Sino-Nasal Outcome Test Research Articles

Quality of Life in Symptomatic Septal Perforation.

The aim of this study is to investigate the impact of septal perforation (SP) on quality of life (QoL). SP is compared to the general population and patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) using the Sino-Nasal Outcome Test 22 (SNOT-22). Prospective single-center study in a referral Rhinology Unit from January 2014 to March 2023. A total of 392 patients were included in three groups: controls (n = 141), CRSwNP (n = 118), and SP (n = 133). The mean score of the SNOT-22 was significantly higher in the CRSwNP group (42.4, SD = 24.4) and SP (46.5, SD = 22) compared to the control group (6.2, SD = 8.4). Scores by either items or domains were significantly higher in the CRSwNP and SP groups compared to the control group. There were no significant differences in the mean SNOT-22 between the CRSwNP and SP groups (p = 0.26; 95% CI -1.68-9.99). Domain-specific analysis of overall SNOT-22 scores revealed that patients with SP experienced higher levels of disturbances in sleep, function, and psychological domains (p ≤ 0.001). SP produces a negative impact on QoL similar to CRSwNP. Moreover, sleep, psychological, and function domains are significantly worse in SP. Etiology and area of SP influence nasal and emotion domain, though more studies on SP using SNOT-22 and specific questionnaires are needed. 3 Laryngoscope, 134:4480-4487, 2024.

Investigation of Blood Count-Based Inflammatory Biomarkers as Predictors of Response to Dupilumab Treatment in Patients with Chronic Rhinosinusitis with Nasal Polyps

Background/Objectives: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a type 2 inflammatory disease often resistant to standard treatments. Dupilumab, a monoclonal antibody targeting the IL-4α receptor, has shown efficacy in CRSwNP, but a significant subset of patients do not respond to this therapy. This study aims to investigate pretreatment complete blood count (CBC)-based inflammatory biomarkers as predictors of response to dupilumab in patients with CRSwNP. Methods: This mono-centric, retrospective, single-arm longitudinal cohort study included 80 patients with uncontrolled CRSwNP who received dupilumab treatment at the Medical University of Graz. Patients were classified into responder and non-responder groups based on a reduction of >1 in nasal polyp score (NPS) and a sinonasal outcome test-22 (SNOT-22) score <40 points at six months. Pretreatment CBC-derived biomarkers, including eosinophil count, neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic inflammation indices including the aggregate inflammation systemic index (AISI), systemic inflammation index (SII), and systemic inflammation response index (SIRI), were analyzed for their predictive value. Results: Of the 80 patients, 72.5% were classified as responders, while 27.5% were non-responders. A significant positive correlation was found between baseline eosinophil count and NPS reduction (p = 0.027), suggesting that higher eosinophil levels may predict higher NPS reduction in dupilumab treatment. However, no significant associations were observed between NLR, PLR, and systemic inflammation indices with treatment outcomes. Conclusions: Pretreatment eosinophil count may serve as a potential biomarker for predicting nasal polyp reduction in dupilumab treatment of CRSwNP. Other CBC-based inflammatory markers did not show significant predictive value. Further prospective studies are needed to validate these findings and explore additional, reliable biomarkers to optimize treatment outcomes for CRSwNP patients.

Differential Nasal Recolonization and Microbial Profiles in Chronic Rhinosinusitis With Nasal Polyps Patients After Endoscopic Sinus Surgery or Dupilumab Treatment: A Prospective Observational Study.

The role of microbial profiles in Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) pathogenesis is increasingly recognised, with microbial imbalances perpetuating inflammation. We performed this study to associate the different nasal microbiological profile changes with the response to surgical or monoclonal treatment. This prospective observational study evaluated changes in the nasal microbial profiles of 44 patients (22 dupilumab, 22 surgery) over 6 months. Clinical assessments were performed at baseline and follow-ups, including Sino-Nasal Outcome Test-22 (SNOT-22) scores and Sniffin Sticks-Identification (SS-I) olfactory testing. Microbial profiling of nasal swabs was carried out by microbial culture and subsequent molecular identification by Polymerase chain reaction (PCR) and sequencing. Baseline characteristics of 44 patients (22 dupilumab, 22 surgery) enrolled in this study were similar between groups. In the dupilumab group, Staphylococcus epidermidis prevalence rose from 37.03% to 59.25%, while Pseudomonas aeruginosa was eradicated. Moreover, dupilumab stabilised Staphylococcus aureus at 63.64%, while its prevalence increased in the surgery group (from 22.72% to 50%). When bacterial groups were associated with clinical scores, P. aeruginosa carriers had worse SNOT-22 (21.00 ± 1.41) and SS-I (5.50 ± 0.71) scores. Instead, S. epidermidis-colonised patients exhibited significantly lower mean SNOT-22 (15.39 ± 8.54) and greater SS-I scores (8.39 ± 3.77). The best outcomes were found in the subgroup of S. epidermidis carriers undergoing the dupilumab treatment. The two treatments modulated the microbial profiles differently, and, most importantly, clinical responses might depend on the association between treatment and the dominant bacterial species colonising the nasal cavity. Further investigation into microbial-restorative strategies could enhance outcomes for better treatment of CRS.

Correlation between Lund-Mackay computed tomography score and subjective symptoms in Chinese patients with nasal polyps.

The association between objective imaging findings and subjective symptoms remains undefined. To investigate the correlation between objective imaging findings and symptom severity in the overall chronic rhinosinusitis with nasal polyps (CRSwNP) population as well as its subendotypes according to the eosinophilic inflammation. Patients with CRSwNP undergoing endoscopic sinus surgery were included. All participants completed the Sino-Nasal Outcome Test (SNOT-22) questionnaire. The Lund-Mackay (LM) CT scores was also obtained. Spearman correlation analysis was performed to evaluate the correlation between CT scores and SNOT-22 scores. Forty-four non-eosinophilic CRSwNP(neCRSwNP) and 93 eosinophilic CRSwNP (eCRSwNP) patients were recruited. There was significant association between LM total score and nasal subdomain of SNOT-22 in the overall CRSwNP patients. The nasal symptom of SNOT-22 was significantly associated with maxillary, frontal, sphenoid, anterior drainage, and posterior drainage in all CRSwNP patients. In eCRSwNP and neCRSwNP patients, the sense of smell/taste was associated with sphenoid and posterior drainage. Thick nasal discharge was positively correlated with maxillary, frontal, and anterior drainage only in eCRSwNP patients. The high score of sphenoid and posterior drainage may suggest the occurrence of loss of sense of smell/taste, while high score of maxillary sinus may indicate suffering from thick nasal discharge in eCRSwNP patients.

Sinonasal Outcomes after Endoscopic Pituitary Surgery in Patients With Cushing's Disease.

The endoscopic endonasal approach (EEA) has become the preferred treatment for pituitary tumors, with minimal sinonasal morbidity. However, patients with Cushing's disease (CD) may represent a subgroup with prolonged impairment of sinonasal quality of life (QOL). We retrospectively identified patients with CD who underwent EEA at our institution. Control patients with non-functional tumors were matched by age, gender, and extent of EEA. The primary outcome was post-operative 22-item Sino-Nasal Outcome Test (SNOT-22) scores. Ten patients with CD met the selection criteria and 20 controls were selected for comparison. Nine of the CD patients achieved persistent endocrinologic remission post-operatively. Comparing the CD and control groups, there was no difference in post-operative SNOT-22 score at 1 or 3 months. At 6 months, SNOT-22 scores were significantly worse in the CD group (27.4 ± 21.6 vs. 2.8 ± 2.3, P = .039). SNOT-22 scores improved to normal from 1 to 6 months in the control cohort (P = .007), but not in the Cushing's group (P = .726). Morbidity was present across all SNOT-22 domains, but was highest in the sleep domain (P = .023). Only morbidity in the facial domain improved over time (P = .032). Patients with CD have significantly prolonged postoperative sinonasal QOL impairment following EEA compared to patients with non-functioning tumors, who normalize within 6 months. In CD patients, only morbidity in the facial domain, likely related to post-operative pain and nasal packing, improved over time, while the sleep domain was the most affected.

Improvement in health-related quality of life questionnaires with biologic treatment in severe asthma and comorbid chronic rhinosinusitis with or without nasal polyposis: a real-life experience.

Patients with severe asthma frequently have comorbid chronic rhinosinusitis (CRS) with or without nasal polyps, that can increase the symptom burden and complicate treatment. Real-life clinical data on the impact of biologic treatments on CRS-specific quality-of-life questionnaires are still lacking. In this retrospective real-life study, we collected data from patients with severe asthma with comorbid CRS with/without nasal polyposis at baseline, and after 3, 6 and 12 months of treatment with omalizumab, mepolizumab, benralizumab or dupilumab. In particular, we evaluated improvements in HRQoL as measured by SinoNasal Outcome Test-22 (SNOT-22, 0 - 110), Visual Analog Scale symptom scores (VAS, 0-10), and Asthma Control Test (ACT, 5-25) and the proportion of patients meeting the minimal clinically important difference (MCID). Disease-specific HRQoL, as measured by SNOT 22 and VAS score improved in all patients at 3, 6, and 12 months of treatment compared with baseline (SNOT-22: 14, IQR: 0-52 vs 10, IQR:0-30 vs 0, IQR:0-15 vs 0, IQR:0-12, p < 0.001, VAS score: 1, IQR: 0-5 vs 0, IQR:0-3 vs 0, IQR:0-2 vs 0, IQR 0-1, p < 0.001). After 3 months of treatment >80% of patients reached the MCID for ACT, while only patients on dupilumab showed to reach a MCID in 100% of cases. The effect size depended upon the symptom burden at baseline. The study confirms the efficacy of omalizumab, mepolizumab, benralizumab, and dupilumab in a real-life setting, with a rapid improvement in CRS-specific HRQoL and general health status. These data highlight the importance of targeting type 2 inflammation in asthmatic patients with co-existing upper and lower airways disease.The Authors disclose that preliminary data and analysis of the present study have been presented in abstract form during the "X International Workshop on Lung Health - Respiratory Disease and Immune Response", held in Nice on 19-21 January 2023.

S100A9 induces tissue remodeling of human nasal epithelium in chronic rhinosinusitis with nasal polyp.

Chronic inflammation triggers tissue remodeling in human nasal epithelial (HNE) cells. S100A9, a protein secreted by inflammatory cells, exhibits potent proinflammatory activity. However, its effect on HNE cell remodeling, such as squamous metaplasia, remains unclear. Therefore, this study aimed to determine the effects and underlying pathways of S100A9 on HNE cell remodeling and investigate its clinical implications in chronic rhinosinusitis (CRS). Cultured HNE cells were treated with S100A9. Bulk RNA sequencing was performed to analyze gene ontology (GO). Ingenuity pathway analysis (IPA) and Kyoto Encyclopedia of Genes and Genomes (KEGG) were also analyzed. Additionally, immunohistochemistry and multiplex immunofluorescence were performed on tissue samples obtained from 60 patients, whose clinical informations were also reviewed. GO enrichment analysis indicated that S100A9 induced tissue remodeling in HNE cells toward squamous metaplasia. IPA and KEGG commonly showed that S100A9 affected HNE cells associated with the IL-17 signaling pathway, including target molecules such as matrix metalloproteinase 1 (MMP1) and small proline-rich protein 2A (SPRR2A). Squamous metaplasia with a marked expression of S100A9 was observed in 50% of CRS with nasal polyps (CRSwNPs). In addition, in multiplex immunofluorescence, the S100A9 in sub-epithelium was co-expressed with myeloperoxidase, a neutrophil marker, and MMP1 and SPRR2A were strongly expressed in epithelial remodeling. Clinically, the expression of S100A9 correlated with sino-nasal outcome test-22 (r=0.294, p=0.022) and Lund-Mackay scores (r=0.348, p=0.006). S100A9 induces tissue remodeling in HNE cells. Its increased expression in CRSwNP, particularly squamous epithelium, correlates with disease severity. This suggests the clinical potential of S100A9 as a biomarker for CRS severity.

Screening for Psychiatric Disorders in Chronic Rhinosinusitis Patients Waiting for Surgery: A Prospective Cross-Sectional Study.

To assess the prevalence of depression, anxiety, insomnia and somatic symptom disorder (SSD) in chronic rhinosinusitis (CRS) patients who were waiting for surgery and to predict these psychiatric disorders using the 22-item Sinonasal Outcome Test (SNOT-22). A prospective cross-sectional study. The rhinology ward at our institution, a tertiary hospital. Adult patients (> 18 years) diagnosed with CRS who were admitted to the rhinology ward for endoscopic sinus surgery and were able to understand and complete the study questionnaires. Patient Health Questionnaire-9 (PHQ-9), Generalised Anxiety Disorder-7 (GAD-7), Insomnia Severity Index (ISI), Patient Health Questionnaire-15 (PHQ-15) and SNOT-22. Of the 159 participants recruited, 58 were at risk of depression (defined by PHQ-9 > 4, while 25 with PHQ-9 > 9), 49 were at risk of anxiety (defined by GAD-7 > 4, while 25 with GAD-7 > 9), 81 were at risk of insomnia (defined by ISI > 7, while 51 with ISI > 14) and 69 were at risk of SSD (defined by PHQ-15 > 4, while 24 with PHQ-15 > 9). The SNOT-22 score was closely correlated with the scores of psychometric tests and was an independent predictor of these psychiatric disorders. Patients with a high SNOT-22 score (> 30) are likely to be affected by comorbid psychiatric disorders and should be further evaluated by otolaryngologists. Depression, anxiety, insomnia and SSD are prevalent in CRS patients. Otolaryngologists should have a low threshold to ask the patient about psychiatric symptoms, especially for patients with an SNOT-22 score > 30.

Sinonasal Complications of Combined Transseptal–Transnasal and Bilateral Transnasal Approaches for Endoscopic Endonasal Transsphenoidal Pituitary Surgery

BackgroundThe endoscopic combined transseptal–transnasal technique for pituitary adenoma excision is notable for enhanced postoperative functional outcomes. Our study compared the incidence of anterior nasal septal perforation and the resulting sinonasal complications between this method and the bilateral transnasal approach. MethodsUtilizing a retrospective cohort from a preeminent tertiary referral center, we analyzed 141 cases of endoscopic endonasal transsphenoidal surgery performed between March 2018 and May 2023. Outcomes for the transseptal–transnasal group (n = 71) and the conventional bilateral transnasal group (n = 70) were compared. Nasal endoscopy and computed tomography were used to assess anterior nasal septal perforation. Functional outcomes were assessed preoperatively and at 6 months postoperatively using the Connecticut Chemosensory Clinical Research Center (CCCRC) test, Cross-Cultural Smell Identification Test (CCSIT), Sino-Nasal Outcome Test-22 (SNOT-22), and nasal obstruction symptom evaluation (NOSE) ResultsThe transseptal–transnasal approach exhibited reduced rates of postoperative ear fullness (p < 0.001), along with fewer subjective complaints of smell/taste loss (p = 0.022) and thick nasal discharge (p = 0.008), compared to the conventional approach. However, objective smell test results were not significantly different between the two approaches (p = 0.243 and p = 0.454 for CCCRC and CCSIT, respectively). Additionally, although statistically insignificant, a higher incidence of anterior septal perforation was observed with the transseptal–transnasal approach (p = 0.067). ConclusionFor the surgical treatment of pituitary adenomas, the transseptal–transnasal approach offers several advantages over the bilateral transnasal method, particularly in reducing postoperative complications. However, this technique requires careful attention for preventing the occurrence of anterior septal perforation.

Optimizing Corticosteroid Sinonasal Irrigation Outcomes Through 3D Printing: A Randomized Pilot Clinical Trial.

Topical corticosteroid irrigation plays critical role in the management of chronic rhinosinusitis (CRS). Yet, its efficacy can be highly variable. We sought to determine if personalized, 3-dimensional (3D)-printed nasal models can optimize head positioning and irrigation parameters, therefore improving patient outcomes. Randomized, single-blinded clinical trial. Tertiary medical center from November 2021 to July 2023. Sixty-two patients with CRS were randomized into either control (CG), backfill (BG), or model (MG) groups; daily 2 mg mometasone irrigations were then performed for 2 months with either standard head-forward and natural side-tilt position (CG), a head tilt of 90° to the side with fluid entering the lower nostril (BG), or in an optimized position as determined by a patient-specific 3D printed irrigation model (MG), respectively. A total of 36 patients completed the trial (CG: N = 14/23; BG N = 11/23, MG: N = 11/16). Significant posttreatment improvement in Lund-Mackay (LM) scoring was only observed in the MG (-3.73, 95% confidence interval = -5.71, -1.75; P < .001). Patient-reported outcome measures (Nasal Obstruction Symptom Evaluation, Sinonasal Outcome Test-22, and Visual Analog Scale of nasal congestion) improved significantly among all groups. Optimal model penetration scores significantly correlated to posttreatment MG LM score (Spearman's r = 0.65, P < .05). Among all groups, patients with prior endoscopic sinus surgery (ESS) (n = 19) had objectively less opacification at baseline; however, experienced the same degree of opacification reduction and symptom reduction as those without prior ESS (n = 17). The use of 3D printing to personalize head positioning may significantly improve objective corticosteroid irrigation outcomes. Mometasone irrigation may have similar subjective and objective effects on patients regardless of prior surgical history. Level 1 prospective, randomized, single-blinded clinical trial NCT06118554.

Functional and radiological sinonasal outcomes of CFTR modulators for sinus disease in cystic fibrosis: A meta-analysis.

Cystic fibrosis transmembrane conductance regulator (CFTR) modulators improve pulmonary outcomes in cystic fibrosis (CF) by stabilizing the CFTR protein on respiratory epithelial surfaces. To determine the efficacy of CFTR modulators on sinonasal outcomes in patients with CF, we performed a meta-analysis of clinical trials to date that include functional and radiographic evidence of sinus disease. English full-text articles were searched in PubMed, Embase, and Scopus databases. Two reviewers screened articles and a third reviewer resolved disagreements. Articles were included if they reported functional or radiological sinonasal outcomes in patients with CF before and after CFTR modulator therapies. Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed, and the risk of bias in non-randomized studies of interventions tool was used for quality assessment. The generic inverse variance method with random effects model was used for meta-analysis. Standardized mean difference (SMD) and mean difference (MD) were used as effect measurements. Seven prospective and two retrospective studies representing 248 patients were included in this analysis. There was a significant improvement in sinonasal outcome test-22 scores on elexacaftor‒tezacaftor‒ivacaftor (MD=12.80, [95% confidence interval, CI: 10.46‒15.13], p<0.001, n=222), with no heterogeneity detected (I2=0%, p=0.820). There was also a significant improvement in Lund‒Mackay scores (SMD=1.25, [95% CI: 0.58‒1.91], p<0.001, n=88), with heterogeneity detected (I2=67%, p=0.030). CFTR modulators improve functional and radiologic sinonasal outcomes. Given the utility of CFTR modulators, the treatment paradigm for CF-related chronic rhinosinusitis promises to evolve.

Multi-center study on sellar reconstruction after endoscopic transsphenoidal pituitary surgery.

Surgical techniques for sellar reconstruction include no reconstruction, use of synthetic materials, autologous grafts, and/or vascularized flaps. The aim of this study was to conduct a multi-center study comparing the efficacy and postoperative morbidity associated with different sellar reconstruction techniques. A retrospective chart review of patients who underwent endoscopic transsphenoidal surgery for pituitary tumors from five participating sites between January 2021 and March 2023 was performed. The variables included demographics, tumor characteristics, reconstruction technique, postoperative cerebrospinal fluid leak (CSF) leak, and 22-item Sino-Nasal Outcome Test (SNOT-22) scores. Comparisons of postoperative complications, SNOT-22 scores, and duration of surgery by type of onlay reconstruction were evaluated using Fisher's exact test, analysis of variance, and Kruskal‒Wallis test. Five hundred and one patients were identified. The median tumor size was 2.1cm, and 64% were non-functioning. Intraoperative CSF leak was identified in 38% of patients. A total of 89% of patients underwent onlay reconstruction: 49% were reconstructed with mucosal grafts, 35% with nasoseptal flaps, and 5% with other onlay techniques. Nasoseptal flaps were utilized more frequently in the setting of giant pituitary adenomas (>3cm), medial cavernous sinus wall resection, and high-flow intraoperative CSF leaks. Cases who utilized mucosal grafts had an overall shorter operating time (median: 183 min vs. 240 min; p<0.001). Five postoperative CSF leaks were identified, and therefore, statistical analysis could not be performed for this complication. The effectiveness and morbidity of different sellar reconstruction techniques are comparable. Vascularized flaps were utilized more frequently in the setting of larger tumors and high-flow intraoperative CSF leaks.

The effect of allergen immunotherapy in patients with central compartment atopic disease post-surgery.

To assess the effect of allergen immunotherapy (AIT) on patients with central compartment atopic disease (CCAD) and house dust mite (HDM) sensitization post-surgery. A retrospective cohort of surgically treated, HDM-sensitized CRSwNP patients phenotyped as CCAD was assessed. Patients were divided into two groups based on whether they had AIT commenced as part of their surgical care. All AIT patients started immunotherapy prior to their surgery. The primary endpoint was reformation of middle turbinate (MT) edema 12 months postsurgery. Secondary endpoints were corticosteroid irrigation use (<4 times/week vs. ≥4 times/week, %) and the rhinologic domain of the 22-item sino-nasal outcome test (SNOT-22). Demographic characteristics, concomitant asthma, smoking status, history of aspirin-exacerbated respiratory disease, conjunctival symptoms, polysensitization, serum eosinophils (cell×109/L), tissue eosinophilia (%>100/HPF), and serum IgE (kU/L) were also recorded. Eighty-six CCAD patients were assessed (41±14yrs, 64% female). AIT was applied in 37% (n=32). Baseline features were similar apart from greater conjunctival symptoms (72 vs. 45%, p=0.02) in the AIT group. At 12 months post-surgery, the AIT group has less MT edema (%≥diffuse 15.6 vs. 52.9, p<0.01). Patients on AIT also had less pharmacotherapy requirements at 12 months (%≥4/week, 37.5 vs. 79.6%, p<0.01). The rhinologic symptoms were similar (21.1±17.1 vs. 20.1±21.6, p=0.83). Surgery and pharmacotherapy are effective in managing CCAD, but the addition of AIT improved allergic phenomenon and allowed de-escalation of topical therapy. Longer term studies are required to demonstrate further immunomodulation.

Correlation between Serum Vitamin D Levels and Allergic Rhinitis Severity at Vajira Hospital: A Cross-Sectional Study

OBJECTIVE: Vitamin D affects the immune system and inflammatory process, and its deficiency is significantly associated with an increased prevalence of allergic rhinitis (AR). Therefore, the correlation between the serum 25-hydroxyvitamin D levels and the severity of AR symptoms must be investigated.METHODS: This research utilized a cross-sectional approach, focusing on patients aged 18 years and above diagnosed with AR at the Vajira Hospital, Navamindradhiraj University, Bangkok, Thailand from August 15, 2023, to January 15, 2024. The relationship between AR severity and serum vitamin D levels was analyzed using Pearson correlation coefficient. AR severity on symptoms and quality of life was assessed using the Thai version of Sinonasal Outcome Test-22 (SNOT-22) and Rhinoconjunctivitis Quality of Life questionnaire-36 (RCQ-36) questionnaires. Serum-specific immunoglobulin E (IgE) and total IgE levels were also measured to examine their relationship with the serum vitamin D level.RESULTS: Among the 58 participants, 34 (58.60%) had vitamin D deficiency. These individuals with vitamin D deficiency exhibited significantly higher AR severity compared with those without vitamin D deficiency. The mean difference between these groups was 21.90 points for SNOT-22 scores (95%CI: 17.71–26.69, p-value &lt; 0.001) and 19.17 points for RCQ-36 scores (95%CI: 12.08–27.34, p-value &lt; 0.001). Further analysis revealed a significant inverse correlation between serum vitamin D level and AR severity, with Pearson correlation coefficients of −0.72 for RCQ-36 (95%CI: −0.82 to −0.56, p-value &lt; 0.001) and 0.80 for SNOT-22 (95%CI: −0.88 to −0.68, p-value &lt; 0.001). No correlation with serum vitamin D level was found for serum-specific IgE and total IgE levels.CONCLUSION: A significant inverse relationship existed between serum vitamin D levels and AR severity. No correlation with serum vitamin D level was found for serum-specific IgE and total IgE levels.

Sinonasal Outcomes Obtained after 2 Years of Treatment with Benralizumab in Patients with Severe Eosinophilic Asthma and CRSwNP: A "Real-Life" Observational Study.

Benralizumab is a monoclonal antibody that targets the interleukin-5 receptor (IL-5Rα), leading to the rapid depletion of blood eosinophils. RCTs have demonstrated efficacy in patients with severe eosinophilic asthma (SEA). The aim of this study was to assess the efficacy of benralizumab on sinonasal outcomes in a real-life setting in patients with SEA and concomitant chronic rhinosinusitis with nasal polyps (CRSwNP). We included 25 patients (mean age: 57.47 years, range: 35-77, F/M = 12:13) who were prescribed 30 mg benralizumab every month for the first three administrations and then every 2 months. The primary endpoint was to evaluate changes in the SinoNasal Outcome Test-22 (SNOT-22) and nasal polyp score (NPS) over a 24-month treatment period. Secondary endpoints included measuring the effects on nasal obstruction and impaired sense of smell. The mean NPS score decreased significantly from 5.11 ± 1.84 at baseline to 2.37 ± 1.96 at 24 months. The mean SNOT-22 decreased from 57 ± 15.30 at baseline to 26 ± 16.73 at 24 months. The SSIT-16 mean score improved with an increase in olfactory performance from 5.23 ± 2.58 at baseline to 7 ± 3.65 at 24 months. Moreover, 8/25 patients (32%) required rescue treatment with systemic steroids and 2 patients required endoscopic sinus surgery. While the improvement may not seem optimal at 12 months, a progressive enhancement was noted during the second year of treatment. Despite our data showing an improvement in quality of life and a reduction in the size of nasal polyps, no significant improvement in olfactory sensitivity was observed. In addition, in several patients, rescue treatments were required to maintain control of nasal and sinus symptoms. A careful risk-benefit assessment is therefore needed when deciding to continue treatment, weighing the potential for further improvement against the risks of complications. Such decisions should always be made in the context of a multidisciplinary team.

Correlation of sino-nasal outcome test and nasal polyp score in dupilumab-treated chronic rhinosinusitis with nasal polyps

Correlation of sino-nasal outcome test and nasal polyp score in dupilumab-treated chronic rhinosinusitis with nasal polyps

Safety and effectiveness of a drug-loaded haemostatic sponge in chronic rhinosinusitis: a randomized, controlled, double-blind study

Some cases of chronic rhinosinusitis (CRS) require surgical treatment and postoperative nasal packing, but bleeding and adhesion are common complications after nasal surgery. Biodegradable drug-loaded implants hold great therapeutic options for the treatment of CRS, but little data are available regarding the safety and efficacy of a novel drug-loaded haemostatic sponge (DLHS) in the sinus. The aim of this study was to investigate the safety and efficacy of DLHS in the sinus. We conducted a prospective, randomized, controlled, double-blind clinical trial. In this clinical trial, 49 patients were enrolled and randomly divided into 2 groups: group A (n = 25) had the DLHS containing 1 mg budesonide and 0.67 mg sodium hyaluronate placed into the sinus, and group B (n = 24) had the Nasopore placed after ESS. Endoscopic follow-up was performed for 12 weeks, and the findings were classified using the discharge, inflammation, polyps/oedema (DIP) endoscopic appearance scores. All patients completed questionnaires to evaluate their sinonasal symptoms by using the sinonasal outcome test-22 (SNOT-22) Chinese version and visual analogue scale (VAS). Serum cortisol concentration in group A was measured prior to surgery and at days 1, 3, 7, and 14 after nasal surgery. Comparing group A and group B, at 2 weeks, no significant differences were observed in either objective or subjective parameters. The mean value of VAS for rhinorrhoea and DIP for oedema and the mean value of nasal adhesion were significantly lower in Group A than in Group B at 6 and 12 weeks, but a significant difference did not occur in SNOT-22 and VAS for dysosmia between the two groups at 6 and 12 weeks. The mean serum cortisol concentrations in group A at the follow-up were within normal limits without remarkable fluctuations. This study demonstrates the safety and efficacy of a novel biodegradable DLHS with the possibility of being used in CRS patients, and this sponge may reduce inflammation and minimize adhesions via controlled local drug delivery without measurable systemic exposure.

Non-Mucosa Sparing (Reboot) Surgery as a Possible Rescue Therapy in Patients Locally Unresponsive to Biologics

Objective: Evaluation of effectiveness of non-mucosa-sparing (eg, reboot) surgery in patients with chronic rhinosinusitis with nasal polyps (CRSwNP), poorly responders to mAb therapy, who failed repeated comprehensive endoscopic surgeries. Methods: Retrospective observational study. Patients who were under mAb for a comorbid condition but still had no control over their CRSwNP were included. Data collected were preoperative tissue eosinophilia, nasal polyp score (NPS), 22-item sinonasal outcome test (SNOT-22), visual analog scale (VAS) for nasal symptoms, Lund–Kennedy score for nasal crusts (LK-c) and synechiae (LK-s), and Lund–Mackay score (LMS). The same data were also collected postoperatively (at 12 months), besides LMS, and compared. Results: Overall, 20 patients were included. Pre-reboot scores were: NPS = 4.95 ± 1.70; SNOT-22 = 63.90 ± 19.15; VAS-global = 7.06 ± 1.50; LM = 19.0 ± 4.01; LK-c = 1.10 ± 0.64; and LK-s = 1.30 ± 0.73. Tissue biopsies revealed a high density of eosinophils in all cases, ≥10/HPF (range 10-60). Mean postoperative outcomes were: NPS = 0; SNOT-22 = 17.90 ± 6.80; VAS-global = 1.91 ± 1.17; LK-c = 1.45 ± 0.51; and LK-s = 1.50 ± 0.61. The difference of mean pre- and postoperative scores was significant for both NPS, SNOT-22 and VAS-global ( P &lt; .001). No differences were observed for LK-c and LK-s ( P &gt; .05). Nasal specimens showed markedly reduced tissue eosinophils (100% of cases). Conclusion: Reboot sinus surgery might be an effective solution for recalcitrant CRSwNP patients unresponsive to mAbs and multiple sinus surgeries.

Comparison between clinical and cytological findings in chronic rhinosinusitis with nasal polyps treated with Dupilumab.

Biologics represent a new therapeutic strategy for severe and recurrent chronic rhinosinusitis with nasal polyps (CRSwNP). Usually, their actual therapeutic effectiveness is assessed by reduction in nasal polyps and/or improvement in nasal symptoms and quality of life. However, these measures do not consider nasal immunophlogosis, which can be evaluated through nasal cytology. The purpose of this study was to assess not only the clinical impact but also the cellular changes in the nasal inflammatory infiltrate observed through nasal cytology of CRSwNP patients treated with Dupilumab for 24 months. Fifty-five CRSwNP patients treated with Dupilumab were collected. Patients were evaluated before starting treatment and at one, three, six, nine months, one year, one and a half years, and two years after the first drug administration. During follow-up visits patients underwent endoscopic evaluation, nasal symptoms and quality of life assessment, complete blood count and nasal cytology. During follow-up, significant improvement was found in Nasal Polyps Score (NPS), nasal patency, olfaction, Sino-Nasal Outcome Test (SNOT-22) score, and Visual Analogue Scale (VAS). Regarding nasal cytology, a reduction in eosinophils and mast cells in the cellular infiltrate was observed over the two-year follow-up period compared to baseline. Dupilumab has demonstrated broad efficacy in the management of CRSwNP from both clinical and cytological findings. Further studies are needed to confirm our findings and evaluate the biologics' impact on nasal mucosal inflammatory cells by nasal cytology with the aim of better identifying each patient's endotype and predicting the response to biologics.

Patient-reported disease control versus overall symptom severity as global metrics of chronic rhinosinusitis disease status.

Overall symptom severity (OSS) and patient-reported chronic rhinosinusitis (CRS) control are global measures of CRS identified as consensus, essential criteria for CRS disease control assessment. We sought to determine the functional relationship between these two metrics. Using an international multicenter mixed-methods design, 260 CRS patients were recruited. OSS score was measured using a visual analog scale. Patient-reported CRS control was measured as "controlled," "partly controlled," and "uncontrolled." Twelve participants underwent semi-structured interviews to discuss OSS and patient-reported CRS control. The majority of interviewed participants felt OSS and patient-reported CRS control measured different constructs-while OSS only measured symptoms, patient-reported CRS control was more global, including not only symptom severity but also concepts such as medication usage, activity impairment, and exacerbations. Nevertheless, OSS score was strongly correlated with (ρ=0.67, p<0.001) and highly predictive of patient-reported CRS control. OSS score of >4 (95% confidence interval [CI]: 1.8-4.2) had 74.7% sensitivity and 93.2% specificity in identifying patients reporting their CRS as not controlled. OSS score of >6.6 (95% CI: 4.1-7.1) had 77.0% sensitivity and 75.9% specificity in identifying patients reporting their CRS as uncontrolled. The 22-item Sinonasal Outcome Test score was also predictive of patient-reported CRS disease control but OSS was significantly more predictive. Patients conceptually view patient-reported CRS control as a more global measure that subsumes OSS. Quantitatively, however, OSS is highly correlated with patient-reported CRS control, possibly reflecting their redundancy. For ease of use, we recommend patient-reported CRS control be reflected by OSS <4 for controlled, 4≤ OSS<7 for partly controlled, and OSS ≥7 for uncontrolled CRS.