Spesolimab

Spevigo® Spesolimab

Boehringer Ingelheim

A human monoclonal anti-interleukin-36 receptor antibody that prevents its activation by its ligands (interleukin-36 α, β and γ) and, consequently, the downstream activation of pro-inflammatory signalling pathways.

Not yet authorised in Switzerland (off-label use) or see Compassionate Use Programmes.

Authorised in the EU since February 2023 and in the USA since September 2022 as monotherapy for the treatment of flares in adult patients with generalised pustular psoriasis (GPP).

No

Off-label use

450 mg concentrate for the preparation of a solution for infusion.

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

Complete blood count (CBC), liver function tests, CRP

EFFISAYIL™-1 (registration trial): After one week, 54 per cent of treated patients showed no visible pustules (GPPGA pustulation score 0), compared with 6 per cent of patients treated with placebo. In 43 per cent of patients treated with spesolimab, the skin was clear or almost clear (GPPGA score 0/1) after one week (placebo group: 11 per cent).

i.v.

A single dose of 900 mg of spesolimab administered intravenously over 90 minutes; if relapse symptoms persist, a further single dose of 900 mg may be administered intravenously after one week. No premedication is required.
Clinical data on the treatment of subsequent relapses are currently still very limited.

If symptoms of a relapse persist, a further 900 mg may be administered one week after the initial dose.

Store in the fridge at 2 to 8 °C.

There must be an interval of at least four weeks between the administration of live vaccines and the start of spesolimab treatment.

No live vaccines should be administered for a period of at least 16 weeks following treatment with the antibody.

The concomitant use of other immunosuppressants and spesolimab is not recommended.
At the start of spesolimab treatment, other GPP treatments should be discontinued and other treatments (for example, with systemic immunosuppressants) should not be used concomitantly to treat the disease flare.

EU: approx. €22,000

If there are any signs of anaphylaxis or other severe hypersensitivity reactions, treatment must be discontinued immediately.

After 7 days, repeat the single dose of 900 mg if necessary (e.g. if GPPGA ≥ 2 & GPPGA pustulation subscore ≥ 2).

No data

Absolute contraindications: Clinically significant active infections, active tuberculosis, pregnancy and breastfeeding.

Relative contraindications: Spesolimab may increase the risk of infection.

In patients with a history of chronic or recurrent infection, the risks and benefits of treatment should be weighed up beforehand.

Hypersensitivity reactions and infusion-related reactions, increased susceptibility to infection (particularly upper respiratory tract infections and urinary tract infections), injection-site reactions, anaphylaxis pruritus, fatigue, DRESS syndrome, peripheral neuropathy.

Insufficient data

Insufficient data

Insufficient data

No live vaccines; no CYP interactions known.

In patients with latent TB, a history of TB or possible previous exposure to individuals with active TB, where adequate treatment cannot be confirmed, anti-TB therapy should be considered before starting treatment
Following treatment with spesolimab, patients should be monitored for signs and symptoms of active TB.

Insufficient data