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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

  • Yoshiya TanakaEmail author
  • Kazuteru Wada
  • Yoshinori Takahashi
  • Owen Hagino
  • Hubert van Hoogstraten
  • Neil M. H. Graham
  • Hideto Kameda
Open Access
Correction
  • 129 Downloads

Correction to: Arthritis Res Ther

https://doi.org/10.1186/s13075-019-1856-4

Following publication of the original article [1], the authors reported an error in Table 2. The data for ‘HAQ-DI response (MCID ≥ 0.3), n (%) / At week 52’ for the ‘Sarilumab 150 mg q2w + MTX’ and ‘Sarilumab 200 mg q2w + MTX’ groups should be 41 (50.6) and 37 (46.3), respectively (last row, last two entries of the table).

The corrected table is given below.

Table 2

Efficacy results (mITT population)

 

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)

*p <  0.05; **p < 0.01; ***p < 0.001

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

Reference

  1. 1.
    Tanaka, et al. 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. Arthritis Res Ther. 2019;21:79.  https://doi.org/10.1186/s13075-019-1856-4.CrossRefPubMedPubMedCentralGoogle Scholar

Copyright information

© The Author(s). 2019

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Authors and Affiliations

  • Yoshiya Tanaka
    • 1
    Email author
  • Kazuteru Wada
    • 2
  • Yoshinori Takahashi
    • 2
  • Owen Hagino
    • 3
  • Hubert van Hoogstraten
    • 4
  • Neil M. H. Graham
    • 5
  • Hideto Kameda
    • 6
  1. 1.The First Department of Internal Medicine, School of MedicineUniversity of Occupational and Environmental Health, JapanKitakyushuJapan
  2. 2.Sanofi K.KTokyoJapan
  3. 3.SanofiBridgewaterUSA
  4. 4.Sanofi-GenzymeCambridgeUSA
  5. 5.Regeneron Pharmaceuticals, Inc.TarrytownUSA
  6. 6.Division of Rheumatology, Department of Internal Medicine, School of MedicineToho UniversityTokyoJapan

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