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Table 4 Laboratory values through week 52 (safety 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 + MTX to 150 mg q2w
(n = 14)
Placebo + MTX to 200 mg q2w
(n = 15)
150 mg q2w + MTX
(n = 81)
200 mg q2w + MTX
(n = 80)
Absolute neutrophil count, n (%)
 Grade 1: ≥ 1.5 Giga/l to < LLN 3 (21.4) 2 (13.3) 14 (17.3) 19 (23.8)
 Grade 2: ≥ 1 to < 1.5 Giga/l 2 (14.3) 6 (40.0) 20 (24.7) 18 (22.5)
 Grade 3: ≥ 0.5 to < 1 Giga/l 2 (14.3) 0 10 (12.3) 6 (7.5)
 Grade 4: < 0.5 Giga/l 1 (7.1) 0 1 (1.2) 0
Hepatic enzyme levels, n (%)
 ALT
  > 1 ULN and ≤ 3 ULN 7 (50.0) 10 (66.7) 41 (50.6) 43 (53.8)
  > 3 ULN and ≤ 5 ULN 2 (14.3) 0 11 (13.6) 5 (6.3)
  > 5 ULN and ≤ 10 ULN 0 1 (6.7) 1 (1.2) 2 (2.5)
  > 10 ULN 0 0 0 0
 AST
  > 1 ULN and ≤ 3 ULN 9 (64.3) 9 (60.0) 52 (64.2) 42 (52.5)
  > 3 ULN and ≤ 5 ULN 1 (7.1) 1 (6.7) 5 (6.2) 2 (2.5)
  > 5 ULN and ≤ 10 ULN 0 0 0 1 (1.3)
  > 10 ULN 0 0 0 0
  1. The number (n) represents the subset of the total number of patients who met the criterion in question at least once during treatment-emergent adverse event period
  2. ALT alanine aminotransferase, AST aspartate aminotransferase, LLN lower limit of normal, MTX methotrexate, q2w every 2 weeks, ULN upper limit of normal