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Taltz ® (ixekizumab) injektion
Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska
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
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
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
Datum fӧr senaste ӧversyn 2020 M03 03