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Table 2 Baseline demographics and disease characteristics (core period; safety population)

From: Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis

  Treatment naive
(n = 1244)
Previously treated with another DMT
(n = 270)
Recently treated with another DMT
(n = 247)
Overall population (N = 1702)a
Placebo
(n = 586)
Teriflunomide 14 mg
(n = 658)
Placebo
(n = 131)
Teriflunomide 14 mg
(n = 139)
Placebo
(n = 89)
Teriflunomide 14 mg
(n = 158)
Placebo (N = 806) Teriflunomide 14 mg (N = 896)a
Age, mean (SD) years 38.8 (9.0) 37.9 (9.2) 37.5 (8.6) 37.9 (8.4) 36.4 (9.5) 39.0 (9.6) 38.3 (9.0) 38.0 (9.1)
Female gender, n (%) 414 (70.6) 458 (69.6) 105 (80.2) 103 (74.1) 65 (73.0) 114 (72.2) 584 (72.5) 634 (70.8)
White, n (%) 518 (88.5)b 595 (90.4) 124 (94.7) 131 (94.9)c 84 (94.4) 154 (97.5) 726 (90.2)d 821 (91.7)e
Time since diagnosis of MS, mean (SD) years 4.42 (5.73) 4.40 (5.55)f 6.83 (4.92) 8.00 (5.55) 5.85 (5.26) 6.18 (6.04) 4.97 (5.62) 5.24 (5.85)e
Time since first symptoms of MS, mean (SD) years 7.79 (7.28) 7.49 (6.74)f 9.26 (5.63) 10.90 (6.87) 8.79 (7.02) 9.39 (7.19) 8.14 (7.02) 8.26 (6.91)e
Number of relapses within past year, mean (SD) 1.40 (0.71)g 1.37 (0.69)h 1.42 (0.87)i 1.36 (0.81)j 1.49 (0.81)k 0.90 (0.88)l 1.42 (0.75)m 1.37 (0.71)n
Baseline EDSS score
 Mean (SD) 2.61 (1.37) 2.57 (1.33) 2.97 (1.32) 2.79 (1.37) 2.58 (1.37) 2.49 (1.38) 2.67 (1.37) 2.64 (1.34)
 Median (min, max) 2.50 (0.0, 6.0) 2.50 (0.0, 6.5) 3.00 (0.0, 6.0) 2.50 (0.0, 6.0) 2.50 (0.0, 5.5) 2.00 (0.0, 6.5) 2.50 (0.0, 6.0) 2.50 (0.0, 6.5)
Last prior DMT,o,p n (%)
 Fingolimod 0 1 (4.5) 1 (0.8) 3 (2.2) 0 0 1 (0.4) 4 (1.5)
 GA 6 (27.3) 4 (18.2) 42 (32.1) 51 (36.7) 33 (37.1) 27 (17.1) 81 (33.5) 82 (31.5)
 IFNBq 0 0 3 (2.3) 0 2 (2.2) 2 (1.3) 5 (2.1) 2 (0.8)
 IFNB-1a 11 (50.0) 9 (40.9) 57 (43.5) 55 (39.6) 36 (40.4) 110 (69.6) 104 (43.0) 115 (44.2)
 IFNB-1b 5 (22.7) 8 (36.4) 27 (20.6) 27 (19.4) 18 (20.2) 19 (12.0) 50 (20.7) 54 (20.8)
 Natalizumab 0 0 1 (0.8) 3 (2.2) 0 0 1 (0.4) 3 (1.2)
  1. The safety population included patients who were analyzed according to the treatment they actually received during the studies; aExcludes a cohort of 59 patients who switched from IFNB-1a to teriflunomide 14 mg (TENERE study); bn = 585; cn = 138; dn = 805; en = 895; fn = 657; gn = 521; hn = 598; in = 112; jn = 119; kn = 86; ln = 151; mn = 719; nn = 809; oTreatment-naive subgroup (no prior DMT in the 2 years prior to randomization): placebo, n = 22; TFL 14 mg, n = 22; pLast prior DMT data were based on a total of 242 placebo-treated patients and 260 teriflunomide 14 mg-treated patients for the overall population; qIFNB formulation not specified. DMT disease-modifying therapy, EDSS Expanded Disability Status Scale, GA glatiramer acetate, IFNB interferon beta, max maximum, min minimum, MS minimum sclerosis, SD standard deviation, TFL teriflunomide
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