Table 1.
Baseline characteristics and drug exposure/compliance of patients with RRMS and healthy controls.
| Patients with RRMS |
HCs |
||
|---|---|---|---|
| n = 23 | n = 15 | ||
| Age, years, mean (SD)a | 39.9 (10.17) | 36.7 (10.31) | |
| Female, n (%)a | 14 (61) | 8 (53) | |
| Race, n (%)a | |||
| White | 20 (87) | 14b (93) | |
| Black | 3 (13) | 0 | |
| Other: Indian | 0 | 1 (7) | |
| Mean (SD) weight, kga | 79.9 (22.25) | 87.0 (18.33) | |
| Mean (SD) height, cma | 171.0 (8.48) | 168.5 (6.99) | |
| Mean (SD) BMI, kg/m2a | 27.2 (6.90) | 30.5 (5.37) | |
| Mean (SD) years since MS diagnosis, range | 6.6 (5.65), 0–20 | — | |
| Mean (SD) years since most recent relapse, range | 1.0 (1.14), 0.1–5.0 | — | |
| Mean (SD) number of relapses in past 12 monthsc | 1.26 (1.18) | — | |
| 0, n (%) | 7 (30) | ||
| 1, n (%) | 7 (30) | ||
| 2, n (%) | 7 (30) | ||
| 4, n (%) | 2 (9) | ||
| Most recent disease-modifying drug use, n (%) | — | ||
| Intramuscular IFN beta 1-a | 8 (35) | ||
| Subcutaneous IFN beta 1-a | 5 (22) | ||
| Glatiramer acetate | 4 (17) | ||
| Natalizumab | 2 (9) | ||
| Intravenous immunoglobulin | 1 (4) | ||
| None | 3 (13) | ||
| Median (range) Expanded Disability Status Scale score | 2.5 (1–5.5) | — | |
| Mean (SD) ambulation distance, meters | 475 (94.2) | — | |
|
| |||
| Study drug exposure and complianced | Interferon beta-1a administered subcutaneously three times per week |
||
| n = 23 | |||
| 8.8 µg | 22 µg | 44 µg | |
|
| |||
| Total dose received, µg, mean (SD) | 52.5 (7.60) | 133.9 (9.17) | 2,174.9 (584.47) |
| Doses missed, mean (SD) | 0 (0.2) | 0 (0) | 5 (7.6) |
| Compliance, %, mean (SD) | 99 (3.5) | 100 (0) | 92 (12.2) |
a
No significant differences were seen between groups by the Student’s t-test (for age, weight, height, and body mass index) or Fisher’s exact test (for race and gender).
b
Includes one patient of Hispanic ethnicity (all other subjects were not Hispanic).
c
Patients reported the same number of relapses for the past 24 months.
d
Compliance was calculated at study visits using subject diaries and returned drug. Exposure was calculated from compliance. BMI, body mass index; HC, healthy control; IFN, interferon; RRMS, relapsing–remitting multiple sclerosis; SD, standard deviation.