Literature DB >> 30992058

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 Tanaka1, Kazuteru Wada2, Yoshinori Takahashi2, Owen Hagino3, Hubert van Hoogstraten4, Neil M H Graham5, Hideto Kameda6.   

Abstract

Following publication of the original article [1], the authors reported an error in Table 2.

Entities:  

Year:  2019        PMID: 30992058      PMCID: PMC6469054          DOI: 10.1186/s13075-019-1887-x

Source DB:  PubMed          Journal:  Arthritis Res Ther        ISSN: 1478-6354            Impact factor:   5.156


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).
Table 2

Efficacy results (mITT population)

Sarilumab
Placebo to 150 mg q2w + MTX(n = 41 (n = 14 at week 52))aPlacebo to 200 mg q2w + MTX(n = 40 (n = 15 at week 52))a150 mg q2w + MTX(n = 81)200 mg q2w + MTX(n = 80)
Signs and symptoms
 ACR20 response, n (%)
  At week 1215 (18.5)54 (66.7)***52 (65.0)***
  At week 2412 (14.8)55 (67.9)***46 (57.5)***
  At week 529 (64.3)10 (66.7)58 (71.6)48 (60.0)
 ACR50 response, n (%)
  At week 125 (6.2)22 (27.2)***25 (31.3)***
  At week 248 (9.9)35 (43.2)***31 (38.8)***
  At week 528 (57.1)10 (66.7)37 (45.7)38 (47.5)
 ACR70 response, n (%)
  At week 121 (1.2)5 (6.2)15 (18.8)***
  At week 243 (3.7)15 (18.5)**12 (15.0)*
  At week 524 (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 123 (3.7)21 (25.9)***27 (33.8)***
  At week 246 (7.4)29 (35.8)***32 (40.0)***
  At week 527 (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 1202 (2.5)7 (8.8)**
  At week 241 (1.2)5 (6.2)10 (12.5)**
  At week 522 (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 1201 (1.2)5 (6.3)*
  At week 241 (1.2)5 (6.2)8 (10.0)*
  At week 521 (7.1)017 (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 1219 (23.5)39 (48.1)**38 (47.5)**
  At week 1619 (23.5)37 (45.7)**37 (46.3)**
  At week 2410 (12.3)39 (48.1)***39 (48.8)***
  At week 529 (64.3)8 (53.3)41 (50.6)37 (46.3)

*p <  0.05; **p < 0.01; ***p < 0.001

Data 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

The corrected table is given below. Efficacy results (mITT population) *p <  0.05; **p < 0.01; ***p < 0.001 Data 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
  1 in total

1.  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.

Authors:  Yoshiya Tanaka; Kazuteru Wada; Yoshinori Takahashi; Owen Hagino; Hubert van Hoogstraten; Neil M H Graham; Hideto Kameda
Journal:  Arthritis Res Ther       Date:  2019-03-20       Impact factor: 5.156

  1 in total
  1 in total

1.  Changes in rheumatoid arthritis under ultrasound before and after sinomenine injection.

Authors:  Yi-Min Huang; Yu Zhuang; Zhi-Ming Tan
Journal:  World J Clin Cases       Date:  2022-01-07       Impact factor: 1.337

  1 in total

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