Table 1.
Baseline demographic and disease characteristics by disease phenotype.
| Characteristic |
PPMS (n = 134) |
SPMS (n = 121) |
P‐value 1 |
|---|---|---|---|
| Age (yrs), mean (SD) | 55.24 (6.93) | 56.17 (7.64) | 0.31 |
| Females, n (%) | 57 (42.54%) | 79 (65.29%) | <0.01 |
| Race | |||
| Caucasian, n (%) | 124 (92.54%) | 112 (92.56%) | 1.00 2 |
| Black/ African American, n (%) | 5 (3.73%) | 6 (4.96%) | |
| Other, n (%) | 3 (2.24%) | 1 (0.83%) | |
| Unknown/Not Reported, n (%) | 2 (1.49%) | 2 (1.65%) | |
| Hispanic/Latino, n (%) | 3 (2.24%) | 4 (3.31%) | 0.71 3 |
| Ibudilast, n (%) | 68 (50.75%) | 61 (50.41%) | 0.96 |
| use of im therapy, n (%) | 31 (23.13%) | 49 (40.50%) | <0.01 4 |
| Glatiramer Acetate, n (%) | 21 (15.67%) | 22 (18.18%) | |
| Interferon‐beta, n (%) | 10 (7.46%) | 27 (22.31%) | |
| disease duration (yrs), median (min, max) | 6 (0, 34) | 16 (1, 41) | <0.01 6 |
| Expanded Disability Status Scale, median (min, max) 5 | 6.0 (2.5, 6.5) | 6.0 (3.0, 7.0) | <0.01 6 |
| 25‐foot walk (sec), median (min, max) | 8.13 (3.60, 75.30) | 11.60 (4.05, 180.00) | <0.01 6 |
| 9‐hole peg test (sec), median (min, max) | 28.73 (16.58, 167.75) | 30.75 (17.83, 201.88) | 0.08 6 |
| Symbol Digit Modality Test (number correct), mean (SD) | 42.41 (13.88) | 42.71 (14.88) | 0.87 |
| Low contrast visual acuity test (number correct), mean (SD) 7 | 29.53 (12.21) | 26.27 (13.02) | 0.04 |
| Brain parenchymal fraction (unitless), mean (SD) | 0.8087 (0.0262) | 0.7988 (0.0323) | 0.01 |
| T2 Lesion volume (cm 3 ), mean (SD) | 8.46 (10.80) | 12.44 (11.17) | <0.01 |
| median (min, max) | 4.05 (0.03, 55.80) | 9.28 (0.11, 47.47) | <0.01 6 |
| Magnetization transfer ratio in normal‐appearing brain tissue (normalized units), mean (SD) 8 | 0.34 (0.25) | 0.26 (0.30) | 0.03 |
| Cortical thickness (mm), mean (SD) | 3.0846 (0.1951) | 2.9759 (0.2450) | <0.01 |
|
Diffusion tensor imaging, longitudinal diffusivity (10‐3 mm2/sec), mean (SD) |
1.23 (0.05) | 1.25 (0.05) | 0.01 |
|
Diffusion tensor imaging, transverse diffusivity (10‐3 mm2/sec), mean (SD) |
0.55 (0.04) | 0.56 (0.05) | 0.10 |
| Retinal nerve fiber layer thickness (µm), mean (SD) 9 | 85.31 (12.03) | 78.50 (11.03) | <0.01 |
The P‐value for continuous variables was based on Student’s t‐test, unless specified otherwise. The P‐value for nominal variables was based on a chi‐square test, unless specified otherwise.
The P‐value for Caucasians vs. Non‐Caucasians was based on Fishers exact test.
The P‐value for Hispanics vs. Non‐Hispanics was based on Fishers exact test.
The P‐value compares use of IM therapy vs untreated.
Scores on the Expanded Disability Status scale range from 0.0 to 10.0, with higher scores indicating worse disability. For study eligibility, scores had to be within 3.0‐6.5 (inclusive). One subject was enrolled with a score below the required level. A protocol deviation was entered and the subject was kept in the study.
The P‐value was based on a Wilcoxon Rank Sum Test.
Data were not available for 1 patient in the PPMS group and 1 patient in the SPMS group.
Data were not available for 3 patients in the PPMS group.
Data were not available for 2 patients in the PPMS group and 7 patients in the SPMS group.