TABLE 2.
Summary of secondary endpoints
| Cohort A | Cohort B | |||||
| Lebrikizumab (n=78) | Placebo (n=76) | p-value | Lebrikizumab+pirfenidone (n=174) | Placebo+pirfenidone (n=177) | p-value | |
| Time-to-event analyses HR (95% CI) | ||||||
| PFS# | 0.65 (0.39–1.09) | 0.097¶ | 1.01 (0.72–1.42) | 0.93¶ | ||
| Time to first ≥10% absolute decline in % predicted FVC or all-cause mortality | 0.79 (0.44–1.41) | 0.42¶ | 0.84 (0.56–1.24) | 0.37¶ | ||
| Time to first ≥10% absolute decline in % predicted DLCO or all-cause mortality | 0.72 (0.23–2.26) | 0.56¶ | 0.68 (0.37–1.23) | 0.19¶ | ||
| Time to first respiratory hospitalisation | NA | NA | 0.89 (0.52–1.54) | 0.68¶ | ||
| Time to first acute IPF exacerbation or death from any cause | 1.21 (0.41–3.61) | 0.73¶ | 0.61 (0.29–1.25) | 0.17¶ | ||
| Time to first SGRQ worsening ≥7 or all-cause mortality | 0.84 (0.54–1.31) | 0.44¶ | NA | NA | ||
| Time to all-cause mortality through week 52 | 1.01 (0.25–4.02) | 0.99¶ | 0.42 (0.17–1.04) | 0.053¶ | ||
| Annualised rate of decrease in % predicted DLCO over 52 weeks | ||||||
| Slope | −4.24 | −4.78 | 0.607 | −5.57 | −5.75 | 0.780 |
| Absolute difference | 0.54 | 0.18 | ||||
| Relative difference % | 11.3 | 3.2 | ||||
| Decline ≥15% or death n (%) | 1 (2) | 3 (6) | 3 (2.5) | 5 (4.5) | ||
| Relative difference % | −67.3 | −44.9 | ||||
| Annualised rate of decline in 6MWD | ||||||
| Slope | −22.7 | −44.6 | 0.312 | −46.9 | −25.6 | 0.203 |
| Absolute difference | 21.9 | −21.4 | ||||
| Relative difference % | 49.1 | −83.7 | ||||
| Annualised rate of decline in ATAQ-IPF total score over 52 weeks | ||||||
| Slope | 4.78 | 6.89 | 0.385 | 5.45 | 5.61 | 0.905 |
| Absolute difference | −2.10 | −0.16 | ||||
| Relative difference % | −30.5 | −2.9 | ||||
| Proportion of patients with ≥10% decline in % predicted FVC or death from any cause | ||||||
| Decline ≥10% or death n (%) | 9 (16.4) | 12 (22.6) | 0.89 | 22 (16.4) | 19 (15.8) | 0.67 |
| Relative difference % | −27.7 | 3.7 | ||||
ATAQ-IPF: A Tool to Assess Quality of Life in IPF; DLCO: diffusing capacity of the lungs for carbon monoxide; FVC: forced vital capacity; HR: hazard ratio; IPF: idiopathic pulmonary fibrosis; PFS: progression-free survival; SGRQ: St. George's Respiratory Questionnaire; 6MWD: 6-min walk distance. #: PFS was defined as time from randomisation to the first occurrence of: death from any cause, non-elective hospitalisation for any cause, relative decline in FVC ≥10%; ¶: log rank.