Numbers of PBH that evolved from GdE, new T2 and all active lesions
| GdE lesions | New T2 lesions | Active lesions | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Mean* (SE) [n patients evaluable] | RR† | p Value | Mean (SE) [n patients evaluable] | RR† | p Value | Mean* (SE) [n patients evaluable] | RR† | p Value | |
| PBH at month 12 from lesions at baseline | |||||||||
| Laquinimod 0.6 mg | 0.5 (0.16) [26] | 0.53 | 0.112 | NA | NA | NA | NA | NA | NA |
| Placebo | 0.9 (0.19) [41] | ||||||||
| PBH at month 24 from lesions at baseline | |||||||||
| Laquinimod 0.6 mg | 0.6 (0.17) [26] | 0.65 | 0.184 | NA | NA | NA | NA | NA | NA |
| Placebo | 1.0 (0.17) [41] | ||||||||
| PBH at month 12 from lesions at month 3 | |||||||||
| Laquinimod 0.6 mg | 0.6 (0.25) [14] | 0.58 | 0.244 | 0.40 (0.15) [28] | 0.52 | 0.143 | 0.41 (0.14) [29] | 0.44 | 0.040 |
| Placebo | 1.0 (0.22) [37] | 0.77 (0.20) [42] | 0.94 (0.20) [45] | ||||||
| PBH at month 24 from lesions at month 3 | |||||||||
| Laquinimod 0.6 mg | 0.6 (0.24) [14] | 0.55 | 0.193 | 0.43 (0.14) [28] | 0.50 | 0.076 | 0.47 (0.14) [29] | 0.45 | 0.025 |
| Placebo | 1.1 (0.22) [37] | 0.86.(0.18) [42] | 1.03 (0.19) [45] | ||||||
| PBH at month 12 from lesions at months 3 and 6 | |||||||||
| Laquinimod 0.6 mg | 0.6 (0.18) [25] | 0.45 | 0.022 | 0.57 (0.16) [40] | 0.48 | 0.030 | 0.59 (0.15) [41] | 0.42 | 0.004 |
| Placebo | 1.3 (0.22) [50] | 1.20 (0.24) [56] | 1.40 (0.23) [58] | ||||||
| PBH at month 24 from lesions at months 3, 6 and 12 | |||||||||
| Laquinimod 0·6 mg | 0.7 (0.19) [32] | 0.44 | 0.005 | 0.87 (0.17) [51] | 0.52 | 0.009 | 0.95 (0.18) [52] | 0.50 | 0.002 |
| Placebo | 1.7 (0.26) [54] | 1.67 (0.25) [65] | 1.91 (0.26) [66] | ||||||
| PBH at month 24 from all lesions | |||||||||
| Laquinimod 0·6 mg | 1.0 (0.20) [41] | 0.45 | 0.001 | 0.87 (0.17) [51] | 0.52 | 0.009 | 1.20 (0.19) [55] | 0.51 | <0.001 |
| Placebo | 2.1 (0.29) [60] | 1.67 (0.25) [65] | 2.34 (0.28) [69] | ||||||
*Adjusted means.
†Laquinimod versus placebo; NA, not assessed, since ‘new’ T2 lesions were not available at baseline. Data generated using a negative binomial regression model as described in statistical methods.
GdE, gadolinium enhancing; PBH, permanent black holes; RR, risk ratio.