Dupilumab in the treatment of severe uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP): A multicentric observational Phase IV real-life study (DUPIREAL).

BACKGROUND: Chronic rhinosinusitis with nasal polyps (CRSwNP) is associated with significant morbidity and reduced health-related quality of life. Findings from clinical trials have demonstrated the effectiveness of dupilumab in CRSwNP, although real-world evidence is still limited. METHODS: This Phase IV real-life, observational, multicenter study assessed the effectiveness and safety of dupilumab in patients with severe uncontrolled CRSwNP (n = 648) over the first year of treatment. We collected data at baseline and after 1, 3, 6, 9, and 12 months of follow-up. We focused on nasal polyps score (NPS), symptoms, and olfactory function. We stratified outcomes by comorbidities, previous surgery, and adherence to intranasal corticosteroids, and examined the success rates based on current guidelines, as well as potential predictors of response at each timepoint. RESULTS: We observed a significant decrease in NPS from a median value of 6 (IQR 5-6) at baseline to 1.0 (IQR 0.0-2.0) at 12 months (p < .001), and a significant decrease in Sino-Nasal Outcomes Test-22 (SNOT-22) from a median score of 58 (IQR 49-70) at baseline to 11 (IQR 6-21; p < .001) at 12 months. Sniffin' Sticks scores showed a significant increase over 12 months (p < .001) compared to baseline. The results were unaffected by concomitant diseases, number of previous surgeries, and adherence to topical steroids, except for minor differences in rapidity of action. An excellent-moderate response was observed in 96.9% of patients at 12 months based on EPOS 2020 criteria. CONCLUSIONS: Our findings from this large-scale real-life study support the effectiveness of dupilumab as an add-on therapy in patients with severe uncontrolled CRSwNP in reducing polyp size and improving the quality of life, severity of symptoms, nasal congestion, and smell.

Interactive music as a treatment for pain and stress in children during venipuncture: a randomized prospective study.

OBJECTIVE: The experience of venipuncture is seen by children as one of the most fearful experiences during hospitalization. Children experience anxiety both before and during the procedure. Therefore, any intervention aiming to prevent or reduce distress should focus on the entire experience of the procedure, including waiting, actual preparation, and conclusion. This study was designed to determine whether the presence of musicians, who had attended specific training to work in medical settings, could reduce distress and pain in children undergoing blood tests. METHODS: Our sample population was composed of 108 unpremedicated children (4-13 years of age) undergoing blood tests. They were randomly assigned to a music group (n=54), in which the child underwent the procedure while interacting with the musicians in the presence of a parent or to a control group (n=54), in which only the parent provided support to the child during the procedure. The distress experienced by the child before, during and after the blood test was assessed with the Amended Form of the Observation Scale of Behavioral Distress, and pain experience with FACES scale (Wong Baker Scale) only after the venipuncture. RESULTS: Our results show that distress and pain intensity was significantly lower (p<.001; p<.05) in the music group compared with the control group before, during, and after blood sampling. CONCLUSIONS: This controlled study demonstrates that songs and music, performed by "professional" musicians, have a beneficial effect in reducing distress before, during, and after blood tests. This study shows, moreover, that the presence of musicians has a minor, but yet significant, effect on pain due to needle insertion.