Results

Baseline characteristics of subgroups by sex, age, race and FVC

Mean (SD) or % of patients.

Annual rate of decline in FVC (mL/year) by sex, age, race and FVC at baseline

In the placebo group, the annual rate of decline in FVC was numerically greater in subjects who:

The effect of nintedanib versus placebo on reducing the annual rate of decline in FVC was consistent across subgroups by sex, age, race, and FVC at baseline (Figure 1).

Figure 1. Treatment effect of nintedanib versus placebo on annual rate of decline in FVC (mL/year) in subgroups by sex, age, race and FVC at baseline

Subgroups by ILD diagnosis

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Mean (SD) or % of patients. ^*Included rheumatoid arthritis-associated ILD, systemic sclerosis-associated ILD, mixed connective tissue disease-associated ILD, plus subjects with an autoimmune disease noted in the “Other fibrosing ILDs” category of the case report form. ^†Included sarcoidosis, exposure-related ILDs and selected terms in the “Other fibrosing ILDs” category of the case report form.

Annual rate of decline in FVC (mL/year) by ILD diagnosis

The effect of nintedanib versus placebo on reducing the rate of FVC decline was consistent across the subgroups by ILD diagnosis (Figure 2).

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^*Included rheumatoid arthritis-associated ILD, systemic sclerosis-associated ILD, mixed connective tissue disease-associated ILD, plus subjects with an autoimmune disease noted in the “Other fibrosing ILDs” category of the case report form. ^†Included sarcoidosis, exposure-related ILDs and selected terms in the “Other fibrosing ILDs” category of the case report form.