Table 3.
Clinical outcomes at 24 months, stratified by annualized percent change in body weight category
| Outcome | Annualized percent change in body weight (categorical) | ||
|---|---|---|---|
| No weight loss (n = 95) | > 0 to < 5% weight loss (n = 425) | ≥ 5% weight loss (n = 80) | |
| Primary outcome: all-cause mortality | |||
| Total observations, Na | 84 | 365 | 71 |
| Times response occurred, n | 5 | 65 | 17 |
| Estimate (95% CI)b | 0.05 (0.02, 0.13) | 0.14 (0.10, 0.18) | 0.15 (0.09, 0.25) |
| Odds ratio (95% CI)c | 2.83 (1.14, 8.62) | 3.28 (1.15, 10.95) | |
| Secondary outcome: annualized change in percent predicted FVC, % | |||
| Number of patients, na | 84 | 365 | 71 |
| Enrollment FVC (95% CI)d | 71.23 (69.40, 73.05) | 70.90 (70.03, 71.77) | 69.38 (67.40, 71.37) |
| Change (95% CI)e | − 3.07 (− 4.24, − 1.91) | − 2.28 (− 2.88, − 1.68) | − 3.52 (− 4.85, − 2.20) |
| Difference (95% CI)f | 0.79 (− 0.53, 2.11) | − 0.45 (− 2.22, 1.32) | |
| Secondary outcome: annualized change from enrollment in percent predicted DLco, % | |||
| Number of patients, na | 84 | 365 | 71 |
| Enrollment DLco (95% CI)d | 42.75 (41.67, 43.83) | 42.38 (41.87, 42.89) | 42.78 (41.59, 43.96) |
| Change (95% CI)e | − 3.79 (− 5.10, − 2.47) | − 3.19 (− 3.86, − 2.52) | − 5.33 (− 6.89, − 3.78) |
| Difference (95% CI)f | 0.60 (− 0.89, 2.08) | − 1.54 (− 3.58, 0.49) | |
| Secondary outcome: annualized change from enrollment in 6MWD, m | |||
| Number of patients, ng | 54 | 259 | 49 |
| Enrollment 6MWD (95% CI)d | 387.58 (355.50, 419.67) | 370.20 (355.94, 384.45) | 346.86 (314.64, 379.08) |
| Change (95% CI)e | − 29.39 (− 46.56, − 12.22) | − 14.94 (− 23.45, − 6.43) | 0.46 (− 17.54, 18.45) |
| Difference (95% CI)f | 14.45 (− 4.78, 33.68) | 29.85 (5.31, 54.38) | |
| Exploratory outcome: all-cause hospitalizations | |||
| Total observations, Nh | 79 | 300 | 54 |
| Times response occurred, n | 16 | 67 | 19 |
| Estimate (95% CI)b | 0.20 (0.12, 0.31) | 0.22 (0.17, 0.27) | 0.31 (0.20, 0.45) |
| Odds ratio (95% CI)c | 1.10 (0.59, 2.15) | 1.80 (0.80, 4.07) | |
| Exploratory outcome: respiratory-related hospitalizations | |||
| Total observations, Nh | 79 | 300 | 54 |
| Times response occurred, n | 7 | 25 | 13 |
| Estimate (95% CI)b | 0.07 (0.03, 0.16) | 0.06 (0.04, 0.09) | 0.14 (0.07, 0.25) |
| Odds ratio (95% CI)c | 0.76 (0.31, 2.08) | 2.06 (0.73, 6.16) | |
| Exploratory outcome: acute exacerbations | |||
| Total observations, Nh | 79 | 300 | 54 |
| Times response occurred, n | 6 | 15 | 5 |
| Estimate (95% CI)b | 0.06 (0.02, 0.14) | 0.03 (0.01, 0.06) | 0.04 (0.02, 0.12) |
| Odds ratio (95% CI)c | 0.45 (0.15, 1.42) | 0.73 (0.19, 2.75) | |
6MWD 6-min walk distance, CI confidence interval, DLco diffusing capacity for carbon monoxide, FVC forced vital capacity, OR odds ratio
aThe total number of patients for whom a complete set of predictor variables (including enrollment DLco) was obtained was N = 520
bProbability of event occurrence for an average patient in the specified category
cEstimated OR for the specified category relative to reference (blank) category
dEstimated response for an average patient at enrollment
eEstimated change in the response variable per year
fDifference in estimated annualized change compared with the reference (blank) category
gThe total number of patients with a complete set of predictor variables (including enrollment DLco) and non-missing 6MWD measurements was N = 362
hThe total number of patients for whom a complete set of predictor variables (including enrollment DLco) was obtained, excluding 87 patients who died during the 2-year study window, was N = 433