Ustekinumab

Stelara® Ustekinumab

Janssen

Human monoclonal IgG1 antibody that binds to and blocks p40 of IL-12 and IL-23

Moderate plaque psoriasis from the age of 12; severe plaque psoriasis, authorised from the age of 6; psoriatic arthritis in adults.

Patients aged 6 years and older with severe plaque psoriasis (PASI > 10 or BSA > 10 and/or DLQI > 10), in whom UVB and PUVA or one of the following three systemic therapies (cyclosporine, methotrexate, acitretin) has failed to produce a therapeutic response.
Treatment of adult patients with active psoriatic arthritis, either as monotherapy or in combination with methotrexate (MTX), when the response to DMARDs has been inadequate.

Pre-filled syringe

Differential blood count, liver enzymes, creatinine, urinalysis, pregnancy test, CRP, screening for HBV, HCV, HIV and TB (optional: including chest X-ray).

Only differential blood count and liver enzymes, every 6 months.

At each injection.

Weeks 0 and 4, then every 12 weeks.

Plaque psoriasis: 45 mg s.c. for patients <100 kg; 90 mg s.c. for patients ≥100 kg.

Psoriatic arthritis: 45 mg s.c.; if the response is inadequate, the dose may be increased to 90 mg s.c.

In patients who show no response after up to 28 weeks of treatment, discontinuation of therapy should be considered.

Week 12: 45/90 mg: 70.1/75.5%

Week 24: 45/90 mg: 66.5/75.0%

Week 12: 45/90 mg: 47.2/58.2%

Week 24: 45/90 mg: 35.5/48.5%

45 mg: 13,588 (15,852)

90 mg (> 100 kg): 13,588 (15,852)

Insufficient data; individual treatment decision

PASI (use PrecisePASI for greater accuracy once PASI < 10), BSA and DLQI after 12 and 24 weeks.

3.8–5.1%, associated with a loss of clinical efficacy.

Absolute contraindications: Active infections, including TB, pregnancy and breastfeeding.

Relative contraindications: Malignant tumours, except for treated basal cell carcinomas and lymphoproliferative disorders; live vaccines. Concomitant immunosuppressive therapy; active HBV infection.

Local reactions at the injection site, upper respiratory tract infections including allergic alveolitis, eosinophilic pneumonia and non-infectious organising pneumonia, infections, cellulitis, depression, vertigo, headache, pharyngolaryngeal pain, diarrhoea, pruritus, back pain, myalgia, fatigue, development of exfoliative dermatitis, erythroderma, and, very rarely, cases of systemic lupus erythematosus.

Decision on a case-by-case basis.

Decision on a case-by-case basis.

Insufficient data.

None known.

Requires treatment with isoniazid and vitamin B6 for 9 months; treatment with a biologic may be started after 1 month.

The risk of cancer is slightly increased for non-melanoma skin cancers, but not for other tumours.