Patient characteristics of PML reports (levels 1–4)
| MAB (underlying disease as reported) | No. (levels 1–4) | Male | Female | Non- specified gender | Age (years) mean and range (min, max) | Exposure to drug (months) median and range (min, max)* | Immunosuppressive treatment prior to receiving MAB | Death as outcome | |
| Yes | No or unknown | ||||||||
| Natalizumab (MS) | 43 | 15 | 28 | – | 43.0 (23–67) | 27.5 (5–48) | 13 | 30 | 2 |
| Rituximab (haematological malignancies, RA, Wegener's granulomatosis)† | 39 | 22 | 14 | 3 | 65.8 (49–83) | 6 (1 month–4 years) | NA | NA | 11‡ |
| Alemtuzumab (B-CLL)§ | 4 | 4 | – | – | 65.3 (58–73) | 1; 3; 3; unknown | NA | NA | 4 |
| Efalizumab (psoriasis) | 3 | 3 | – | – | 55.7 (46–66) | 13; 39; unknown | 2 | 1 | 1 |
| Ofatumumab (B-CLL)§ | 1 | 1 | – | – | 69 | 5 | NA | NA | 1 |
| All MABs | 90 | 45 | 42 | 3 | 54.2 (23–83) | 21.5 (1–48) | NA | NA | 19 |
↵* Individual exposures to drug are presented for alemtuzumab, efalizumab and ofatumumab.
↵† Out of these, in 32 cases haematological malignancies and in two cases RA were reported as indication for therapy with rituximab, one case is attributed to a patient with Wegener's granulomatosis and in four cases no specific indication was available. For PML patients treated with rituximab due to haematological malignancies, the underlying disease may have contributed to the occurrence of PML.
↵‡ Out of these, in eight cases haematological malignancies were reported as an indication for therapy with rituximab, one case is attributed to a patient with Wegener's granulomatosis and in two cases no specific indication was available. The underlying disease may have contributed to the fatal outcome.
↵§ For PML patients treated with alemtuzumab or ofatumumab due to B-CLL, the underlying disease may have contributed to the occurrence of PML and to the fatal outcome.
B-CLL, B cell chronic lymphocytic leukaemia; MABs, monoclonal antibodies; MS, multiple sclerosis; NA, not applicable; PML, progressive multifocal leukoencephalopathy; RA, rheumatoid arthritis.