Table 3.
Participants achieving clinical remission at week 52 as defined by JGL (four-component) and PGAM (three-component) (FAS-Modified-1)
| FF/UMEC/VI (N = 619) |
ICS/LABA (N = 617) |
|
|---|---|---|
| JGL 2024 definition using optimized lung function (CFB in trough FEV1 ≥ 100 mL) | ||
| n/619 (%) | n/617 (%) | |
| Responders | 123 (19.9) | 64 (10.4) |
| No OCS use since baseline | 551 (89.0) | 533 (86.4) |
| No severe asthma exacerbations since baseline | 541 (87.4) | 533 (86.4) |
| ACT total score ≥ 23 | 256 (41.4) | 204 (33.1) |
| CFB in trough FEV1 ≥ 100 mL | 253 (40.9) | 167 (27.1) |
| Non-responders | 496 (80.1) | 553 (89.6) |
| Non-responder due to missing dataa | 94 (19.0) | 104 (18.8) |
| Adjusted OR (95% CI), P value | 2.21 (1.52, 3.23), P < 0.0001b | |
| JGL 2024 definition using stabilized lung function (CFB in trough FEV1 ≥ 0 mL) | ||
|---|---|---|
| n/619 (%) | n/617 (%) | |
| Responders | 169 (27.3) | 97 (15.7) |
| No OCS use since baseline | 551 (89.0) | 533 (86.4) |
| No severe asthma exacerbations since baseline | 541 (87.4) | 533 (86.4) |
| ACT total score ≥ 23 | 256 (41.4) | 204 (33.1) |
| CFB in trough FEV1 ≥ 0 mL | 351 (56.7) | 262 (42.5) |
| Non-responders | 450 (72.7) | 520 (84.3) |
| Non-responder due to missing dataa | 94 (20.9) | 104 (20.0) |
| Adjusted OR (95% CI), P value | 2.16 (1.56, 3.00), P < 0.0001b | |
| PGAM 2024 definition | ||
|---|---|---|
| n/619 (%) | n/617 (%) | |
| Responders | 227 (36.7) | 183 (29.7) |
| No OCS use since baseline | 551 (89.0) | 533 (86.4) |
| No severe asthma exacerbations since baseline | 541 (87.4) | 533 (86.4) |
| ACT total score ≥ 23 | 256 (41.4) | 204 (33.1) |
| Non-responders | 392 (63.3) | 434 (70.3) |
| Non-responder due to missing dataa | 90 (23.0) | 99 (22.8) |
| Adjusted OR (95% CI), P value | 1.49 (1.10, 2.02), P = 0.0100b | |
ACT Asthma Control Test, CFB change from baseline, CI confidence interval, FEV1 forced expiratory volume in 1 s, FF fluticasone furoate, ICS inhaled corticosteroid, JGL Japanese Guidelines for Adult Asthma, LABA long-acting β2-agonist, OCS oral corticosteroid, OR odds ratio, PGAM Practical Guidelines for Asthma Management, UMEC umeclidinium, VI vilanterol
aPercentages based on the number of non-responders
bP value was not adjusted for multiplicity and is considered descriptive