Ustekinumab
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 not shown therapeutic success. In Iximab, additional failure of another TNF blocker approved for psoriasis
Pre-filled syringe
Blood 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
Inj Solvent
systemic