Table S3.
Summary of first and sustained composite CID by subgroup in Study A (ITT population)
| Deterioration type/subgroup | UMEC/VI (n=413) | UMEC (n=418) | VI (n=421) | Placebo (n=280) |
|---|---|---|---|---|
| First deterioration | ||||
| GOLD B, n (%) | 89 (48) | 76 (47) | 92 (58) | 76 (72) |
| vs placebo, HR (95% CI) | 0.43 (0.32, 0.58)*** | 0.41 (0.29, 0.56)*** | 0.56 (0.41, 0.76)*** | – |
| UMEC/VI vs UMEC or VI, HR (95% CI) | – | 1.06 (0.78, 1.44) | 0.76 (0.57, 1.02) | – |
| GOLD D, n (%) | 93 (41) | 133 (52) | 144 (55) | 133 (76) |
| vs placebo, HR (95% CI) | 0.32 (0.25, 0.42)*** | 0.50 (0.39, 0.64)*** | 0.54 (0.42, 0.68)*** | – |
| UMEC/VI vs UMEC or VI, HR (95% CI) | – | 0.64 (0.49, 0.84)** | 0.60 (0.46, 0.78)*** | – |
| Concurrent ICS use, n (%) | 85 (40) | 116 (53) | 123 (58) | 110 (80) |
| vs placebo, HR (95% CI) | 0.28 (0.21, 0.38)*** | 0.46 (0.35, 0.59)*** | 0.52 (0.40, 0.68)*** | – |
| UMEC/VI vs UMEC or VI, HR (95% CI) | – | 0.62 (0.47, 0.82)*** | 0.54 (0.41, 0.71)*** | – |
| No concurrent ICS use, n (%) | 97 (48) | 94 (47) | 113 (54) | 99 (69) |
| vs placebo, HR (95% CI) | 0.47 (0.36, 0.63)*** | 0.47 (0.35, 0.62)*** | 0.57 (0.44, 0.75)*** | – |
| UMEC/VI vs UMEC or VI, HR (95% CI) | – | 1.02 (0.76, 1.35) | 0.83 (0.63, 1.09) | – |
| Sustained deteriorationa | ||||
| GOLD B, n (%) | 50 (27) | 34 (21) | 54 (34) | 50 (47) |
| vs placebo, HR (95% CI) | 0.47 (0.31, 0.69)*** | 0.34 (0.22, 0.53)*** | 0.63 (0.43, 0.92)* | – |
| UMEC/VI vs UMEC or VI, HR (95% CI) | – | 1.35 (0.87, 2.09) | 0.74 (0.50, 1.09) | – |
| GOLD D, n (%) | 50 (22) | 84 (33) | 89 (34) | 87 (50) |
| vs placebo, HR (95% CI) | 0.33 (0.23, 0.47)*** | 0.57 (0.42, 0.77)*** | 0.58 (0.43, 0.78)*** | – |
| UMEC/VI vs UMEC or VI, HR (95% CI) | – | 0.58 (0.41, 0.83)** | 0.57 (0.41, 0.81)** | – |
| Concurrent ICS use, n (%) | 47 (22) | 64 (29) | 80 (38) | 74 (54) |
| vs placebo, HR (95% CI) | 0.31 (0.21, 0.44)*** | 0.44 (0.31, 0.61)*** | 0.60 (0.44, 0.82)** | – |
| UMEC/VI vs UMEC or VI, HR (95% CI) | – | 0.70 (0.48, 1.02) | 0.51 (0.36, 0.74)*** | – |
| No concurrent ICS use, n (%) | 53 (26) | 54 (27) | 63 (30) | 63 (44) |
| vs placebo, HR (95% CI) | 0.49 (0.34, 0.71)*** | 0.51 (0.36, 0.74)*** | 0.60 (0.42, 0.85)** | – |
| UMEC/VI vs UMEC or VI, HR (95% CI) | – | 0.96 (0.66, 1.41) | 0.82 (0.57, 1.19) | – |
Notes:
*
P<0.05;
**
P<0.01;
***
P<0.001.
a
Any first exacerbation was also considered a sustained deterioration as patients were withdrawn by protocol following a first event.
Abbreviations: CI, confidence interval; CID, clinically-important deterioration; GOLD, Global initiative for chronic Obstructive Lung Disease classification; HR, hazard ratio; ICS, inhaled corticosteroid; ITT, intent-to-treat; VI, vilanterol; UMEC, umeclidinium.