SID | Total EID | EED | LED | VED | Within EID | |
---|---|---|---|---|---|---|
Participants (n) | 1080 | 894 | 246 | 269 | 379 | |
Number of MRIs | 2.91 (2.36) | 4.98* (4.14) | 4.98* (4.98) | 4.05* (2.90) | 5.63* (4.18) | VED, >EED, LED |
Patients with T2 lesions | 161/946 =17% | 75/653* =11% | 18/234 =8% | 28/255* =11% | 57/360† =16% | VED>LED, EED |
Scans with T2 lesions | 193/2607 7.0% | 122/4253* 2.9% | 17/1103* 1.5% | 28/1084* 2.6% | 77/2066* 3.6% | |
Patients with Gad lesions | 64/1019 =6% | 65/683† =10% | 9/195 =5% | 11/142† =8% | 45/346* 13% | |
Scans with Gad lesions | 111/2521 4.4% | 93/3666† 2.5% | 14/1060† 1.3% | 13/537 2.4% | 66/2069† 3.1% | VED>LED |
Patients with clinical relapse | 247/1068 23% | 157/883* 18% | 53/241 22% | 24/266* 9% | 80/376 21% | VED, EED>LED |
Total relapses (per group, per participant) | 354 0.35 (0.81) | 218* 0.26 (0.70) | 82* 0.41 (0.99) | 46 0.13 (0.51) | 90† 0.26 (0.57) | LED<EED, VED |
Patients with steroids | 218/960 23% | 126/622 20% | 42/203* 11% | 25/148 17% | 59/271 22% | LED, VED>EED |
Total steroids (per group, per participant) | 354 0.37 (0.87) | 218 0.35 (0.93) | 82* 0.40 (1.0) | 46* 0.31 (1.0) | 90 0.33 (0.78) | EED>LED |
Adjusted annualised relapse rate | 0.15 | 0.12* | 0.11 | 0.08† | 0.12 | EED>LED, VED |
Means and SDs (in parentheses).
(A) Comparisons in columns 2–5 are to SID group. Comparisons between the three EID groups (EED vs LED vs VED) are displayed in column 6. (B) Since the adjusted annualised relapse rate was allowed to vary across site, the rates in table 1 are the marginal means treating site as balanced.
*Indicates EID group differs from SID group at p<0.05.
†Indicates EID group differs from SID group at 0.05<p<0.10.
EED, early extended dosing; EID, extended interval dosing; LED, late extended dosing; SID, standard interval dosing; VED, variable extended dosing.