Stelara®

Stelara® Ustekinumab UST

Janssen

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

Plaque psoriasis in adults, in ETA, IFX, ADA, UST and SEC also psoriatic arthritis, in ETA: indicated from 6 years of age

Under SVK Contract

Treatment of adult patients with severe psoriasis (Def. in USZ and Swiss S1 Guideline): PASI > 10 or BSA > 10 and/or DLQI > 10) in which UVB and PUVA or one of the following three systemic therapies (Ciclosporin, Methotrexate, Acitretin) have shown no therapeutic success. In Iximab, additional failure of another TNF blocker approved for psoriasis

Pre-filled syringe

lood count, liver enzymes, creatinine, U status, swan shaft test in urine, CRP/ ESR. Screening for HBV, HCV, HIV and tuberculosis incl. Rx thorax. Optional: ANA, HLA-Cw6 (personalized medicine as not yet validated response predictor for Ustekinumab)

Blood count, CRP, liver transaminases, creatinine, possibly β-HCG

Every injection

Every injection

s.c.

Week 0 and 4, repeated every 12 weeks: 45 mg s.c. <100 kg 90 mg s.c. ≥100 kg

2 - 4 weeks

Injection in the practice, since high costs per injection

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 %

17‘724.80 (22‘156) (45 mg = 90 mg)

Not recommended

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

3.8 - 5.1 %, association with clinical loss of efficacy

Absolute contraindications: Active infections including TB, pregnancy and breastfeeding. Relative contraindications: Malignant tumours, except treated basal cell carcinomas and lymphoproliferative diseases, live vaccinations. Simultaneous immunosuppressive therapy, to active infections: HBV

Local reactions at the injection site, upper respiratory tract infections, infections, cellulite, depression, vertigo, headache, pharyngolaryngeal pain, diarrhea, pruritus, back pain, myalgia, fatigue

Case-by-case decision

Case-by-case decision

Insufficient data

None known

Cancer risk is slightly increased for non-melanoma skin carcinomas, but not for other tumors