Table 2.
Section A reports the demographics and baseline disease characteristics for the total randomised population by treatment arm and section B reports the demographics and baseline disease characteristics of the all-time on-study population by treatment arm
| Section A | |||||
|---|---|---|---|---|---|
| Characteristics | Group A (n=20) | Group B*(n=20) | Group C (n=20) | Placebo (n=20) | p Value |
| Sex | |||||
| Female—no. (%) | 15 (75) | 15 (75) | 15 (75) | 15 (75) | 1.000 |
| Age (years) | |||||
| Mean±SD | 38.0±11.9 | 36.9±8.4 | 37.7±8.7 | 38.1±10.9 | 0.982 |
| Median (range) | 38.0 (22 –65) | 37.0 (25 –61) | 36.5 (24–54) | 36.0 (21–58) | |
| Treatment history | |||||
| Patients on DMT—no. (%) | 11 (55) | 9 (45) | 12 (60) | 10 (50) | 0.875 |
| Pretreatment disease duration (years) | |||||
| Mean±SD | 9.0±7.6 | 8.6±4.8 | 8.6±5.3 | 7.7±5.7 | 0.909 |
| Median (range) | 7.5 (2–37) | 8.0 (2–20) | 8.0 (3–24) | 6.5 (2–25) | |
| Pretreatment relapses† | |||||
| Mean±SD | 2.33±1.68 | 2.41±1.73 | 2.31±1.66 | 2.10±1.32 | 0.946 |
| Median (range) | 2.0 (1–6) | 2.0 (1–7) | 2.0 (1–6) | 2.0 (1–4) | |
| ARR | 1.17 | 1.21 | 1.16 | 1.05 | 0.946 |
| Patients % with ≤1 relapse | 40 | 45 | 40 | 35 | |
| Baseline EDSS score† | |||||
| Mean±SD | 2.52±1.23 | 2.15±1.05 | 2.42±1.21 | 2.39±0.93 | 0.775 |
| Median (range) | 2.5 (1.0–5.5) | 2.0 (1.0–4.0) | 2.5 (0.0–5.0) | 2.5 (1.0–4.0) | |
| Section B Characteristics |
Group A (n=10) | Group B*(n=10) | Group C (n=9) | Placebo (n=12) | p Value |
|---|---|---|---|---|---|
| Sex | |||||
| Female—no. (%) | 5 (50) | 7 (70) | 6 (66.6) | 10 (83.3) | 0.419 |
| Age (years) | |||||
| Mean±SD | 36.6±13.5 | 34.8±5.4 | 40.9±8.1 | 39.8±13.2 | 0.572 |
| Median (range) | 34.5 (22–65) | 34.5 (26–43) | 40.0 (29–54) | 37.5 (21–58) | |
| Treatment history | |||||
| Patients on DMT—no. (%) | 6 (60) | 4 (40) | 6 (67) | 6 (50) | 0.949 |
| Pretreatment disease duration (years) | |||||
| Mean±SD | 9.7±10.0 | 8.3±5.3 | 11.3±6.1 | 8.7±7.1 | 0.807 |
| Median (range) | 7.5 (2–37) | 8.0 (2–20) | 8.0 (4–24) | 5.5 (2–25) | |
| Pretreatment relapses | |||||
| Mean±SD | 2.20±1.47 | 2.70±1.25 | 1.78±0.66 | 1.67±1.37 | 0.241 |
| Median (range) | 2.0 (1–6) | 2.5 (1–4) | 2.0 (1–3) | 1.5 (1–4) | |
| ARR | 1.10 | 1.35 | 0.89 | 0.83 | |
| Patients % with ≤1 relapse | 30 | 20 | 33 | 50 | |
| Baseline EDSS score | |||||
| Mean±SD | 2.65±1.37 | 2.40±1.12 | 2.11±1.02 | 2.16±0.96 | 0.698 |
| Median (range) | 3.0 (1.0–5.5) | 2.5 (1.0–4.0) | 2.0 (1.0–4.0) | 2.0 (1.0–3.5) | |
There were no significant between study-group differences at baseline for any characteristic.
*PLP10 group.
†Available data at entry baseline (n=18 for group A, n=17 for group B, n=19 for group C, n=19 for group D).
ARR, annual relapse rate; DMT, disease-modifying treatment.