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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.
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Arthritis Research & Therapy

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