Baseline characteristics
| Characteristics | TOP (N=4821) | AFFIRM overall (N=942) | AFFIRM natalizumab (n=627) |
|---|---|---|---|
| A. Baseline characteristics of patients currently enrolled in TOP, compared with AFFIRM patients | |||
| Mean age, years (SD) | 37.2 (9.69) | 36.0 (8.3) | 35.6 (8.5) |
| Female, n (%) | 3466 (72) | 660 (70) | 449 (72) |
| Mean number of relapses in prior year (SD) | 1.99 (1.03) | 1.52 (0.86) | 1.53 (0.91) |
| Number of relapses in prior year, n (%) | |||
| ≤1 | 1713 (36) | 560 (59) | 374 (60) |
| >1 | 3108 (64) | 382 (41) | 253 (40) |
| EDSS score, mean (SD) | 3.5 (1.62)† | 2.3 (1.2) | 2.3 (1.2) |
| EDSS score, n (%) | |||
| 0.0–2.0 | 1297 (27) | 510 (54) | 339 (54) |
| 2.5–4.0 | 2114 (44) | 369 (39) | 246 (39) |
| 4.5–9.5 | 1386 (29) | 63 (7) | 42 (7) |
| B. Additional baseline characteristics of patients currently enrolled in TOP | |||
| EDSS score, n (%)* | |||
| <3.0 | 1773 (37) | ||
| ≥3.0 | 3024 (63) | ||
| MSSS score, †‡ mean (SD) | 4.97 (2.40) | ||
| Prior treatment | |||
| Yes, n (%) | 4384 (90.9) | ||
| Prior number of DMTs used, n (%) | |||
| 0 DMT | 437 (9) | ||
| 1 DMT | 2213 (46) | ||
| ≥2 DMTs | 2171 (45) | ||
| Treatment history, §¶ n (%) | |||
| Therapy naïve | 437 (10) | ||
| IFN only | 2131 (47) | ||
| GA only | 421 (9) | ||
| Switched between GA and IFN | 855 (19) | ||
| Prior IS use** | 697 (15) | ||
| Disease duration†† | |||
| Median duration, years (range) | 7.3 (0.0–43.9) | ||
| Duration ≥8 years, n (%) | 2203 (46) | ||
| Treatment duration | |||
| Median duration, years (range) | 3.0 (0.0–26.5) | ||
| Mean duration, years (SD) | 4.1 (3.71) | ||
| Duration ≥3 years, n (%) | 2435 (51) | ||
*n=4797.
†n=4728.
‡Ninety-three patients were not included because of missing baseline EDSS or disease duration information, and/or disease duration greater than 30 years (MSSS calculation does not include durations >30 years).
§n=4541.
¶Two hundred eighty patients were not included because of use of other therapies, such as fingolimod, and combination with various steroid treatments.
**Prior IS use included azathioprine, cyclophosphamide, cyclosporine, methotrexate, mitoxantrone, mycophenolate mofetil, rituximab and tacrolimus.
††n=4799.
DMT, disease-modifying therapy; EDSS, Expanded Disability Status Scale; GA, glatiramer acetate; IFN, interferon β-1; IS, immunosuppressant; MSSS, Multiple Sclerosis Severity Scale; TOP, The Tysabri (natalizumab) Observational Program.