Aspirin-Exacerbated Respiratory Disease (AERD), although uncommon in the general population,
is an important phenotype of severe asthma and nasal polyposis where it occurs in 15% of
severe asthmatics, and up to 30% of those with nasal polyposis. An important therapy for AERD
is aspirin therapy after desensitization (ADAT). This is an inexpensive and proven therapy to
improve the burden of sinus disease in AERD. Aspirin desensitization is the mechanism by
which tolerance is induced in AERD patients. This is a 1-2 day outpatient procedure whereby
increasing doses of aspirin are administered and the patients invariably experience some
degree of hypersensitivity reactions.
It is important to understand the effect of medications on the aspirin desensitization. It is
known that the leukotriene modifier medications decrease the severity of the reactions in
AERD. Other treatments such as antihistamines and the biologic agent omalizumab might have an
effect on either blocking or blunting reactivity in AERD during desensitization.
Dupilumab is a new respiratory biologic approved for atopic dermatitis, eosinophilic asthma
and nasal polyposis. As such, it is well situated to be used for many AERD patients whose
disease cannot be well controlled. The effect of dupilumab on the aspirin desensitization
process and reaction is unknown and is the topic of this investigation.
The primary objective is to determine the effect of dupilumab on reactions during aspirin
challenge/desensitization.
Phase:
Phase 2
Details
Lead Sponsor:
Scripps Clinic
Collaborators:
Regeneron Pharmaceuticals University of California, San Diego