Methods

Data were pooled from the placebo-controlled periods of five clinical trials of nintedanib: the Phase II TOMORROW trial (52 weeks),³ the two Phase III INPULSIS trials (52 weeks),² the INMARK trial (12 weeks)⁴ and a Phase IIIb trial (approximately 6 months).⁵
In subgroups of patients with <5 versus ≥5 comorbidities (i.e. below and at least the median number of comorbidities) at baseline, we analyzed the following:
- Annual rate of decline in FVC (mL/year)
- Change from baseline in St George’s Respiratory Questionnaire (SGRQ) total score (a measure of health-related quality of life)
- Time to first acute exacerbation (investigator-reported)
- Time to death
- Adverse events.