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Table 5 Summary of ACR20 and ACR50 responses and DAS28-CRP based on concomitant medication at and after week 52 (efficacy full analysis set)

From: Sirukumab in rheumatoid arthritis refractory to sulfasalazine or methotrexate: a randomized phase 3 safety and efficacy study in Japanese patients

Efficacy parameter Sirukumab 50 mg q4w Sirukumab 100 mg q2w
ACR20 response
 Methotrexate
  Week 52a 29/44 (65.9) 34/42 (81.0)
  Week 52b 29/36 (80.6) 34/38 (89.5)
  Week 16, posttreatment phaseb 32/36 (88.9) 32/38 (84.2)
 DMARDs (including methotrexate)
  Week 52a 31/49 (63.3) 34/44 (77.3)
  Week 52b 31/38 (81.6) 34/38 (89.5)
  Week 16, posttreatment phaseb 33/38 (86.8) 32/38 (84.2)
 Corticosteroid (oral)
  Week 52a 2/7 (28.6) 8/11 (72.7)
  Week 52b 2/3 (66.7) 8/9 (88.9)
  Week 16, posttreatment phaseb 3/3 (100.0) 9/9 (100.0)
 Corticosteroid (oral, intramuscular)
  Week 52a 4/11 (36.4) 11/15 (73.3)
  Week 52b 4/6 (66.7) 11/12 (91.7)
  Week 16, posttreatment phaseb 5/6 (83.3) 12/12 (100.0)
 No DMARD and corticosteroid
  Week 52a 7/11 (63.6) 8/12 (66.7)
  Week 52b 8/8 (100.0) 8/10 (80.0)
  Week 16, posttreatment phaseb 8/8 (100.0) 8/10 (80.0)
ACR50 response
 Methotrexate
  Week 52a 21/44 (47.7) 24/42 (57.1)
  Week 52b 21/36 (58.3) 24/38 (63.2)
  Week 16, posttreatment phaseb 23/36 (63.9) 27/38 (71.1)
 DMARDs (including methotrexate)   
  Week 52a 22/49 (44.9) 24/44 (54.5)
  Week 52b 22/38 (57.9) 24/38 (63.2)
  Week 16, posttreatment phaseb 23/38 (60.5) 27/38 (71.1)
 Corticosteroid (oral)
  Week 52a 0/7 (0) 6/11 (54.5)
  Week 52b 0/3 (0) 6/9 (66.7)
  Week 16, posttreatment phaseb 1/3 (33.3) 8/9 (88.9)
 Corticosteroid (oral, intramuscular)
  Week 52a 1/11 (9.1) 9/15 (60.0)
  Week 52b 1/6 (16.7) 9/12 (75.0)
  Week 16, posttreatment phaseb 2/6 (33.3) 11/12 (91.7)
 No DMARD and corticosteroid
  Week 52a 7/11 (63.6) 8/12 (66.7)
  Week 52b 7/8 (87.5) 8/10 (80.0)
  Week 16, posttreatment phaseb 7/8 (87.5) 8/10 (80.0)
DAS28-CRP score
 All, n 61 61
  Week 52,b n 47 52
   Mean (SD) 2.4 (1.07) 2.3 (1.03)
  Week 16, posttreatment phase, nb 61 60
   Mean (SD) 2.5 (1.17) 2.4 (1.19)
Methotrexate, n 44 42
 Week 52, nb 36 38
  Mean (SD) 2.5 (1.09) 2.5 (0.94)
 Week 16, posttreatment phase, nb 44 41
   Mean (SD) 2.5 (1.10) 2.6 (1.18)
Corticosteroid (oral, intramuscular), n 11 15
 Week 52, nb 6 12
  Mean (SD) 3.0 (1.69) 1.9 (0.97)
 Week 16, posttreatment phase, nb 11 15
  Mean (SD) 3.0 (1.59) 2.1 (0.89)
  1. Data presented as n/N (%)
  2. aData imputation was nonresponder imputation for categorical parameters and last observation carried forward for noncategorical parameters
  3. bWeek 52 and week 16, posttreatment phase: values were as observed
  4. ACR20/50/70 American College of Rheumatology 20/50/70 response, DMARD Disease-modifying anti-rheumatic drug, n number of patients, N total number of patients, q4w once in 4 weeks, q2w once in 2 weeks, SD standard deviation