Pirometaxine™ (Narlisim™) in pediatric nasal congestion: a retrospective study.

BACKGROUND: Nasal congestion represents a troublesome health issue which is especially and invalidating in children. Effective nasal drugs, such as sympathomimetic drugs, are usually forbidden in children under 12 years of age because of their potential systemic adverse effects. Hypertonic nasal physiological solutions have recently been successfully used to decongest nasal mucosa in children: its mechanical activity has been universally recognized as safe and effective and it represents a well-established, useful treatment in children. METHODS: We have retrospectively analyzed a case series of 40 children treated for 4 days (96 hours) with a new class 1s medical device nasal hypertonic spray containing Pirometaxine™ (Narlisim™) in outpatient affected by nasal congestion due to common cold. Every child was evaluated on a 3-point symptom assessment scale (0: no symptom; 1: mild symptom; 2: moderate symptom; 3: severe symptom) at the beginning of the trial (T0) and after 48 (T1) and 96 hours (T2). The symptoms assessed were nasal obstruction, nasal secretion, headache, flash of cold, pharyngodynia, cough, and sneeze. RESULTS: The results, in terms of short-term efficacy to control nasal obstruction (T1 vs. T0: P<0.0001; T2 vs. T0: P<0.0001), nasal secretion (T1 vs. T0: P<0.0001; T2 vs. T0: P<0.0001) and all the symptoms related to common cold have supported the efficacy of this hypertonic nasal solution. No adverse events have been pointed out during the trial supporting the safety of this new nasal hypertonic approach. CONCLUSIONS: The absence of adverse events after 48-96 hours along with the short-term effectiveness of this new treatment seems to represent a new, safe option to treat children affected by nasal congestion secondary to common cold. Considering the current lack of safe treatments for children under 12 years of age, Narlisim™ can be considered as a useful short-term option to control nasal congestion in children.

A 52-week multicenter retrospective real-world study on effectiveness and safety of dupilumab in children with atopic dermatitis aged from 6 to 11 years.

Background: Dupilumab has been shown to be a safe and effective drug for the treatment of atopic dermatitis (AD) in children from 6 months to 11 years in randomized clinical trials. Aim: The aim of this real-life study was to determine the effectiveness in disease control and safety of dupilumab at W52 in moderate-to-severe AD children aged 6-11 years.Methods: All data were collected from 36 Italian dermatological or paediatric referral centres. Dupilumab was administered at label dosage with an induction dose of 300 mg on day 1 (D1), followed by 300 mg on D15 and 300 mg every 4 weeks (Q4W). Treatment effect was determined as overall disease severity, using EASI, P-NRS, S-NRS and c-DLQI at baseline, W16, W24, and W52. Ninety-six AD children diagnosed with moderate-to-severe AD and treated with dupilumab were enrolled.Results: Ninety-one (94.8%) patients completed the 52-week treatment period and were included in the study. A significant improvement in EASI score, P-NRS, S-NRS and c-DLQI was observed from baseline to weeks 16, 24 and 52.Conclusions: Our real-life data seem to confirm dupilumab effectiveness and safety in paediatric patients. Moreover, our experience highlighted that patients achieving clinical improvement at W16 preserved this condition over time.

Dupilumab Treatment in Children Aged 6-11 Years With Atopic Dermatitis: A Multicentre, Real-Life Study.

BACKGROUND: The management of paediatric atopic dermatitis (AD) is challenging, mostly relying on emollients and topical corticosteroids. Dupilumab, a fully human monoclonal antibody, has been recently approved for the treatment of children aged 6-11 years with moderate-to-severe AD not adequately controlled with topical therapies or when those therapies are not advisable. OBJECTIVES: The aim of this study was to evaluate in real life the effectiveness and safety of dupilumab in the treatment of children aged from 6 to 11 years. METHODS: Demographic and clinical data of children aged 6-11 years, affected by moderate-to-severe AD and treated with dupilumab, were retrospectively collected from 24 dermatological and paediatric referral centres. Dupilumab was administered subcutaneously at an induction dose of 300 mg on day (D) 1, followed by 300 mg on D15 and 300 mg every 4 weeks. Disease severity was assessed at baseline and after week 2 (W2), W4 and W16 of dupilumab therapy using Eczema Area Severity Index (EASI), Pruritus Numerical Rating Scale (P-NRS) and Sleep NRS (S-NRS) and Children's Dermatology Life Quality Index (c-DLQI) score. RESULTS: A total of 55 AD children (24 males [43.64%], 31 females [56.36%]; mean age 9.35 ± 1.75 years) were included. A significant improvement in EASI score, P-NRS, S-NRS and c-DLQI was observed from baseline to W16 of treatment with dupilumab. In particular, at W16 the proportion of patients achieving EASI75 was 74.54%. Moreover, at the same timepoint a significant mean percentage reduction for P-NRS, S-NRS and c-DLQI was also observed (68.39%, 70.22% and 79.03%, respectively). CONCLUSIONS: Our real-life data seem to confirm the effectiveness of dupilumab in paediatric patients on all disease aspects, including extent and severity of signs, intensity of symptoms, sleep and QoL, with a good safety profile.