Real-World Study Confirms Effectiveness, Safety of Therapy for CRSwNP

Patients who received dupilumab therapy for chronic rhinosinusitis with nasal polyps (CRSwNP) the first year after its approval in Italy experienced improvements in nasal polyps, quality of life, and sense of smell, according to a single-site study published in Acta Otorhinolaryngologica Italica.

“Our study confirms the efficacy and safety of dupilumab reported in registrational studies in a real-life context for all the main assessment parameters of CRSwNP,” researchers wrote.

The prospective study included 21 patients administered biweekly 300 mg dupilumab therapy for CRSwNP. Patients were evaluated at baseline and at 2-month intervals over 6 months.

Between baseline and 6 months, patient improvement on all assessment tools was progressive and significant, according to the study. Specifically, median values increased 5 points (from 3 to 8 points out of a possible 12) on the Brief Smell Identification Test and 8 points on the Asthma Control Test (from 15 to 23 points out of a possible 25). Meanwhile, median values decreased 3 points on the Nasal Polyp Score (from 5 to 2 out of a possible 8), 4 points on the Lund-Kennedy score (from 10 to 6 out of a possible 20), and 51 points on the Sinonasal Outcome Test (from 65 to 14 out of a possible 110).

The study found mostly mild adverse events, such as discomfort or burning at the injection site and transient weakness/headache. Four patients developed hypereosinophilia but without any symptoms. No patients discontinued treatment.

The patient with the weakest response to therapy (a 9-point reduction in Sinonasal Outcome Test and a stable Nasal Polyp Score and Lund-Kennedy score), researchers noted, had baseline laboratory results not suggestive of type 2 inflammation.

“A … topic worthy of further exploration is identification of a subset of patients who may benefit more from biologics,” the authors wrote. “In this perspective, it must be considered that dupilumab inhibits type 2 inflammation, which (in Western countries) is responsible for a majority—but not all—cases of CRSwNP; nevertheless, the evidence of this kind of inflammation is not strictly mandatory for prescription.”

Reference:
Trimarchi M, Vinciguerra A, Rampi A, et al. A prospective study on the efficacy of dupilumab in chronic rhinosinusitis with type 2 inflammation. Acta Otorhinolaryngol Ital. 2022;42(6):538-544. doi:10.14639/0392-100X-N2156