Table 1

Baseline demographics and disease characteristics*

Sarilumab
VariablePlacebo +csDMARDs (n=181)150 mg q2w+csDMARDs (n=181)200 mg q2w+csDMARDs (n=184)
Age, years51.9±12.454.0±11.752.9±12.9
Female, n (%)154 (85.1)142 (78.5)151 (82.1)
Race, n (%)
 White124 (68.5)134 (74.0)130 (70.7)
 Black7 (3.9)8 (4.4)5 (2.7)
 Asian1 (0.6)3 (1.7)1 (0.5)
 Other49 (27.1)36 (19.9)48 (26.1)
Geographic region, n (%)†
 Region 177 (42.5)77 (42.5)79 (42.9)
 Region 274 (40.9)74 (40.9)74 (40.2)
 Region 330 (16.6)30 (16.6)31 (16.8)
Duration of RA, years12.0±10.011.6±8.612.7±9.6
Prior anti-TNF exposure, n (%)181 (100)181 (100)184 (100)
 1135 (74.6)143 (79.4)140 (76.5)
 >146 (25.4)37 (20.6)43 (23.5)
Reason for anti-TNF failure, n (%)
 Inadequate response174 (96.1)163 (90.1)167 (90.8)
 Intolerance6 (3.3)17 (9.4)15 (8.2)
 Other1 (0.6)1 (0.6)2 (1.1)
Rheumatoid factor positive, n (%)142 (78.9)135 (74.6)132 (72.9)
Anti-CCP antibody positive, n (%)150 (83.3)135 (75.0)137 (76.1)
DAS28-CRP6.2±0.96.1±0.96.3±1.0
Tender joint count (of 68 joints)29.4±14.527.7±15.629.6±15.5
Swollen joint count (of 66 joints)20.2±11.319.6±11.220.0±11.9
PtGA VAS‡68.8±18.167.7±17.570.9±17.4
Pain VAS‡71.6±18.271.0±19.374.9±18.4
HAQ-DI§1.8±0.61.7±0.61.8±0.6
FACIT-F¶23.7±10.823.5±10.623.1±10.8
SF-36 PCS**29.7±7.830.3±6.729.4±6.7
SF-36 MCS**38.5±12.638.6±11.439.1±11.4
RAID score††6.6±2.06.5±2.06.8±1.8
Morning stiffness VAS‡66.8±24.169.9±21.671.2±22.6
WPS-RA (n)‡‡
 Work days missed due to arthritis4.1±6.7 (32)3.3±6.1 (43)4.0±7.1 (45)
 Days with work productivity reduced by ≥50% due to arthritis6.7±8.1 (32)6.4±9.2 (43)6.9±8.5 (45)
 Rate of arthritis interference with work productivity§§5.0±2.9 (32)4.9±2.8 (42)5.1±3.4 (45)
 House work days missed due to arthritis8.6±9.2 (101)9.5±9.7 (126)9.9±10.5 (133)
 Days with household work productivity reduced by ≥50% due to arthritis10.0±10.1 (101)9.1±8.9 (125)9.4±9.0 (133)
 Rate of arthritis interference with household work productivity§§5.7±3.2 (100)6.2±2.8 (126)6.5±2.8 (132)
 Days with outside help hired due to arthritis4.9±9.5 (101)5.2±9.1 (126)6.7±11.3 (133)
 Days with family, social or leisure activities missed due to arthritis5.2±8.5 (101)5.3±8.0 (127)5.6±8.9 (133)
  • *Values are the mean±SD unless indicated otherwise.

  • †Region 1: Australia, Canada, Czech Republic, Germany, Greece, Hungary, Israel, Italy, New Zealand, Portugal, Spain, USA. Region 2: Argentina, Brazil, Chile, Colombia, Ecuador, Guatemala, Mexico, Peru. Region 3: Lithuania, Poland, Russia, South Korea, Taiwan, Thailand, Turkey, Ukraine.

  • ‡Scale range, 0–100; lower scores indicate better outcomes.

  • §Scale range, 0–3; lower scores represent less difficulty with physical functioning.

  • ¶Scale range, 0–52; higher scores represent less fatigue.

  • **Scale range, 0–100; higher scores represent less impaired physical/mental health status.

  • ††Scale range, 0–10; higher scores indicate a greater (negative) impact of RA.

  • ‡‡Number of patients with assessment at baseline and week 24.

  • §§Scale of 0=no interference to 10=complete interference.

  • Anti-CCP, anti–cyclic citrullinated peptide; anti-TNF, anti-tumour necrosis factor inhibitor; csDMARDs, conventional synthetic disease-modifying anti-rheumatic drugs; DAS28-CRP, 28-joint disease activity using C reactive protein; FACIT-F, Functional Assessment of Chronic Illness Therapy–Fatigue scale; HAQ-DI, Health Assessment Questionnaire Disability Index; MCS, mental component summary; PCS, physical component summary; PtGA, patient global assessment of disease activity; q2w, every 2 weeks; RA, rheumatoid arthritis; RAID, Rheumatoid Arthritis Impact of Disease; SF-36, Short Form 36 Health Survey V.2; VAS, visual analogue scale.