Drug Action
Brodalumab is a recombinant human monoclonal antibody that binds with high affinity to interleukin-17RA and blocks the activity of pro- inflammatory cytokines.
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Drug reference
Brodalumab is a recombinant human monoclonal antibody that binds with high affinity to interleukin-17RA and blocks the activity of pro- inflammatory cytokines.
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Moderate-to-severe plaque psoriasis (under expert supervision) ▶BY SUBCUTANEOUS INJECTION ▶Adult: 210 mg every week for 3 doses, followed by 210 mg every 2 weeks, consider discontinuing treatment if no response after 16 weeks
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Active Crohn’s disease. clinically significant active infection
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Chronic infection. history of Crohn’s disease (monitor for exacerbations). history of depressive disorders (discontinue if new or worsening symptoms develop). history of recurrent infection. history of suicidal ideation or behaviour (discontinue if new or worsening symptoms develop) CAUTIONS, FURTHER INFORMATION ▶Infection Manufacturer advises to consider anti- tuberculosis therapy for patients with latent tuberculosis before starting treatment with brodalumab. Manufacturer advises patients should be brought up-to- date with current immunisation schedule before initiating treatment.
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Brodalumab 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 ▶Brodalumab for treating moderate to severe plaque psoriasis (March 2018) NICE TA511 Brodalumab 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 therapies, including ciclosporin, methotrexate and PUVA (psoralen and long-wave ultraviolet A radiation), or these options are contra-indicated or not tolerated, and . the manufacturer provides the drug with the discount agreed in the patient access scheme. Stop brodalumab at 12 weeks if the psoriasis has not responded adequately, 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/ta511 Scottish Medicines Consortium (SMC) decisions SMC No. 1283/17 The Scottish Medicines Consortium has advised (updated May 2018) that brodalumab (Kyntheum ®) is accepted for restricted use within NHS Scotland for the treatment of moderate-to-severe plaque psoriasis in adults 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.
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→Appendix 1: monoclonal antibodies
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▶Common or very common Arthralgia. diarrhoea. fatigue. headache. increased risk of infection. myalgia. nausea. oropharyngeal pain ▶Uncommon Conjunctivitis ▶Frequency not known Meningitis cryptococcal. suicidal tendencies
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Manufacturer advises that women of childbearing potential should use effective contraception during treatment and for at least 12 weeks after stopping treatment.
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Manufacturer advises avoid—limited information available.
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Manufacturer advises avoid—no information available.
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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 tender, bruised, or affected by psoriasis. Patients may self-administer Kyntheum ®, 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 ▶Kyntheum (LEO Pharma) A Brodalumab 140 mg per 1 ml Kyntheum 210mg/1.5ml solution for injection pre-filled syringes | 2 pre-filled disposable injection P £1,280.00
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Manufacturer advises patients and their carers should be given training in subcutaneous injection technique. Manufacturer advises patients and their carers should seek medical advice if new or worsening symptoms of depression, suicidal ideation, or behaviour occur; they should also be advised to report signs and symptoms of infection.
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210 mg every week for 3 doses, followed by
First-line fragment. Read the complete Indications and Dose section above.
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