Tysabri-Associated PML Incidence

3.50

3.00
PML Incidence per 1000 patients

2.50

2.00

1.50

1.00

0.50

0.00

Clinical Trials All Post Marketing Patients Patients Treated ≥ 12 Infusions Patients Treated ≥ 18 Infusions
Patient Uptake as of: 28-Oct-09 30-Nov-09 31-Dec-09 31-Jan-10 28-Feb-10 31-Mar-10 30-Apr-10 31-May-10 30-Jun-10 31-Jul-10 2-Sep-10 1-Oct-10 28-Oct-09 30-Nov-09 31-Dec-09 31-Jan-10 28-Feb-10 31-Mar-10 30-Apr-10 31-May-10 30-Jun-10 31-Jul-10 2-Sep-10 1-Oct-10 28-Oct-09 30-Nov-09 31-Dec-09 31-Jan-10 28-Feb-10 31-Mar-10 30-Apr-10 31-May-10 30-Jun-10 31-Jul-10 2-Sep-10 1-Oct-10

High 2.80 0.57 0.63 0.67 0.73 0.83 0.89 0.92 1.00 1.03 1.09 1.14 1.15 1.01 1.09 1.15 1.23 1.39 1.47 1.51 1.62 1.65 1.73 1.80 1.80 1.23 1.29 1.31 1.42 1.63 1.72 1.77 1.92 1.93 2.00 2.09 2.09
Mid 1.00 0.38 0.43 0.47 0.52 0.62 0.67 0.70 0.77 0.80 0.85 0.90 0.91 0.68 0.76 0.81 0.89 1.03 1.10 1.14 1.24 1.27 1.35 1.42 1.42 0.79 0.86 0.89 1.00 1.18 1.27 1.32 1.46 1.47 1.54 1.63 1.63
Low 0.20 0.25 0.29 0.32 0.36 0.44 0.49 0.52 0.58 0.61 0.65 0.70 0.71 0.43 0.50 0.55 0.62 0.74 0.81 0.84 0.94 0.97 1.04 1.10 1.11 0.47 0.54 0.58 0.67 0.83 0.91 0.96 1.08 1.10 1.16 1.25 1.26

Case Location US 10 11 15 16 19 20 22 25 28 29
EU 19 21 24 27 27 32 32 34 36 37
ROW (understood to all be in Switzerland) 2 3 3 3 3 3 4 4 4 4
Total PML Cases 24 28 31 35 42 46 49 55 58 63 68 70
as of 28-Oct-09 30-Nov-09 12-Jan-09 9-Feb-10 10-Mar-10 6-Apr-10 6-May-10 7-Jun-10 2-Jul-10 4-Aug-10 2-Sep-10 1-Oct-10
Total Deaths 7 11 11 11 12 12 14 14

Estimated Patients in Treatment Cohort*: 37,567 38,644 39,700 40,833 41,967 43,100 43,633 44,167 44,700 45,233 45,767 46,300 26,667 28,451 30,200 31,333 32,467 33,600 34,000 34,400 34,800 35,200 35,600 36,000
Estimated PML Cases in Treatment Cohort: 24 28 31 35 42 46 49 55 58 63 68 70 21 24 27 31 38 43 45 50 51 54 58 59
Monthly Increase: 4 3 4 7 4 3 6 3 5 5 2
ence by Treatment Duration Cohort

Patients Treated ≥ 24 Infusions Patients Treated ≥ 30 Infusions Patients Treated ≥ 36 Infusions Patients Treated ≥ 42 Infusions
28-Oct-09 30-Nov-09 31-Dec-09 31-Jan-10 28-Feb-10 31-Mar-10 30-Apr-10 31-May-10 30-Jun-10 31-Jul-10 2-Sep-10 1-Oct-10 28-Oct-09 30-Nov-09 31-Dec-09 31-Jan-10 28-Feb-10 31-Mar-10 30-Apr-10 31-May-10 30-Jun-10 31-Jul-10 2-Sep-10 1-Oct-10 28-Oct-09 30-Nov-09 31-Dec-09 31-Jan-10 28-Feb-10 31-Mar-10 30-Apr-10 31-May-10 30-Jun-10 31-Jul-10 2-Sep-10 1-Oct-10 30-Jun-10 31-Jul-10 2-Sep-10 1-Oct-10

1.98 1.96 1.93 1.91 2.19 2.21 2.22 2.36 2.28 2.32 2.43 2.42 2.65 1.99 1.88 1.92 2.28 2.37 2.24 2.25 2.17 2.07 2.25 2.22 3.14 2.28 1.79 1.81 1.80 2.04 1.78 1.75 1.73 1.70 1.79 1.74 2.74 2.65 2.75 2.69
1.26 1.28 1.29 1.29 1.55 1.59 1.62 1.76 1.71 1.76 1.86 1.87 1.44 1.05 1.02 1.10 1.42 1.53 1.47 1.50 1.46 1.40 1.58 1.57 0.87 0.63 0.50 0.62 0.70 0.94 0.82 0.85 0.88 0.90 1.00 1.00 1.07 1.14 1.34 1.36
0.75 0.79 0.82 0.84 1.06 1.11 1.14 1.28 1.25 1.30 1.40 1.41 0.69 0.48 0.49 0.57 0.83 0.94 0.91 0.95 0.93 0.91 1.07 1.08 0.11 0.08 0.06 0.13 0.19 0.34 0.30 0.34 0.38 0.41 0.50 0.52 0.29 0.37 0.54 0.59

16,233 17,479 18,700 20,100 21,500 22,900 24,033 25,167 26,300 27,433 28,567 29,700 8,667 9,643 10,600 11,633 12,667 13,700 14,400 15,100 15,800 16,500 17,200 17,900 4,053 4,410 4,760 5,440 6,120 6,800 7,400 8,000 8,600 9,200 9,800 10,400 3,500 4,100 4,700 5,300
20 22 24 26 33 36 39 44 45 48 53 56 12 10 11 13 18 21 21 23 23 23 27 28 3 3 2 3 4 6 6 7 8 8 10 10 4 5 6 7