Table 1.
Study | HETA | Comparator | Duration | Reduction | NEDA | ||||
---|---|---|---|---|---|---|---|---|---|
ARR | 3mCDW | Gd+ | T2 | BV | T2 | ||||
Transforms [55] | Fingolimod | IM Interferon beta-1a | 12 months | 52% | ns | 59% | 30% | 27% | 63.4% v.44.3% |
CARE MS I [56] | Alemtuzumab | SC Interferon beta-1a | 24 months | 54.9% | ns (27.3%)a | 51.5% | 27% | 42% | 38.6% v.26.7 |
CARE MS-II [57] | Alemtuzumab | SC Interferon beta-1a | 24 months | 49.4% | 42%a | 71% | 57.5% | 23% | 32.2% v.13.6 |
Opera I [29] | Ocrelizumab | IM Interferon beta-1a | 24 months | 46% | 43% | 94% | 77% | 23.5% | 48 v.29% |
Opera II [29] | Ocrelizumab | IM Interferon beta-1a | 24 months | 47% | 37% | 95% | 83% | 23.8% | 48 v.25% |
Radiance [60] | Ozanimod | IM Interferon beta-1a | 24 months | 38% | ns | 53% | 42% | 27% | 24.2% v. 17% |
Sunbeam [59] | Ozanimod | IM Interferon beta-1a | 12 months | 48% | ns | 63% | 48% | 31% | NA |
Optimum [61] | Ponesimod | Teriflunomide | 24 months | 30.5% | ns (17%) | 56%b | 34% | 25 v.16.5% | |
Asclepios I [30] | Ofatumumab | Teriflunomide | 24 months | 50.5% | 34.4c | 97.5% | 82% | ns (7%) | 44.6 v. 17.7% |
Asclepios II [30] | Ofatumumab | Teriflunomide | 24 months | 58.5% | 93.8% | 84.5% | ns (7%) | ||
Ultimate I [50] | Ublituximab | Teriflunomide | 24 months | 59.4% | ns | 96.7% | 92.4% | NA | 44.6 v. 15.0% |
Ultimate II [50] | Ublituximab | Teriflunomide | 24 months | 49.1% | ns | 96.5% | 90% | NA | 43.0 v. 11.4% |
ARR annual relapse rate, ns non significant, 3mCDW 3-month confirmed disability worsening, BV brain volume, ns not significant
a6mCDW
bCUALS (combined unique active lesions—Gd+ and new and enlarging T2 lesions)
cPooled data from both studies as per predefined conditions