Table 1

Demographics and disease activity at entry into the double-blind study by original randomisation group for the double-blind (n=1197) and open-label extension (n=901) populations

Parameter at double-blind study baselineDouble-blind studyOpen-label extension
Placebo + MTX (n=398)Sarilumab q2w + MTXPlacebo + MTX (n=307)Sarilumab q2w + MTX
150 mg (n=400)200 mg (n=399)150 mg (n=300)200 mg (n=294)
Female, n (%)321 (81)319 (80)337 (84)246 (80)241 (80)246 (84)
Age, mean (SD), years50.9 (11.2)50.1 (11.9)50.8 (11.8)50.8 (10.7)50.3 (11.8)50.2 (11.6)
Prior biological DMARD use, n (%)86 (22)87 (22)84 (21)71 (23)75 (25)64 (22)
Duration of RA, mean (range), years9 (0–44)10 (0–45)9 (0–34)9 (0–44)10 (0–45)9 (0–34)
Seropositive for RF, n (%)336 (84)345 (87)*328 (83)*260 (85)261 (88)†250 (85)†
Seropositive for anti-CCP autoantibody, n (%)340 (85)359 (90)‡337 (85)‡264 (86)273 (91)255 (87)§
Tender joint count (0–68), mean (SD)26.8 (13.7)27.2 (14.1)26.5 (14.5)26.8 (13.6)27.4 (14.4)26.9 (14.4)
Swollen joint count (0–66), mean (SD)16.7 (9.3)16.6 (9.0)16.8 (9.7)17.1 (9.4)16.7 (9.2)17.0 (9.5)
CRP, mean (SD), mg/L20.5 (23.0)22.5 (23.1)22.2 (23.8)20.1 (22.1)22.8 (24.0)21.5 (20.6)
DAS28-CRP, mean (SD)5.9 (0.9)6.0 (0.9)6.0 (0.9)5.9 (0.9)6.0 (0.9)6.0 (0.9)
HAQ-DI, mean (SD)1.6 (0.7)1.6 (0.6)1.7 (0.6)1.6 (0.7)1.6 (0.6)1.7 (0.6)
  • *For RF, n=396 for sarilumab 150 mg and n=397 for sarilumab 200 mg.

  • †For RF, n=298 for sarilumab 150 mg and n=293 for sarilumab 200 mg.

  • ‡For anti-CCP, n=398 for sarilumab 150 mg and n=293 for sarilumab 200 mg.

  • §n=293.

  • CCP, cyclic citrullinated peptide; CRP, C reactive protein; DAS28-CRP, Disease Activity Score (28 joints) using C reactive protein; DMARD, disease-modifying antirheumatic drug; HAQ-DI, Health Assessment Questionnaire-Disability Index; MTX, methotrexate; q2w, every 2 weeks; RA, rheumatoid arthritis; RF, rheumatoid factor; SD, standard deviation.