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Table 4 Summary of the efficacy data proof of concept phase IIa study

From: Biomarkers can predict potential clinical responders to DIMS0150 a toll-like receptor 9 agonist in ulcerative colitis patients

 

ITT population (n = 34)

 

Placebo (n = 12)

DIMS0150 (n = 22)

P value

Clinical response 1

   

Week 1 (wk1)

2 (17%)

7 (32%)

0.43

Week 4 (wk4)

4 (33%)

9 (41%)

0.71

Sustained clinical response:

   

Wk1 and wk4

0/12 (0%)

6/22 (27%)

0.06

Clinical remission 2

   

Wk1

1 (8%)

2 (9%)

1.0

Wk4

0 (0%)

3 (13%)

0.27

Sustained clinical remission:

   

Wk1 and wk4

0/12 (0%)

2/22 (9%)

0.18

Histological response 3

   

Wk4

0 (0%)

6 (27%)

0.06

Sustained histological response:

  

Wk4 and wk12

0/8 (0%)

3/16 (19%)

0.2

Histological remission 4

   

Wk4

0 (0%)

6 (27%)

0.06

Sustained histological remission:

  

Wk4 and wk12

0/8 (0%)

3/16 (19%)

0.2

Clinical response paralleled with histological remission

   

Wk4

0/4 (0%)

4/9 (44%)

0.22

  1. 1defined as DAI score decrease of at least 3 points from baseline.
  2. 2defined as a total DAI score of 2 points or lower, with no individual sub-score exceeding 1 point.
  3. 3defined as histology score decrease of at least 3 points from baseline.
  4. 4defined as histology score decrease to a score of zero.
  5. No wk24 data of patients with sustained remission available.
  6. (ITT) Intention-To-Treat; P values calculated with Fisher’s Exact Test for response/remission rates.