Table 3.
The effect of DMTs on BVL in RRMS patients in Phase III trials
| Drug (REF.) | Changes in Brain Volume Loss | ||
|---|---|---|---|
| Year 0–1 | Year 1–2 | Year 0–2 | |
| IFN-β-1a IM [33] | x | ✓ 55% reduction vs. placebo |
x |
| IFN-β-1a SC [34] | - | - | x |
| IFN-β-1b SC [52, 53] | - | - | - |
| Glatiramer acetate [35, 36–38] | x | ✓ | x |
| (Eur/Canadian GA trial) | 40% reduction vs. placebo (Eur/Canadian GA trial) |
(Eur/Canadian GA trial) | |
| 8% reduction vs. sc IFN-β-1a (REGARD)+ |
22% reduction vs. sc IFN-β-1a (REGARD)+ |
13% reduction vs. IFN-β-1a (REGARD) |
|
| No sig. difference with GA +/− sc IFN-β-1b (BEYOND) |
No sig. difference with GA +/−. sc IFN-β-1b (BEYOND) |
No sig. difference with GA +/− sc IFN-β-1b (BEYOND |
|
| No sig. difference with GA +/− sc IFN-β-1a (COMBIRx) |
No sig. difference with GA +/−. sc IFN-β-1a (COMBIRx) |
No sig. difference with GA +/− sc IFN-β-1a (COMBIRx) |
|
| Natalizumab [40, 41] | ✓ | x (AFFIRM) |
|
| 40% increase vs. placebo (AFFIRM) |
44% reduction vs. placebo (AFFIRM) |
||
| 19% increase vs. placebo (SENTINEL) |
x 23% reduction with Natalizumab+ IM IFN-β-1a vs. IM IFN-β-1a + placebo (SENTINEL) |
x (SENTINEL) |
|
| Teriflunomide [42] | 37% reduction vs. placebo (TEMSO) | 31% reduction vs. placebo (TEMSO)- | X |
| Dimethyl fumarate [43, 44] | - | 21% reduction vs. placebo (DEFINE) Significant effect (DEFINE) ׇ (CONFIRM) |
✓21% reduction vs. placebo (DEFINE) × ‡ () |
| Alemtuzumab [45, 46] | - | ✓ 24–42% reduction vs IFN-β-1a |
|
| Laquinimod [47, 48] | - | - | ✓ (ALLEGRO) 33% reduction vs placebo (BRAVO) 28–34% reduction vs placebo |
| Daclizumab [49] | ✓ | ✓ | - |
| Significant effect (Week 0–24) 9% reduction vs IM IFN-β-1a |
Significant effect (Week 24–96) 7% reduction vs IM IFN-β-1a |
||
| Fingolimod [6–8] | ✓ | ✓ | ✓ |
| 23–40% reduction vs placebo | 28–45% reduction vs placebo | 33–35% reduction vs placebo | |
| ✓§ 45% reduction vs. IM IFN β-1a (TRANSFORMS) |
- | - | |
BID twice daily, TID three times daily, SC subcutaneous, GA Glatiramer acetate, IFN Interferon
– Data not reported/available × No significant effect or not statistically significant ✓ Significant effect
* Not all approved therapies have significant effects on BVL and effects can be delayed until the second year of therapy. + No P value reported †Significant effect at 9–18 months
‡Significant effect at 6–24 months in DEFINE (only BID, not TID dose arm), but not in CONFIRM study
§Significant effect also seen at 0–6 months