Drug Action
Tildrakizumab is a recombinant human monoclonal antibody that specifically binds to interleukin- 23 and inhibits the release of pro-inflammatory cytokines and chemokines.
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Drug reference
Tildrakizumab is a recombinant human monoclonal antibody that specifically binds to interleukin- 23 and inhibits the release of pro-inflammatory cytokines and chemokines.
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Moderate-to-severe plaque psoriasis (under expert supervision) ▶BY SUBCUTANEOUS INJECTION ▶Adult: Initially 100 mg, then 100 mg after 4 weeks, then maintenance 100 mg every 12 weeks, consider discontinuation if no response after 28 weeks, in patients with a high disease burden, or with a body weight 90kg, a dose of 200 mg may provide greater efficacy
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Clinically significant active infection
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Chronic infection. history of recurrent infection. recent serious infection CAUTIONS, FURTHER INFORMATION ▶Risk of infection Manufacturer advises consider anti- tuberculosis therapy before initiation of tildrakizumab in patients with a history of tuberculosis, in whom an adequate course of treatment cannot be confirmed. Manufacturer advises consider completion of immunisations according to current guidelines before initiating treatment (consult product literature for appropriate interval between vaccination and administration of tildrakizumab).
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Manufacturer advises patients should be evaluated for tuberculosis infection before treatment.
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Tildrakizumab is a biological medicine. Biological medicines must be prescribed and dispensed by brand name, see Biological medicines and Biosimilar medicines, under Guidance on prescribing p. 1; manufacturer advises to record the brand name and batch number after each administration. l HANDLING AND STORAGE Manufacturer advises store in a refrigerator (2–8°C) and protect from light—consult product literature for further information regarding storage outside refrigerator.
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NICE decisions ▶Tildrakizumab for treating moderate to severe plaque psoriasis (April 2019) NICE TA575 Tildrakizumab (Ilumetri ®) is recommended as an option for treating plaque psoriasis in adults, only if: . the disease is severe, as defined by a total Psoriasis Area and Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10, and . the disease has not responded to other systemic treatments, including ciclosporin, methotrexate and phototherapy, or these options are contra-indicated or not tolerated, and . the manufacturer provides the drug according to the commercial arrangement. Consider stopping tildrakizumab between 12 weeks and 28 weeks if there has not been at least a 50% reduction in the PASI score from when treatment started. Stop tildrakizumab at 28 weeks if the psoriasis has not responded adequately. An adequate response is defined as: . a 75% reduction in the PASI score (PASI 75) from when treatment started, or . a 50% reduction in the PASI score (PASI 50) and a 5- point reduction in DLQI from when treatment started. 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/ta575 Scottish Medicines Consortium (SMC) decisions SMC No. SMC2167 The Scottish Medicines Consortium has advised (August 2019) that tildrakizumab (Ilumetri ®) is accepted for Skin restricted use within NHS Scotland in adults with moderate to severe plaque psoriasis who have failed to respond to conventional 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.
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→Appendix 1: monoclonal antibodies
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▶Common or very common Back pain. diarrhoea. headache. increased risk of infection. nausea
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Manufacturer advises that women of childbearing potential should use effective contraception during treatment and for at least 17 weeks after stopping treatment.
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Manufacturer advises avoid—limited information available.
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Manufacturer advises avoid—limited information available.
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Manufacturer advises monitor for signs and symptoms of active tuberculosis during and after treatment
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Manufacturer advises to take the syringe out of the refrigerator at least 30 minutes before administration, and to avoid injecting into areas of the skin that are affected by psoriasis or are tender, bruised, red, hard, thick, or scaly. Patients may self-administer Ilumetri ®, after appropriate training in subcutaneous injection technique.
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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 ▶Ilumetri (Almirall Ltd) A Tildrakizumab 100 mg per 1 ml Ilumetri 100mg/1ml solution for injection pre-filled syringes | 1 pre-filled disposable injection P £3,241.00 | 2 pre-filled disposable injection P £3,241.00 RETINOID AND RELATED DRUGS
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Manufacturer advises patients and their carers should be advised to seek medical advice if signs or symptoms of infection occur.
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Initially 100 mg, then 100 mg after 4 weeks, then
First-line fragment. Read the complete Indications and Dose section above.
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