Effect of nintedanib in subgroups of idiopathic pulmonary fibrosis by diagnostic criteria

Raghu, Ganesh, Wells, Athol U., Nicholson, Andrew G., Richeldi, Luca, Flaherty, Kevin R., Maulf, Florence Le, Stowasser, Susanne, Schlenker-Herceg, Rozsa and Hansell, David M. (2017) Effect of nintedanib in subgroups of idiopathic pulmonary fibrosis by diagnostic criteria. American Journal of Respiratory and Critical Care Medicine, 195 (1), 78-85. (doi:10.1164/rccm.201602-0402OC).

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 2225.7 and 2221.0 ml/yr, and the nintedanib versus placebo difference in the adjusted annual rate of declineinFVCwas117.0ml/yr(95%confidenceinterval,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 undergonesurgicallungbiopsyhaddiseasethatprogressedinasimilar way, and responded similarly to nintedanib, to that of patients with honeycombing on HRCT and/or confirmation of UIP by biopsy.

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