Tysabri PML Update 6 May 2010

Natalizumab PML Incidence Estimates
by Treatment Duration
3.0
2.80
Incidence per 1000 Patients
2.5
2.22 2.24
2.0
1.77 1.78
1.62
1.5 1.51 1.47
1.32
1.14 1.14
1.0 1.00
0.92 0.96
0.91
0.84 0.82
0.70
0.5 0.52
0.30
0.20
0.0
s
g
ns
ns
ns
ns
ls
on
tin
ia
o
si
si
si
si
si
ke
Tr
fu
fu
fu
fu
fu
ar
al
In
In
In
In
In
tM
ic
18
12
24
30
36
l in
>=
>=
>=
>=
Po
C
>=
*Incidence estimates by treatment duration are calculated based on TYSABRI exposure through April 30, 2010 and 49 confirmed cases as
of May 6, 2010. The incidence for each time period is calculated as the number of PML cases divided by the number of patients exposed to
TYSABRI (e.g. for ≥24 infusions all PML cases diagnosed with exposure of 24 infusions or more divided by the total number of patients
exposed to at least 24 infusions). The 95% confidence interval (CI) is an estimated range that is 95% likely to include the true rate of PML.
The width of the CI is an indication of the precision of the estimate. The wider the confidence intervals in relation to the point estimate
indicate a higher level of uncertainty. Increasing the denominator of treated patients will increase the precision of the estimates and narrow
the confidence interval. There are limited data beyond three years of treatment. 1
3.0
2.80
Incidence per 1000 patients
2.5
2.37
2.21
2.0 2.04
1.72
1.59 1.53
1.5 1.47
1.27
1.10 1.11
1.0 1.00
0.89 0.91 0.94 0.94
0.81
0.67
0.5 0.49
0.34
0.20
0.0
s
g
ns
ns
ns
ns
ls
on
tin
ia
o
si
si
si
si
si
ke
Tr
fu
fu
fu
fu
fu
ar
al
In
In
In
In
In
tM
ic
18
36
12
24
30
lin
>=
>=
>=
>=
Po
C
>=
*Incidence estimates by treatment duration are calculated based on TYSABRI exposure through March 31, 2010 and 46 confirmed
cases as of April 6, 2010. The incidence for each time period is calculated as the number of PML cases divided by the number of
patients exposed to TYSABRI (e.g. for ≥24 infusions all PML cases diagnosed with exposure of 24 infusions or more divided by the
total number of patients exposed to at least 24 infusions). The 95% confidence interval (CI) is an estimated range that is 95% likely
to include the true rate of PML. The width of the CI is an indication of the precision of the estimate. The wider the confidence
intervals in relation to the point estimate indicate a higher level of uncertainty. Increasing the denominator of treated patients will
increase the precision of the estimates and narrow the confidence interval. 2
3.0
2.80
2.5
2.28
2.19
2.0
1.80
1.63
1.55
1.5 1.39 1.42
1.18
1.03 1.06
1.0 1.00
0.83 0.83 0.83
0.74 0.70
0.62
0.5 0.44
0.20 0.19
0.0
s
g
ns
ns
ns
ns
ls
on
tin
ia
o
si
si
si
si
si
ke
Tr
fu
fu
fu
fu
fu
ar
al
In
In
In
In
In
tM
ic
18
24
30
36
12
lin
>=
>=
>=
>=
Po
C
>=
*Incidence estimates by treatment duration are calculated based on TYSABRI exposure through February 28, 2010 and 42
confirmed cases as of March 10, 2010. The incidence for each time period is calculated as the number of PML cases divided by the
number of patients exposed to TYSABRI (e.g. for ≥24 infusions all PML cases diagnosed with exposure of 24 infusions or more
divided by the total number of patients exposed to at least 24 infusions). The 95% confidence interval (CI) is an estimated range
that is 95% likely to include the true rate of PML. The width of the CI is an indication of the precision of the estimate. The wider the
confidence intervals in relation to the point estimate indicate a higher level of uncertainty. Increasing the denominator of treated
patients will increase the precision of the estimates and narrow the confidence interval. 3
3.0
2.80
2.5
2.0 1.91 1.92

1.81
1.5 1.42
1.23 1.29
1.10
1.0 1.00
0.89
1.00
0.84
0.73 0.67
0.62 0.57 0.62
0.5 0.52
0.36
0.20 0.13
0.0
s
g
ns
ns
ns
ns
ls
on
tin
ia
o
si
si
si
si
si
ke
Tr
fu
fu
fu
fu
fu
ar
al
In
In
In
In
In
tM
ic
18
12
24
30
36
lin
>=
>=
>=
>=
Po
C
>=
Incidence calculated based on natalizumab exposure through January 31, 2010 and 35 confirmed cases
as of February 9, 2010. 4
3.0
2.80
2.5
2.0 1.93 1.88

1.79
1.5
1.31 1.29
1.15
1.0 1.00 1.02
0.89 0.82
0.81
0.67 0.58
0.5 0.55 0.49 0.50
0.47
0.32
0.20
0.06
0.0
s
g
ns
ns
ns
ns
ls
on
tin
ia
o
si
si
si
si
si
ke
Tr
fu
fu
fu
fu
fu
ar
al
In
In
In
In
In
tM
ic
18
12
24
30
36
lin
>=
>=
>=
>=
Po
C
>=
*Incidence calculated based on natalizumab exposure through December 31, 2009 and 31 confirmed
cases as of January 12, 2010. 5
Updated 30 November 2009 based on 28 cases
3.0
2.80
2.5
2.28
2.0 1.96 1.99
1.5
1.29 1.28
1.09 1.05
1.0 1.00
0.86 0.79
0.76
0.63 0.54 0.63
0.5 0.43 0.50 0.48
0.29
0.20
0.08
0.0
g
ls
s
t in
s
ia
on
on
on
on
on
ke
Tr
si
si
si
si
si
ar
al
fu
fu
fu
fu
fu
M
ic
In
In
In
In
In
lin
st
6
8
≥1
≥2
≥3
≥3
Po
C
≥1
6
Updated 28 October 2009 based on 24 cases
3.5
3.14
3.0
2.80
2.65
2.5
2.0 1.98
1.5 1.44
1.23 1.26
1.0 1.00 1.01
0.79 0.75 0.87
0.68 0.69
0.5 0.57 0.47
0.38 0.43
0.20 0.25
0.11
0.0
g
ls
t in
s
s
ia
on
on
on
on
on
ke
Tr
si
si
si
si
si
ar
al
fu
fu
fu
fu
fu
M
ic
In
In
In
In
In
lin
st
6
8
Po
≥1
≥2
≥3
≥3
C
≥1

Tysabri PML Update 6 May 2010

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Natalizumab PML Incidence Estimates

2.0 1.91 1.92

2.0 1.93 1.88

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