Drug Action
Guselkumab is a recombinant human monoclonal antibody that binds selectively to interleukin- 23 and blocks the activity of pro-inflammatory cytokines.
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Drug reference
Guselkumab is a recombinant human monoclonal antibody that binds selectively to interleukin- 23 and blocks the activity of pro-inflammatory cytokines.
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Moderate-to-severe plaque psoriasis (specialist use only) ▶BY SUBCUTANEOUS INJECTION ▶Adult: Initially 100 mg, then 100 mg after 4 weeks, then maintenance 100 mg every 8 weeks, consider discontinuation if no response after 16 weeks
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Clinically significant active infection
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Risk of infection CAUTIONS, FURTHER INFORMATION ▶Risk of infection Manufacturer advises consider anti- tuberculosis therapy before initiation of guselkumab in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Manufacturer advises consider completion of appropriate immunisations according to current guidelines before initiating treatment (consult product literature for appropriate interval between vaccination and administration of guselkumab).
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Manufacturer advises that patients should be evaluated for tuberculosis infection before treatment.
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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.
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NICE decisions ▶Guselkumab for treating moderate to severe plaque psoriasis (June 2018) NICE TA521 Guselkumab 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 according to the commercial arrangement. Stop guselkumab treatment at 16 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/ta521 Scottish Medicines Consortium (SMC) decisions SMC No. 1340/18 The Scottish Medicines Consortium has advised (June 2018) that guselkumab (Tremfya ®) 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 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 Arthralgia. diarrhoea. headache. increased risk of infection. skin reactions
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Manufacturer advises effective contraception in women of childbearing potential during treatment and for at least 12 weeks after treatment.
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Manufacturer advises avoid—no information available.
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Manufacturer advises avoid during treatment and for up to 12 weeks after discontinuing treatment—no 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 avoid injecting into areas of the skin that show psoriasis. Patients may self-administer Tremfya ®, 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 ▶Tremfya (Janssen-Cilag Ltd) A Guselkumab 100 mg per 1 ml Tremfya 100mg/1ml solution for injection pre-filled pens | 1 pre-filled disposable injection P £2,250.00
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Manufacturer advises patients and their carers should be advised to seek medical attention if signs or symptoms of infection occur (monitor closely and suspend treatment if infection is clinically significant or unresponsive to treatment). Self-administration Manufacturer advises patients may self- administer following training in subcutaneous injection technique.
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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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