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Table 2 Inflammation markers and disease activity outcomes (per protocol population)

From: Results of a proof of concept, double-blind, randomized trial of a second generation antisense oligonucleotide targeting high-sensitivity C-reactive protein (hs-CRP) in rheumatoid arthritis

  Placebo ISIS-CRP Rx   ISIS-CRP Rx p-value ISIS-CRP Rx  
Nimber = 11 100 mg   200 mg   400 mg
Number = 10   Number = 8   Number = 11
INFLAMMATION MARKERS    P -value a   P -value a   P -value a
hs-CRP (mg/L) Number = 11 Number = 10   Number = 8   Number = 11  
Baseline, mean (SD) 22.4 (18.1) 29.7 (29.0) 0.97 35.2 (36.4) 0.24 19.3 (13.6) 0.65
  Number = 10 Number = 10   Number = 8   Number = 11  
Day 36, mean (SD) 16.4 (12.3) 16.9 (16.2) 0.85 19.1 (25.9) 0.57 4.26 (4.2) 0.004
Day 36, mean change from baseline (SD) −6.8 (15.6) −12.8 (20.9) 0.85 −16.1 (12.1) 0.15 −15.0 (11.5) 0.07
Day 36, percentage change from baseline, mean (SD) −14.4 (66.3) −19.5 (63.6) 0.97 −56.6 (26.2) 0.10 −76.7 (16.4) 0.002
  Number = 11 Number = 10   Number = 8   Number = 11  
Day 92, mean (SD) 10.8 (10.5) 15.0 (19.1) 0.93 12.0 (10.7) 0.89 5.6 (5.2) 0.22
Day 92, mean change from baseline (SD) −11.6 (17.3) −14.7 (18.9) 0.81 −23.2 (28.2) 0.13 −13.7 (13.3) 0.80
Day 92, percentage change from baseline, mean (SD) −44.5 (60.2) −33.8 (82.3) 0.86 −66.9 (23.0) 0.49 −64.4 (38.6) 0.19
    P -value a   P -value a   P -value a
TNF-α (pg/mL) Number = 11 Number = 10   Number = 8   Number = 11  
Baseline, mean (SD) 15.6 (0.0) 15.6 (0.0) 1.00 15.6 (0.0) 1.00 15.6 (0.0) 1.00
  Number = 10 Number = 10   Number = 8   Number = 11  
Day 36, mean (SD) 15.6 (0.0) 15.6 (0.0) 1.00 15.6 (0.0) 1.00 15.6 (0.0) 1.00
  Number = 11 Number = 10   Number = 8   Number = 11  
Day 92, mean (SD) 15.6 (0.0) 15.6 (0.0) 1.00 15.9 (0.8) 0.42 16.0 (1.4) 1.00
    P -value a   P -value a   P -value a
IL-6 (pg/mL) Number = 10 Number = 9   Number = 8   Number = 11  
Baseline, mean (SD) 24.6 (20.3) 46.2 (45.3) 0.24 35.7 (32.9) 0.57 25.6 (26.1) 0.92
  Number = 10 Number = 10   Number = 7   Number = 11  
Day 36, mean (SD) 21.4 (19.8) 35.7 (32.5) 0.68 27.9 (21.6) 0.67 28.3 (42.1) 0.97
  Number = 11 Number = 10   Number = 7   Number = 11  
Day 92, mean (SD) 30.3 (41.6) 32.1 (28.1) 0.65 83.1 (142.6) 0.20 53.5 (62.3) 0.30
    P -value a   P -value a   P -value a
Serum Amyloid A (mg/L) Number = 11 Number = 10   Number = 8   Number = 11  
Baseline, mean (SD) 75.5 (167.4) 67.9 (85.4) 0.92 171.1 (255.1) 0.35 35.5 (44.4) 0.62
  Number = 10 Number = 10   Number = 8   Number = 11  
Day 36, mean (SD) 33.9 (41.2) 45.8 (38.4) 0.44 105.1 (192.2) 0.24 48.3 (86.4) 0.67
  Number = 11 Number = 10   Number = 8   Number = 11  
Day 92, mean (SD) 24.8 (30.0) 42.6 (39.2) 0.28 96.8 (112.0) 0.03 88.9 (98.9) 0.07
DISEASE ACTIVITY OUTCOMES        
ACR    P -value b   P -value b   P -value b
Day 36, number (% of responders) Number = 10 Number = 10   Number = 8   Number = 11  
ACR20% by hs-CRP 2 (20.0) 3 (30.0) 1.000 0 0.477 4 (36.4) 0.635
ACR20% by ESR 2 (20.0) 3 (30.0) 1.000 0 0.477 3 (27.3) 1.000
ACR50 by hs-CRP 1 (10.0) 2 (20.0) 1.000 0 1.000 1 (9.1) 1.000
ACR50 by ESR 0 2 (20.0) 0.474 0   0  
    P -value b   P -value b   P -value b
Day 92, number (% of responders) Number = 11 Number = 10   Number = 8   Number = 11  
ACR20 by hs-CRP 6 (54.5) 5 (50.0) 1.000 1 (12.5) 0.147 4 (36.4) 0.392
ACR20 by ESR 6 (54.5) 4 (40.0) 0.670 1 (12.5) 0.147 4 (36.4) 0.392
ACR50 by hs-CRP 2 (18.2) 2 (20.0) 1.000 0 0.485 3 (27.3) 1.000
ACR50 by ESR 1 (9.1) 2 (20.0) 0.586 0 1.000 2 (18.2) 1.000
DAS28-ESR    P -value a   P -value a   P -value a
  Number = 11 Number = 10   Number = 8   Number = 11  
Baseline, mean (SD) 6.7 (0.6) 6.4 (1.1) 0.4298 6.3 (0.7) 0.3352 6.2 (0.9) 0.2489
  Number = 10 Number = 10   Number = 8   Number = 11  
Day 36, mean (SD) 6.2 (1.1) 5.4 (1.5) 0.1097 5.8 (1.1) 0.4974 5.2 (1.2) 0.0572
Day 36, mean change from baseline (SD) −0.5 (0.6) −1.0 (0.9) 0.2176 −0.4 (0.7) 0.8286 −1.0 (0.8) 0.0986
Day 36, percentage change from baseline, mean(SD) −8.0 (10.7) −16.3 (16.1) 0.1431 −7.1 (11.2) 0.8968 −16.8 (12.7) 0.1321
  Number = 11 Number = 10   Number = 8   Number = 11  
Day 92, mean (SD) 5.3 (1.6) 5.2 (1.5) 0.8711 5.6 (1.1) 0.7164 5.1 (1.2) 0.6880
Day 92, mean change from baseline (SD) −1.3 (1.2) −1.1 (1.1) 0.6833 −0.7 (0.7) 0.2422 −1.1 (1.3) 0.6887
Day 92, percentage change from baseline, mean (SD) −20.7 (19.7) −17.5 (18.1) 0.6873 −11.7 (11.1) 0.2982 −16.9 (21.2) 0.6237
  1. a P-values calculated using a pairwise comparison between active treatment and placebo using the analysis of variance or Wilcoxon Rank Sum test; b P-values calculated using a pairwise comparison between active treatment and placebo using the Fisher’s Exact Test or Chi-square test. ACR, American College of Rheumatology; DAS28-ESR, disease activity score 28-erythrocyte sedimentation rate (DAS28-ESR = 0.56*square root of tender joint count + 0.28* square root of swollen joint count + 0.014*subject assessment of pain + 0.70*ln(ESR)); ESR, erythrocyte sedimentation rate; hs-CRP, high sensitivity C-reactive protein; SD, standard deviation.