Table 3.
Number of exacerbations, hospitalizations, and courses of medication before and post ivacaftor treatment
| Pre-ivacaftor −12 to 0 months (n = 129) |
Post-ivacaftor > 0 to 12 months (n = 129) |
Post-ivacaftora Overall (n = 129) |
|
|---|---|---|---|
| PEx | |||
| PExb | |||
| Events, n | 114 | 63 | 372 |
| pwCF with events, N1 | 55 | 44 | 78 |
| Estimated annualized event rate per person with CFc (95% CI) | 0.86 (0.66–1.13) | 0.49 (0.36–0.66) | 0.57 (0.44–0.73) |
| Estimated rate ratio (95% CI) | 0.57 (0.43–0.75) | ||
| PEx requiring hospitalizationb | |||
| Events, n | 24 | 7 | 56 |
| pwCF with events, n | 15 | 7 | 22 |
| Estimated annualized event rate per person with CFc (95% CI) | 0.11 (0.04–0.27) | 0.03 (0.01–0.08) | 0.06 (0.03–0.13) |
| Estimated rate ratio (95% CI) | 0.25 (0.13–0.48) | ||
| Hospitalizations | |||
| Hospitalizations (all causes)b | |||
| Events, n | 70 | 34 | 155 |
| pwCF with events, n | 38 | 24 | 51 |
| Estimated annualized event rate per person with CFc (95% CI) | 0.47 (0.33–0.67) | 0.22 (0.15–0.33) | 0.22 (0.16–0.31) |
| Estimated rate ratio (95% CI) | 0.48 (0.32–0.71) | ||
| Medications | |||
| Courses of all acute antibiotics due to PExb | |||
| Courses, n | 204 | 106 | 638 |
| pwCF using antibiotics, n | 52 | 45 | 79 |
| Estimated annualized course rate per person with CFc (95% CI) | 1.43 (1.06–1.93) | 0.79 (0.58–1.07) | 0.88 (0.65–1.20) |
| Estimated rate ratio (95% CI) | 0.55 (0.40–0.75) | ||
| Courses of acute IV antibiotics due to PExb | |||
| Courses, n | 88 | 32 | 178 |
| pwCF using IV antibiotics, n | 23 | 12 | 27 |
| Estimated annualized course rate per person with CFc (95% CI) | 0.45 (0.26–0.78) | 0.18 (0.09–0.36) | 0.15 (0.09–0.27) |
| Estimated rate ratio (95% CI) | 0.39 (0.23–0.66) | ||
CF cystic fibrosis, IV intravenous, PEx pulmonary exacerbation, pwCF people with cystic fibrosis
aThe post-ivacaftor > 0 months period includes the entire follow-up period of pwCF while receiving ivacaftor treatment and was calculated using the exposure per pwCF as the denominator
bEvents with start date in interval were analyzed. PwCF could be counted in > 1 interval for the same event
cEvent rate per person-year was the number of events divided by total time on study in person-years within a time interval