Table 2.
Summary of unadjusted outcomes at 24-month follow-up.
| DMF |
Fingolimod |
||||
|---|---|---|---|---|---|
|
n = 395 |
n = 264 |
||||
| n | % or SD | n | % or SD | p-Value | |
| Discontinued drug by 24 months | 163 | 41.3% | 94 | 35.6% | 0.168 |
| Discontinued drug between 12 and 24 months | 42 | 10.6% | 34 | 12.9% | 0.080 |
| Disease activity | 40 | 10.1% | 32 | 12.1% | 0.498 |
| Clinical relapse | 9 | 2.3% | 6 | 2.3% | |
| MRI activity | 20 | 5.1% | 9 | 3.4% | |
| Disability progression | 12 | 3.0% | 20 | 7.6% | |
| Intolerance/adverse effects | 100 | 25.3% | 39 | 14.8% | 0.002 |
| Lymphopenia | 11 | 2.8% | 3 | 1.1% | |
| Mean time to discontinuation (months, SD) | 3.90 | 3.54 | 6.58 | 4.23 | <0.001 |
| Median time to discontinuation | 3.0 | 6.0 | |||
| Clinical relapse by 24 months | 66 | 16.8% | 45 | 17.0% | 1.000 |
| Relapses per patient (mean, SD) | 0.21 | 0.54 | 0.20 | 0.47 | 0.690 |
| Mean time to first relapse (months, SD) | 3.83 | 2.78 | 7.56 | 4.34 | <0.001 |
| MRI available for review by 24 months on DMT a | 329 | 83.3% | 231 | 87.5% | |
| Disease activity on MRI by 24 months on DMT | 80 | 34.9% | 49 | 30.1% | 0.449 |
| Gadolinium enhancement | 34 | 14.8% | 22 | 13.5% | 0.360 |
| New T2 lesions | 67 | 29.3% | 35 | 21.5% | 0.250 |
| MRI available for review at 24 months on DMT | 167 | 42.3% | 127 | 48.1% | |
| Disease activity on MRI between 12–24 months on DMT | 31 | 18.6% | 16 | 12.7% | |
| Gadolinium enhancement | 19 | 11.4% | 9 | 7.1% | 0.298 |
| New T2 lesions | 23 | 13.8% | 11 | 8.7% | 0.250 |
| Adverse effects (number of patients) | 158 | 40.0% | 108 | 40.9% | |
| Mean WBC (×109/l) | 5.77 | 1.81 | 4.68 | 1.62 | <0.001 |
| Mean ALC (×109/l) | 1.34 | 0.98 | 0.55 | 0.32 | <0.001 |
| Measures of neurologic disability | |||||
| T25FW (mean sec, SD) | 8.83 (n = 194) | 8.78 | 6.96 (n = 159) | 4.42 | 0.013 |
| 20% worsening of T25FW | 82 | 42.3% | 51 | 32.1% | 0.049 |
| 9-HPT- dominant (mean, SD) | 24.81 (n = 111) | 9.44 | 24.46 (n = 85) | 9.96 | 0.766 |
| 20% worsening of 9 HPT- dominant | 23 | 20.7% | 21 | 24.7% | 0.600 |
| 9-HPT- non-dominant (mean, SD) | 27.52 (n = 133) | 15.44 | 27.40 (n = 83) | 15.97 | 0.949 |
| 20% worsening of 9 HPT- non-dominant | 33 | 24.8% | 20 | 24.1% | 0.905 |
| Patient reported outcomes | |||||
| PHQ-9 score (mean, SD) | 6.44 (n = 194) | 5.43 | 5.26 (n = 155) | 4.85 | 0.035 |
| PHQ-9 score ≥10 | 54 | 27.8% | 27 | 17.4% | 0.030 |
9-HPT: nine-hole peg test; ALC: absolute lymphocyte count; DMF: dimethyl fumarate; DMT: disease-modifying therapy; EQ5D: European Quality of Life-5 Dimensions; MRI: magnetic resonance imaging; MS: multiple sclerosis; MSPS: Multiple Sclerosis Performance Scale; PHQ9: Patient Health Questionnaire-9; SD: standard deviation; T25FW: timed 25-foot walk; WBC: white blood cell.
a
cumulative MRI data that include 12-month and 24-month MRI time points.