Clinical response1 Placebo DIMS0150 P value
(n=12) (n=22)
Week 1 (wk1) 2/12 (17) 7/22 (32) 0.43
Week 4 (wk4) 4/12 (33) 9/22 (41) 0.71
Clinical remission2      
wk1 1/12 (8) 2/22 (9) 1
wk4 0/12 3/22 (13) 0.27
Histological response3      
wk4  0/12 (0) 6/22 (27) 0.06
Histological remission4      
wk4  0/12 (0) 6/22 (27) 0.06
Clinical response paralleled with histological remission      
wk4 0/4 (0) 4/9 (44) 0.22
Table 2A: Response and remission rates upon DIMS0150 treatment. Summary of the efficacy results following treatment with DIMS0150 or placebo at the times indicated given both as single time observations. LOCF handling was used for missing data. P values calculated with Fisher’s Exact Test. 1 defined as DAI score decrease of at least 3 points from baseline. 2 defined as a total DAI score of 2 points or lower, with no individual sub-score exceeding 1 point. 3 defined as histology score decrease of at least 3 points from baseline. 4 defined as histology score decrease to a score of zero.