Tildrakizumab

Ilumetri® Tildrakizumab

Almirall AG

Humanised monoclonal IgG1 kappa antibody that binds to and blocks IL-23p19.

For moderate to severe plaque psoriasis in patients aged 18 and over.

Yes

Treatment of adult patients with severe plaque psoriasis (defined in the USB as: 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) have not been successful.

Pre-filled syringe

Full blood count, liver enzymes, creatinine, CRP, HBV/HBC, HIV, TB test, urinalysis, pregnancy test.

Blood count, liver function tests.

Every 3–6 months

s.c.

100 mg in weeks 0 and 4, then every 12 weeks; (no dose adjustment required for patients over 65 years of age or with renal or hepatic impairment), if necessary 200 mg in each case for high disease burden and/or body weight > 90 kg.

Discontinuation of treatment if no improvement is seen after 28 weeks (SL).

Week 12: 63.8 per cent, Week 28: 80.4 per cent

(reSURFACE 1+2 at a dose of 100 mg)

Week 12: 34.6 per cent, Week 28: 51.6 per cent

(reSURFACE 1+2 at a dose of 100 mg)

Wait at least 4 weeks after live vaccination before administering an injection; no injection until at least 17 weeks after the last dose.

16,187 CHF (22,931)

No loss of efficacy following interruption has been reported; the mean time to loss of PASI75 is 32 weeks after the last injection.

PASI, BSA and DLQI after 16 and 28 weeks.

Antibody formation against tildrakizumab in 7.3 per cent, with no impact on efficacy or safety.

Absolute contraindications: Clinically significant active infections.

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

Upper respiratory tract infection (TIL 100 mg 12.9 per cent, placebo 11.0 per cent), headache (TIL 100 mg 3.7 per cent, placebo 3.7 per cent); adverse reactions at placebo levels.

Insufficient data

Insufficient data

Insufficient data

None known. Avoid live vaccines.

Start TB prophylaxis at least 1 month before the start of treatment.

Limited data available. The specific mechanism of action (IL-23p19 inhibition) means that the likelihood of impaired wound healing is very low. Planned operations should not be scheduled during the period leading up to the next dose.

No increased risk has been identified to date.