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Nintedanib can be used safely and effectively for idiopathic pulmonary fibrosis with predicted forced vital capacity ? 50%: A multi-center retrospective analysis.

ABSTRACT: BACKGROUND:Nintedanib is a multi-kinase inhibitor approved for idiopathic pulmonary fibrosis (IPF); however, its efficacy and safety for patients with IPF and restricted pulmonary function remain unclear. Therefore, the objective of this study was to determine the efficacy and safety of nintedanib for patients with IPF and forced vital capacity (FVC) ? 50%. METHODS:This was a multi-center retrospective study performed by the Okayama Respiratory Disease Study Group. Patients were allocated into FVC ? 50% and FVC > 50% groups based on their predicted FVC. The primary endpoints were FVC changes from baseline after 6 and 12 months. RESULTS:45 patients were eligible for the study. 18 patients had FVC ? 50%, and 27 patients had FVC > 50%. Overall, 31 and 19 patients underwent pulmonary function tests at 6 and 12 months after initiating nintedanib, respectively. FVC changes from baseline at 6 and 12 months after initiating nintedanib were comparable between the two groups. Adverse events were seen in all patients, and the rates of patients who discontinued nintedanib were also comparable (38.9% vs. 37.0%, p = 1.000). Multiple regression analysis showed that age and forced expiratory volume in 1 second (FEV1)/FVC were negatively correlated with changes in FVC at 6 months after initiating nintedanib. CONCLUSIONS:Our data suggest that nintedanib can be a useful agent for IPF patients, including those with a low FVC, and that age and FEV1/FVC are predictive markers for changes in FVC following nintedanib treatment.

SUBMITTER: Senoo S

PROVIDER: S-EPMC7451511 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Nintedanib can be used safely and effectively for idiopathic pulmonary fibrosis with predicted forced vital capacity ≤ 50%: A multi-center retrospective analysis.

Senoo Satoru S Miyahara Nobuaki N Taniguchi Akihiko A Oda Naohiro N Itano Junko J Higo Hisao H Hara Naofumi N Watanabe Hiromi H Kano Hirohisa H Suwaki Toshimitsu T Fuchimoto Yasuko Y Kajimoto Kazuhiro K Ichikawa Hirohisa H Kudo Kenichiro K Shibayama Takuo T Tanimoto Yasushi Y Kuyama Shoichi S Kanehiro Arihiko A Maeda Yoshinobu Y Kiura Katsuyuki K

PloS one 20200827 8

<h4>Background</h4>Nintedanib is a multi-kinase inhibitor approved for idiopathic pulmonary fibrosis (IPF); however, its efficacy and safety for patients with IPF and restricted pulmonary function remain unclear. Therefore, the objective of this study was to determine the efficacy and safety of nintedanib for patients with IPF and forced vital capacity (FVC) ≤ 50%.<h4>Methods</h4>This was a multi-center retrospective study performed by the Okayama Respiratory Disease Study Group. Patients were a ...[more]

PMID: 32853277

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Project description:BACKGROUND:Forced Vital Capacity (FVC) is an important predictor of all-cause mortality in the absence of chronic respiratory conditions. Epidemiological evidence highlights the role of early life factors on adult FVC, pointing to environmental exposures and genes affecting lung development as risk factors for low FVC later in life. Although highly heritable, a small number of genes have been found associated with FVC, and we aimed at identifying further genetic variants by focusing on lung development genes. METHODS:Per-allele effects of 24,728 SNPs in 403 genes involved in lung development were tested in 7,749 adults from three studies (NFBC1966, ECRHS, EGEA). The most significant SNP for the top 25 genes was followed-up in 46,103 adults (CHARGE and SpiroMeta consortia) and 5,062 children (ALSPAC). Associations were considered replicated if the replication p-value survived Bonferroni correction (p<0.002; 0.05/25), with a nominal p-value considered as suggestive evidence. For SNPs with evidence of replication, effects on the expression levels of nearby genes in lung tissue were tested in 1,111 lung samples (Lung eQTL consortium), with further functional investigation performed using public epigenomic profiling data (ENCODE). RESULTS:NCOR2-rs12708369 showed strong replication in children (p = 0.0002), with replication unavailable in adults due to low imputation quality. This intronic variant is in a strong transcriptional enhancer element in lung fibroblasts, but its eQTL effects could not be tested due to low imputation quality in the eQTL dataset. SERPINE2-rs6754561 replicated at nominal level in both adults (p = 0.036) and children (p = 0.045), while WNT16-rs2707469 replicated at nominal level only in adults (p = 0.026). The eQTL analyses showed association of WNT16-rs2707469 with expression levels of the nearby gene CPED1. We found no statistically significant eQTL effects for SERPINE2-rs6754561. CONCLUSIONS:We have identified a new gene, NCOR2, in the retinoic acid signalling pathway pointing to a role of vitamin A metabolism in the regulation of FVC. Our findings also support SERPINE2, a COPD gene with weak previous evidence of association with FVC, and suggest WNT16 as a further promising candidate.

Project description:RationaleBlack Africans have reduced FVC compared with white persons, but the prevalence and determinants of reduced values are not well understood.ObjectivesTo evaluate the prevalence and factors leading to reduced FVC in a Nigerian population and to examine current theories regarding the determinants of this difference.MethodsWe studied the ventilatory function of 883 adults aged 40 years or older participating in the Burden of Obstructive Lung Disease Study in Ile-Ife, Nigeria. Respondents completed pre- and post-bronchodilator spirometry test and provided information on their smoking history, respiratory symptoms, risk factors, and diagnoses, including anthropometric details. We used standard categories to define body mass index as either underweight, normal, overweight, or obese. We defined reduced FVC as a post-bronchodilator FVC below the lower limit of normal using National Health and Nutrition Examination Survey (NHANES) equations, Global Lung Function Initiative 2012 equations, and local reference equations based on nonsmoking study participants without a respiratory diagnosis. We fit multivariate linear regression models to FVC as a continuous measure, adjusting for age, sex, height, and other confounders.ResultsThe prevalence of reduced FVC was 70.4% for men and 72.8% for women when using NHANES values for white Americans, 17.8% for men and 14.4% for women using NHANES equations for African Americans, and 15.5% for men and 20.5% for women using the Global Lung Function Initiative 2012 equations. Using the equations derived from nonsmoking respondents in the survey without a respiratory diagnosis, the prevalence of reduced FVC was less than 4% for both men and women. FVC was lower in participants who had less than 7 years of education (FVC, -96 ml; 95% confidence interval [CI], -172 to -19), were underweight (FVC, -269 ml; 95% CI, -464 to -73), were overweight (FVC, -132 ml; 95% CI, -219 to -46), and were obese (FVC, -222 ml; 95% CI, -332 to -112).ConclusionsThere is a wide variation in the prevalence of reduced FVC based on the reference standard used. This variation is not satisfactorily explained by factors thought to affect FVC within individual populations. However, the prevalence strongly associates with both education level and body mass index in this population, regardless of the specific standard used.

Dataset Information

Nintedanib can be used safely and effectively for idiopathic pulmonary fibrosis with predicted forced vital capacity ? 50%: A multi-center retrospective analysis.

Publications

Nintedanib can be used safely and effectively for idiopathic pulmonary fibrosis with predicted forced vital capacity ≤ 50%: A multi-center retrospective analysis.

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