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. Author manuscript; available in PMC: 2022 Sep 1.
Published in final edited form as: Lancet Neurol. 2021 Sep;20(9):729–738. doi: 10.1016/S1474-4422(21)00237-4

Table 1:

Demographic and disease characteristics of participants at baseline


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.