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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
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Arthritis Research & Therapy

ISSN: 1478-6362

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