Drug Action
Ixekizumab is a human monoclonal antibody that binds to interleukin-17A and inhibits the release of pro-inflammatory cytokines and chemokines.
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Drug reference
Ixekizumab is a human monoclonal antibody that binds to interleukin-17A and inhibits the release of pro-inflammatory cytokines and chemokines.
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Moderate-to-severe plaque psoriasis (under expert supervision) | Psoriatic arthritis with concomitant moderate-to-severe plaque psoriasis (under expert supervision) ▶BY SUBCUTANEOUS INJECTION ▶Adult: Initially 160 mg for 1 dose, followed by 80 mg after 2 weeks, then 80 mg every 2 weeks for 5 further doses (at weeks 4, 6, 8, 10 and 12), then maintenance 80 mg every 4 weeks, consider discontinuation of treatment if no response after 16–20 weeks Psoriatic arthritis (under expert supervision) ▶BY SUBCUTANEOUS INJECTION ▶Adult: Initially 160 mg for 1 dose, then maintenance 80 mg every 4 weeks, consider discontinuation of treatment if no response after 16–20 weeks
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Active infections (including active tuberculosis)
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Chronic infection—monitor carefully and discontinue if serious, unresponsive infection develops. Crohn’s disease. ulcerative colitis CAUTIONS, FURTHER INFORMATION ▶Severe hypersensitivity reactions Severe hypersensitivity reactions have been reported—discontinue treatment immediately if symptoms occur. ▶Latent tuberculosis Manufacturer advises that patients with latent tuberculosis should complete anti-tuberculosis therapy before starting ixekizumab. ▶Inflammatory bowel disease Manufacturer advises to monitor closely for exacerbation.
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NICE decisions ▶Ixekizumab for treating moderate to severe plaque psoriasis (April 2017) NICE TA442 Ixekizumab (Taltz ®) is recommended as an option for treating plaque psoriasis only if: . the disease is severe, defined by a total Psoriasis Area and Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of 10 or more; . the disease has not responded to standard systemic therapies (e.g. ciclosporin, methotrexate and PUVA) or these treatments are contra-indicated or not tolerated, and . the manufacturer provides ixekizumab with the discount agreed in the patient access scheme Skin Ixekizumab should be discontinued if there is an inadequate response at 12 weeks. Patients currently receiving ixekizumab, whose disease does not meet the above criteria, should have the option to continue treatment until they and their clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta442 ▶Ixekizumab for treating active psoriatic arthritis after inadequate response to DMARDs (August 2018) NICE TA537 Ixekizumab (Taltz ®) alone, or with methotrexate, is recommended as an option for treating active psoriatic arthritis in adults only if: . it is used as described in the NICE technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis (TA199 recommendations 1.1 and 1.2), or . the person has had a tumour necrosis factor (TNF)-alpha inhibitor but their disease has not responded within the first 12 weeks or has stopped responding after the first 12 weeks, or . TNF-alpha inhibitors are contra-indicated but would otherwise be considered (as described in the NICE technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis). Ixekizumab is only recommended if the manufacturer provides it according to the commercial arrangement. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta537 Scottish Medicines Consortium (SMC) decisions SMC No. 1223/17 The Scottish Medicines Consortium has advised (April 2017) that ixekizumab (Taltz ®) is accepted for restricted use within NHS Scotland for the treatment of moderate-to- severe plaque psoriasis only in patients who have failed to respond to standard systemic therapies (including ciclosporin, methotrexate and phototherapy), are intolerant to, or have a contra-indication to these treatments. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland, or a list price that is equivalent or lower. SMC No. SMC2097 The Scottish Medicines Consortium has advised (October 2018) that ixekizumab (Taltz ®) is accepted for restricted use within NHS Scotland, alone or in combination with methotrexate, for the treatment of active psoriatic arthritis in adults whose disease has not responded adequately to at least two conventional disease-modifying anti-rheumatic drugs given either alone or in combination, and who have had an inadequate response to a tumour necrosis factor inhibitor. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.
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→Appendix 1: monoclonal antibodies
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▶Common or very common Increased risk of infection. nausea. oropharyngeal pain ▶Uncommon Conjunctivitis. neutropenia. skin reactions. thrombocytopenia ▶Frequency not known Angioedema. dyspnoea. hypersensitivity (occasionally late-onset). inflammatory bowel disease
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Manufacturer advises effective contraception during treatment and for at least 10 weeks after treatment in women of childbearing potential.
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Manufacturer advises avoid—limited information available.
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Manufacturer advises avoid—present in milk in animal studies.
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Manufacturer advises to avoid injecting into areas of the skin that show psoriasis; injection sites may be alternated. Patients may self-administer Taltz ®, after appropriate training in subcutaneous injection technique. l HANDLING AND STORAGE Manufacturer advises store in a refrigerator (2–8°C).
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There can be variation in the licensing of different medicines containing the same drug. Solution for injection EXCIPIENTS: May contain Polysorbates ▶Taltz (Eli Lilly and Company Ltd) A Ixekizumab 80 mg per 1 ml Taltz 80mg/1ml solution for injection pre-filled pens | 1 pre-filled disposable injection P £1,125.00 (Hospital only) Taltz 80mg/1ml solution for injection pre-filled syringes | 1 pre-filled disposable injection P £1,125.00 (Hospital only)
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Self-administration If appropriate, patients and their carers should be given training in subcutaneous injection technique.
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Initially 160 mg for 1 dose, followed by 80 mg
First-line fragment. Read the complete Indications and Dose section above.
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Initially 160 mg for 1 dose, then maintenance
First-line fragment. Read the complete Indications and Dose section above.
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