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. 2017 Jan 1;195(1):78-85.
doi: 10.1164/rccm.201602-0402OC.

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

Ganesh Raghu  1 , Athol U Wells  2 , Andrew G Nicholson  2 , Luca Richeldi  3 , Kevin R Flaherty  4 , Florence Le Maulf  5 , Susanne Stowasser  6 , Rozsa Schlenker-Herceg  7 , David M Hansell  2
Affiliations

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

Ganesh Raghu et al. Am J Respir Crit Care Med. .

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.

Keywords: HRCT; diagnosis; high-resolution computed tomography; honeycombing; traction bronchiectasis.

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Figures

Figure 1.
Figure 1.
Eligibility criteria based on high-resolution computed tomography (upper, middle, and lower zones). (A) Criteria A, B, and C met. (B) Criteria B and C met.
Figure 2.
Figure 2.
Annual rate of decline in FVC (ml/yr) by subgroup. CI = confidence interval; HRCT = high-resolution computed tomography; UIP = usual interstitial pneumonia.
Figure 3.
Figure 3.
Change from baseline in FVC over time by subgroup. SLB = surgical lung biopsy; UIP = usual interstitial pneumonia.
Figure 4.
Figure 4.
Time to first acute exacerbation over 52 weeks by subgroup. SLB = surgical lung biopsy; UIP = usual interstitial pneumonia.
Figure 5.
Figure 5.
Change from baseline in St. George’s Respiratory Questionnaire (SGRQ) total score over 52 weeks by subgroup. CI = confidence interval; HRCT = high-resolution computed tomography; UIP = usual interstitial pneumonia.
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