Canadian real-world study of access and clinical results using dupilumab for chronic rhinosinusitis with polyps

Abstract

Background Dupilumab is the first monoclonal antibody therapy to be approved in Canada for the treatment of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). The goal of the study was to assess its effectiveness and efficacy in a real-world setting. This study aims to assess how clinical outcomes of biologic therapy in real-world application (effectiveness) correspond to outcomes in clinical trials (efficacy) and to look into factors that might explain an efficacy-effectiveness gap. Methods A retrospective study evaluating disease specific sinonasal outcomes routinely collected for clinical care. This study included patients who were evaluated for coverage of dupilumab at a tertiary care rhinology clinic for the treatment of CRSwNP in the first year since dupilumab was approved in Canada for this indication. Sinonasal outcomes were be evaluated by collecting data on the Sino-Nasal Outcome Test (SNOT)-22 questionnaire. Results Eighty-five patients were considered for dupilumab therapy during the study period, 49% patients were able to attain coverage for the requested therapy. The mean SNOT-22 score at baseline was 60.56 (SD 21.63). After 16 weeks of treatment the mean SNOT-22 score decreased by 37 points to 23.36; at 28 weeks the mean SNOT-22 was 23.47. After 1 year, the mean SNOT-22 score was 14.37. Conclusion Patients treated with dupilumab for CRSwNP at out tertiary rhinology clinic showed substantial clinical symptom improvement that is similar to that observed in prior randomised clinical trials. No serious adverse effects related to dupilumab were reported in this cohort. Long-term follow-up is needed to inform effectiveness analyses beyond the 1 year clinical trial duration. Graphical Abstract

Validity and reliability of a french version of the olfactory disorders questionnaire

“…In future studies, authors may use the smell identification test (UPSIT) in addition to TDI to strengthen the olfactory evaluation. The Fr-ODQ could be used in many future French studies from France, Belgium or Canada in which authors will investigate smell function in common conditions, including chronic rhinosinusitis with or without polyps [ 16 , 17 ], or COVID-19 [ 18 ]. The main strengths of this study are the realization of TDI evaluations, allowing the confirmation of the olfactory dysfunction and the evaluation of ‘responsiveness to change’ parameter.…”

Measuring Nasal Patency and the Sense of Smell in CRSwNP Patients Treated with Dupilumab

“…This new approach is based on the identification of patients that have a higher chance to respond to a specific treatment according to the inflammatory pathways of the disease, following the principles of so-called precision medicine [ 3 ]. In this scenario, dupilumab (a biologic drug able to simultaneously block both IL-4 and IL-13 pathways) has been demonstrated effective in reducing the size of the nasal polyps and improving their QoL not only in randomised clinical trials [ 3 ], but also in real-life studies conducted on severe CRSwNP patients [ 4 , 5 , 6 ].…”

Clinical outcomes of dupilumab therapy in chronic rhinosinusitis with nasal polyps in a Canadian tertiary care rhinology practice

“…Following its approval by Health Canada in August 2020, dupilumab has been recommended for the treatment of Canadian patients with CRSwNP and prior functional endoscopic sinus surgery and medical therapy [ 14 ]. Since then, short-term results have been reported in Canadian patients who meet this criteria; among these patients, the most significant benefits to quality of life were seen in rhinologic symptoms, sleep quality, and mental health [ 15 ]. In Canada, dupilumab is not routinely covered by universal health insurance and may be only covered by private insurers in some circumstances.…”