Table 1.
Severe infusion-related adverse effect | Timing | Infusion number | Withdrawal | Anti-NTZ antibody concentration (AU/ml)a |
---|---|---|---|---|
Case 1 | ||||
Generalised rash | During | 2 | Yes | 740b |
Case 2 | ||||
Pruritic rash | During | 2 | Yes | 26c |
Case 3 | ||||
Pruritic rash | During | 2 | Yes | 890c |
Case 4 | ||||
1. Chest discomfort, headache, sweating, facial erythema | During | 2 | Yes | 580b |
2. Chest discomfort, headache, sweating, facial erythema | During | 3 | ||
Case 5 | ||||
Generalised erythema | During | 3 | No | 80c |
Case 6 | ||||
Pruritic erythema | During | 6 | Yes | < 12d |
Case 7 | ||||
Generalised rash | Unknown | 1e | No | 13c |
Case 8 | ||||
1. Pruritic erythema | During | 28 | Yes | < 12c |
2. Pruritic erythema | During | 29 | ||
Case 9 | ||||
Generalised urticaria | During | 58 | Yes | < 12b |
Except for case 2 and case 8, all patients received oral or IV clemastine.
NTZ: natalizumab; IV: intravenous; IAE: infusion-related adverse event.
High concentration > 100 AU/ml, low concentration ⩾ 12–100 AU/ml, negative concentration < 12 AU/ml.
3–12 months between serum sample and IAE.
< 3 months between serum sample and IAE.
> 1 year between serum sample and IAE.
The first infusion after NTZ discontinuation, that is, the second therapy course.