Table 4.
Overview of cases of discontinuation/withdrawal (n = 27)
| Registry number | Reason for discontinuation/withdrawal | EDSS at baseline | Number of relapses in past 1 year | Prior MS therapy | Duration of natalizumab exposure (months) | Number of relapses after discontinuation/withdrawal | Severity of relapses | Time interval between last natalizumab infusion and occurrence of relapse (days) |
|---|---|---|---|---|---|---|---|---|
| 0005 | Other reason (moving) | 3.0 | 0 | DMT-naïve | 16.7 | 0 | – | – |
| 0011 | No hospital visit | 3.0 | 0 | Fingolimod only | 4.8 | 0 | – | – |
| 0013 | Other reason (concerns about the risk of PML) | 0.0 | 2 | Switched between IFN and fingolimod | 7.4 | 0 | – | – |
| 0016 | Insufficient effect/worsening of MS | 1.5 | 0 | Fingolimod only | 5.8 | 0 | – | – |
| 0019a | Insufficient effect/worsening of MS | Unknown | Unknown | IFN only | 1.1 | 1 | Non-serious | 17 |
| 0020a | Other reason (follow-up) | 1.5 | 1 | DMT-naïve | 4.7 | 0 | – | – |
| 0023 | AEs and patient request | 2.0 | 0 | Fingolimod only | 3.9 | 0 | – | – |
| 0024 | Insufficient effect/worsening of MS | 5.0 | 1 | Switched between IFN and fingolimod | 0.0b | 1 | Serious | 3 |
| 0031 | AEs | 7.0 | 1 | Switched between IFN and fingolimod | 3.7 | 0 | – | – |
| 0033 | Insufficient effect/worsening of MS | 8.5 | Unknown | Switched between IFN and fingolimod | 1.2 | 0 | – | – |
| 0035a | Other reason (concerns about the risk of PML) | 3.5 | 0 | IFN only | 9.9 | 0 | – | – |
| 0036a | Other reason (concerns about the risk of PML) | 1.0 | 0 | IFN only | 8.5 | 0 | – | – |
| 0038a | Other reason (change of hospital) | 1.5 | 0 | Switched between IFN and fingolimod | 5.8 | 0 | – | – |
| 0041a | Other reason (concerns about the risk of PML) | 2.0 | 2 | DMT-naïve | 0.0b | 0 | – | – |
| 0043a | Other reason (concerns about the risk of PML) | 1.0 | 0 | DMT-naïve | 0.0b | 0 | – | – |
| 0044 | AEs | 5.5 | 0 | IFN only | 3.9 | 0 | – | – |
| 0048a | Pregnancy | 0.0 | 0 | IFN only | 5.5 | 2 |
Non-serious Non-serious |
161 283 |
| 0050a | Other reason (concerns about the risk of PML) | 1.0 | 0 | IFN only | 0.0b | 0 | – | – |
| 0052a | Other reason (concerns about the risk of PML) | 3.0 | 0 | IFN only | 6.8 | 0 | – | – |
| 0060a | Other reason (economic reason) | 2.0 | 0 | Switched between IFN and fingolimod | 14.3 | 0 | – | – |
| 0061 | Insufficient effect/worsening of MS | 7.0 | 4 | DMT-naïve | 1.3 | 1 | No-Serious | 24 |
| 0074 | Patient request and JCV antibody positive | 2.0 | 0 | IFN only | 13.1 | 0 | – | – |
| 0084 | Insufficient effect/worsening of MS | 3.5 | 0 | Fingolimod only | 10.6 | 0 | – | – |
| 0087a | Anti-JCV antibody positive | 1.0 | 0 | IFN only | 11.7 | 0 | – | – |
| 0100 | Other reason (concerns about the risk of PML) | 6.0 | 1 | IFN only | 2.1 | 1 | Serious | 134 |
| 0153 | AEs | Unknown | 0 | DMT-naïve | 0.9 | 0 | – | – |
| 0160 | AEs | 2.0 | 2 | DMT-naive | 1.0 | 1 | Non-serious | 10 |
AE adverse event, MS multiple sclerosis, DMT disease-modifying therapy, EDSS expanded disability status scale, IFN interferon, JCV John Cunningham virus, PML progressive multifocal leukoencephalopathy
aPatients from phase 2 study
bNatalizumab was administered on only one occasion