 (31.9%) patients had no honeycombing or biopsy. In these subgroups, respectively, the adjusted annual rate of decline in FVC in patients treated with placebo was -225.7 and -221.0 ml/yr, and the nintedanib versus placebo difference in the adjusted annual rate of decline in FVC was 117.0 ml/yr (95% confidence interval, 76.3-157.8) and 98.9 ml/yr (95% confidence interval, 36.4-161.5). There was no significant treatment-by-subgroup interaction (P = 0.8139). Adverse events were similar between the subgroups.

CONCLUSIONS:

Patients with IPF diagnosed in clinical practice who had possible UIP with traction bronchiectasis on HRCT and had not undergone surgical lung biopsy had disease that progressed in a similar way, and responded similarly to nintedanib, to that of patients with honeycombing on HRCT and/or confirmation of UIP by biopsy.

• Authors: Ganesh Raghu, Athol U Wells, Andrew G Nicholson, Luca Richeldi, Kevin R Flaherty, Florence Le Maulf, Susanne Stowasser, Rozsa Schlenker-Herceg, David M Hansell
• Journal: American journal of respiratory and critical care medicine (Am J Respir Crit Care Med) Vol. 195 Issue 1 Pg. 78-85 (01 01 2017) ISSN: 1535-4970 [Electronic] United States
• PMID: 27331880 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Indoles
• Protein-Tyrosine Kinases
• nintedanib

Topics

• Aged
• Biopsy
• Disease Progression
• Female
• Humans
• Idiopathic Pulmonary Fibrosis (diagnosis, diagnostic imaging, drug therapy, pathology)
• Indoles (therapeutic use)
• Lung (diagnostic imaging, pathology)
• Male
• Protein-Tyrosine Kinases (antagonists & inhibitors)
• Tomography, X-Ray Computed
• Treatment Outcome