Guselkumab

Tremfya® Guselkumab

Janssen-Cilag AG

Human monoclonal IgG1 lambda antibody, binds to and blocks IL-23p19.

Moderate to severe plaque psoriasis and psoriatic arthritis; approved for use from the age of 18.

Yes

Treatment of adult patients with severe psoriasis (defined in the USB as: PASI ≥ 10 or BSA ≥ 10 and/or DLQI > 10), in whom phototherapy or one of the following three systemic therapies (ciclosporin, methotrexate, acitretin) has not been successful.

Patients aged 18 years and over with active psoriatic arthritis, either on its own or in combination with DMARDs, where the response to previous therapy with DMARDs has been inadequate.

Pre-filled syringe, pre-filled pen.

Complete blood count, liver function tests, creatinine, urinalysis, pregnancy test, CRP, screening for HBV, HCV, HIV and TB (optional: including chest X-ray). Update vaccinations in accordance with the vaccination schedule.

None, PASI every 6 months.

Months 1 to 3: every 4 weeks; thereafter every 3–6 months.

s.c.

100 mg in weeks 0 and 4, then 100 mg every 8 weeks.

Discontinuation of treatment if no improvement is seen after 16 weeks (SL).

Week 16: 91.2%

Week 48: 87.8%

Week 16: 73.3%

Week 48: 76.3%

Avoid live vaccines (recommendation from the European Guidelines: no injections for at least 4 weeks following a live vaccine, and for at least 12 weeks after the last dose), infections, tuberculosis, malignant diseases, concomitant treatment with other systemic immunosuppressants or phototherapy, hypersensitivity.

15,162 (17,689)

84.1% achieve PASI 90 again following retreatment after 16–20 weeks.

PASI, BSA and DLQI after 12 and 24 weeks.

15 per cent, of which 7 per cent are neutralising. The implications for treatment remain unclear.

Absolute contraindications: Clinically relevant active infections

Relative contraindications: Acute, recurrent or chronic infections; pregnancy/breastfeeding.

Upper respiratory tract infection (13.9 per cent), herpes simplex infections, dermatophytosis, diarrhoea, urticaria, arthralgia, headache, elevated transaminases, reactions at the injection site.

Insufficient data

Insufficient data

Drug interactions between guselkumab and substrates of various CYP enzymes (CYP3A4, CYP2C9, CYP2C19, CYP2D6 and CYP1A2) are unlikely.

Requires treatment with tuberculostatic therapy (e.g. isoniazid) and vitamin B6 for 9 months; treatment with a biologic may be started after one month.

Treatment may be interrupted in the event of major surgery (decision to be made on a case-by-case basis; or surgery between two applications).

No increased risk has been identified to date.