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BackgroundCognitive impairment is common in people with neurological diseases and severely affects their social and professional life. It has been shown that intensive and personalized cognitive rehabilitation (CR), based on working memory exercises, leads to improved cognitive status of healthy and cognitive-impaired subjects. New technologies would help to promote accessible, at-home, and self-managed CR interventions. ObjectiveThe aim of this paper is to describe the design of Cognitive Training Kit (COGNI-TRAcK), an app for mobile devices, to self-administer an at-home, intensive, and personalized CR intervention based on working memory exercises, and test its disposability-to-use (usability, motivation to use, compliance to treatment) on cognitive-impaired patients with multiple sclerosis (MS). MethodsCOGNI-TRAcK includes user-friendly interfaces for personal data input and management and for CR intervention configurations. Inner routines automatically implement adaptive working load algorithms and allow data processing and analysis. A dedicated team developed COGNI-TRAcK with C# programming language, by using the platform Xamarin Studio 4.0.10 for Android (API level 15 and following). Three exercises based on working memory are now available. To assess the disposability-to-use of the system, patients with MS were selected as likely users due to the young age of disease onset. Cognitive-impaired patients with MS (N=16) with a mean age of 49.06 years (SD 9.10) and a mean score of 3.75 (SD 1.92) on the Expanded Disability Status Scale (EDSS) were submitted to an 8-week at-home intervention administered by the app. The intervention consisted of 5 daily scheduled 30-minute sessions per week. Disposability-to-use of COGNI-TRAcK was investigated by means of a questionnaire administered to patients at the end of the training. ResultsThe adherence to the treatment was 84% (33.4/40). Of the patients with MS, 94% (15/16) understood the instructions given, 100% (16/16) felt independent to use COGNI-TRAcK at home, 75% (12/16) found the exercises interesting, and 81% (13/16) found the exercises useful and were motivated to use the app again. Moreover, during the exercises, patients with MS were highly motivated to perform well (mean score 3.19/4, SE 0.16), experienced rather low levels of stress (mean score 2.19/4, SE 0.26), were not bored (mean score 1.81/4, SE 0.30), and felt amusement (mean score 2.25/4, SE 0.23). ConclusionsAs COGNI-TRAcK is highly usable, motivating, and well-accepted by patients with MS, its effectiveness can now be investigated. To improve COGNI-TRAcK, new releases should contain more working memory exercises, have enhanced perceived amusement, and promote Internet communication procedures for data transfer and fostering remote control of the intervention.

Background: There is limited epidemiological evidence on outcomes associated with dupilumab exposure during pregnancy; monitoring pregnancy outcomes in large populations is required. Objective: To investigate the potential association between exposure to dupilumab in pregnant women with atopic dermatitis and any adverse pregnancy, neonatal, congenital and post‐partum outcomes. Methods: We performed a multicentre retrospective cohort study across 19 Italian tertiary referral hospital. Childbearing women were eligible if aged 18–49 years and carried out the pregnancy between 1 October 2018 and 1 September 2022. Results: We retrospectively screened records of 5062 patients receiving dupilumab regardless of age and gender, identifying 951 female atopic dermatitis patients of childbearing age, 29 of whom had been exposed to the drug during pregnancy (3%). The median duration of dupilumab treatment prior to conception was 22.5 weeks (range: 3–118). The median time of exposure to the drug during pregnancy was 6 weeks (range: 2–24). All the documented pregnancies were unplanned, and the drug was discontinued in all cases once pregnancy status was reported. The comparison of the study cohort and the control group found no significant drug‐associated risk for adverse pregnancy, congenital, neonatal or post‐partum outcomes. The absence of a statistically significant effect of exposure on the event was confirmed by bivariate analysis and multivariate analysis adjusted for other confounding factors. Conclusions: This cohort of pregnant patients exposed to dupilumab adds to the existing evidence concerning the safety of biologic agents in pregnancy. No safety issues were identified regarding the primary outcome assessed. In clinical practice, these data provide reassurance in case of dupilumab exposure during the first trimester. However, the continuous use of dupilumab throughout pregnancy warrants further research. [ABSTRACT FROM AUTHOR]

Background Managing a pregnant patient with chronic spontaneous urticaria (CSU) is often challenging. Recent data have shown that most CSU treatments in pregnant patients are second-generation H1 antihistamines (sgAHs), while data on the safety of omalizumab are scant. Objectives To evaluate, in a routine clinical practice setting, the efficacy and safety of omalizumab in patients with severe CSU refractory to sgAHs who either became pregnant during treatment or who started the drug during pregnancy. Methods We conducted a retrospective study of women aged ≥ 18 years who were pregnant, who received one or more doses of omalizumab at any time during their pregnancy or who were taking omalizumab at the time of, or in the 8 weeks before, conception. Results Twenty-nine pregnant patients were evaluated: 23 (79%) conceived a child while taking omalizumab (group A), while 6 (21%) started omalizumab treatment during pregnancy (group B). Among patients in group A, we observed 23 births (21 liveborn singletons and 1 liveborn twin pair) and 1 miscarriage. Fifteen (65%) patients discontinued omalizumab after confirming their pregnancy, while eight (35%) were exposed to omalizumab during their entire pregnancy. In group B, omalizumab was introduced at a mean (SD) 10.83 (3.60) weeks' gestation and all patients were exposed to it until the end of pregnancy. In this group, there were seven liveborn infants (five singletons and one twin pair). No adverse events, pregnancy complications or congenital anomalies in newborns were recorded in either group. Conclusions Omalizumab for CSU treatment before and during pregnancy does not appear to have negative effects on maternal or fetal outcomes. [ABSTRACT FROM AUTHOR]

Microbiome dysbiosis and cytokine alternations are key features of atopic dermatitis (AD) and psoriasis (PsO), two of the most prevalent and burdensome pruritic skin conditions worldwide. Interleukin (IL)-33 and IL-31 have been recognized to be major players who act synergistically in the pathogenesis and maintenance of different chronic inflammatory conditions and pruritic skin disorders, including AD and PsO, and their potential role as therapeutic targets is being thoroughly investigated. The bidirectional interplay between dysbiosis and immunological changes has been extensively studied, but there is still debate regarding which of these two factors is the actual causative culprit behind the aetiopathological process that ultimately leads to AD and PsO. We conducted a literature review on the Pubmed database assessing articles of immunology, dermatology, microbiology and allergology with the aim to strengthen the hypothesis that dysbiosis is at the origin of the IL-33/IL-31 dysregulation that contributes to the pathogenesis of AD and PsO. Finally, we discussed the therapeutic options currently in development for the treatment of these skin conditions targeting IL-31, IL-33 and/or the microbiome. [ABSTRACT FROM AUTHOR]

Long-term efficacy and safety of Dupilumab in adolescents with moderate-to-severe atopic dermatitis: results through week 52 from a phase III open-label extension trial (LIBERTY AD PED-OLE). The mean percentage reduction of NRS itch score (mean value of 8.2 at baseline, 1.6 at week 32 and 1.3 at week 52) showed a reduction of 80.5% at week 32 and of 84.1% at week 52. Dupilumab, a fully human monoclonal antibody inhibiting signalling of both interleukin (IL)-4 and IL-13, was approved by European Medical Agency (EMA) in August 2019 for adolescents aged >=12 years with moderate-to-severe atopic dermatitis (AD) after randomized clinical trials demonstrating long-term efficacy and safety.[[1], [3]] Real-world studies, both at week 16[5] and week 32/52,[[6]] are rarely reported. [Extracted from the article]

The prevalence of asthma in Italy is estimated to be around 4%; it affects approximately 2,000,000 citizens, and up to 80–90% of patients have mild-to-moderate asthma. Despite the clinical relevance of mild-to-moderate asthma, longitudinal observational data are very limited, including data on disease progression (worsening vs. improvement), the response to treatment, and prognosis. Studies are needed to develop long-term, observational, real-life research in large cohorts. The primary outcomes of this study will be based on prospective observation and the epidemiological evolution of mild and moderate asthma. Secondary outcomes will include patient-reported outcomes, treatments over time, disease-related functional and inflammatory patterns, and environmental and life-style influences. This study, called the Mild/Moderate Asthma Network of Italy (MANI), is a research initiative launched by the Italian Respiratory Society and the Italian Society of Allergology, Asthma and Clinical Immunology. MANI is a cluster-based, real world, cross-sectional, prospective, observational cohort study that includes 20,000 patients with mild-to-moderate asthma. (ClinicalTrials.gov Identifier: NCT04796844). Despite advances in asthma care, several research gaps remain to be addressed through clinical research. This study will add important new knowledge about long-term disease history, the transferability of clinical research results to daily practice, the efficacy of currently recommended strategies, and their impact on the burden and evolution of the disease. MANI: Mild/Moderate Asthma Network of Italy SANI: Severe Asthma Network Italy GINA: Global Initiative for Asthma SABA: short acting β2-agonists ICS: inhaled corticosteroids CRF: Case Report Form [ABSTRACT FROM AUTHOR]

Gait and balance impairment is common in multiple sclerosis (MS), often leading to walking aids need. Rehabilitation is the most common and effective approach to tackle the burden of these symptoms, but less attention is given to the correct use of an assistive device for ambulation. Here, we aimed to maximise the effect of a rehabilitation program including walking aid training with a sensorized crutch in people with MS (PwMS). 24 PwMS (15 females, age=57.8±9.8 years, all EDSS=6) underwent a 20-session rehabilitation program focusing on gait, balance, and proper assistive device use. The experimental group (FB_group, N=12) used a crutch with real-time feedback based on user support load, whilst the control group (NOFB_group, N=12) used a standard crutch. Assessment included Timed 25 Foot Walk (T25FW), Timed Up and Go (TUG) and Modified Fatigue Impact Scale (MFIS). Moreover, functional Near-Infrared Spectroscopy (fNIRS) was used to investigate cortical activity during linear and curvilinear walking tasks. At baseline, no differences were found between groups concerning either clinical or neural evaluations. Following rehabilitation, we observed a reduction in fatigue perception in both groups (p=0.038). Moreover, FB_group performed better than NOFB_group in T25FW and TUG (p=0.028 and p=0.038, respectively). Further, after treatment, FB_group showed increased neural activity in areas involved in cognitive functions (Brodmann Areas-BA 9,10, p<0.01), multisensory integration and body representation (BA39, p=0.01) during both linear and curvilinear walking. Instead, NOFB_group showed increased activity in motor planning areas (BA 6,8, p<0.05). A significant difference was also found between groups in BA9 after treatment (FB_group>NOFBgroup, p=0.04). A 20-session rehabilitation period effectively reduces fatigue among PwMS. Moreover, a real-time feedback crutch seems to have a positive impact on walking ability. This might be due to a feedback-induced increased attention focusing on the assistive device, as suggested by the fNIRS results. [ABSTRACT FROM AUTHOR]