Taltz® (ixekizumab): Användning hos plackpsoriasis eller psoriasisartritpatienter med multipel skleros och behandlingsrelaterade biverkningar

Information from the Label

Multiple sclerosis is not listed as adverse reaction in the Taltz summary of product characteristics.¹

Exclusion Criteria in Psoriasis and Psoriatic Arthritis Clinical Trials

Psoriasis Clinical Trials

• Patients were excluded from UNCOVER-2 and -3 if they had a presence or history of a demyelinating disorder.² 

• In UNCOVER-1, patients were not specifically excluded from the trial if they had a presence or history of demyelinating disorder; however, patients with significant neurologic disorders that, in the opinion of the investigator, posed an unacceptable risk to the patient if participating in the study or of interfering with the interpretation of data were excluded from UNCOVER-1.³

Psoriatic Arthritis Clinical Trials

• Patients were excluded from SPIRIT-P1 if they had a presence, personal history, or family history of demyelinating disorder.⁴

• In SPIRIT-P2, patients were not specifically excluded from the trial if they had a presence of a demyelinating disorder; however, patients with significant neurologic disorders that, in the opinion of the investigator, posed an unacceptable risk to the patient if participating in the study or of interfering with the interpretation of data were excluded from SPIRIT-P2.⁵

Multiple Sclerosis Treatment-Emergent Adverse Events in Clinical Trials

• Treatment-emergent adverse events were evaluated using MedDRA terms and were defined as events that first occurred or worsened in severity, relative to baseline, at any time during a clinical study. Treatment-emergent adverse events reported during the studies are not always attributed to study medications and the frequencies do not reflect investigator assessment of causality.⁴

• The term “multiple sclerosis” is a MedDRA preferred term.

• This information is for reference only and is not a treatment recommendation. Decisions regarding the use of ixekizumab in patients with multiple sclerosis (or any medical condition) should be made at the discretion of the prescribing physician using their best clinical judgment.

Psoriasis Clinical Trials

• As of the March 2019 database lock, 3 TEAEs of multiple sclerosis were reported out of 6091 patients exposed to ixekizumab (17,499.3 total PY of ixekizumab exposure). All 3 TEAEs were considered serious and 2 of the events led to treatment discontinuation.⁴  

Psoriatic Arthritis Clinical Trials

• As of the March 2019 database lock, no TEAEs of multiple sclerosis were reported in 1401 patients exposed to ixekizumab (2228.6 total PY of ixekizumab exposure).⁴   

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. Griffiths CE, Reich K, Lebwohl M, et al. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomized trials. Lancet. 2015;386(9993):541-551. http://dx.doi.org/10.1016/S0140-6736(15)60125-8

3. Gordon KB, Blauvelt A, Papp KA, et al. Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis. N Engl J Med. 2016;375:345-356. http://dx.doi.org/10.1056/NEJMoa1512711

4. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

5. Nash P, Kirkham B, Okada M, et al. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomized, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017;389(10086):2317-2327. http://dx.doi.org/10.1016/S0140-6736(17)31429-0

Glossary

Lilly = Eli Lilly and Company

MedDRA = Medical Dictionary for Regulatory Activities

PY = patient-years

TEAE = treatment-emergent adverse event