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Table 2 Study summaries in trials reporting MRI changes and disability progression

From: Relating relapse and T2 lesion changes to disability progression in multiple sclerosis: a systematic literature review and regression analysis

Trial Follow-up (months) Comparison Patients Analyzed Change in T2 Lesion Volume Experimental Arm Change in T2 Lesion Volume Control Arm Final T2 Lesion Volume Ratio New and/or Enlarged T2 Lesion Experimental Arm New and or Enlarged T2 Lesion Control Arm T2 Lesion Count Ratio EDSS Progression Experimental Arm EDSS Progression Control Arm Disability Risk Ratio
Kappos L, et al. [29] 24 IFNB-1b 250 μg vs. Placebo 468 -10.60 -5.00 0.941 3.70 8.50 0.435 12.00 20.00 0.600
Comi G, et al. [17] 24 IFNB-1a 22 μg vs. Placebo 300 -13.00 8.80 0.800 2.00 3.00 0.667 15.00 20.00 0.750
Hartung HP, et al. [24] 36 Mitoxantrone 12 mg vs. Placebo 124     0.29 1.94 0.149 8.00 22.00 0.364
Rudick RA, et al. [38] 24 IFNB-1a plus Natalizumab vs. IFNB 1a 1171     0.90 5.40 0.167 23.00 29.00 0.793
Havrdova E, et al. [25] 24 IFNB-1a plus Azathioprinethioprine vs. IFNB-1a 88 24.60 30.30 0.956     20.70 16.80 1.232
Havrdova E, et al. [25] 24 IFNB-1a plus azathioprine plus prednisone vs. IFNB-1a 93 14.50 30.30 0.879     17.50 16.80 1.042
Mikol DD, et al. [32] 22 Glatiramer acetate vs. IFNB-1a 585     0.82 0.67 1.224 8.70 11.70 0.744
Ravnborg M, et al. [37] 36 IFNB-1a plus Methylprednisolone vs. IFNB-1a 220 -1.06 1.21 0.978 5.20 8.00 0.650 25.00 28.50 0.877
Sorensen PS, et al. [39] 22 IFNB-1a plus Methylprednisolone vs. IFNB-1a 110     2.70 3.50 0.771 16.00 25.00 0.640
O’Connor P, et al. [34] 42 Glatiramer acetate vs. IFNB-1b 250 μg 913 17.00 10.00 1.064 4.60 3.30 1.394 20.50 22.30 0.919
O’Connor P, et al. [34] 42 Glatiramer acetate vs. IFNB-1b 500 μg 971 17.00 12.00 1.045 4.60 3.30 1.394 20.50 22.30 0.919
Freedman MS, et al. [21] 36 Placebo/IFNB-1a 44 μg vs. Placebo/IFNB-1a 22 μg 53 -3.40 1.10 0.955 2.00 1.70 1.176 46.00 40.00 1.150
Freedman MS, et al. [21] 36 Placebo/IFNB-1a 44 μg vs. IFNB-1a 22 μg 83 5.40 1.10 1.043 1.70 1.70 1.000 39.00 40.00 0.975
Freedman MS, et al. [21] 36 Placebo/IFNB-1a 44 μg vs. IFNB-1a 22 μg 85 1.80 1.10 1.007 1.30 1.70 0.765 35.00 40.00 0.875
Coles AJ, et al. [16] 36 Alemtuzumab vs. IFNB-1a 227 -16.40 -13.30 0.964     9.00 26.20 0.344
Kappos L, et al. [30] 24 Fingolimod 0.5 mg vs. Placebo 537 -1.69 8.61 0.905 2.50 9.80 0.255 17.70 24.10 0.734
Kappos L, et al. [30] 24 Fingolimod 1.25 mg vs. Placebo 512 -3.10 8.61 0.892 2.50 9.80 0.255 16.60 24.10 0.689
Polman CH, et al. [36] 24 Natalizumab vs. Placebo 942     1.90 11.00 0.173 17.00 29.00 0.586
Clanet M et al. [14] 36 IFNB-1a 60 μg vs. IFNB-1a 30 μg 386 -0.20 -1.29 1.011 8.00 9.00 0.889 37.00 37.00 1.000
Ebers GC, et al. [9]   IFNB-1a 22 μg vs. Placebo 279 -1.20 10.90 0.891 9.00 15.50 0.581 30.00 38.00 0.789
Ebers GC, et al. [9]   IFNB-1a 44 μg vs. Placebo 281 -3.80 10.90 0.867 5.50 15.50 0.355 26.50 38.00 0.697
Baumhackl U, et al. [13] 24 Hydrolytic enzymes vs. Placebo 291 -1.00 -1.00 1.000     28.00 26.00 1.077
Millefiorini E, et al. [33] 24 Mitoxantrone vs. Placebo 42     3.50 7.30 0.479 7.00 37.00 0.189
Giovannoni G, et al. [22] 22 Cladribine 5.25 mg/kg bw vs. Placebo 674     0.33 1.43 0.231 15.10 20.60 0.733
Giovannoni G, et al. [22] 22 Cladribine 3.5 mg/kg bw vs. Placebo 651     0.38 1.43 0.266 14.30 20.60 0.694
Jacobs LD, et al. [26] 24 IFNB-1a vs. Placebo 164 -13.20 -6.50 0.928     21.10 33.30 0.633
Ebers GC, et al. [8] 36 IFNB-1b 1.6 MIU vs. Placebo 164 0.20 15.00 0.871 1.80 4.90 0.367 28.00 28.00 1.000
Ebers GC, et al. [8] 36 IFNB-1b 8 MIU vs. Placebo 167 -9.30 15.00 0.789 2.00 4.90 0.408 20.00 28.00 0.714
Panitch H, et al. [35] 36 IFNB-1b 160 μg vs. Placebo 81 0.80 10.90 0.909     39.00 34.00 1.147
Panitch H, et al. [35] 36 IFNB-1b 250 μg vs. Placebo 81 0.40 10.90 0.905     32.00 34.00 0.941
Edan G, et al. [41] 36 Mitoxantrone 12 mg/m2 vs. IFNβ-1b 250 μg 109     2.15 3.50 0.614 9.10 25.90 0.351
Freedman MS, et al. [42] 24 MBP8298 vs. Placebo in DR2+ and/or DR4+ haplotypes 513 0.90 6.20 0.95 3.90 3.30 1.182 30.70 27.80 1.104
Freedman MS, et al. [42] 24 MBP8298 vs. Placebo in DR2- and/or DR4- haplotypes 99 16.10 0.70 1.15 3.20 3.30 0.970 28.30 35.80 0.791
Comi G, et al. [45] 24 Laquinimod 0.6 mg vs. Placebo 1,106     5.03 7.14 0.704 11.10 15.70 0.707
Cohen JA, et al. [43] 24 Alemtuzumab 12 mg vs. IFNβ-1a 44 μg 563 -9.30 -6.50 0.97     8.00 11.12 0.719
Coles AJ, et al. [44] 24 Alemtuzumab 12 mg vs. IFNβ-1a 44 μg 667 -1.27 -1.23 1.00     12.71 21.13 0.602
Gold R, et al. [47] 24 Dimethyl fumarate 240 mg BID vs. Placebo 818     2.60 17.00 0.153 16.00 27.00 0.593
Gold R, et al. [47] 24 Dimethyl fumarate 240 mg TID vs. Placebo 824     4.40 17.00 0.259 18.00 27.00 0.667
Fox RJ, et al. [46] 24 Dimethyl fumarate 240 mg BID vs. Placebo 480     5.10 17.40 0.293 13.00 17.00 0.765
Fox RJ, et al. [46] 24 Dimethyl fumarate 240 mg TID vs. Placebo 466     4.70 17.40 0.270 13.00 17.00 0.765
Fox RJ, et al. [46] 24 Glatiramer acetate vs. Placebo 471     8.00 17.40 0.460 16.00 17.00 0.941
  1. BID, twice daily; EDSS, Expanded Disability Status Scale; IFNB, Interferon-beta; μg, microgram; mg, milligram; mg/m2, milligrams per square meter of body surface; mg/kg bw, milligram per kilogram of body weight; MIU, million international units; TID, three times daily.