Table 4. Changes in Clinical Parameters for Participants With Cystic Fibrosis During the 1-Year Elexacaftor-Tezacaftor-Ivacaftor Treatment Period.
| Measurement time | |||||
|---|---|---|---|---|---|
| Baseline | 3 Months | 6 Months | 9 Months | 12 Months | |
| ppFEV1 | |||||
| Median (IQR) | 67 (56-85) | 85 (68-98) | 90 (79-101) | 87 (72-98) | 86 (71-99) |
| Change from baseline, % | NA | 26.9 | 34.3 | 29.9 | 28.4 |
| β Coefficient (95% CI)a | NA | 13.2 (11.3-15.2) | 15.1 (13.0-17.2) | 15.0 (13.0-17.0) | 14.2 (12.3-16.2) |
| BMI | |||||
| Median (IQR) | 21.0 (19.1-24.3) | 22.3 (20.4-24.8) | 23.0 (20.5-25.2) | 22.9 (20.5-26.5) | 23.0 (20.4-26.7) |
| Change from baseline, % | NA | 6.2 | 9.5 | 9.0 | 9.5 |
| β Coefficient (95% CI)a | NA | 1.1 (0.7-1.5) | 1.5 (1.1-2.0) | 1.8 (1.4-2.2) | 1.9 (1.5-2.3) |
| Positivity for Pseudomonas aeruginosa | |||||
| Total No. of participants | 64 | 56 | 60 | 60 | 62 |
| No. (%) with finding | 34 (53.1) | 15 (26.8) | 15 (25.0) | 12 (20.0) | 14 (22.3) |
| OR (95% CI)b | NA | 0.06 (0.01-0.26) | 0.04 (0.01-0.17) | 0.02 (0.01-0.12) | 0.03 (0.01-0.15) |
| Positivity for MRSA | |||||
| Total No. of participants | 64 | 56 | 60 | 60 | 62 |
| No. (%) with finding | 19 (29.7) | 11 (19.6) | 11 (18.3) | 9 (15.0) | 11 (17.7) |
| OR (95% CI)b | NA | 0.03 (0.01-0.33) | 0.06 (0.01-0.55) | 0.02 (0.01-0.25) | 0.06 (0.01-0.54) |
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); MRSA, methicillin-resistant Staphylococcus aureus; NA, not applicable; OR, odds ratio; ppFEV1, percent predicted forced expiratory volume in 1 second.
a
Represents estimated mean changes from baseline using linear mixed effects models.
b
Compared with baseline using logistic mixed effects models.