TABLE 2

Patient demographics and baseline characteristics (randomised population)

PlaceboSAR156597 Q2WSAR156597 QW
Demographics
 Subjects n110109108
 Age years
  Mean±sd69.0±8.667.4±7.268.0±7.6
  Median (range)70.0 (40–84)67.0 (48–85)68.0 (44–85)
 Sex
  Male88 (80.0)77 (70.6)81 (75.0)
  Female22 (20.0)32 (29.4)27 (25.0)
 Race
  White105 (95.5)104 (95.4)99 (91.7)
  Black/African American002 (1.9)
  Asian5 (4.5)5 (4.6)7 (6.5)
  Other000
Baseline characteristics
 Smoking habits
  Never smoker36 (32.7)44 (41.1)32 (30.2)#
  Former smoker70 (63.6)59 (55.1)70 (66.0)#
  Current smoker4 (3.6)4 (3.7)4 (3.8)#
 Time since IPF diagnosis years
  Mean±sd1.9±1.41.8±1.41.8±1.3
  Median (range)1.7 (0.1–5.0)1.6 (0.1–4.8)1.6 (0.1–5.0)
 Time since first IPF symptoms years
  Mean±sd3.2±2.23.5±2.33.4±2.0
  Median (range)2.8 (0.1–12.2)3.1 (0.3–16.2)3.1 (0.4–10.2)
 Acute exacerbation within 12 months prior to enrolment
  Yes6 (5.5)6 (5.5)5 (4.6)
  No104 (94.5)103 (94.5)103 (95.4)
 Family IPF history
  Yes10 (9.1)6 (5.6)+10 (9.3)
  No93 (84.5)99 (91.7)+94 (87.0)
  Unknown7 (6.4)3 (2.8)+4 (3.7)
 Supplemental oxygen use
  Yes17 (15.5)12 (11.0)16 (14.8)
  No93 (84.5)97 (89.0)92 (85.2)
Pulmonary function tests
 FVC % pred
  Mean±sd71.5±16.0§70.3±17.868.9±16.0
  Median (range)72.0 (40–118)§69.0 (37–117)68.5 (38–114)
 FVC % pred
  ≤60%29 (26.6)§38 (34.9)35 (32.4)
  >60% and ≤75%32 (29.4)§34 (31.2)36 (33.3)
  >75%48 (44.0)§37 (33.9)37 (34.3)
 FVC L
  Mean±sd2.7±0.8§2.6±0.72.5±0.7
  Median (range)2.7 (1.1–5.0)§2.5 (0.9–4.6)2.5 (1.2–5.0)
DLCO % pred
  Mean±sd51.6±16.948.7±15.3+48.7±15.1
  Median (range)50.0 (27–130)45.0 (20–104)+47.0 (28–110)
DLCO % pred
  ≤40%32 (29.1)36 (33.3)+39 (36.1)
  >40% and ≤55%36 (32.7)43 (39.8)+38 (35.2)
  >55%42 (38.2)29 (26.9)+31 (28.7)
 FEV1/FVC
  Mean±sd80.8±5.6§81.7±5.781.1±6.2
  Median (range)81.0 (66–96)§82.0 (66–95)82.0 (68–99)
Concomitant medication
  Any specific concomitant medication87 (79.1)83 (76.1)85 (78.7)
  Pirfenidone background therapy43 (39.1)40 (36.7)38 (35.2)
  Nintedanib background therapy14 (12.7)15 (13.8)18 (16.7)
  Systemic corticosteroid therapy11 (10.0)8 (7.3)7 (6.5)
  N-acetylcysteine therapy10 (9.1)11 (10.1)15 (13.9)
  Antacid therapy4 (3.6)4 (3.7)6 (5.6)
  Proton pump inhibitor therapy56 (50.9)47 (43.1)56 (51.9)
  H2-receptor blocker therapy3 (2.7)4 (3.7)5 (4.6)

Data are presented as n (%), unless otherwise stated. Q2W: once every 2 weeks; QW: once every week; IPF: idiopathic pulmonary fibrosis; FVC: forced vital capacity; DLCO: diffusing capacity of the lung for carbon monoxide; FEV1: forced expiratory volume in 1 s. #: n=106; : n=107; +: n=108; §: n=109.