Table 1.
Prospective randomized trials evaluating the effect of neutralizing antibodies on interferon-β efficacy in relapsing remitting multiple sclerosis.
| MSSG (IFNβ-1b, 250 µg) | PRISMS-4 (IFNβ-1a, 44 μg) | EDCT (IFNβ-1a, 30 and 60 µg) | |
|---|---|---|---|
| Annualized relapse rate | 13–36 months on study | 36–48 months on study | 12–48 months on study |
| NAb positive | 1.08 (n = 35) | 0.81 (n = 28) | 0.97 (n = 26) |
| NAb negative | 0.56 (n = 56) | 0.50 (n = 120) | 0.70 (n = 606) |
| (p < 0.05) | (p = 0.002) | (p = 0.04) | |
| MRI (new T2 lesions) | 24–36 months on study | 0–48 months on study | 12–36 months on study |
| NAb positive | 1.03 (n = 34) | 1.4 (n = 28) | 4.9 (n = 9) |
| NAb negative | 0.40 (n = 54) | 0.3 (n = 120) | 2.9 (n = 279) |
| (p = 0.067) | (p < 0.001) | (p = not significant) | |
| EDSS (sustained progression) | 0–36 months on study | Time to sustained progression prolonged | 0–48 months on study |
| NAb positive | –0.06 (n = 35) | EDSS not provided | 0.89 (n = 14) |
| NAb negative | +0.19 (n = 56) | 0.29 (n = 286) | |
| Not significant (p = 0.083) | (p = 0.01) | ||
| Conclusions | NAbs reduce clinical efficacy | NAbs reduce clinical efficacy | NAbs reduce clinical efficacy |
MSSG, MS Study Group [1996]; PRISMS-4, PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group [2001]; EDCT, [Kappos et al. 2005].
EDSS, Expanded Disability Status Scale; IFN, interferon; MRI, magnetic resonance imaging; NAb, neutralizing antibody.