Results
Patients
Proportions of patients in age, FVC and DLco ranges and with comorbidities used to calculate TORVAN stage
% of patients
TORVAN stages
Baseline characteristics by TORVAN stage
Mean or % of patients
Annual rate of decline in FVC
- In the placebo group, the annual rate of decline in FVC was similar across subgroups by TORVAN stage. The effect of nintedanib on reducing the annual rate of decline in FVC was consistent across the subgroups (Figure 1).
Figure 1. Annual rate of decline in FVC (mL/year) by TORVAN stage at baseline
Treatment-by-time-by-subgroup interaction p=0.92
Disease progression and acute exacerbations
- The effect of nintedanib on disease progression (absolute decline in FVC ≥10% predicted or death) was consistent across the subgroups by TORVAN stage (Table).
- In both treatment groups, the proportion of patients with acute exacerbations increased with increasing TORVAN stage at baseline. Numerically smaller proportions of patients treated with nintedanib than placebo had acute exacerbations in all subgroups by TORVAN stage (Table).
Table. Time to disease progression and first acute exacerbation over 52 weeks by TORVAN stage at baseline
Change in SGRQ total score
- In the placebo group, SGRQ total score increased (worsened) over 52 weeks to a greater extent with increasing TORVAN stage at baseline. Increases (worsening) in SGRQ total score were numerically smaller in the nintedanib group than in the placebo group in all the subgroups (Figure 2).
Figure 2. Change from baseline in SGRQ total score at week 52 by TORVAN stage at baseline
Treatment-by-subgroup interaction p=0.21
Adverse events
Most frequent adverse events in subgroups by TORVAN stage at baseline
Data are % of subjects with ≥1 such adverse event reported (irrespective of causality) in >10% of subjects in any of these subgroups, coded using preferred terms in the Medical Dictionary for Regulatory Activities (MedDRA). Adverse events with onset after the first dose and up to 28 days (in INPULSIS trials) or 14 days (in TOMORROW trial) after the last dose of study drug are shown. *Corresponded to MedDRA term ‘IPF’, which included disease worsening and acute exacerbations of IPF.
Adverse events leading to discontinuation of trial drug and serious adverse events in subgroups by TORVAN stage at baseline
Data are % of subjects with ≥1 such adverse event with onset after the first dose and up to 28 days (in INPULSIS trials) or 14 days (in TOMORROW trial) after the last dose of study drug. *Events that resulted in death, were life-threatening, resulted in hospitalization or prolonged hospitalization, resulted in persistent or clinically significant disability or incapacity, were a congenital anomaly or birth defect, or were deemed serious for any other reason.