Dupilumab in chronic rhinosinusitis with nasal polyps: Real life data in a multicentric Sicilian experience.

OBJECTIVE: This study aimed to evaluate the effectiveness and safety of dupilumab during the first year of treatment in a real-life setting, focusing on improvement in nasal polyp score (NPS) as well as specific symptoms, quality of life and olfactory function. METHODOLOGY/PRINCIPAL: A multicentric observational cohort study was carried out. A total of 170 patients were enrolled in the Otorhinolaryngology Unit of the three University Hospitals and considered for dupilumab therapy. All recorder characteristics were age (at the first dupilumab application visit), sex, smoke habits, previous local and systemic corticosteroid therapy, history of endoscopic sinus surgery, number of previous endoscopic sinus surgery, concomitant asthma, history of an allergic condition, immunoglobulin E (IgE), allergy to nonsteroidal anti-inflammatory drugs (NSAIDs), Aspirin Exacerbated Respiratory Disease (AERD), other comorbidities associated, blood eosinophils, nasal polyp score, sinonasal outcome test 22 (SNOT 22), sniffin' stick test, the start date of dupilumab therapy and number of doses of dupilumab and eventually, Dupilumab's adverse events related to administration. The Wilcoxon test for dependent samples was performed to compare variables. Statistical significance was assumed for p values < 0.05. RESULTS: A statistically significant reduction in SNOT-22 and NPS was shown at the 6th and 12th month compared to baseline values (p < 0.001 for both comparisons). A statistically significant increase value at the Sniffin' sticks test was shown in the 6th and 12th month compared to baseline values (p < 0.001 for both comparisons). At the 12-month follow-up, according to EUFOREA indications, all patients were considered to remain in treatment with dupilumab and continued the treatment because of a reduced NPS, improved quality of life and a reduced need for system corticosteroids. Dupilumab seemed to be well tolerated by all patients. Any adverse effect of the drug led to the quit of biological treatment. CONCLUSIONS: This multi-centric real-life study supported the effectiveness of dupilumab as an add-on therapy to intranasal corticosteroids in patients with severe uncontrolled CRSwNP in improvement of quality of life, severity of symptoms, polyp size reduction and smell function. Furthermore, our data support the safety profile of monoclonal therapy with dupilumab.

Effectiveness and rapidity on olfatory fuction recovery in CRS patients treated with Dupilumab: a real life prospective controlled study.

BACKGROUND: Recovery of olfactory function plays a prominent role in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). While rates and timing of such recovery vary, monoclonal antibodies might yield better results which we aimed at evaluating with this study. METHODOLOGY: A prospective controlled study was conducted at our tertiary otolaryngological center from April 1, 2021, to October 1, 2022, in CRSwNP patients. We included an active group (n = 60 patients) performing dupilumab treatment and a control group (n = 60 patients) treated with intranasal and oral corticosteroids. Primary endpoints were changes in smell visual analogical scale (VAS) and SS-I (Sniffin' Sticks-identification) scores, and olfactory recovery rate. The secondary efficacy endpoints were nasal obstruction, rhinorrhea, headache, SNOT-22, and nasal congestion score (NCS). RESULTS: At 6 months, the active group demonstrated better outcomes than control in SS-I scores (10.23 ± 4.21 vs.3.68 ± 3.08; p < 0.001). No significant differences were found in blood eosinophil count, SNOT-22, and NPS (p > 0.05 for all). Olfactory function in the treatment arm improved in 86.66% (52/60 cases), with normal scores in 48.33% (29/60), while the control group reported a lower recovery rate (3/60; 5%), with no normal olfaction cases. Log-rank comparison for Kaplan-Meier functions was statistically significant (p < 0.001), but no differences were found in subanalysis in the active group based on blood eosinophil count at baseline, SNOT-22, and NPS scores. CONCLUSIONS: Patients who receive dupilumab treatment may experience a faster recovery of olfactory function compared to those receiving corticosteroid therapy. This result would be maintained regardless of the severity of type 2 CRSwNP inflammation, the volume of the polyps, or the patient's subjective symptomatology.

Sensibility, specificity, and accuracy of the Sinonasal Outcome Test 8 (SNOT-8) in patients with chronic rhinosinusitis (CRS): a cross-sectional cohort study.

PURPOSE: To analyze as the primary endpoint the accuracy, sensitivity, and specificity of the SNOT-22 assessing CRS severity and to compare the results with a version of the SNOT-8 obtained from the nasal domain items. METHODS: Data were obtained from a prospective multicenter controlled study of dupilumab in adults with moderate-severe CRSwNP. EQUATOR and STROBE network guidelines were adopted. A multivariate logistic regression model was used to evaluate the accuracy of the model with the full (SNOT-22) and reduced (SNOT-8) item set to predict the severity outcome. RESULTS: SNOT-22 demonstrated an AUC of 0.885 (95% CI 0.825, - 0.945), and sensitivity and specificity of 91.49% (83.92-96.25%) and 69.23% (48.21-85.67%), respectively. Interestingly, after stepwise items elimination good outcomes were reported for SNOT-8, with an AUC of 0.818 (95% CI 0.744-0.892), achieving a sensitivity of 93.51% (85.49-97.86%) and specificity of 57.14% (40.96-72.28%). CONCLUSION: Psychometric analyses support the accuracy, sensitivity, and specificity of the nasal domains of SNOT-22 to assess the impact on HRQoL in patients with CRSwNP.

Phonosurgery of Reinke's edema with microdebrider.

PURPOSE: To present our experience with a new microsurgical approach for treatment of the Reinke's edema in suspension laryngoscopy-microdebridement. After a short review of existing literature we introduce speech therapy before and after the surgery into the protocol. METHODS:  The authors compare the phonatory outcome, laryngostroboscopical results and subjective improvement of the voice of 30 patients with Reinke's edema that were operated with either microdebridement or cold steel surgery techniques. "Sandwich" speech therapy strategy was applied for the vocal rehabilitation before and after surgery in both patient groups. RESULTS: After the microdebridement and the speech therapy the mucosal wave was regular, symmetric and periodic in all patients. No signs of abnormal scar tissue or anterior adhesions were observed. Significant improvement of vocal parameters was found after the surgery in both groups of patients: operated with the microdebridement technique and the cold steel technique. The subjective voice evaluated by Voice Handicap Index (VHI-10) was improved for both patient groups in a homogenous way. CONCLUSIONS: Based on the similarity of the vocal outcome in the two groups, microdebridement of the vocal folds is an excellent method for removing the edema of the Reinke's space. Careful suction at a low voltage protects the lamina propria during the microdebridement. The authors discuss the indication to this innovating procedure in patients with difficult laryngeal exposure and small operating field.

A Supplement with Ribes Nigrum, Boswellia Serrata, Bromelain and Vitamin D to Stop Local Inflammation in Chronic Sinusitis: A Case-Control Study.

Although chronic sinusitis widely affects the adult population, the treatments currently used did not always satisfactorily solve the symptoms. Traditional therapy with steroids and antibiotics presents risks and benefits and the new drugs, i.e., monoclonal antibody, are valid solutions despite being quite expensive. Natural molecules could be a valid treatment that combines good efficacy and low price. We conducted a case -control study to evaluate the benefit of an oral supplement with Ribes nigrum, Boswellia serrata, Bromelain and Vitamin D on chronic sinusitis symptoms. 60 patients were randomly assigned to one of the three groups: control using nasal steroids only, treatment 1 using nasal steroid and 1 dose of the oral supplement for 30 days and treatment 2 in which patients used nasal steroid and two oral supplement doses daily for 15 days. Conditions of the nasal mucosa and a blood sample (WBC, IgE and CRP) were analyzed at T0, T1 (15 days after treatment) and T2 (30 days after treatment. Patients treated with the supplement improved their nasal findings (hyperemia of mucosa and rhinorrhea) with statistically significant differences from the control. Our preliminary data suggest that the addition of supplement containing Ribes nigrum, Boswellia serrata, Vitamin D and Bromelain to the traditional local therapy (nasal spray with cortisone) can be a supporting therapy to modulate the local inflammation in the nose in patients affected by chronic sinusitis.