Use of dupilumab was associated with significant improvement in clinical symptoms of chronic rhinosinusitis (CRS) with nasal polyps among real-world patients in Canada, with benefits shown to be similar to that observed in randomized clinical trials.
Use of dupilumab was associated with significant improvement in clinical symptoms of chronic rhinosinusitis with nasal polyps (CRSwNP) among real-world patients from Canada, according to study findings published this week in the Journal of Otolaryngology - Head & Neck Surgery.
As the first monoclonal antibody therapy to be approved in the United States and Canada for the treatment of CRSwNP, dupilumab has been associated with substantial disease-modifying properties, including improved sense of smell and health-related quality of life.
However, as it is a newly approved therapy for the treatment of CRSwNP, researchers note that questions about its real-world efficacy in comparison to clinical trial results and the processes for accessing treatment remain a concern.
They conducted a retrospective cohort study of patients with CRSwNP being considered for coverage of dupilumab at a tertiary care rhinology clinic at The Ottawa Hospital, Canada, in the first year since the biologic was approved in Canada (August 18, 2020, to September 15, 2021).
Participants had undergone prior sinus surgery and had been managed with topical steroid therapy, with or without systemic steroids. The Sinonasal Outcome Test-22 (SNOT-22) questionnaire was used to evaluate patient outcomes, in which the minimal clinically important diference (MCID) was set at 8.9 points.
A total of 85 patients from the study cohort were considered for dupilumab therapy, with 49% able to attain coverage for the requested therapy—10 patients were noted to be awaiting the decision from their insurer during the study period.
Among the 53 patients who started therapy or were awaiting a decision, the mean number of prior surgeries was 2.6, mean time since the last surgical procedure was 49.5 months, and mean SNOT-22 score was 60.56 at baseline, which is considered to indicate severe CRS disease symptomatology.
“All patients who initiated dupilumab therapy opted to receive therapy by self-injection at home rather than receiving treatment in the rhinology clinic,” said the study authors.
After 16 weeks of treatment with dupilumab, mean (SD) SNOT-22 score decreased by 37 points from baseline to 23.36 (15.97) among patients. This improvement was maintained at 28 weeks with a mean (SD) SNOT-22 score of 23.47 (17.66).
For the 16 patients who completed 1 year of therapy at the time of the review, mean (SD) SNOT-22 score was 14.37 (11.76). The mean (SD) baseline score of the loss of sense of smell and taste item of the SNOT-22 was 4.24 (1.2), which reduced to 1.8 (1.7) and 1.65 (1.53) after 16 and 28 weeks of treatment, respectively.
Baseline SNOT-22 scores grouped by domains indicated that the rhinologic symptoms domain (maximum score = 30) had the highest score (mean [SD], 20.4 [5.8]) followed by the sleep dysfunction domain (mean, 15.6 [6.7]) and the extranasal rhinologic symptoms domain (mean [SD], 8.7 [3.2]).
“Further study is required to evaluate the long-term implications of monoclonal antibody therapy use in patients with poorly controlled CRS despite adequate surgical and medical therapy,” concluded the study authors.
Kilty SJ, Lasso A. Canadian real-world study of access and clinical results using dupilumab for chronic rhinosinusitis with polyps. J Otolaryngol Head Neck Surg. 2022;51(1):17. doi:10.1186/s40463-022-00570-0