Table 3

Pulmonary function test results for patients at baseline, 24 and 48 weeks

 50 mg once per day 100 mg two times per day Baseline Change from baseline Baseline Change from baseline 24 weeks 48 weeks 24 weeks 48 weeks FVC % predicted Patients, n 46 26 28 42 26 28 Mean (SD)* 71.4 (11.8) −1.7 (5.4) −4.6 (5.6) 72.0 (9.6) 0.0 (7.0) −0.4 (7.9) Patients, n – 35 39 – 34 34 Slope (95% CI)† – −2.5 (−5.3 to 0.4) −4.9 (−7.5 to −2.3) – 0.6 (−2.2 to 3.4) −0.4 (−3.2 to 2.3) Patients, n – 26 28 – 26 28 LS mean (95% CI)‡ – −1.0 (−3.2 to 1.2) −3.5 (−5.7 to −1.3) – −0.7 (−3.0 to 1.6) −2.8 (−5.1 to −0.6) FVC Patients, n 46 26 28 42 26 28 Mean (SD)* 2.5 (0.6) L −66 (191) mL −191 (191) mL 2.6 (0.6) L −17 (259) mL −40 (286) mL Patients, n – 35 39 – 34 34 Slope (95% CI)† – −88 (−190 to 15) −188 (−277 to −99) – 10 (−91 to 110) −34 (−127 to 60) DLCO % predicted Patients, n 46 26 28 42 25 28 Mean (SD)* 47.7 (12.7) −0.1 (4.3) −3.3 (7.8) 49.1 (11.7) 0.2 (5.2) −2.6 (6.9) DLCO mL/min/mm Hg Patients, n 46 26 28 42 25 28 Mean (SD)* 10.0 (4.2) −0.1 (0.9) −0.7 (1.6) 10.4 (3.8) 0.1 (1.1) −0.5 (1.4)
• *Mean (SD) are calculated based on observed data with no imputation.

• †Slope (95% CI) for FVC % predicted (or FVC mL) are from a random coefficients model with change from baseline in FVC % predicted (or FVC mL) as the dependent variable, patient and time (continuous) as random effects, fixed effect of time and treatment group and treatment-by-time interaction and baseline FVC % predicted, region, sex, baseline DLCO % predicted, age at screening, baseline progression-related biomarkers (CXCL13, CCL18, MMP3), each categorised as >median level versus ≤median level as fixed effects.

• ‡LS mean (95% CI) for FVC % predicted are from a random coefficients model with a spatial power variance–covariance matrix, change from baseline in FVC % predicted as the dependent variable, patient as a random effect, fixed effect of time and time-varying effects for treatment group and treatment-by-time interaction and baseline FVC % predicted, region, sex, baseline DLCO % predicted, age at screening, baseline progression-related biomarkers (CXCL13, CCL18, MMP3), each categorised as >median level versu ≤median level as fixed effects.

• DLCO, diffusion capacity to carbon monoxide; FVC, forced vital capacity; LS, least squares.