The value of imaging and clinical outcomes in a phase II clinical trial of a lysophosphatidic acid receptor antagonist in idiopathic pulmonary fibrosis.
Ther Adv Respir Dis
; 15: 17534666211004238, 2021.
Article
em En
| MEDLINE
| ID: mdl-33781141
ABSTRACT
BACKGROUND:
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive fibrotic lung disease characterized by worsening dyspnea and lung function and has a median survival of 2-3 years. Forced vital capacity (FVC) is the primary endpoint used most commonly in IPF clinical trials as it is the best surrogate for mortality. This study assessed quantitative scores from high-resolution computed tomography (HRCT) developed by machine learning as a secondary efficacy endpoint in a 26-week phase II study of BMS-986020 - an LPA1 receptor antagonist - in patients with IPF.METHODS:
HRCT scans from 96% (137/142) of randomized subjects were utilized. Quantitative lung fibrosis (QLF) scores were calculated from the HRCT images. QLF improvement was defined as ⩾2% reduction in QLF score from baseline to week 26.RESULTS:
In the placebo arm, 5% of patients demonstrated an improvement in QLF score at week 26 compared with 15% and 27% of patients in the BMS-986020 600 mg once daily (QD) and twice daily (BID) arms, respectively [versus placebo p = 0.08 (600 mg QD); p = 0.0098 (600 mg BID)]. Significant correlations were found between changes in QLF and changes in percent predicted FVC, diffusing capacity for carbon monoxide (DLCO), and shortness of breath at week 26 (ρ = -0.41, ρ = -0.22, and ρ = 0.27, respectively; all p < 0.01).CONCLUSIONS:
This study demonstrated the utility of quantitative HRCT as an efficacy endpoint for IPF in a double-blind, placebo-controlled clinical trial setting.The reviews of this paper are available via the supplemental material section.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Tomografia Computadorizada por Raios X
/
Receptores de Ácidos Lisofosfatídicos
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Fibrose Pulmonar Idiopática
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
Limite:
Aged
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Female
/
Humans
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Male
/
Middle aged
Idioma:
En
Revista:
Ther Adv Respir Dis
Assunto da revista:
PNEUMOLOGIA
/
TERAPEUTICA
Ano de publicação:
2021
Tipo de documento:
Article
País de afiliação:
Estados Unidos