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Table 1 Study summaries in trials reporting relapse 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 ARR experimental arm ARR control arm Relapse rate ratio EDSS progression experimental arm EDSS Progression control arm Disability risk ratio
Comi G, et al., [17] 24 IFNB-1a 22 μg vs. Placebo 309 0.33 0.43 0.767 15.00 20.00 0.750
Hartung HP, et al. [24] 36 Mitoxantrone 12 mg vs. Placebo 124 0.35 1.02 0.343 8.00 22.00 0.364
Durelli L, et al. [18] 24 IFNB-1a 30 μg vs. IFNB-1b 250 μg 188 0.50 0.70 0.714 13.00 30.00 0.433
Rudick RA, et al. [38] 24 IFNB-1a plus Natalizumab vs. IFNB- 1a 1,171 0.34 0.75 0.453 23.00 29.00 0.793
Havrdova E, et al. [25] 24 IFNB-1a plus azathioprinethioprine vs. IFNB-1a 116 0.91 1.05 0.867 20.70 16.80 1.232
Havrdova E, et al. [25] 24 IFNB-1a plus azathioprine plus prednisone vs. IFNB-1a 120 0.73 1.05 0.695 17.50 16.80 1.042
Mikol DD, et al. [32] 22 IFNB-1a vs. Glatiramer acetate 764 0.29 0.30 0.967 8.70 11.70 0.744
Ravnborg M, et al. [37] 36 IFNB-1a plus Methylprednisolone vs. IFNB-1a 338 0.21 0.33 0.636 25.00 28.50 0.877
Sorensen P, et al. [39] 22 IFNB-1a plus Methylprednisolone vs. IFNB-1a 130 0.22 0.59 0.373 16.00 25.00 0.640
O’Connor P, et al. [34] 42 Glatiramer acetate vs. IFNB-1b 250 μg 1,158 0.34 0.36 0.944 20.50 22.30 0.919
O’Connor P, et al. [34] 42 Glatiramer acetate vs. IFNB-1b 500 μg 1,100 0.34 0.33 1.030 20.50 22.30 0.919
Gonsette RE, et al. [23] 24 IFNB-1b plus Inosine vs. IFNB-1b 157 0.50 0.38 1.316 17.78 18.18 0.978
Coles AJ, et al. [16] 36 Alemtuzumab vs. IFNB-1a 333 0.1 0.36 0.278 9.00 26.20 0.344
Kappos L, et al. [30] 24 Fingolimod 0.5 mg vs. Placebo 843 0.18 0.40 0.450 17.70 24.10 0.734
Kappos L, et al. [30] 24 Fingolimod 1.25 mg vs. Placebo 847 0.16 0.40 0.400 16.60 24.10 0.689
Polman CH, et al. [36] 24 Natalizumab vs. Placebo 942 0.23 0.73 0.315 17.00 29.00 0.586
Clanet M, et al. [14] 36 IFNB-1a 30 μg vs. IFNB-1a 60 μg 802 0.81 0.77 1.052 37.00 37.00 1.000
Ebers GC, et al. [9] 104 IFNB-1a 22 μg vs. Placebo 376 0.91 1.28 0.711 30.00 38.00 0.789
Ebers GC, et al. [9] 104 IFNB-1a 44 μg vs. Placebo 373 0.87 1.28 0.676 26.50 38.00 0.697
Johnson KP, et al. [27] 24 Glatiramer acetate vs. Placebo 251 0.59 0.84 0.702 21.60 24.60 0.878
Achiron A, et al. [11] 24 Immunoglobulin vs. Placebo 40 0.59 1.61 0.366 13.70 17.10 0.801
Baumhackl U, et al. [13] 24 Hydrolytic enzymes vs. Placebo 291 0.63 0.74 0.851 28.00 26.00 1.077
Fazekas F, et al. [20] 24 Immunoglobulin vs. Placebo 148 0.52 1.26 0.413 17.00 23.00 0.739
Millefiorini E, et al.[33] 24 Mitoxantrone vs. Placebo 51 0.445 1.31 0.340 7.00 37.00 0.189
Jacobs LD, et al. [26] 24 IFNB-1a vs. Placebo 172 0.61 0.90 0.678 21.10 33.30 0.633
Ebers GC, et al. [8] 36 IFNB-1b 1.6 MIU vs. Placebo 228 1.05 1.21 0.868 28.00 28.00 1.000
Ebers GC, et al. [8] 36 IFNB-1b 8 MIU vs. Placebo 227 0.84 1.21 0.694 20.00 28.00 0.714
van de Wyngaert FA, et al. [40] 36 Mitoxantrone vs. Methylprednisolone 28 0.26 1.00 0.260 21.00 21.00 1.000
Andersen O et al. [12] 36 IFNB-1a 22 μg vs. Placebo 364 0.25 0.27 0.926 41.00 38.00 1.079
Cohen JA, et al. [15] 24 IFNB-1a 60 μg vs. Placebo 379 0.20 0.30 0.667 28.50 33.70 0.846
Panitch H, et al. [35] 36 IFNB-1b 160 μg vs. Placebo 622 0.20 0.28 0.714 39.00 34.00 1.147
Panitch H, et al. [35] 36 IFNB-1b 250 μg vs. Placebo 625 0.16 0.28 0.571 32.00 34.00 0.941
Kappos L, et al. [28] 36 IFNB-1b vs. Placebo 718 0.44 0.64 0.688 38.90 49.70 0.783
Edan G, et al. [41] 36 Mitoxantrone 12 mg/m2 vs. IFNβ-1b 250 μg 109 0.39 0.71 0.549 9.10 25.90 0.351
Freedman MS, et al. [42] 24 MBP8298 vs. Placebo in DR2+ and/or DR4+ haplotypes 513 0.13 0.14 0.929 30.70 27.80 1.104
Freedman MS, et al. [42] 24 MBP8298 vs. Placebo in DR2- and/or DR4- haplotypes 99 0.08 0.20 0.400 28.30 35.80 0.791
Comi G, et al. [45] 24 Laquinimod 0.6 mg vs. Placebo 1,106 0.30 0.39 0.769 11.10 15.70 0.707
Cohen JA, et al. [43] 24 Alemtuzumab 12 mg vs. IFNβ-1a 44 μg 563 0.18 0.39 0.462 8.00 11.12 0.719
Coles AJ, et al. [44] 24 Alemtuzumab 12 mg vs. IFNβ-1a 44 μg 667 0.26 0.52 0.500 12.71 21.13 0.602
Fox RJ, et al. [46] 24 Dimethyl fumarate 240 mg BID vs. Placebo 480 0.22 0.40 0.550 13.00 17.00 0.765
Fox RJ, et al. [46] 24 Dimethyl fumarate 240 mg TID vs. Placebo 466 0.20 0.40 0.500 13.00 17.00 0.765
Fox RJ, et al. [46] 24 Glatiramer acetate vs. Placebo 471 0.29 0.40 0.725 16.00 17.00 0.941
  1. ARR, annualized relapse rate; BID, twice daily; EDSS, Expanded Disability Status Scale; IFNB, Interferon-beta; μg, microgram; mg, milligram; mg/m2, milligrams per square meter of body surface; MIU, million international units; TID, three times daily.