Table 1.
Baseline patient demographics and characteristics in PREFERMS.
| Characteristic | Fingolimod 0.5 mg (n = 436) |
iDMT (n = 439) |
p value |
|---|---|---|---|
| Age, years | 41.5 (10.84) 41.0 (19–64) |
41.9 (10.39) 42.0 (18–65) |
0.6310 |
| Sex, n (%) | |||
| Male | 125 (28.7) | 110 (25.1) | 0.2282 |
| Female | 311 (71.3) | 329 (74.9) | |
| Race, n (%) | |||
| White | 355 (81.4) | 355 (80.9) | 0.6553 |
| Black | 69 (15.8) | 72 (16.4) | |
| Asian | 1 (0.2) | 1 (0.2) | |
| Native American | 1 (0.2) | 1 (0.2) | |
| Pacific Islander | 0 | 2 (0.5) | |
| Other | 10 (2.3) | 8 (1.8) | |
| Height, cm | 168.5 (8.99) 168 (128–193) |
167.5 (10.06) 167 (123–196) |
0.1388 |
| Weight, kg | 82.94 (20.1) 80.5 (44–163) |
83.56 (22.3) 80.7 (41–170) |
0.6651 |
| Body mass index, kg/m2 | 29.19 (6.70) 28.11 (18–60) |
29.76 (7.55) 28.34 (15–65) |
0.2335 |
| Duration of MS since diagnosis, years | n = 434 | n = 434 | |
| 4.42 (6.67) 1.4 (0–38) |
4.21 (5.94) 1.7 (0–34) |
0.6314 | |
| Duration of MS since first symptoms, years | n = 434 | n = 434 | |
| 7.29 (8.21) 4.2 (0–40) |
7.21 (7.66) 4.4 (0–42) |
0.8871 | |
| Number of relapses in the past year | n = 430 | n = 436 | |
| 0.6 (0.95) 0 (0–8) |
0.6 (0.94) 0 (0–10) |
0.6041 | |
| Number of relapses in the past 2 years | n = 430 | n = 436 | |
| 0.9 (1.51) 0 (0–14) |
0.9 (1.41) 0 (0–10) |
0.9502 | |
| Expanded Disability Status Scale score | n = 433 | n = 427 | |
| 2.36 (1.56) 2.0 (0–6.0) |
2.44 (1.51) 2.0 (0–7.0) |
ND | |
| T2 lesion volume, cm3 | n = 431 | n = 415 | |
| 7.65 (11.60) 3.20 (0–92) |
7.44 (10.17) 3.64 (0–77) |
ND | |
| Normalized brain volume, cm3 | n = 431 | n = 412 | |
| 1521.42 (83.9) 1519 (1241–1746) |
1511.19 (90.5) 1518 (1161–1732) |
ND | |
| Number of gadolinium-enhanced lesions | n = 429 | n = 414 | |
| 1.08 (3.75) 0 (0–42) |
0.85 (3.03) 0 (0–27) |
ND | |
Values are mean (SD) and median (range) unless stated otherwise. Treatment group comparisons were made using the Cochran–Mantel–Haenszel test for categorical variables and a two-sample t test for continuous variables.
iDMT, injectable disease-modifying therapy; MS, multiple sclerosis; ND, not determined; PREFERMS, Prospective, Randomized, active-controlled, open-label study to Evaluate patient retention on Fingolimod versus approved first-line disease modifying thErapies in adults with Relapsing remitting Multiple Sclerosis; SD, standard deviation.