Dupilumab

Dupixent® Dupilumab

Regeneron Pharmaceuticals / Sanofi

Human monoclonal IgG4 antibody that binds to the α subunit of the IL-4/13 receptors.

Second-line treatment for moderate to severe atopic dermatitis in children aged 6 years and over and adults, where the condition is not adequately controlled or where topical corticosteroids cannot be used.

No

Reimbursement for adolescents (aged 6 years and over) and adults with severe atopic dermatitis (IGA 4 [on the IGA scale of 0–4] or SCORAD >50 or EASI ≥ 21.1).

Bronchial asthma subject to various conditions.

Moderate to severe prurigo nodularis in adults whose condition is not adequately controlled with topical corticosteroids.

Restrictions on use (at least 1 month of prior treatment with intensified topical therapy, phototherapy and, from the age of 16, systemic immunosuppressive therapy).

Restrictions regarding specialist doctors (only FMH-certified dermatologists and FMH-certified allergists may establish the indication).

Pre-filled syringe, pre-filled pen.

No blood tests required before starting treatment. Optional: complete blood count, liver function tests, screening for HBV and HCV.

Not necessary; clinical monitoring only.

Every 3 months, with clinical monitoring.

s.c.

Adults and adolescents > 60 kg: Initial dose: 600 mg (2 x 300 mg); children and adolescents: 15–30 kg: 300 mg on day 1, followed by 300 mg on day 15; 30–60 kg: 400 mg (2 x 200 mg); 60 kg and over: 600 mg (2 x 300 mg); thereafter, 300 mg every 2 weeks for all weight categories.

Treatment discontinuation after 16 weeks if no therapeutic success is evident.

(Definition of treatment success in AD: a reduction in the IGA score of ≥ 2 points, or an improvement of ≥ 50 per cent in the EASI score (EASI 50), or an improvement of ≥ 50 per cent in the SCORAD score (SCORAD 50) compared with baseline).

Week 16: 65 per cent, Week 52 (+TCS): 65 per cent according to the SOLO 1, SOLO 2 and CHRONOS studies.

Week 16: 23 per cent, according to the ADOL study.

Week 16: 40 per cent (+TCS), Week 52 (+TCS): 51 per cent, according to CHRONOS.

Hypersensitivity reactions, helminthiasis (patients with pre-existing helminthiasis must be treated before starting therapy; if an infection occurs during treatment with dupilumab, treatment must be suspended), persistent conjunctivitis, live and attenuated live vaccines (do not administer concurrently with dupilumab; it is recommended that vaccinations be updated in accordance with the Swiss vaccination schedule before starting treatment).

< 60 kg: 15,286 (16,560)

> 60 kg: 26,620 (27,625)

If a patient with a helminth infection does not respond to appropriate treatment, treatment with dupilumab must be suspended until the infection has cleared.

For AD: EASI and/or SCORAD after 16 weeks.

Antibodies were present in 5 per cent to 9 per cent of patients, were persistent in 2 per cent to 4 per cent, and were neutralising in 2 per cent to 4 per cent. Fewer than 0.6 per cent of patients showed a response with a high ADA titre, which was associated with reduced exposure and efficacy.

Hypersensitivity to the active substance or to any of the other ingredients. No data are currently available regarding pregnancy, breastfeeding or fertility.

Conjunctivitis, reactions at the injection site, cold sores, eosinophilia, headache, itchy eyes, blepharitis, serum sickness/serum sickness-like reactions, keratitis.

Live vaccines should not be administered during treatment. Dupilumab may affect the production of CYP450 liver enzymes. No clinically relevant effects of dupilumab on the activity of CYP1A2, CYP3A4, CYP2C19, CYP2D6 or CYP2C9.

Requires treatment with antituberculosis therapy (e.g. isoniazid) and vitamin B6 for 9 months; treatment with a biologic may be started after 1 month.

Insufficient data

No increased risk has been identified to date.