1. Filming: 15th of Febuary 2016, London, UK
INPULSIS® Subgroups
Filming: 15th of Febuary 2016, London, UK
Prof. Vincent Cottin
Prof. Luca Richeldi

2. Treatment by time by subgroup interaction p=0.5300
Nintedanib slows disease progression in patients with IPF independent of lung function impairment at baseline1,2
Annual rate of decline in FVC by baseline FVC % predicted ≤90% vs >90%1
FVC ≤90% predicted*
FVC >90% predicted*
n=472
n=315
n=166
n=108
Adjusted annual rate (SE) of
decline in FVC (mL/year)
Treatment by time by subgroup interaction p=0.5300
∆102.1 mL (95% CI: 61.9, 142.3)
∆133.1 mL (95% CI: 68.0, 198.2)
Nintedanib 150 mg bid Placebo
*In a post hoc subgroup analysis of the primary endpoint for the INPULSIS® trials, annual rate of FVC decline, the treatment effect was similar in patients with ≤90% predicted FVC at baseline and those with >90% predicted FVC at baseline.
1. Kolb M, et al. AJRCCM 191;2015:A Keating GM. Drugs 2015;75:1131–1140.
references

3. Nintedanib slows disease progression in patients with IPF independent of the presence of honeycombing on HRCT and/or biopsy1,2
Annual rate of decline in FVC in different HRCT diagnostic subgroups1*
Honeycombing on HRCT and/or confirmation of UIP pattern by surgical lung biopsy
Features of possible UIP pattern** on HRCT and no surgical lung biopsy
n=425
n=298
n=213
n=125
Adjusted annual rate (SE) of decline in FVC (mL/year)
Treatment by time by subgroup interaction p=0.8139
∆117.0 mL (95% CI: 76.3, 157.8)
∆98.9 mL (95% CI: 36.4, 161.5)
Nintedanib 150 mg bid Placebo
*In a post hoc subgroup analysis of the primary endpoint for the INPULSIS® trials, annual rate of FVC decline, the treatment effect was similar in patients with honeycombing on HRCT and/or confirmation of UIP pattern by surgical lung biopsy and those without .**and traction bronchiectasis
1. Raghu G, et al. AJRCCM 191;2015:A Keating GM. Drugs 2015;75:1131–1140.

4. In the nintedanib group the annual rate of decline in FVC was comparable for patients with and without emphysema on HRCT at baseline1,2
Annual rate of decline in FVC in subgroups by absence/presence of emphysema at baseline1*
No emphysema at baseline**
Emphysema at baseline**
n=384
n=257
n=254
n=166
Adjusted annual rate (SE) of decline in FVC (mL/year)
Treatment by time by subgroup interaction p=0.5199
∆115.4 mL (95% CI: 73.8, 157.1)
∆102.0 mL (95% CI: 43.2, 160.9)
Nintedanib 150 mg bid Placebo
*In a post hoc subgroup analysis of the primary endpoint for the INPULSIS® trials, annual rate of FVC decline, the treatment effect was similar in patients with emphysema on HRCT at baseline and those without. **Concomitant centri-lobular emphysema was diagnosed on HRCT based on qualitative assessment.
1. Cottin V, et al. Presented at ICLAF Keating GM. Drugs 2015;75:1131–1140.
references