RESUMO
Objectives: For nearly 3 years, the monoclonal antibody dupilumab has been approved in Germany for the treatment of patients with chronic rhinosinusitis with nasal polyps (CRSwNP). Although efficacy has been demonstrated in large double-blind, placebo-controlled clinical trials, few reports of real-world data on this therapy have been published to date. Methods: Patients with an indication for treatment with dupilumab for CRSwNP were included in the study and followed up every 3 months for a period of 1 year. At the baseline visit, demographic data, medical history, comorbidities, nasal polyp score, disease-related quality of life (SNOT-22), nasal congestion, and sense of smell (VAS and Sniffin Sticks test) were recorded. In addition, total blood eosinophil counts and serum total IgE were measured. During follow-up, all of the described parameters and possible adverse events were recorded. Results: Eighty-one patients were enrolled in the study, of whom 68 patients were still receiving dupilumab after 1 year of follow-up. Eight patients discontinued therapy, with only 1 patient discontinuing due to severe side effects. The Polyp score decreased substantially during follow-up, and parameters for disease-related quality of life and sense of smell increased significantly. Total IgE levels decreased significantly, and eosinophils leveled off at baseline after an initial increase after three months of therapy. No clinical data could be identified to a priori predict a treatment response. Conclusions: Dupilumab shows effectiveness and safety in the treatment of CRSwNP under real-world conditions. More research on systemic biomarkers and clinical parameters to predict treatment response is necessary.
RESUMO
BACKGROUND: Choanal Atresia is a congenital condition that presents as a blockage from the nasal cavity to the nasopharynx. According to the German statistical Institute (Statistisches Bundesamt), the incidence in Germany in 2018 reached 2.74 in 10,000 live births. It can present unilaterally or bilaterally. As newborns are obligate nasal breathers, management of bilateral atresia has to be performed early after birth. As for unilateral atresia, the optimal age for treatment was determined to be between 6 and 12 months in a recently published consensus. OBJECTIVE: The main purpose of this study is to characterize the patients treated for choanal atresia in the Department of Otorhinolaryngology and Head and Neck Surgery at a tertiary hospital in the south of Germany and, based in the demographic characteristics as well as intra- and post-operative treatment, to identify factors for success or failure of the surgery. A secondary goal was to describe the complications in the use of stents and analyse its influence in the results. MATERIAL AND METHODS: The cohort-based observational study included 29 patients, with a minimum follow up of one year, who underwent surgical endoscopic correction of both unilateral and bilateral choanal atresia from 2003 to 2020. Analysis of the demographics, intraoperative, and postoperative treatment, and their results, was performed. Multinomial logistic regression was applied for categorical values. Comparisons were performed using Fischer/chi-square test where applicable. A significance level of 0.05 was reached. RESULTS: The population was comprised of 34.5% male and 65.5% female patients. The age varied from 2 days to 20 years old, with a mean of 4.98 years and Standard Deviation (SD) 6.88. The weight of the patients varied between 1.4 kg and 85.0 kg, with a mean of 19.36 and SD 22.58. Unilateral choanal atresia was present in 58.6%, and bilateral in 41.4%. Out of this population, 48.3% presented with associated malformations. The number of procedures per patient performed in general anesthesia varied from 1 to 9, with a mean of 2.52 and SD of 2.23: statistically higher for patients presenting with bilateral atresia with a p value of 0.001*. 20 patients had a tube (Vygon, France) placed at first surgery. In 5 patients, a drug-eluting stent (Propel mini (R); Intersect ENT, USA) was applied intraoperatively, without complications. In unilateral choanal atresia, surgical and functional success was attained in 88.2% of the cases. In bilateral cases, it reached 75%. We observed a strong linear relationship between the weight of the patient and the size of the choana perioperatively: R quadrat 0.596, which may be a determinant factor in the wound healing. Weight, age, and concomitant pathology achieved statistical significance in the logistic regression model (p respectively 0.001*, 0.001* and 0.010*), which shows its influence in the result of the surgery. In particular, weight inferior to 3 kg (p 0.001*, chi-square test) at the time of the first surgery is a determinant demographic factor for need of revision in order to achieve patency. There were no major complications associated with the use of a stent, besides its dislodgement. We could not infer an implication of its use on the success of the surgery in the present cohort. LIMITATIONS: for this study were the small size of the cohort and non-standardized records for some variables. CONCLUSIONS: Younger patients presenting with low weight and concomitant pathology have worse results after surgical endoscopic treatment of choanal atresia, revealing these characteristics to be determinant for success. The size of the neochoana is related to the weight of the patient, which is a limiting factor. In particular, patients under 3 kg had to undergo more procedures in order to achieve patency. The implication of the use of locally applied medication needs to be further studied.