Table 1.
Time to ILD progression (absolute decline in FVC % predicted ≥ 10%) or death over the whole INBUILD trial in subgroups by baseline characteristics
| Baseline characteristic | n/N (%) with event | Hazard ratio (95% CI) |
Treatment-by-subgroup interaction p value |
|
|---|---|---|---|---|
| Nintedanib | Placebo | |||
| Sex | ||||
| Male | 76/179 (42.5) | 105/177 (59.3) | 0.62 (0.46, 0.84) | 0.66 |
| Female | 58/153 (37.9) | 76/154 (49.4) | 0.72 (0.51, 1.01) | |
| Age | ||||
| < 65 years | 49/139 (35.3) | 54/121 (44.6) | 0.74 (0.50, 1.09) | 0.58 |
| ≥ 65 years | 85/193 (44.0) | 127/210 (60.5) | 0.64 (0.49, 0.85) | |
| Racea | ||||
| White | 100/242 (41.3) | 137/246 (55.7) | 0.65 (0.50, 0.84) | 0.93 |
| Asian | 32/84 (38.1) | 41/80 (51.3) | 0.71 (0.45, 1.13) | |
| Body mass index (BMI) | ||||
| < 25 kg/m2 | 44/90 (48.9) | 59/98 (60.2) | 0.74 (0.50, 1.10) | 0.85 |
| ≥ 25 to < 30 kg/m2 | 48/130 (36.9) | 61/112 (54.5) | 0.65 (0.44, 0.94) | |
| ≥ 30 kg/m2 | 42/111 (37.8) | 61/121 (50.4) | 0.64 (0.43, 0.95) | |
| Time since diagnosis of ILD | ||||
| ≤ 1 year | 23/67 (34.3) | 41/67 (61.2) | 0.44 (0.26, 0.74) | 0.09 |
| > 1 to ≤ 3 years | 54/118 (45.8) | 59/112 (52.7) | 0.82 (0.56, 1.18) | |
| > 3 to ≤ 5 years | 24/73 (32.9) | 34/57 (59.6) | 0.50 (0.29, 0.84) | |
| > 5 years | 33/73 (45.2) | 47/95 (49.5) | 0.88 (0.56, 1.39) | |
| FVC % predicted | ||||
| ≤ 50% | 25/42 (59.5) | 20/33 (60.6) | 0.70 (0.38, 1.29) | 0.44 |
| > 50 to ≤ 70% | 55/154 (35.7) | 89/160 (55.6) | 0.57 (0.41, 0.80) | |
| > 70 to ≤ 90% | 41/104 (39.4) | 50/105 (47.6) | 0.80 (0.53, 1.21) | |
| > 90% | 13/32 (40.6) | 22/33 (66.7) | 0.51 (0.26, 1.03) | |
| DLco % predictedb | ||||
| ≤ median (43.3%) | 82/177 (46.3) | 92/150 (61.3) | 0.65 (0.48, 0.88) | 0.97 |
| > median (43.3%) | 51/149 (34.2) | 87/178 (48.9) | 0.66 (0.46, 0.93) | |
| CPI | ||||
| ≤ 45 | 25/82 (30.5) | 57/120 (47.5) | 0.61 (0.38, 0.98) | 0.77 |
| > 45 | 108/244 (44.3) | 122/208 (58.7) | 0.66 (0.51, 0.85) | |
| GAP stage | ||||
| I | 41/142 (28.9) | 68/152 (44.7) | 0.59 (0.40, 0.88) | 0.42 |
| II or III | 93/190 (48.9) | 113/179 (63.1) | 0.70 (0.53, 0.93) | |
| Taking anti-acid therapyc | ||||
| Yes | 88/201 (43.8) | 101/180 (56.1) | 0.72 (0.54, 0.96) | 0.34 |
| No | 46/131 (35.1) | 80/151 (53.0) | 0.58 (0.40, 0.83) | |
| DMARDsd | ||||
| Yes | 16/43 (37.2) | 31/48 (64.6) | 0.49 (0.26, 0.91) | 0.28 |
| No | 118/289 (40.8) | 150/283 (53.0) | 0.70 (0.55, 0.89) | |
CPI composite physiologic index, DLco diffusing capacity of the lung for carbon monoxide, DMARDs disease-modifying anti-rheumatic drugs, FVC forced vital capacity, GAP gender, age, lung physiology, ILD interstitial lung disease
aData on Black patients are not shown as the number of patients in this subgroup (n = 10) was too small for the data to be interpretedbCorrected for haemoglobin
cBased on WHO Drug Dictionary [version 19.MAR) (Anatomical Therapeutic Chemical codes for ‘antacids’ and ‘drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD)’ and preferred name ‘drugs for acid related disorders’]
dBased on WHO Drug Dictionary (version 19.MAR) standardised drug grouping excluding denosumab, plus baricitinib