Format

Send to

Choose Destination
See comment in PubMed Commons below
Am J Respir Crit Care Med. 2016 Jan 15;193(2):178-85. doi: 10.1164/rccm.201503-0562OC.

Efficacy of Nintedanib in Idiopathic Pulmonary Fibrosis across Prespecified Subgroups in INPULSIS.

Author information

1
1 Ruhrlandklinik, University Hospital, University of Duisburg-Essen, Essen, Germany.
2
2 Clinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan.
3
3 National Institute for Health Research Southampton Respiratory Biomedical Research Unit and Clinical and Experimental Sciences, University of Southampton, Southampton, United Kingdom.
4
4 Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of California San Francisco, San Francisco, California.
5
5 Boehringer Ingelheim France S.A.S., Reims, France.
6
6 Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany; and.
7
7 Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.

Abstract

RATIONALE:

In the two replicate, placebo-controlled, 52-week, phase III INPULSIS trials, nintedanib 150 mg twice daily significantly reduced the annual rate of decline in FVC, the primary endpoint, in subjects with idiopathic pulmonary fibrosis (IPF). It is unknown if this effect was uniform across all subjects treated with nintedanib.

OBJECTIVES:

To investigate the potential association of demographic and clinical variables with the effect of nintedanib in subjects with IPF.

METHODS:

Subgroup analyses of pooled data from the INPULSIS trials were prespecified. Subgroups were analyzed by sex, age (<65, ≥65 yr), race (white, Asian), baseline FVC percentage predicted (≤70%, >70%), baseline St. George's Respiratory Questionnaire (SGRQ) total score (≤40, >40), smoking status (never, ex/current), systemic corticosteroid use (yes/no), and bronchodilator use (yes/no).

MEASUREMENTS AND MAIN RESULTS:

A total of 1,061 subjects were treated (nintedanib n = 638, placebo n = 423). There was no statistically significant difference in the effect of nintedanib for the primary endpoint or the key secondary endpoints of change from baseline in SGRQ total score or time to first acute exacerbation in any subgroup. Treatment effects for the key secondary endpoints seemed more pronounced in subjects with baseline FVC ≤70% predicted, because the majority of acute exacerbations and a greater deterioration in SGRQ total score occurred in placebo-treated subjects in this subgroup.

CONCLUSIONS:

Pooled data from the INPULSIS trials support a consistent effect of nintedanib across a range of IPF phenotypes by slowing disease progression across a number of prespecified subgroups.

KEYWORDS:

disease progression; forced vital capacity; quality of life

PMID:
26393389
DOI:
10.1164/rccm.201503-0562OC
[Indexed for MEDLINE]
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Atypon
    Loading ...
    Support Center