Taltz® ▼ (ixekizumab)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Taltz Summary of Product Characteristics (SmPC)

Taltz® ▼ (ixekizumab): Events of Multiple Sclerosis or Progressive Multifocal Leukoencephalopathy in Clinical Trials

There were no cases of PML identified in ixekizumab pivotal clinical trials.

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

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

Therapeutic Indications

Ixekizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.1

Ixekizumab, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies.1

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

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.

Date of Last Review: March 03, 2020

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