Table 2. Primary and Secondary Efficacy End Points for Full Analysis Set.
| End point | No. (%) | ||
|---|---|---|---|
| Fingolimod groups | GA, 20 mg, group | ||
| 0.5 mg | 0.25 mg | ||
| Total participants, No. | 345 | 366 | 324 |
| Primary | |||
| Aggregate ARR up to month 12 (confirmed relapses only) | |||
| ARR estimate (95% CI) | 0.15 (0.11 to 0.21) | 0.22 (0.17 to 0.29) | 0.26 (0.20 to 0.34) |
| ARR ratio vs GA 20 mg | 0.59 | 0.85 | NA |
| Relative reduction vs GA 20 mg, % | 40.7 | 14.6 | NA |
| P value | .01a | .42 | NA |
| Secondary | |||
| New or newly enlarging T2 lesions at month 12 or end of treatment | |||
| Participants evaluated, No. | 303 | 331 | 272 |
| Mean (SD) | 2.6 (5.4) | 3.3 (6.9) | 5.7 (10.7) |
| P value | <.001a | <.001a | NA |
| Participants without new or newly enlarging T2 lesions | 156 (51.5) | 155 (46.8) | 96 (35.3) |
| P value vs GA | <.001a | <.001a | NA |
| Gadolinium-enhancing T1 lesions at month 12 or end of treatment | |||
| Participants evaluated, No. | 302 | 325 | 263 |
| Mean (SD) | 0.4 (1.6) | 0.4 (1.6) | 0.9 (3.7) |
| P value | .02a | .001a | NA |
| Participants without gadolinium-enhancing T1 lesions | 261 (86.4) | 269 (82.8) | 202 (76.8) |
| P value vs GA | .004a | .06 | NA |
| Change from baseline in T2 lesion volume at month 12 or end of treatment | |||
| Participants evaluated, No. | 304 | 332 | 272 |
| Mean (SD), mL | –0.14 (1.58) | –0.05 (2.34) | 0.42 (2.31) |
| P value vs GA | <.001a | .006a | NA |
| Change from baseline in T1 hypointense lesion volume at month 12 or end of treatment | |||
| Participants evaluated, No. | 302 | 331 | 271 |
| Mean (SD), mL | 0.33 (1.08) | 0.37 (1.01) | 0.25 (1.04) |
| P value vs GA | .25 | .03a | NA |
| Gadolinium-enhancing T1 lesion volume at month 12 or end of treatment | |||
| Participants evaluated, No. | 302 | 325 | 263 |
| Mean (SD), mL | 0.06 (0.22) | 0.05 (0.18) | 0.12 (0.45) |
| P value vs GA | .005a | .06 | NA |
| % Change in brain volume from baseline to month 12 or end of treatment | |||
| Participants evaluated, No. | 284 | 305 | 252 |
| Mean (SD) | –0.65 (0.78) | –0.64 (0.81) | –0.56 (0.78) |
| P value vs GA | .10 | .14 | NA |
| Annualized rate of brain atrophy up to month 12 or end of treatment | |||
| Participants evaluated, No. | 345 | 366 | 324 |
| Mean (95% CI) | –0.68 (–0.80 to –0.56) | –0.69 (–0.81 to –0.58) | –0.68 (–0.81 to –0.56) |
| P value vs GA | .99 | .90 | NA |
| Change from baseline in TSQM scoresb | |||
| Global satisfaction | |||
| Participants evaluated, No. | 185 | 201 | 180 |
| Mean (SD) | 19.2 (31.9) | 20.5 (32.2) | 9.4 (30.4) |
| P value vs baseline | <.001a | <.001a | <.001a |
| Effectiveness | |||
| Participants evaluated, No. | 187 | 198 | 178 |
| Mean (SD) | 16.8 (26.9) | 17.9 (28.3) | 8.0 (27.4) |
| P value vs baseline | <.001a | <.001a | <.001a |
| Adverse effects | |||
| Participants evaluated, No. | 185 | 194 | 174 |
| Mean (SD) | 16.2 (31.5) | 17.2 (32.5) | 7.6 (32.8) |
| P value vs baseline | <.001a | <.001a | .005a |
| Convenience | |||
| Participants evaluated, No. | 187 | 198 | 178 |
| Mean (SD) | 29.5 (24.4) | 26.5 (26.4) | 0.8 (25.7) |
| P value vs baseline | <.001a | <.001a | .46 |
| Change from baseline in PASAT-3 score | |||
| Participants evaluated, No. | 291 | 317 | 276 |
| Mean (SD) | 2.4 (9.5) | 1.7 (10.0) | 1.1 (8.0) |
| P value vs GA 20 mg | .01a | .26 | NA |
| Change from baseline in symbol Digit Modalities Test score | |||
| Participants evaluated, No. | 301 | 319 | 278 |
| Mean (SD) | 6.2 (12.6) | 6.6 (12.3) | 5.1 (13.5) |
| P value vs GA 20 mg | .29 | .19 | NA |
| Change from baseline in PRIMUS–Activities score | |||
| Participants evaluated, No. | 261 | 281 | 230 |
| Mean (SD) | –0.12 (4.21) | 0.17 (4.89) | 0.55 (4.13) |
| P value vs GA 20 mg | .008a | .53 | NA |
| Change from baseline in MSIS-29 score | |||
| Physical impact score | |||
| Participants evaluated, No. | 315 | 336 | 291 |
| Mean (SD) | –3.5 (16.2) | –1.5 (15.3) | –0.8 (17.1) |
| P value vs GA 20 mg | .007a | .15 | NA |
| Psychological impact score | |||
| Participants evaluated, No. | 312 | 336 | 290 |
| Mean (SD) | –6.6 (19.9) | –3.3 (19.8) | –2.2 (21.4) |
| P value vs GA 20 mg | .001a | .12 | NA |
Abbreviations: ARR, annualized relapse rate; GA, glatiramer acetate; MSIS-29, 29-item Multiple Sclerosis Impact Scale; PASAT-3, Paced Auditory Serial Addition Test 3; PRIMUS–Activities, Patient-Reported Indices in Multiple Sclerosis–Activities scale; TSQM, Treatment Satisfaction Questionnaire for Medication.
a
Indicates an unpaired 2-sided statistical significance threshold of P = .05.
b
Only participants who were receiving disease-modifying therapy for multiple sclerosis at the screening visit completed the TSQM.