Table 1

Patient demographic and clinical characteristics at baseline

Placebo
QW
(n=49)
Romilkimab
200 mg QW
(n=48)
All patients
(N=97)
Age (years)
 Mean (SD)47.2 (12.1)52.3 (10.8)49.7 (11.7)
 Median (range)45.0 (27–72)53.0 (20–78)51.0 (20–78)
Sex, n (%)
 Male11 (22)9 (19)20 (21)
 Female38 (78)39 (81)77 (79)
Race, n (%)
 American Indian or Alaska Native01 (2)1 (1)
 Asian1 (2)01 (1)
 Black or African American2 (4)2 (4)4 (4)
 Native Hawaiian or other Pacific Islander1 (2)01 (1)
 White45 (92)45 (94)90 (93)
Ethnicity, n (%)
 Hispanic or Latino12 (25)10 (21)22 (23)
 Not Hispanic or Latino37 (76)38 (79)75 (77)
BMI (kg/m2)
 Mean (SD)24.9 (5.3)24.3 (4.4)24.6 (4.9)
 Median (range)23.2 (18–41)24.4 (16–33)23.9 (16–41)
Weight (kg)
 Mean (SD)68.1 (18.0)67.1 (15.3)67.6 (16.6)
 Median (range)61.5 (46–118)64.5 (36–105)62.4 (36–118)
Disease duration from the time of first non-Raynaud’s phenomenon manifestation (months)
 Mean (SD)21.8 (10.7)19.3 (9.2)20.6 (10.0)
 Median (range)25.4 (5–36)19.4 (6–36)20.0 (5–36)
Baseline mRSS
 Mean (SD)20.6 (7.0)20.5 (6.1)20.6 (6.5)
 Median (range)18.0 (10–35)19.5 (11–35)19.0 (10–35)
Baseline FVC (% predicted)
 Mean (SD)89.5 (15.8)96.1 (17.4)92.8 (16.9)
 Median (range)91.9 (48–127)97.3 (54–127)93.0 (48–127)
Baseline DLCO (% haemoglobin corrected)
 Mean (SD)66.5 (14.6)72.4 (14.2)69.4 (14.7)
 Median (range)67.3 (38–102)72.7 (39–102)70.0 (38–102)
Medical history of SSc-ILD, n (%)
 Yes18 (37)18 (38)36 (37)
 No31 (63)30 (63)61 (63)
Background medication of interest, n (%)
 Methotrexate21 (43)12 (25)33 (34)
 Mycophenolate mofetil7 (14)10 (21)17 (18)
 Azathioprine1 (2)4 (8)5 (5)
  • Demographic and baseline characteristics were comparable between groups based on descriptive analysis.

  • BMI, body mass index; DLCO, diffusing lung capacity for carbon monoxide; FVC, forced vital capacity; ILD, interstitial lung disease; mRSS, modified Rodnan skin score; QW, one time per week; SSc, systemic sclerosis.