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Table 2 Efficacy results (mITT population)

From: Correction to: 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 = 41 (n = 14 at week 52))a Placebo to 200 mg q2w + MTX (n = 40 (n = 15 at week 52))a 150 mg q2w + MTX (n = 81) 200 mg q2w + MTX (n = 80)
Signs and symptoms
 ACR20 response, n (%)
  At week 12 15 (18.5) 54 (66.7)*** 52 (65.0)***
  At week 24 12 (14.8) 55 (67.9)*** 46 (57.5)***
  At week 52 9 (64.3) 10 (66.7) 58 (71.6) 48 (60.0)
 ACR50 response, n (%)
  At week 12 5 (6.2) 22 (27.2)*** 25 (31.3)***
  At week 24 8 (9.9) 35 (43.2)*** 31 (38.8)***
  At week 52 8 (57.1) 10 (66.7) 37 (45.7) 38 (47.5)
 ACR70 response, n (%)
  At week 12 1 (1.2) 5 (6.2) 15 (18.8)***
  At week 24 3 (3.7) 15 (18.5)** 12 (15.0)*
  At week 52 4 (28.6) 3 (20.0) 29 (35.8) 22 (27.5)
 ACR components, mean (SD) change from baseline at week 24
  Tender joint count − 9.1 (10.2) − 13.4 (9.9) − 12.4 (11.3)
  Swollen joint count − 7.2 (6.7) − 10.6 (8.1) − 9.5 (9.1)
  Pain VAS − 22.9 (27.7) − 36.5 (23.4) − 30.2 (23.3)
  Physician global VAS − 26.8 (18.4) − 41.8 (21.6) − 43.9 (19.4)
  Patient global VAS − 18.3 (22.6) − 32.4 (21.0) − 30.6 (21.9)
  HAQ-DI − 0.3 (0.4) − 0.5 (0.5) − 0.6 (0.5)
  CRP, mg/l − 1.7 (12.2) − 21.1 (19.5) − 21.3 (18.0)
 DAS28-CRP response, mean (SD) change from baseline
  At week 12 − 0.8 (1.1) − 2.3 (1.1)*** − 2.3 (1.2)***
  At week 24 − 1.5 (1.2) − 2.8 (1.0)*** − 2.8 (1.1)***
  At week 52 − 3.1 (1.2) − 2.9 (1.2) − 3.2 (1.2) − 3.2 (1.1)
 DAS28-CRP < 2.6, n (%)
  At week 12 3 (3.7) 21 (25.9)*** 27 (33.8)***
  At week 24 6 (7.4) 29 (35.8)*** 32 (40.0)***
  At week 52 7 (50.0) 9 (60.0) 41 (50.6) 43 (53.8)
 SDAI, mean (SD) change from baseline
  At week 12 − 8.9 (12.0) − 20.7 (11.0)*** − 18.9 (11.6)***
  At week 24 − 16.0 (11.6) − 25.2 (11.6)*** − 23.8 (11.3)***
  At week 52 − 29.6 (9.9) − 23.4 (12.4) − 29.4 (13.6) − 26.9 (11.5)
 SDAI ≤ 3.3, n (%)
  At week 12 0 2 (2.5) 7 (8.8)**
  At week 24 1 (1.2) 5 (6.2) 10 (12.5)**
  At week 52 2 (14.3) 1 (6.7) 19 (23.5) 18 (22.5)
 CDAI, mean (SD) change from baseline
  At week 12 − 8.7 (11.4) − 18.8 (10.6)*** − 16.8 (10.9)***
  At week 24 − 15.7 (11.1) − 23.1 (11.2)*** − 21.7 (10.7)***
  At week 52 − 28.4 (9.7) − 21.1 (11.4) − 27.2 (13.1) − 24.8 (10.8)
 CDAI ≤ 2.8, n (%)
  At week 12 0 1 (1.2) 5 (6.3)*
  At week 24 1 (1.2) 5 (6.2) 8 (10.0)*
  At week 52 1 (7.1) 0 17 (21.0) 15 (18.8)
Physical function
 HAQ-DI, mean (SD) change from baseline
  At week 12 − 0.1 (0.3) − 0.4 (0.5)*** − 0.4 (0.5)***
  At week 24 − 0.3 (0.4) − 0.5 (0.5)*** − 0.6 (0.5)***
  At week 52 − 0.7 (0.6) − 0.5 (0.3) − 0.6 (0.6) − 0.6 (0.6)
 HAQ-DI response (MCID ≥ 0.3), n (%)
  At week 12 19 (23.5) 39 (48.1)** 38 (47.5)**
  At week 16 19 (23.5) 37 (45.7)** 37 (46.3)**
  At week 24 10 (12.3) 39 (48.1)*** 39 (48.8)***
  At week 52 9 (64.3) 8 (53.3) 41 (50.6) 37 (46.3)
  1. *p <  0.05; **p < 0.01; ***p < 0.001
  2. aData for combined placebo groups (n=81) shown at weeks 12, 16 and 24. ACR American College of Rheumatology, ACR20/50/70 American College of Rheumatology 20%/50%/70% improvement criteria, CDAI Clinical Disease Activity Index, CRP C-reactive protein, DAS28 Disease Activity Score 28-joint count, HAQ-DI Health Assessment Questionnaire-Disability Index, MCID minimum clinically important difference, mITT modified intent-to-treat, MTX methotrexate, q2w every 2 weeks, SDAI Simplified Disease Activity Index, SD standard deviation, SJC swollen joint count, TJC tender joint count, VAS visual analog scale