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Characteristic Placebo Group (n = 120) GA Group (n = 119) Age (y) 34.0 ± 7.5 34.1 ± 7.4 Disease duration (y) 8.3 ± 5.5 7.9 ± 5.5 Prior 2-year relapse rate 2.5 ± 1.4 2.8 ± 1.8 EDSS score 2.4 ± 1.2 2.3 ± 1.1 No. of Gd-enhancing lesions 4.4 ± 7.1 4.2 ± 4.8 Volume of lesions (cm3) Gd enhancing 0.7 ± 2.2 0.6 ± 0.7 Hyperintense on T2-weighted images 20.5 ± 18.8 20.0 ± 17.2 Hypointense on T1-weighted images 4.0 ± 4.9 3.4 ± 3.9 Note.—Data are the mean ± SD.
- TABLE 2:
Univariate correlations between clinical and MR imaging measures of MS disease activity
Variable 1* Variable 2* All Patients (n = 239) Placebo Group (n = 120) GA Group (n = 119) Pre-study relapses On-trial relapses 0.21 (.001) 0.19 (.04) 0.25 (.006) Pre-study relapses Baseline EL 0.10 0.09 0.11 Pre-study relapses On-trial EL 0.15 (.02) 0.14 0.20 (.03) Pre-study relapses On-trial new T2 lesions 0.19 (.003) 0.15 0.27 (.003) On-trial relapses Baseline EL 0.25 (<.001) 0.30 (.001) 0.22 (.02) On-trial relapses On-trial EL 0.30 (<.001) 0.36 (<.001) 0.21 (.02) On-trial relapses On-trial new T2 lesions 0.32 (<.001) 0.34 (<.001) 0.25 (.006) Baseline EL On-trial EL 0.64 (<.001) 0.66 (<.001) 0.65 (<.001) On-trial EL On-trial new T2 lesions 0.88 (<.001) 0.90 (<.001) 0.84 (<.001) Note.—Values are the Spearman rank correlation coefficients. Data in parentheses are P values ≤.05.
* Pre-study relapses indicate the number of relapses during the 2 years prior to the study period; baseline EL, the number of Gd-enhancing lesions on the images obtained at study entry; and on-trial EL, the total number of Gd-enhancing lesions during the 9 months of the study.
- TABLE 3:
Univariate correlations between MR imaging measures of MS burden of disease and clinical disability
Measure EDSS Score, All Patients (n = 239) EDSS Score, Placebo Group (n = 120) EDSS Score, GA Group (n = 119) Baseline Change Baseline Change Baseline Change Baseline T2 LV 0.28 (<.001) 0.16 (.02) 0.27 (.003) 0.09 0.29 (.001) 0.24 (.008) Baseline T1 LV 0.19 (.003) 0.18 (.006) 0.24 (.009) 0.12 0.12 0.23 (.01) T2 DLV 0.13 0.17 (.007) 0.12 0.10 0.10 0.25 (.005) T1 DLV 0.17 (.007) 0.18 (.006) 0.16 0.09 0.20 (.03) 0.31 (<.001) Note.—Values are the Spearman rank correlation coefficients. Data in parentheses are P values ≤.05. DLV indicates the difference in lesion volume between month 9 images and baseline images; EDSS change, the difference in the EDSS score between month 9 evaluations and baseline evaluations; and LV, lesion volume.
- TABLE 4:
Univariate correlations between MR imaging measures of MS activity and burden of disease
Variable 1* Variable 2* All Patients (n = 239) Placebo Group (n = 120) GA Group (n = 119) Baseline T2 LV On-trial EL 0.51 (<.001) 0.55 (<.001) 0.47 (<.001) Baseline T2 LV On-trial new T2 lesions 0.32 (<.001) 0.40 (<.001) 0.24 (.009) Baseline T2 LV T2 DLV 0.37 (<.001) 0.44 (<.001) 0.30 (.001) Baseline T2 LV T1 DLV 0.50 (<.001) 0.48 (<.001) 0.53 (<.0001) Baseline T1 LV On-trial EL 0.36 (<.001) 0.41 (<.001) 0.29 (.001) Baseline T1 LV On-trial new T2 lesions 0.19 (.003) 0.28 (.002) 0.10 Baseline T1 LV T1 DLV 0.29 (<.001) 0.33 (<.001) 0.24 (.009) Baseline T1 LV T2 DLV 0.17 (.007) 0.22 (0.02) 0.13 Note.—Values are the Spearman rank correlation coefficients. Data in parentheses are P values ≤.05.
* DLV indicates the difference in lesion volume between month 9 images and baseline images; LV, lesion volume; on-trial EL, the total number of Gd-enhancing lesions during the 9 months of the study.