IL-13-Inhibitor Lebrikizumab

Ebglyss® 

Almirall

Selective monoclonal antibody against IL-13 and prevention of the heterodimeric receptor signalling complex of IL-13Rα1 and IL-4Rα

Ebglyss is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents aged 12 years and over weighing at least 40 kg when treatment with topical medicinal products does not provide adequate disease control or is not medically recommended.

Currently missing: https://svk.org/dienstleistungen/medikamente/

Lebrikizumab is reimbursed for the treatment of adult and adolescent patients (aged 12 years and over and weighing at least 40 kg) with severe atopic dermatitis (IGA 4 [on IGA scale of 0-4] or SCORAD >50 or EASI ≥ 21. 1), provided that the patients have responded inadequately to intensified local treatment with prescription topical therapies (topical corticosteroids and/or calcineurin inhibitors) and phototherapy (if available and indicated) and to systemic treatment with a conventional immunosuppressant (excluding systemic corticosteroids) for at least one month or for whom these therapies are contraindicated or had to be discontinued due to clinically relevant side effects.

Injection solution s.c. (pre-filled syringes / pre-filled pen)

Patient training before using autoinjectors; first administration under medical supervision

None

every 3 months: EASI

s.c.

Two initial doses of 500 mg each as a subcutaneous injection (two injections of 250 mg each) at weeks 0 and 2, followed by a dose of 250 mg as a subcutaneous injection every fortnight until week 16 and then a maintenance dose of 250 mg as a subcutaneous injection every four weeks.

Onset of effect after 2 - 6 weeks

If no therapeutic success has been achieved after 16 weeks of treatment with lebrikizumab, i.e. no IGA reduction of ≥ 2 points compared to the initial value or no ≥50% improvement in the EASI score (EASI 50) compared to the initial value or no ≥50% improvement in the SCORAD score (SCORAD 50) compared to the initial value, treatment should be discontinued.
After 52 weeks of uninterrupted treatment of atopic dermatitis with lebrikizumab, a new cost approval must be obtained from the health insurer after prior consultation with the medical examiner.

EASI-75 was achieved with lebrikizumab after 16 weeks in 52-59%, and only in 11-16% with placebo. 

 ‘Clear or almost clear’ after 16 weeks was achieved with lebrikizumab in 33-43%, and in 11-13% with placebo

Hypersensitivity to active substance content, no data on safety and efficacy in patients with liver dysfunction, no live vaccines

CHF 18.909 and around CHF 13.656,50 in the following year.

Insufficient data

Insufficient data

Insufficient data

Hypersensitivity to the active substance or any of the other ingredients. Active, severe infections, especially helminthoses. Pregnancy and breastfeeding (critical risk-benefit assessment recommended). Live vaccines and live attenuated vaccines should not be administered concomitantly with lebrikizumab as clinical safety and efficacy have not been established.

The most common adverse effects are conjunctivitis (6.9%), reactions at the injection site (2.6%), allergic conjunctivitis (1.8%) and dry eyes (1.4%). Herpes zoster is also occasionally observed.

Data still insufficient

Data still insufficient

Data still insufficient

Data still insufficient

Data still insufficient

Data still insufficient

Data still insufficient