Taltz ® (ixekizumab) injektion

För fullständig produktresumé för Taltz® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Taltz® ▼ (ixekizumab): Förekomst av multipel scleros (MS) eller progressiv multifokal leukoencefalopati (PML) i kliniska prövningar

Inga fall av PML identifierades i pivotala kliniska prövningar av ixekizumab.

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

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

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn 2020 M03 03


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