Table 3.
Comparison of output variables between the two groups.
|
Variable
|
DMF
|
TRF
|
SD*
|
|---|---|---|---|
| No. Group | No. Group | 234 | 234 |
| NEDA 3, No. (%) | |||
| No disease activity | 181 (77.2) | 188 (80.3) | 0.42 |
| Disease activity | 53 (22.6) | 46 (19.7) | |
| NEDA-relapse, No. (%) | |||
| No disease activity | 209 (89.3) | 210 (89.7) | 0.87 |
| Disease activity | 25 (10.7) | 24 (10.3) | |
| NEDA-EDSS, No. (%) | |||
| No disease activity | 219 (93.6) | 216 (92.3) | 0.29 |
| Disease activity | 15 (6.4) | 18 (7.7) | |
| NEDA-MRI, No. (%) | |||
| No disease activity | 210 (89.7) | 216 (92.3) | 0.94 |
| Disease activity | 24 (10.3) | 18 (7.7) | |
| pw relapses12 months post beginning study drugs, No. (%) | 29 (10.7) | 28 (10.3) | 0.88 |
| EDSS 6 months post beginning study drug, median (IQR) | 2 (1.5–3.5) | 2 (1.5–3.5) | 0.42 |
| EDSS 12 months post treatment, median (IQR) | 1.5 (1.5–3.5) | 2 (1.5–3.5) | 0.28 |
| pw with new T2 lesions 12 months post beginning study drugs, No. (%) | 17 (7.3) | 13 (5.6) | 0.12 |
| pw with new T1 Gad+ lesions post beginning study drugs, No. (%) | 7 (3) | 5 (2.1) | 0.55 |
| MRI T1 12 months post treatment, mean (SD) | 2.4 (4.9) | 7 (11) | 0.10 |
| MRI T2 12 months post treatment, mean (SD) | 7.2 (14.2) | 10.8 (22.9) | 0.04 |
| MRI Gad+ 12 months post treatment, mean (SD) | 0.1 (0.5) | 0.3 (1.2) | 0.29 |
| pw who stopped study drugs, No. (%) | 10 (4.3) | 7 (3) | 0.45 |
| Safety alerts, No. (%) | 62 (26.5) | 28 (12) | < 0.001 |
*
Differences were evaluated via the Wilcoxon rank sum test or the chi-square test.
Results are expressed as mean (SD), median (IQR) and No. (%).
DMF, dimethyl fumarate; EDSS, Expanded Disability Status Scale; Gad+, gadolinium; IQR, interquartile range; MRI, magnetic resonance imaging; NEDA, no evidence of disease activity; pw, persons with; SD, standard deviation; TRF, teriflunomide.