EDSS and treatment exposure
| Early treatment | Delayed treatment | Total BENEFIT extension population | ||||
|---|---|---|---|---|---|---|
| Mean (SD) | Median (IQR) | Mean (SD) | Median (IQR) | Mean (SD) | Median (IQR) | |
| EDSS score at year 8* | 1.87 (1.29) | 1.5 (1.0 to 2.5) | 1.56 (1.22) | 1.5 (1.0 to 2.0) | 1.75 (1.27) | 1.5 (1.0 to 2.5) |
| Change in EDSS from baseline to year 8*,† | 0.38 (1.22) | 0.5 (−0.5 to 1.0) | 0.07 (1.11) | 0.0 (−0.5 to 0.50) | 0.25 (1.18) | 0.0 (−0.5 to 1.0) |
| Change in EDSS from baseline to LESO (%)‡ | ||||||
| Improved (≤−1.0) | 22.5 | 18.9 | 21.1 | |||
| Stable (>−1.0 to <1.0) | 43.8 | 52.8 | 47.2 | |||
| Worsened (≥1.0) | 33.7 | 28.3 | 31.7 | |||
| Sustained EDSS progression in the BENEFIT Extension study, n (%)‡,§ | ||||||
| ≥1 step | 40 (22.5) | 26 (24.5) | 66 (23.2) | |||
| ≥2.5 steps | 7 (3.9) | 2 (1.9) | 9 (3.2) | |||
| Sustained EDSS thresholds in the BENEFIT Extension study, n (%)‡,§ | ||||||
| ≥3 | 21 (11.8) | 18 (17.0) | 39 (13.7) | |||
| ≥4 | 9 (5.1) | 4 (3.8) | 13 (4.6) | |||
| ≥6 | 3 (1.7) | 0 (0) | 3 (1.1) | |||
| Interferon beta-1b exposure from the beginning of BENEFIT until the end of the extension study | ||||||
| Median, months¶ | 84.0 | 53.4 | 70.6 | |||
*n=181 (early treatment: n=109, delayed treatment: n=72). Includes patients who had a visit at year 8.
†Baseline EDSS is defined as lowest of the EDSS scores obtained during BENEFIT screening or baseline.
‡n=284 (early treatment: n=178, delayed treatment: n=106). Includes patients who participated in the extension study.
§Unadjusted for duration of observation. Sustained EDSS progression assumed an increase of ≥1 point compared with the lowest EDSS score during screening or baseline which was confirmed at the first scheduled visit after at least 140 days (including values obtained during relapses) and persisted for a minimum of one and all further following EDSS values measured at all subsequent scheduled or unscheduled visits after the confirming visit. Includes patients with onset of sustained EDSS progression at any time during the 8-year period.
¶n=278 (early treatment: n=178, delayed treatment: n=100). Includes patients who participated in the extension study and took at least one dose of IFNB-1b during the 8-year period.
EDSS, Expanded Disability Status Scale; LESO, last extension study observation.