Methods
- Data were pooled from three international placebo-controlled trials of nintedanib: the TOMORROW trial4 and the two INPULSIS trials.5
- Points were assigned to age, FVC % predicted, DLco % predicted, and certain comorbidities at baseline to generate a total score that classified patients as at TORVAN stage I, II, III, or IV:
Calculation of TORVAN stage3
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- In post-hoc analyses, we analyzed the following over 52 weeks in subgroups by TORVAN stage (I, II, or III/IV) at baseline:
- Rate of decline in FVC (mL/year)
- Time to disease progression (absolute decline in FVC ≥10% predicted or death)
- Time to first investigator-reported acute exacerbation
- Change in St. George’s Respiratory Questionnaire (SGRQ) total score (a measure of health-related quality of life)6
- Adverse events
- Interaction p-values were calculated to assess potential heterogeneity in the treatment effect of nintedanib versus placebo across the subgroups. No adjustment for multiplicity was made.