Discussion
weight decrease, death, diarrhea, decreased appetite, weight loss
ADVERSE EVENTS, ADVERSE EVENT
These analyses of data from the INBUILD trial suggest that there may be associations between baseline BMI or weight loss and clinically relevant outcomes in patients with PPF. The rate of FVC decline, and the risk of ILD progression or death, were numerically greater in subjects with baseline BMI < 25 kg/mOur finding that the rate of decline in FVC was greatest in subjects with baseline BMI < 25 kg/mVarious approaches can be used to investigate associations between a longitudinal measure such as weight and the risk of an outcome. In these analyses, we used a joint modelling approach, as this enables longitudinal markers and time-to-event endpoints to be analyzed simultaneously, overcoming issues of bias and measurement error that occur when repeated measurements and outcomes are analyzed separately, when analyses are based on post-baseline subgroups, or when analyses do not consider longitudinal endpoints as endogenous time-varying factors [The adverse event profile of nintedanib was generally similar across the subgroups by baseline BMI, but adverse events of diarrhea, decreased appetite and weight decrease, and adverse events leading to dose reduction and treatment discontinuation, were more frequent in subjects who had a baseline BMI < 25 kg/mStrengths of our analyses include the robust collection of data on FVC and weight in the setting of a clinical trial, and the use of a joint modelling approach to assess the associations between weight loss and outcomes [