Table 1.
Extension study patient characteristics by treatment group
| Characteristic | Bridging study part A | Bridging study part B | |
|---|---|---|---|
| Previously on natalizumab (n = 10) | Previously on natalizumab (n = 44) | Previously on placebo (n = 43) | |
| Time on study, mean ± SD, monthsa | 39.4 ± 11.8 | 20.2 ± 11.2 | 20.8 ± 12.5 |
| Time on study, n (%), months | |||
| 0 to <6 | 0 | 6 (14) | 9 (21) |
| 6 to <12 | 0 | 3 (7) | 4 (9) |
| 12 to <18 | 1 (10) | 15 (34) | 2 (5) |
| 18 to <24 | 1 (10) | 3 (7) | 6 (14) |
| 24 to <30 | 0 | 5 (11) | 9 (21) |
| 30 to <36 | 0 | 8 (18) | 9 (21) |
| 36 to <42 | 0 | 4 (9) | 4 (9) |
| 42 to <48 | 8 (80) | 0 | 0 |
| Natalizumab doses received, mean ± SD | 43.3 ± 12.7 | 22.5 ± 12.0 | 23.1 ± 13.2 |
| Natalizumab doses received, n (%) | |||
| ≥1 | 10 (100) | 44 (100) | 43 (100) |
| ≥6 | 10 (100) | 41 (93) | 37 (86) |
| ≥12 | 10 (100) | 36 (82) | 32 (74) |
| ≥18 | 9 (90) | 25 (57) | 28 (65) |
| ≥24 | 9 (90) | 17 (39) | 24 (56) |
| ≥30 | 8 (80) | 15 (34) | 15 (35) |
| ≥36 | 8 (80) | 10 (23) | 11 (26) |
| ≥42 | 8 (80) | 1 (2) | 1 (2) |
| ≥48 | 8 (80) | 0 (0) | 0 (0) |
| Concomitant medications, n (%)b | |||
| Loxoprofen | 6 (60) | 30 (68) | 26 (60) |
| Gadopentetate dimegluminec | 0 (0) | 30 (68) | 27 (63) |
| Gadodiamidec | 0 (0) | 21 (48) | 24 (56) |
| PL granulesd | 4 (40) | 18 (41) | 16 (37) |
| Rebamipide | 3 (30) | 14 (32) | 16 (37) |
| Methylprednisolonee | 2 (20) | 12 (27) | 16 (37) |
| Antihistamines | |||
| Famotidine | 2 (20) | 11 (25) | 15 (35) |
| Fexofenadine | 1 (10) | 8 (18) | 11 (26) |
| Influenza virus vaccine | 4 (40) | 12 (27) | 10 (23) |
| Fingolimodf | 1 (10) | 11 (25) | 11 (26) |
| Carbocisteine | 2 (20) | 7 (16) | 12 (28) |
| Sennoside | 0 (0) | 11 (25) | 10 (23) |
| Brotizolam | 4 (40) | 9 (20) | 7 (16) |
| Meglumine gadopentetatec | 9 (90) | 6 (14) | 5 (12) |
SD standard deviation
aDefined as 30 days
bIncludes medications taken by ≥20% of the overall population
cReceived as the diagnostic contrast medium for gadolinium enhancement
dCaffeine, salicylamide, paracetamol, and promethazine methylene
eFor treatment of on-study relapses
fThe first dose of fingolimod was received after the last dose of natalizumab