Dupilumab for chronic rhinosinusitis with nasal polyposis: proof of added benefit
The extent is non-quantifiable, but at least considerable
The drug dupilumab, already used in the treatment of neurodermatitis and asthma, has also been approved since 2019 as a supplement to intranasal corticosteroids for the treatment of adults with severe chronic rhinosinusitis with nasal polyposis for whom systemic corticosteroids alone or surgery do not provide adequate disease control. The German Institute for Quality and Efficiency in Health Care (IQWiG) has now investigated in an early benefit assessment whether dupilumab as add-on therapy with intranasal corticosteroids offers patients with such chronic inflammation of the nasal mucosa and paranasal sinuses an added benefit in comparison with intranasal corticosteroids alone.
Two randomized controlled trials (RCTs) showed that reduction of several symptoms was greater under a combination of dupilumab and the intranasal corticosteroid mometasone furoate than under treatment with mometasone furoate alone. These advantages were not accompanied by any disadvantages. Thus, there is proof of a non-quantifiable, but at least considerable added benefit.
Severe burden of disease
A chronic inflammation of the nasal mucosa and the paranasal sinuses may at first sound not particularly dramatic. However, the new drug dupilumab is only approved for patients with nasal polyposis who have persistent and partly severe symptoms despite surgery or treatment with systemic corticosteroids. These symptoms can include loss of smell or persistent severe runny or permanently congested nose.
The treatment arms of both studies, on which the IQWiG dossier assessment was based, only included patients with at least two symptoms for at least 12 weeks, one of which had to be moderate to severe nasal congestion. Almost all patients had received at least one sinonasal surgery and/or treatment with systemic corticosteroids in the preceding two years without achieving sufficient symptom relief.
Results on symptoms and side effects
No deaths occurred in the studies, and health-related quality of life was not recorded. Hence, the outcome categories of morbidity (i.e. symptoms) and adverse events (i.e. side effects) remained for the benefit assessment. In terms of symptoms, clear advantages of the new combination were found both in a survey of the patients with the SNOT-22 questionnaire and in the following outcomes: nasal congestion, loss of smell, runny nose, visual analogue scale for rhinosinusitis and visual analogue scale for health status (EQ-5D). No complete assessment of side effects is possible on the basis of the available analyses. However, it can be estimated from the available data that there is no greater harm from dupilumab than from intranasal corticosteroids.
Overall, there is proof of an added benefit of add-on therapy with dupilumab in comparison with the appropriate comparator therapy. This added benefit can be categorized as considerable for one of the symptom outcomes, and is non-quantifiable for the others on the basis of the available data. Overall, the added benefit is therefore rated as non-quantifiable, but at least considerable.
G-BA decides on the extent of added benefit
The dossier assessment is part of the early benefit assessment according to the Act on the Reform of the Market for Medicinal Products (AMNOG) supervised by the Federal Joint Committee (G-BA). After publication of the dossier assessment, the G-BA conducts a commenting procedure and makes a final decision on the extent of the added benefit.
More English-language information will be available soon (Sections 2.1 to 2.6 of the dossier assessment as well as easily understandable information on informedhealth.org). If you would like to be informed when these documents are available, please send an e-mail to email@example.com.