Table 2.
Long-term RWD HETA studies v. LETA
| Study | HETA | Comparator | Duration | Patients # | Endpoint | Results |
|---|---|---|---|---|---|---|
| Harding [65] |
NATZ ALEM |
INFb GLA DMF TERF FINGO |
5 years | 592 |
EDSS Time to CDW |
0.3 v 1.2 3.14 v 6.0 years |
| Brown [66] |
FINGO ALEM NATZ |
INFs GLAT |
5 years | 1555 | Conversion to SP | HR 0.66 |
| He [67] | RTX | None | 6–10 years | 544 | EDSS |
∆ − 0.98 HR 0.34 |
|
OCR MTX ALEM NATZ |
Time to CDW | |||||
| Buron [68] |
NATZ FINGO ALEM CLAD OCRE |
INFs TERF DMF GLAT |
4 years | 388 |
EDSS Time to CDW |
HR 0.50 HR 0.53 |
| Iaffaldano [69] | FINGO | GLAT | 10 years | 726 | EDSS | ∆ − 0.67 |
| NATZ | INFs | |||||
| MTX | AZT | |||||
| ALEM | TERF | |||||
| OCRE | DMF | |||||
| CLAD | ||||||
| Simonsen [70] | NATZ | INFs | 2 years | 694 | NEDA | OR 4.6 |
| FINGO | GLAT | |||||
| ALEM | TERF | |||||
| DMF | ||||||
| Prosperini [71] | MTX | INF beta 1a | 10 years | 150 | EDSS | 4.5 v 5.0 |
| Cyclophosph | INF beta 1b | Time to CDW | HR 0.48 | |||
| Spelman [72] |
RTX NATZ FINGO |
TERF DMF INFs GLAT |
3–7 years | 4861 |
EDSS Time to CDW |
∆ – 1.3 HR 0.71 |
ALEM alemtuzumab, AZT azathioprine, CLAD cladribine, Cyclophosph cyclophosphamide, DMF dimethyl fumarate, FINGO fingolimod, GLAT glatiramer, INF interferon, MTX mitoxantrone, NTZ natalizumab, OCRE ocrelizumab, RTX rituximab, TERF teriflunomide