Table 1 Patient demographic and disease characteristics at baseline
From: Safety and in vivo immune assessment of escalating doses of oral laquinimod in patients with RRMS
MS-LAQ-101 | Pooled placebo (n = 28) | Laquinimod 0.9 mg (n = 12) | Laquinimod 1.2 mg (n = 12) | Laquinimod 1.5 mg (n = 12) | Laquinimod 1.8 mg (n = 11) | Laquinimod 2.1 mg (n = 13) | Laquinimod 2.4 mg (n = 12) | Laquinimod 2.7 mg (n = 12) | All (N = 112) |
|---|---|---|---|---|---|---|---|---|---|
Age, years | |||||||||
 Mean ± SD | 37.3 ± 8.5 | 38.6 ± 10.3 | 35.8 ± 9.4 | 35.2 ± 5.3 | 35.5 ± 8.4 | 41.5 ± 9.8 | 38.3 ± 10.5 | 44.8 ± 7.5 | 38.3 ± 9.0 |
 Range | 20.9–53.9 | 21.4–55.9 | 18.6–48.4 | 28.8–44.8 | 23.2–47.2 | 23.4–56.0 | 23.6–54.5 | 31.3–55.5 | 18.6–56.0 |
Gender N (%) | |||||||||
 Female | 23 (82.1) | 10 (83.3) | 6 (50.0) | 10 (83.3) | 5 (45.5) | 7 (53.8) | 9 (75.0) | 9 (75.0) | 79 (70.5) |
 Male | 5 (17.9) | 2 (16.7) | 6 (50.0) | 2 (16.7) | 6 (54.5) | 6 (46.2) | 3 (25.0) | 3 (25.0) | 33 (29.5) |
Height (cm) | |||||||||
 Mean ± SD | 170.3 ± 9.5 | 174.2 ± 9.8 | 175.8 ± 8.5 | 169.6 ± 8.1 | 177.7 ± 10.5 | 171.9 ± 7.9 | 171.4 ± 7.7 | 173.1 ± 6.8 | 172.6 ± 8.9 |
 Range | 157.0–196.0 | 158.0–198.0 | 164.0–196.0 | 158.0–180.0 | 158.0–193.0 | 158.0–186.5 | 161.0–186.0 | 164.0–187.0 | 157.0–198.0 |
Weight (kg) | |||||||||
 Mean ± SD | 72.9 ± 15.3 | 74.8 ± 14.5 | 75.9 ± 17.4 | 77.7 ± 19.1 | 81.1 ± 18.6 | 81.0 ± 13.9 | 79.9 ± 9.9 | 77.4 ± 12 | 76.9 ± 15.2 |
 Range | 53.0–110.0 | 57.0–99.5 | 58.0–124.0 | 52.0–113.0 | 63.0–123.2 | 62.0–109.5 | 62.0–98.0 | 62.0–97.0 | 52.0–124.0 |
BMI (kg/m2) | |||||||||
 Mean ± SD | 24.9 ± 3.7 | 24.8 ± 5.5 | 24.4 ± 4.3 | 27.0 ± 6.4 | 25.7 ± 5.0 | 27.4 ± 4.2 | 27.3 ± 3.9 | 25.8 ± 3.6 | 25.8 ± 4.5 |
 Range | 20.2–36.6 | 19.8–39.9 | 18.9–32.3 | 18.6–36.5 | 19.1–35.8 | 21.1–33.0 | 22.0–33.9 | 21.5–33.6 | 18.6–39.9 |
EDSS score at screening | |||||||||
 Mean ± SD | 2.1 ± 1.1 | 2.0 ± 1.4 | 1.6 ± 1.2 | 2.1 ± 1.3 | 2.4 ± 1.8 | 2.5 ± 1.2 | 2.7 ± 1.0 | 2.6 ± 1.5 | – |
 Range | 0.0–5.5 | 0.5–5.5 | 0.0–4.0 | 0.0–5.5 | 0.0–5.5 | 1.0–5.0 | 1.0–4.0 | 1.0–5.5 | – |
Total number of exacerbations in the year prior to screening | |||||||||
 Mean ± SD | 0.7 ± 0.6 | 1.2 ± 0.8 | 1.1 ± 0.8 | 0.8 ± 0.7 | 1.2 ± 1.2 | 1.0 ± 0.9 | 1.0 ± 0.6 | 1.0 ± 0.6 | 0.9 ± 0.8 |
 Range | 0.0–2.0 | 0.0–3.0 | 0.0–3.0 | 0.0–2.0 | 0.0–4.0 | 0.0–3.0 | 0.0–2.0 | 0.0–2.0 | 0.0–4.0 |