Skip to main content

Table 1 Demographics and patient characteristics at baseline (randomized population)

From: Sarilumab plus methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate: results of a randomized, placebo-controlled phase III trial in Japan

  Sarilumab
Placebo to 150 mg q2w + MTX(n = 42) Placebo to 200 mg q2w + MTX(n = 40) 150 mg q2w + MTX(n = 81) 200 mg q2w + MTX(n = 80)
Age, mean (SD) years 51.9 (11.0) 55.0 (11.9) 56.1 (9.5) 55.3 (11.0)
Female/male, % 81.0/19.0 77.5/22.5 77.8/22.2 76.3/23.8
Weight, mean (SD) kg 54.5 (11.9) 58.7 (12.3) 56.6 (12.4) 56.7 (10.9)
Race, %
 Asian 100 100 100 100
 MTX dosage, mean (SD) mg/week 9.4 (3.2) 10.4 (3.2) 10.1 (3.0) 10.1 (3.0)
 Prior biologic DMARD use, n (%) 16 (38.1) 7 (17.5) 28 (34.6) 22 (27.5)
 Baseline corticosteroids, n (%) 22 (52.4) 17 (42.5) 42 (51.9) 46 (57.5)
 Duration of RA, mean (range) years 7.6 (0.3–43.1) 8.8 (0.3–35.2) 7.0 (0.3–37.5) 8.3 (0.3–33.6)
 Seropositive for rheumatoid factor, n (%) 32 (76.2) 24 (61.5)a 62 (76.5) 60 (75.0)
 Anti-CCP antibody positive, n (%) 36 (85.7) 32 (82.1)a 71 (87.7) 71 (88.8)
 DAS28-CRP, mean (SD) 5.6 (0.8) 5.3 (1.0) 5.7 (1.0) 5.4 (0.9)
 TJC, mean (SD) 18.9 (10.2) 17.2 (10.4) 19.3 (12.1) 17.9 (12.4)
 SJC, mean (SD) 15.1 (7.6) 14.1 (8.7) 16.1 (9.0) 14.4 (9.7)
 CRP, mean (SD) mg/l 23.7 (19.9) 21.0 (22.8) 22.9 (19.9) 23.1 (20.6)
 SDAI, mean (SD) 36.7 (10.2) 34.3 (12.1) 38.2 (13.2) 35.2 (12.9)
 CDAI, mean (SD) 34.4 (9.5) 31.9 (11.2) 35.9 (12.6) 32.9 (11.9)
 HAQ-DI score, mean (SD) 1.1 (0.6) 1.0 (0.7) 1.2 (0.7) 1.1 (0.7)
  1. an = 39
  2. CCP cyclic citrullinated peptide, CDAI Clinical Disease Activity Index, CRP C-reactive protein, DAS28 Disease Activity Score 28-joint count, DMARD disease-modifying antirheumatic drug, HAQ-DI Health Assessment Questionnaire-Disability Index, MTX methotrexate, q2w every 2 weeks, RA rheumatoid arthritis, SD standard deviation, SDAI Simplified Disease Activity Index, SJC swollen joint count, TJC tender joint count