Incidence of NABs to interferon beta in MS patients treated with interferon beta
| Betaferon (Betaseron) | Avonex | Rebif | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Author/year | Duration of follow up | Assay | N | (%) | Reduced response | N | (%) | Reduced response | N | (%) | Reduced response |
| ELISA = enzyme linked immunosorbent assay, ANB = antiviral neutralisation bioassay, CPE = cytopathic effect, AVA = anti-viral activity. *EVIDENCE Study, 2002, preliminary data, http://www.fda.gov/cber/review/ifnbser030702r1.pdf. **In the EVIDENCE study p values were not presented, but the memorandum mentions that there were differences between NAB+ve and NAB-ve patients receivig Rebif 44 μg sc thrice weekly. | |||||||||||
| Fernandez et al.49 | 12 months | CPE | 31 | 24 | No | 22 | 14 | No | — | — | — |
| Ross et al.18 | 24 months | ANB | 311 | 60 | NR | 140 | NR | NR | 143 | about 50 | NR |
| Jacobs et al.48 | Up to 30 months | CPE | — | — | — | 141 | <1 (18 m) 2 (24–30 m) | NR | — | — | — |
| Myhr et al.9 | Mean = 11 months | ANB MxA | 10 | 80 | NR | 9 | 22 | NR | — | — | — |
| Rudick et al.19 | 24 months | CPE | 43 | 23 (12–18 m) | Yes | 70 | 6 (18 m) | Yes | — | — | — |
| 23 | 26 (>18 m) | 33 | 3 (24 m) | ||||||||
| Jacobs et al.3 | 24 months | NR | — | — | — | 158 | 14 (1 y) | NR | — | — | — |
| 85 | 22 (2 y) | ||||||||||
| Giovannoni et al. (Unpublished data, 2001) | Mean = 31 months (range = 12–48 m) | CPE | 32 | 38 | No | 18 | 0 | No | 23 | 43 | No |
| Kivisakk et al.21 | Mean = 8–11 m (range 1–46 m) | CPE | 48 | 44 | No | 20 | 5 | No | |||
| Deisenhammer et al.14 | 17 months | MxA | 59 | 15 (1–31 months) | Yes | — | — | — | — | — | — |
| Rice et al.45 | 8 years | MxA | 28 | 50 (1 y) 11 (8 y) | — | — | — | — | — | — | — |
| Cook et al.49 | 16 months | MxA | 64 | 39 (>1:20) 22 (>1:60) | Yes | 98 | 9 (>1:20) 7 (>1:60) | Yes | — | — | — |
| European Study group5 | 36 months | MxA | 360 | 27.8 | Yes | — | — | — | — | — | — |
| IFNβ MS Study Group27 | 36 months | AVA | 91 | 38 (3 y) | Yes | — | — | — | — | — | — |
| Antonelli et al.7 | 24 months | CPE | — | — | — | — | — | — | 35 | 16.7 (11 μg sc 3×/week) | No |
| 33 | 15.1 (33 μg sc 3×/week) | ||||||||||
| OWIMS26 | 48 weeks | CPE | — | — | — | — | — | — | 95 | 5.3 (22 μg sc/ week) | No |
| 98 | 16.3 (44 μg sc/week) | ||||||||||
| PRISMS-24 | 24 months | CPE | — | — | — | — | — | — | 189 | 24 (22 μg sc 3×/week) | No |
| 184 | 13 (44 μg sc 3×/week) | ||||||||||
| PRISMS-425 | 48 months | CPE | — | — | — | — | — | — | 167 | 24 (22 μg sc 3×/week) | Yes |
| 167 | 14 (44 μg sc 3×/week) | ||||||||||
| INCOMIN52 | 24 months | CPE | 96 | 30 (1 y) 22 (2 y) | No | 88 | 7 (1 y) 6 (2 y) | No | — | — | — |
| SPECTRIMS53 | 36 months | CPE | — | — | — | — | — | 21 (22μg sc 3×/week) | Yes | ||
| 204 | 15 (44μg sc 3×/week) | ||||||||||
| Bertolotto54 | 6–18 months | CPE | 29 | 31 | — | 44 | 2 | — | 52 | 15 | — |
| EVIDENCE* | 12 months | CPE | — | — | — | 294 | 5 (>1:5) 2 (>1:20) | No** | 298 | 33 (>1:5) 25 (>1:20) | No** |