Table 5.
Results on disability progression from pivotal trials of DMTs approved for RMS by FDA only.
| Intervention (Clinical trial) | N | Comparator | N | Population | Disability progressiona |
|---|---|---|---|---|---|
| Dimethyl fumarateb,20 (DEFINE84 / | 410c | Placebo | 408 | RRMS | 3 m-CDP in RRMS patients HR 0.62; 95% CI [0.44, 0.87]; p = 0.005 6 m-CDP in RRMS patients HR 0.77; 95% CI [0.52, 1.14]; p = 0.1893 |
| CONFIRM)85 | 359c | Placebod | 363 | RRMS | 3 m-CDP in RRMS patients HR 0.79; 95% CI [0.52, 1.19]; p = 0.2536 6 m-CDP in RRMS patients HR 0.67; 95% CI [0.40, 1.11]; p = 0.1172 |
| Ozanimod (pooled analysis of RADIANCE and SUNBEAM)86 |
880e | IFN-beta 1a i.m. | 889 | RRMS | 3 m-CDP in RRMS patients HR 0.950; 95% CI [0.679, 1.330]; p = 0.7651 6 m-CDP in RRMS patients HR 1.413; 95% CI [0.922, 2.165]; p = 0.1126 |
| Peginterferon beta 1a (ADVANCE)69 | 512f | Placebo | 500 | RRMS | 3 m-CDP in RRMS patients HR 0.62; 95% CI [0.40, 0.97]; p = 0.0383 |
| Teriflunomide (pooled analysis of TOWER and TEMSO)65,87 | 728g | Placebo | 751 | RMS | 3 m-CDP in RMS study population HR 0.695; 95% CI [0.542, 0.892]; p = 0.0029 6 m-CDP in RMS study population HR 0.759; 95% CI [0.570, 1.011]; p = 0.055 3 m-CDP in subgroup of patients with SPMS or progressive RMSh HR 0.553; 95% CI [0.166, 1.839]; p = n.a. |
CDP, confirmed disability progression; CI, confidence interval; HR, hazard ratio; m, month; N, number of randomized patients; n.a., not available; RMS, relapsing multiple sclerosis; RRMS, relapsing-remitting multiple sclerosis; SPMS, secondary progressive multiple sclerosis; w, week.
Results are presented as intervention versus comparator.
For diroximel fumarate, no pivotal efficacy study was available, as efficacy was extrapolated from dimethyl fumarate based on pharmacokinetic studies.
Results for the approved dose (240 mg twice daily) are presented.
The active comparator arm of the study (glatiramer acetate) is not presented, no significant effect on disability progression.
Results for the approved dose (1 mg) are presented.
Results for the approved dose (125 µg every two weeks) are presented.
Results for the standard dose in adults (14 mg) are presented.
Teriflunomide 14 mg: N = 30; placebo: N = 44.