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Table 3 Association between slope of FVC% predicted and risk of first hospitalisation endpoints over the whole trial

From: Impact of lung function decline on time to hospitalisation events in systemic sclerosis-associated interstitial lung disease (SSc-ILD): a joint model analysis

 

Time to first hospitalisation or death (n = 568)

Time to first SSc-related hospitalisation or death (n = 570)

Time to first admission to ER or admission to hospital followed by admission to ICU or death (n = 572)

Longitudinal sub-modela

Estimated slope difference nintedanib vs. placebo (95% CI)

1.07 (0.10, 2.05)

1.19 (0.27, 2.12)

1.18 (0.23, 2.13)

 P value

0.03

0.01

0.02

Time to event sub-modelb

 Number of patients with event, n (%)

103 (18.1)

56 (9.8)

90 (15.7)

Difference in estimated slope of FVC% predicted, HR (95% CI)

 1-unit decrease

1.14 (1.08, 1.20)

1.17 (1.09, 1.26)

1.04 (0.96, 1.13)

 3-unit decrease

1.47 (1.25, 1.74)

1.60 (1.29, 1.98)

1.12 (0.89, 1.43)

 5-unit decrease

1.91 (1.44, 2.51)

2.18 (1.52, 3.13)

1.21 (0.82, 1.81)

 P value

< 0.0001

< 0.0001

0.34

  1. Data collected during the treatment period
  2. aRandom effects normal linear model of FVC% predicted with predictor variables ATA status and FVC% predicted at baseline, a separate slope for patients on treatment, trajectories modelled by a linear trend, and an unstructured variance−covariance matrix
  3. bPiecewise exponential baseline hazard, stratified by ATA status, and endogenous time-dependent covariate FVC% predicted as estimated slope of the longitudinal response
  4. ATA, anti-topoisomerase antibody; CI, confidence interval; ER, emergency room; FVC, forced vital capacity; HR, hazard ratio; ICU, intensive care unit; SSc, systemic sclerosis