Table 2.
Patient demographic and clinical characteristics at baseline, and nintedanib treatment pattern in the ‘continued’ and ‘discontinued’ subgroups. All data are n (%) unless otherwise stated
| ‘Continued’ subgroup (n = 2509) | ‘Discontinued’ subgroup (n = 2795) | OR (95% CI) | |
|---|---|---|---|
| Age, years | |||
| Mean (SD) | 71.1 (7.9) | 72.5 (8.1) | |
| Median (range) | 72.0 (17–98) | 73.0 (20–96) | |
| < 75 years (N = 3202), n (%) | 1620 (50.6) | 1582 (49.4) | Ref |
| ≥ 75 years (N = 2102), n (%) | 889 (42.3) | 1213 (57.7) | 1.40 (1.25–1.56)a |
| Sex | |||
| Male (N = 4138) | 1976 (47.8) | 2162 (52.2) | Ref |
| Female (N = 1166) | 533 (45.7) | 633 (54.3) | 1.09 (0.95–1.24) |
| Body weight, kg | (n = 2386) | (n = 2646) | |
| Mean (SD) | 62.1 (12.1) | 56.8 (12.2) | |
| Median (range) | 62.0 (28.0–154.5) | 56.3 (26.0–102.3) | |
| BMI, kg/m2 | (n = 2379) | (n = 2626) | |
| Mean (SD) | 23.7 (3.7) | 22.0 (4.0) | |
| Median (range) | 23.5 (12.4–52.6) | 22.0 (10.8–42.0) | |
| BSA, m2 | (n = 2379) | (n = 2626) | |
| Mean (SD) | 1.66 (0.18) | 1.58 (0.19) | |
| Median (range) | 1.66 (0.99–2.55) | 1.59 (1.00–2.18) | |
| ≥ 1.58 m2 (N = 2948), n (%) | 1600 (54.3) | 1348 (45.7) | Ref |
| < 1.58 m2 (N = 2057), n (%) | 779 (37.9) | 1278 (62.1) | 1.95 (1.74–2.18)a |
| Smoking history, n (%) | |||
| Current or previous smoker (N = 3747) | 1849 (49.3) | 1898 (50.7) | 0.78 (0.68–0.88)a |
| Never smoked (N = 1288) | 555 (43.1) | 733 (56.9) | Ref |
| IPF severity stage, n (%) | |||
| I (N = 1002) | 585 (58.4) | 417 (41.6) | Ref |
| II (N = 207) | 110 (53.1) | 97 (46.9) | 1.24 (0.92–1.67) |
| III (N = 960) | 511 (53.2) | 449 (46.8) | 1.23 (1.03–1.47)a |
| IV (N = 1413) | 561 (39.7) | 852 (60.3) | 2.13 (1.81–2.51)a |
| Data missing/unknown (N = 485) | 246 (50.7) | 239 (49.3) | – |
| I or II (N = 1209) | 695 (57.5) | 514 (42.5) | Ref |
| III or IV (N = 2373) | 1072 (45.2) | 1301 (54.8) | 1.64 (1.43–1.89)a |
| FVC, ml, mean (SD) | (n = 2288) | (n = 2311) | |
| Mean (SD) | 2284.2 (707.1) | 1935.0 (678.2) | |
| FVC, % predicted | (n = 2101) | (n = 2110) | |
| Mean (SD) | 73.2 (25.9) | 65.1 (47.9) | |
| Median (range) | 71.8 (19.8–903.0) | 61.9 (14.7–1810.0) | |
| < 70% (N = 2359), n (%) | 970 (41.1) | 1389 (58.9) | 2.25 (1.98–2.54)a |
| ≥ 70% (N = 1852), n (%) | 1131 (61.1) | 721 (38.9) | Ref |
| Previous IPF treatment n (%) | |||
| Yes (N = 1263) | 551 (43.6) | 712 (56.4) | 1.22 (1.07–1.38)a |
| No (N = 4014) | 1946 (48.5) | 2068 (51.5) | Ref |
| Pirfenidone | |||
| Yes (N = 1000) | 439 (43.9) | 561 (56.1) | 1.19 (1.03–1.36)a |
| No (N = 4296) | 2067 (48.1) | 2229 (51.9) | Ref |
| Corticosteroids | |||
| Yes (N = 217) | 89 (41.0) | 128 (59.0) | 1.31 (0.99–1.72) |
| No (N = 5073) | 2414 (47.6) | 2659 (52.4) | Ref |
| Immunosuppressants | |||
| Yes (N = 115) | 47 (40.9) | 68 (59.1) | 1.31 (0.90–1.90) |
| No (N = 5184) | 2460 (47.5) | 2724 (52.5) | Ref |
| Baseline IPF medication,b n (%) | |||
| Yes (N = 1722) | 709 (41.2) | 1013 (58.8) | 1.33 (1.18–1.49)a |
| No (N = 3102) | 1493 (48.1) | 1609 (51.9) | Ref |
| Corticosteroids | |||
| Yes (N = 1271) | 514 (40.4) | 757 (59.6) | 1.36 (1.19–1.55)a |
| No (N = 3642) | 1748 (48.0) | 1894 (52.0) | Ref |
| Pirfenidone | |||
| Yes (N = 202) | 69 (34.2) | 133 (65.8) | 1.75 (1.30–2.35)a |
| No (N = 5038) | 2395 (47.5) | 2643 (52.5) | Ref |
| Immunosuppressants | |||
| Yes (N = 285) | 107 (37.5) | 178 (62.5) | 1.52 (1.19–1.94)a |
| No (N = 4902) | 2338 (47.7) | 2564 (52.3) | Ref |
| Cyclosporine | |||
| Yes (N = 175) | 57 (32.6) | 118 (67.4) | 1.89 (1.37–2.61)a |
| No (N = 5078) | 2426 (47.8) | 2652 (52.2) | Ref |
| Tacrolimus | |||
| Yes (N = 64) | 28 (43.8) | 36 (56.3) | 1.15 (0.70–1.89) |
| No (N = 5187) | 2451 (47.3) | 2736 (52.7) | Ref |
| Azathioprine | |||
| Yes (N = 38) | 20 (52.6) | 18 (47.4) | 0.81 (0.43–1.53) |
| No (N = 5260) | 2484 (47.2) | 2776 (52.8) | Ref |
| Initial dose, n (%) | |||
| 100 mg bid (N = 683) | 304 (44.5) | 379 (55.5) | 1.15 (0.98–1.36) |
| 150 mg bid (N = 4480) | 2154 (48.1) | 2326 (51.9) | Ref |
| Other (N = 124) | 51 (41.1) | 73 (58.9) | 1.33 (0.92–1.90) |
| Initial dose by BSA, n (%) | |||
| 100 mg bid | |||
| BSA < 1.58 m2 (N = 339) | 133 (39.2) | 206 (60.8) | 1.72 (1.26–2.36)a |
| BSA ≥ 1.58 m2 (N = 300) | 158 (52.7) | 142 (47.3) | Ref |
| 150 mg bid | |||
| BSA < 1.58 m2 (N = 1660) | 631 (38.0) | 1029 (62.0) | 1.97 (1.74–2.23)a |
| BSA ≥ 1.58 m2 (N = 2585) | 1414 (54.7) | 1171 (45.3) | Ref |
bid twice daily, BMI body mass index, BSA body surface area, CI confidence interval, FVC forced vital capacity, IPF idiopathic pulmonary fibrosis, OR odds ratio, Ref reference, SD standard deviation
aUpper 95% CI is < 1 or lower 95% CI is > 1
bIncluding drugs for treatment of acute exacerbation