Table 1:
Demographic and disease characteristics of participants at baseline
|
|
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|---|---|---|---|---|---|---|
| Tolebrutinib |
||||||
| All participants (N=130) | Placeboa (N=66) | 5 mg (n=33) | 15 mg (n=32) | 30 mg (n=33) | 60 mg (n=32) | |
| Age, years | 37 (10) | 36 (10) | 36 (10) | 36 (9) | 39 (10) | 37 (9) |
| Female, n (%) | 91 (70) | 46 (70) | 25 (76) | 21 (66) | 21 (64) | 24 (75) |
| Highly active disease, n (%) | 61 (47) | 29 (44) | 12 (36) | 19 (59) | 16 (48) | 14 (44) |
| RRMS,b n (%) | 128 (99) | 65 (99) | 33 (100) | 32 (100) | 32 (97) | 31 (97) |
| Time since initial relapse, years | 7·8 (7·4) | 7·7 (7·4) | 7·7 (7·8) | 8·0 (7·6) | 8·1 (7·8) | 7·3 (6·7) |
| Relapses in previous year | 1·2 (0·6) | 1·2 (0·5) | 1·2 (0·5) | 1·3 (0·6) | 1·3 (0·6) | 1·2 (0·4) |
| Relapses in previous 2 years | 1·7 (0·9) | 1·7 (0·7) | 1·7 (0·8) | 1·5 (0·8) | 1·8 (1·1) | 1·6 (0·9) |
| EDSS score | 2·5 (1·1) | 2·6 (1·1) | 2·5 (1·0) | 2·2 (1·0) | 2·6 (1·3) | 2·7 (1·2) |
| T2 hyperintense lesion volume, cm3 | 12·76 (11·31) | 12·95 (11·35) | 12·14 (9·86) | 11·74 (9·53) | 14·72 (13·80) | 12·41 (11·78) |
| T1 hypointense lesion volume, cm3 | 0·95 (1·62) | 1·07 (1·97) | 0·49 (0·52) | 1·02 (1·45) | 1·46 (2·11) | 0·85 (1·83) |
| Number of Gd-enhancing lesions | 1·8 (4·7)c | 2·2 (5·9) | 2·3 (5·9)d | 0·7 (1·8)e | 1·9 (4·9)d | 2·1 (4·9) |
| Participants with baseline Gd-enhancing lesions, n (%) | 44 (35)c | 25 (38) | 11 (34)d | 7 (23)e | 11 (34)d | 15 (47) |
Values are mean (SD) except where noted. Highly active disease was defined as 1 relapse in the year prior to screening and ≥1 Gd-enhancing lesion on MRI performed within 6 months prior to screening or ≥9 T2 lesions at baseline or ≥2 relapses in the year prior to screening.
a
Includes data from placebo-treated period of Cohort 2, which began tolebrutinib treatment at week 4 after the placebo run-in.
b
Two participants had a diagnosis of relapsing secondary progressive MS.
c
N=127.
d
N=32.
e
N=31.
EDSS=Expanded Disability Status Scale. Gd=gadolinium. MRI=magnetic resonance imaging. MS=multiple sclerosis. RRMS=relapsing-remitting MS. SD=standard deviation.