Analysis of body mass index, weight loss and progression of idiopathic pulmonary fibrosis

Abstract

Background Nintedanib is an approved therapy for idiopathic pulmonary fibrosis (IPF). Some patients treated with nintedanib experience weight loss. Exploratory data suggest that low body mass index or weight loss are associated with worse outcomes in patients with IPF. We investigated whether BMI at baseline or weight loss over 52 weeks was associated with FVC decline, or influenced the effect of nintedanib, in patients with IPF. Methods Using pooled data from the two INPULSIS trials, we analysed the rate of decline in FVC (mL/yr) over 52 weeks in patients treated with nintedanib and placebo in subgroups by baseline BMI (< 25; ≥25 to < 30; ≥30 kg/m2) and by weight loss over 52 weeks (≤5; > 5%) using random coefficient regression. Results In the placebo group, the mean rate of FVC decline over 52 weeks was numerically greater in patients with lower baseline BMI (− 283.3 [SE 22.4], − 207.9 [20.9] and − 104.5 [21.4] in patients with BMI < 25 kg/m2, ≥25 to < 30 kg/m2 and ≥ 30 kg/m2, respectively). Nintedanib reduced the rate of FVC decline versus placebo in all subgroups by BMI, with a consistent treatment effect across subgroups (interaction p = 0.31). In the placebo group, the mean rate of FVC decline was numerically greater in patients with > 5% than ≤5% weight loss over 52 weeks (− 312.7 [SE 32.2] versus − 199.5 [SE 14.4] mL/year). Nintedanib reduced the rate of FVC decline versus placebo in both subgroups by weight loss, with a greater treatment effect in patients with > 5% weight loss (interaction p = 0.0008). The adverse event profile of nintedanib was similar across subgroups. Conclusions In patients with IPF, lower BMI and weight loss may be associated with faster decline in FVC. Nintedanib reduces the rate of FVC decline both in patients who lose weight on treatment and those who do not. Trial registration ClinicalTrials.gov; Nos. NCT01335464 and NCT01335477; URL: www.clinicaltrials.gov.

Combined assessment of the GAP index and body mass index at antifibrotic therapy initiation for prognosis of idiopathic pulmonary fibrosis

“…Thus, lower BMI partly represents skeletal-muscle wasting in patients with IPF. Further, consistent with our findings, a second analysis of the INPULSIS study reported that lower BMI (< 25 kg/m 2 ) and weight loss (> 5% during 52 weeks) were associated with faster decline in FVC, suggesting shorter survivals in such patients 20 . Although GAP plus BMI did not achieve significant improvement of model discrimination compared with that of the original GAP index, GAP plus BMI distinguished patients into four distinct prognoses.…”

“…Given the small number of patients in each cohort, significance of GAP plus BMI was ascertained when we examined the two cohorts together. Third, the cut-off of the BMI appears to depend on ethnicity and country 20 . In our cohort, although few patients were obese, reverse-J associations were found between BMI and mortality, suggesting that both upper and lower cut-offs in BMI might be needed.…”

Eight months follow-up study on pulmonary function, lung radiographic, and related physiological characteristics in COVID-19 survivors

“…A study of African Americans with no cardiopulmonary or chest wall disease showed that BMI was negatively correlated with DLCO 21 . Another study on patients with COPD from China showed that BMI was positively correlated with DLCO and DLCO/VA 22 .A series of clinical studies on IPF showed that lower BMI is associated with a poorer outcome of IPF 23 – 25 , but indexes of pulmonary diffusion function were not observed in these studies. We speculate that better nutritional status may promote the recovery of lung injury from severe COVID-19, as BMI can be considered as an indicator of nutrition.…”

Nutritional assessment in idiopathic pulmonary fibrosis: a prospective multicentre study

“…[8,22] This discrepancy may be due to the differences in study design, as previous studies included patients in advanced stages of the disease and without exclusion of severe comorbidities. However, recent studies showed that not only overt malnutrition is a negative prognostic factor for patients with IPF, [22] but also body weight loss, sarcopenia and reduced gait speed or hand grip strength are associated with poor clinical outcomes [23][24][25][26] or reduced quality of life. [27] These conditions were observed in a considerable percentage of our normally nourished patients.…”