At the recent American Rhinologic Society (ARS) Annual Meeting (Philadelphia, PA, USA, September 9-10, 2022), a multicenter team sponsored by Sanofi and Regeneron Pharmaceuticals presented their new discoveries in a poster titled “SNOT-22 Items and Association with Objective Measures in Dupilumab-treated Patients with Severe Chronic Rhinosinusitis with Nasal Polyps from SINUS-24 and SINUS-52 Trials”.
Chronic rhinosinusitis with nasal polyps (CRSwNP) is a condition that can cause pain in the sinuses, a stuffy nose, and a reduced ability to smell. Even though nasal polyps are not cancerous growths, CRSwNP can make patients dejected by affecting their quality of life.
Dupilumab is an FDA-approved inflammatory inhibitor used to treat allergic diseases. Dupilumab significantly improved objective standards such as the nasal polyp score (NPS) and the Lund-Mackay CT score (LMK) in clinical studies SINUS-24 and SINUS-52 (NCT02972468; NCT02898454). However, it is still unknown how Dupilumab can relieve the major complaints patients suffer from the most.
The 22-item Sinonasal Outcome Test (SNOT-22) is a subjective questionnaire that measures how a nasal disease affects the health-related quality of life (HRQoL). It includes classic nasal and extra nasal symptoms, like inadequate sleep, ear/face pain, and mood changes. Each item is scored between 0 (no problem) and 5 (worst possible problem).
This study included 724 patients from the SINUS-24 and SINUS-52 trials, with 438 receiving Dupilumab and 286 receiving placebos. Initially, the 5 SNOT-22 items patients rated most important before intervention were evaluated. The results indicated that at baseline, the most important SNOT-22 items were “decreased sense of smell” (87%) and “nasal blockage” (82%).
Twenty-four weeks after treatment with Dupilumab or placebos, the scores for “decreased sense of smell” and “nasal blockage” were rechecked. A patient was considered to be improving if the score decreased from baseline to Week 24. If the score remained the same or increased from the baseline, the patient was considered to have reported a non-improvement (no change or worsening).
The researchers found that significant improvements occurred in 77% of patients receiving Dupilumab for “decreased sense of smell/taste” and 80% for “nasal blockage,” compared to 30% and 44% of patients receiving placebos. Additionally, 71% of patients reported improvements in both items when treated with Dupilumab, whereases only 20% for placebos. Surprisingly, compared to those with no change or worsening on these two SNOT-22 items, Dupilumab-treated patients got a better sense of smell/taste or nasal blockage and had numerically more significant improvements in objective scores (NPS and LMK).
Dr. Mullol, the presenter, concluded, “Dupilumab treatment significantly improved decreased sense of smell/taste and nasal blockage, the two SNOT-22 items identified as most important to patients. Patients who improved in these top two SNOT-22 items also had a greater objective treatment effect in NPS and LMK score.”
Sanofi and Regeneron’s Dupilumab (Dupixent) is the first FDA-approved biologic therapy for CRSwNP with uncontrolled symptoms. Moderate-to-severe eczema and asthma are two other types II inflammatory diseases for which Dupilumab is currently approved. Notably, many CRSwNP patients also have asthma. Dupilumab can improve lung function in these patients as well. In the future, Dupilumab is expected to bring good news to patients suffering from other types II inflammatory diseases.