Table 3.
Baseline demographic and clinical characteristics, original randomization groups, and treatment exposure in patients completing the long-term follow-up visit.
| Characteristic | Cumulative dose of sc IFN beta-1a |
Cumulative time on sc IFN beta-1a |
Noncontinuous versus continuous IFN beta-1a 44 µg sc tiw |
|||
|---|---|---|---|---|---|---|
| MIN | MAX | MIN | MAX | Noncontinuous | Continuous | |
| (n = 96) | (n = 95) | (n = 96) | (n = 95) | (n = 91) | (n = 45) | |
| Age, years | 33.8 ± 7.4 | 35.8 ± 7.7 | 33.8 ± 7.4 | 36.4 ± 6.6) | 34.9 ± 7.9 | 36.4 ± 7.8 |
| Median (range) | 32.9 (21–50) | 36.1 (19–49) | 33.4 (20–50) | 36.1 (21–50) | 34.7 (20–51) | 37.5 (19–49) |
| Women, n (%) | 76 (79.2) | 64 (67.4) | 77 (80.2) | 62 (65.3) | 70 (76.9) | 28 (62.2) |
| Race, n (%) | ||||||
| White | 95 (99.0) | 95 (100) | 95 (99.0) | 95 (100) | 90 (98.9) | 45 (100) |
| Other | 1 (1.0) | 0 | 1 (1.0) | 0 | 1 (1.1) | 0 |
| Time since first exacerbationa, years | 1.53 ± 0.42 | 1.57 ± 0.40 | 1.53 ± 0.47 | 1.58 ± 0.38 | 1.59 ± 0.43 | 1.54 ± 0.41 |
| Median (range) | 1.58 (0.4–2.4) | 1.61 (0.3–2.3) | 1.64 (0.4–2.4) | 1.65 (0.6–2.3) | 1.64 (0.3–2.3) | 1.60 (0.6–2.3) |
| Time since MS onset, years | 6.47 ± 5.25 | 7.72 ± 6.15 | 6.67 ± 5.38 | 7.56 ± 5.36 | 8.02 ± 6.16 | 8.06 ± 6.39 |
| Median (range) | 4.50 (1.1–23.2) | 6.20 (0.6–34.4) | 5.17 (1.3–25.7) | 6.38 (0.6–23.5) | 6.52 (0.6–25.7) | 7.58 (1.3–34.4) |
| EDSS score at baseline | 2.40 ± 1.24 | 2.42 ± 1.23 | 2.41 ± 1.24 | 2.39 ± 1.14 | 2.30 ± 1.27 | 2.59 ± 1.16 |
| Median (range) | 2.25 (0.0–5.5) | 2.0 (0.0–5.0) | 2.25 (0.0–5.5) | 2.0 (0.0–5.0) | 2.0 (0.0–5.0) | 2.50 (1.0–5.0) |
| MS relapses within past 2 years | 2.9 ± 1.2 | 2.9 ± 0.9 | 3.0 ± 1.2 | 2.9 ± 0.8 | 2.8 ± 1.1 | 2.9 ± 0.9 |
| Median (range) | 3.0 (2–8) | 3.0 (1–5) | 3.0 (2–8) | 3.0 (1–5) | 3.0 (2–8) | 3.0 (1–5) |
| Original randomization, n (%) | ||||||
| Placebo | 54 (56.3) | 4 (4.2) | 53 (55.2) | 0 | 0 | 0 |
| IFN beta-1a 22 µg | 28 (29.2) | 0 | 22 (22.9) | 42 (44.2) | 0 | 0 |
| IFN beta-1a 44 µg | 14 (14.6) | 91 (95.8) | 21 (21.9) | 53 (55.8) | 91 (100) | 45 (100) |
| Cumulative time exposure, weeks | 172.42 ± 102.55 | 375.25 ± 26.37 | 156.78 ± 87.66 | 390.27 ± 5.87 | 311.53 ± 105.06 | 385.70 ± 8.81 |
| Cumulative dose exposure, mg | 10.79 ± 5.98 | 46.60 ± 4.56 | 13.65 ± 9.37 | 38.28 ± 10.97 | 34.01 ± 13.53 | 49.43 ± 2.59 |
Values are means ± standard deviations unless indicated otherwise.
a
The length of time between the patient’s first MS exacerbation and their entry into the study.
EDSS, Expanded Disability Status Scale; IFN, interferon; MAX, maximum (highest quartile); MIN, minimum (lowest quartile); MS, multiple sclerosis; sc, subcutaneous; tiw, three times weekly.