Results

Baseline characteristics of subgroups by BMI <25 and ≥25 kg/m2 at baseline

Image
Image

Mean or % of patients

Annual rate of decline in FVC (mL/year)

  • In the placebo group, the rate of decline in FVC (mL/year) over 52 weeks was the same in subjects with BMI <25 and ≥25 kg/m2 at baseline (Figure 1).
  • The effect of nintedanib versus placebo on reducing the rate of FVC decline was numerically more pronounced in subjects with baseline BMI <25 than ≥25 kg/m2, but statistical testing did not indicate heterogeneity between the subgroups (Figure 1).

Figure 1. Annual rate of decline in FVC (mL/yr) over 52 weeks in subgroups by BMI at baseline

Image
Figure 1 Annual_0.png

Treatment-by-time-by-subgroup interaction p=0.63

Categorical declines in FVC over 52 weeks

  • No heterogeneity was detected between subgroups by baseline BMI in the effect of nintedanib versus placebo on categorical declines in FVC (Figure 2).

Figure 2. Absolute and relative declines in FVC in subgroups by BMI at baseline

Image
Figure 2 Absolute_0.png

OR, odds ratio. Missing data were imputed using a worst value carried forward approach.

 

  • A numerically smaller proportion of subjects treated with nintedanib than placebo had an absolute decline in FVC ≥10% predicted or died over 52 weeks in both subgroups by BMI at baseline (Table).

Table. Time to absolute decline in FVC ≥10% predicted or death in subgroups by BMI at baseline

Image
Image 5 time to absolute_0.png

Adverse events

Figure 3. Most frequent adverse events in subgroups by BMI at baseline

Image
Adverse event figure 3_0.png

Adverse events reported (irrespective of causality) in >10% of subjects in either treatment group in the overall population, coded using preferred terms in the Medical Dictionary for Regulatory Activities (MedDRA), are shown. Data are % of subjects with ≥1 such adverse event, reported over 52 weeks (or until 28 days after last trial drug intake in subjects who discontinued trial drug before week 52).

Proportion of subjects with adverse events leading to treatment discontinuation in subgroups by BMI at baseline

Image
Proportion Image

Data are % of subjects with ≥1 such adverse event reported over 52 weeks.

 

  • Diarrhea was the most frequent adverse event that led to discontinuation of nintedanib (in 7.4% and 6.5% of subjects with baseline BMI <25 and ≥25 kg/m2, respectively).
  • One subject (with baseline BMI ≥25 kg/m2) discontinued nintedanib due to an adverse event of weight loss.
Header - Navigation Icon