General
Information
MS
or PML are both not listed as adverse drug reactions in the Taltz
summary of product characteristics.1
The
below mentioned dosing schedule IXEQ12W is not consistent with
the approved dosing schedule in the Taltz summary of product
characteristics. Please refer to the Taltz summary of product
characteristics for approved dosing. 1
Multiple
Sclerosis
Plaque
Psoriasis Clinical Trials
The
primary population of the maintenance period consisted of patients
who were responders to ixekizumab at week 12 (ie, sPGA of 0 or 1) and
who were re-randomized to an additional 48 weeks of either a
maintenance dose of ixekizumab 80 mg Q4W, ixekizumab 80 mg Q12W, or
placebo.2
In
the primary population of the 48-week maintenance period from week 13
to week 60 of UNCOVER-1 and UNCOVER-2 clinical trials in patients
with plaque psoriasis (N=824 total ixekizumab patients), 1 patient
who was receiving ixekizumab Q12W experienced an event of multiple
sclerosis.2
Among
all ixekizumab exposures in PsO (N=6091; 17,499 PYs), as of March 21,
2019, there were 3 (0.0%) reported cases of multiple sclerosis.2
Psoriatic
Arthritis Clinical Trials
Among
all ixekizumab exposures in PsA (data from SPIRIT-P1, -P2, and -P3;
N=1401; 2229 PYs), as of March 21, 2019, there were no cases of
multiple sclerosis identified.2
Axial
Spondyloarthritis
Among
all exposures in axSpA (N=929; 1336.2 PYs), as of April 2019, there
were no cases of multiple sclerosis identified.2
Progressive
Multifocal Leukoencephalopathy
Plaque
Psoriasis Clinical Trials
The
primary population of the maintenance period consisted of patients
who were responders to ixekizumab at week 12 (ie, sPGA of 0 or 1) and
who were re-randomized to an additional 48 weeks of either a
maintenance dose of ixekizumab 80 mg Q4W, ixekizumab 80 mg Q12W, or
placebo.2
There
were no cases of progressive multifocal leukoencephalopathy
identified in ixekizumab clinical trials.2
Among
all ixekizumab exposures in PsO (N=6091; 17,499 PYs), as of March
21, 2019, there were no cases of progressive multifocal
leukoencophalopathy identified.2
Psoriatic
Arthritis Clinical Trials
Among
all ixekizumab exposures in PsA (data from SPIRIT-P1, -P2, and -P3;
N=1401; 2229 PYs), as of March 21, 2019, there were no cases of
progressive multifocal leukoencephalopathy identified.2
Axial
Spondyloarthritis
Among
all exposures in axSpA (N=929; 1336.2 PYs), as of April 2019, there
were no cases of progressive multifocal leukoencephalopathy
identified. 2
Therapeutic
Indications
References
1.
Taltz [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
2.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Glossary
axSpA
= axial spondyloarthritis
MS =
multiple sclerosis
PML
= Progressive Multifocal Leukoencephalopathy
PsA
= psoriatic arthritis
PsO
= psoriasis
PY =
patient-years
Q4W
= every 4 weeks
Q12W
= every 12 weeks
sPGA
= static Physician Global Assessment