DUPIXENT

Key points

Favourable opinion for reimbursement as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP) for whom therapy with systemic corticosteroids and surgery do not provide adequate disease control.

What therapeutic improvement?

Therapeutic improvement in management.

Role in the care pathway?

Local corticosteroids are the reference treatment for CRSwNP irrespective of symptom severity. 

If the condition is severe with very marked symptoms, the need for short-term systemic corticosteroid therapy may be considered. Antibiotics are only used in the event of secondary infection.

If symptoms are not adequately controlled after at least 1 to 2 courses of systemic corticosteroid therapy, surgery is offered in the event of incapacitating CRSwNP resistant to well-managed medical treatment taken as directed by the patient for a sufficiently long period of time. It can be repeated.

The European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS) identified 5 criteria for the use of biologic therapies:

• ­    need for systemic corticosteroid therapy in the past two years;
• ­    evidence of type 2 inflammation;
• ­    significantly impaired quality of life;
• ­    significant loss of smell;
• ­    diagnosis of cormorbid asthma.

It considers that to be eligible for biological treatment:

• 3 out of 5 criteria must be met for patients with a history of surgery for nasal polyps;
• 4 out of 5 criteria in patients with no history of surgery for nasal polyps.

After 16 weeks of treatment and in the absence of a response for these criteria, biologic therapy should be discontinued. Otherwise, treatment is continued and assessed again after 1 year. The response to biologic therapies should be evaluated on the basis of the following criteria:

• reduced nasal polyp size;
• reduced need for systemic corticosteroids;
• improved quality of life;
• improved sense of smell;
• reduced impact of comorbidities.

Role of the medicinal product in the care pathway

DUPIXENT (dupilumab) may be used as a biologic therapy, in accordance with the SPC, as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP) for whom therapy with systemic corticosteroids and surgery do not provide adequate disease control.

Uncertainties remain due to the absence of assessment of the efficacy and safety of dupilumab for more than one year in the available clinical studies.

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