Results
Patient Characteristics
After matching, there were no statistically significant differences between cohorts in age, gender or comorbidity score (see Table 1).
Table 1. Patient Demographics by Cohort and Exacerbation Category
Exacerbation
Kaplan Meier analysis
Occurrence of ≥1 severe exacerbation(s) within 1-year of index date, comparing TIO+OLO vs. TT by baseline exacerbation history category:
- None: 5.92 vs. 13.54% (p=0.002; see Figure 2).
- Single: 7.48 vs. 20.04% (p=0.555).
- Multiple/severe: 17.93 vs. 16.64% (p=0.675).
No statistically significant differences were observed for the ‘any exacerbation’ outcome between cohorts.
Figure 2. Kaplan-Meier curve of severe COPD exacerbation among MAPD patients with no COPD exacerbation history by treatment cohort
Cox proportional hazard model
After adjusting for treatment and additional covariates, the difference in risk for a severe exacerbation was approximately 57% lower for TIO+OLO patients with no exacerbation history, compared to TT patients (see Table 2).
Table 2. Cox proportional hazard models – time to first severe COPD exacerbation1
Time on treatment identified during the follow-up period, including the index date, until the earliest occurrence of index regimen discontinuation (≥60 day gap) or switch, coverage disenrollment, or study end (05/31/2018). 1Identified beginning on index date + 1.
Blue p-values indicate statistical significance. Gray cells indicate variables were not included in the model.
Pneumonia
Kaplan Meier analysis
Occurrence of pneumonia or acute bronchitis/bronchiolitis within 1 year after index, comparing TIO+OLO vs. TT by baseline exacerbation history category:
- None: 15.00 vs. 27.74% (p=0.015; see Figure 3).
- Single: 27.23 vs. 31.02% (p=0.618).
- Multiple/severe: 38.24 vs 32.15% (p=0.667).
Figure 3. Kaplan-Meier curve of pneumonia or acute bronchitis/bronchiolitis diagnosis among MAPD patients with no COPD exacerbation history by treatment cohort
Cox proportional hazard model
After adjusting for treatment and other covariates, the difference in risk for pneumonia or acute bronchitis/bronchiolitis was approximately 34% lower for TIO+OLO patient with no exacerbation history, compared to TT (see Table 3).
Table 3. Cox proportional hazard models – time to pneumonia or acute bronchitis/bronchiolitis diagnosis1
Time on treatment identified during the follow-up period, including the index date, until the earliest occurrence of index regimen discontinuation (≥60 day gap) or switch, coverage disenrollment, or study end (05/31/2018). 1Identified beginning on index date + 1.
Blue p-values indicate statistical significance. Gray cells indicate variables were not included in the model.
Kaplan Meier analysis
Occurrence of ≥1 pneumonia (KM data not shown) within 1-year after index, comparing TIO+OLO vs. TT by baseline exacerbation history category:
- None: 8.74 vs. 16.70% (p=0.016).
- Single: 14.53 vs. 17.35% (p=0.869).
- Multiple/severe: 25.27 vs 27.36% (p=0.377).