Specialty Tertiary Care for CRSwNP Significantly Improves Patient Outcomes

Sinonasal outcomes in chronic rhinosinusitis with nasal polyps (CRSwNP) showed significant improvement following administration of the monoclonal antibody dupilumab at the Rhinology Clinic at St. Michael’s Hospital in Toronto, Ontario, Canada, according to study findings published in Allergy, Asthma & Clinical Immunology.

The mean (SD) treatment duration of dupilumab in this study was 12.1 (5.0) months, and the primary outcome was change in sinonasal outcome test (SNOT-22) score from baseline to 1, 3, 6, and 12 months after dupilumab administration, for which patients completed a questionnaire at each follow-up visit. Higher SNOT-22 scores indicate worse symptoms.

Dupilumab was approved in Canada in 2020, but with hefty annual out-of-pockets costs ranging from $25,000 to $30,000 CAD, “there is a clear need to rigorously evaluate the indications for this novel treatment and its outcomes to guide patients toward the most efficacious and economic therapies,” investigators wrote.

The 27 patients included in this retrospective analysis underwent dupilumab treatment at the clinic between September 1, 2020, and May 1, 2022; 48 had been considered for the treatment but only these 27 received coverage or had the ability to fund the medication independently and were included in the final anallysis. Their mean age was 43.0 (10.9) years, and more than half were male patients. Comorbid aspirin-exacerbated respiratory disease (AERD) and comorbid asthma were seen in 40.7% and 96.3%, respectively—both known factors for CRSwNP recurrence and revision surgery. The most common number of prior surgeries was 3 or more in 10 patients; 7 patients had 2 prior surgeries, 8 patients had 1 surgery, and 2 patients had no surgical history (they instead preferred to try dupilumab first over surgical intervention).

For how the study participants funded the treatment independently, 11% paid out of pocket and 89% used their private insurance coverage. The average wait time for dupilumab approval was 3.6 (3.5) months, and mean total follow-up time was 10.8 (5.1) months.

Baseline SNOT-22 score was 60.6 (18.8), and the decrease was steady through 6 months, before levelling off by 12 months. At 1, 3, 6, and 12 months, the mean SNOT-22 decreases were 8.8, 26.5, 42.8, and 33.8, respectively, with the corresponding SNOT-22 scores being 56.8 (37.4), 40.4 (16.8), 26.1 (22.0), and 26.1 (17.9). The minimum clinically important difference for SNOT-22 scores is 8.9, the study authors wrote.

A comparison with the participants who had AERD showed more fluctuation in SNOT-22 scores. At 1, 3, 6, and 12 months, this group’s mean scores were 24.0 (33.9), 31.3 (22.2), 27.4 (21.8), and 15.2 (17.8), respectively.

The only adverse effects reported, each in 1 patient and because of which they discontinued treatment, were injection-site pain and lower leg edema. Further, all of the patients who remained on dupilumab through the 12-month follow-up did not require any sinus surgeries after starting treatment.

“This is one of few studies that have measured the therapeutic efficacy and assessed the accessibility of dupilumab in Canadian health care settings,” the study authors concluded. “This study further strengthens the existing body of literature supporting the addition of dupilumab as an adjunctive treatment for refractory CRSwNP, a disease entity with high symptom burden and quality of life impact that has remained historically challenging to treat.”

Reference

Grose E, Li AY, Lee JM. Clinical outcomes of dupilumab therapy in chronic rhinosinusitis with nasal polyps in a Canadian tertiary care rhinology practice. Allergy Asthma Clin Immunol. Published online March 30, 2023. doi:10.1186/s13223-023-00782-7