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Background: Insufficient data are available on the long-term “real-life” safety profile of omalizumab in children. This study evaluated the long-term safety of omalizumab in a pediatric cohort with severe asthma or chronic spontaneous urticaria (CSU). Methods: A monocentric, prospective study evaluated the long-term safety of omalizumab in patients aged 6–18 years. Each patient completed the standardized MedDRA questionnaire to identify adverse events (AEs). Results: In total, 23 patients, median age 15 (14–18) years, affected by severe asthma (60.8%) or CSU (39.2%), treated with omalizumab for 2 (1–4) years were enrolled. The most common AEs belong to the system organ class (SOC) of general disorders and administration-site conditions (37.17%). Skin and subcutaneous tissue problems represent the second most frequently reported AEs (24.35%). Central nervous system and musculoskeletal disorders were quite frequent (15.38% and 8.97%, respectively). Other adverse events were tachycardia (5.12%), vertigo and abdominal pain (2.60% and 3.86%, respectively), and dry eye (1.3%). Only one patient reported herpes virus infection during treatment (1.3%). No cases of anaphylaxis, hemopathies, uronephropathies, respiratory, psychiatric, hepatobiliary, or oncological pathologies were reported. Conclusions: Long-term “real-life” treatment with omalizumab in children appears well tolerated. Its safety and efficacy profile makes omalizumab an excellent alternative in severe asthma and CSU in children.

BackgroundSolar urticaria represents an uncomfortable form of chronic inducible urticaria. First and second-line treatments are ineffective in some patients, leading to an impairment in their quality of life. Omalizumab represents a safe therapeutic option in case of refractory solar urticaria.Case presentationWe update a case of a 21-year-old Caucasian girl affected by solar urticaria from the age of 14. Poor disease control was achieved with standard or high-dose of H1-antihistamines. Several omalizumab courses, including a 1-year-long course, were practiced resulting in clinical remission and significant improvement in patient’s quality of life.ConclusionOur experience confirms the effectiveness and safety of omalizumab for the management of refractory solar urticaria. Future studies are awaited in order to monitor long term effects and chronic doses of this treatment, particularly in patients who need concomitant therapy with antihistamines.

Background: Italy was one of the first affected countries by coronavirus disease 2019 (COVID-19) pandemic. Public health measures like quarantine or national lockdown were adopted, with negative psychological and clinical effects on patients with chronic diseases. To investigate the impact of lockdown on patients with multiple sclerosis (MS), we developed a 36 items self-report questionnaire. Methods: Questionnaires were emailed to 120 patients with MS and 100 with chronic migraine (CM) as a control group, matched for age, sex, and education. The questionnaire was divided into five domains, evaluating concerns about 1) MS and therapy during COVID-19 pandemic, 2) personal and family caregiving, 3) working activities, 4) general and disease-related emotions during the lockdown, 5) future expectations concerning health status, social life, and working activity. Results: patients with MS had higher scores than those with CM in domains 4 and 5, investigating respectively general and disease-related emotions and future expectations (p= 0.05 and 0.02 respectively). About half of the patients with MS expressed some concern about the need to continue their therapy during the pandemic compared to people with CM (p= 0.0002). Conclusions: Covid-19 pandemic had a more negative impact on psychological status of patients with MS compared with those with CM

In recent years, the prevalence of large spectrum of gluten-related disorders (GRDs) has increased. Gluten is one of the most widely distributed components of food in both industrialized and developing countries. The main structural protein complex of wheat and its proteins are classified into albumins, salt-soluble globulins, and insoluble prolamins (gliadins and glutenins). Gluten is also included in other cereals, including rye and barley. GRDs can be classified, based on their pathogenic mechanism, into (i) Autoimmune disorders, (ii) Allergic disorders, (iii) No autoimmune, not allergic disorders. Coeliac disease (CD) is an autoimmune disorder that occurs in genetically predisposed individuals who develop an immune reaction to gluten. It affects about 1% of people in most populations. The disease primarily interests the small intestine, but it is characterized by a wide range of clinical presentations, with both intestinal and extra-intestinal symptoms. Wheat allergy (WA) is an adverse immunologic reaction to wheat proteins. In the large field of WA a further classification can be made, distinguishing IgE-dependent WA, triggered by ingestion, inhalation or cutaneous and/or mucosal contact of wheat, and IgE-non-dependent WA. Its prevalence varies depending on the age and region, from 0.4% to 4%. Urticaria and/or angioedema, and anaphylaxis with or without exercise as a trigger, appear typically during childhood, asthma and/or rhinitis (Baker’s asthma) are more common during adulthood. Non-coeliac gluten sensitivity (NCGS) is a condition in which gluten ingestion leads to one or more of a variety of immunological, morphological or symptomatic (both gastrointestinal or extra gastrointestinal) manifestations in people in whom CD has been excluded. It is supposed it’s due to an activated innate immune response.

Allergic individuals at risk for hypersensitivity reactions to measles vaccine marketed for a long time are well established. On the other hand, risk factors for hypersensitivity reactions to the new mRNA COVID-19 vaccines currently include a history of allergy, allergy to excipient of the vaccine, or hypersensitivity reactions to the first dose of COVID-19 vaccine. In the last two cases, the recipient should be assessed by an allergist before vaccination to share a decision on the choice of vaccination. Studies on skin testing accuracy and desensitization protocols to the COVID-19 vaccines and the efficacy of potential alternatives in patients with confirmed hypersensitivity reactions to the first COVID-19 vaccine are necessary to improve the safety of COVID-19 vaccines.

To highlight the current evidence on food desensitization in children with food allergy.Food Allergen Specific Immunotherapy (FA-AIT) is currently recognised as a treatment option for treating children with allergy at least to the main common foods (i.e. milk, egg and peanut). The oral route of administration has been proven to be the most effective in achieving desensitisation. Efforts are devoted to overcome the current unmet needs mainly related to safety issues and long-term efficacy, as well as adherence to the treatment and improvement of health-related quality of life. In this perspective, alternative routes of administration and adjunctive treatments are under investigation.The future of food allergy management is a personalised approach based on a shared decision-making that takes into account the needs of patients and families. Health professionals will be able to offer multiple treatment options, including FA-AIT with adjunctive or alternative therapies. Thus, patients should be correctly identified, using validated predictive factors, in order to select appropriate candidates for these therapies.

Objective Motor surround inhibition (mSI) is a physiological mechanism that contributes to hand movement control by focusing voluntary movement. Growing evidence suggests that hand movement control is impaired in multiple sclerosis. The aim of the study was to evaluate mSI in MS and to investigate the brain structures involved in mSI in multiple sclerosis. Methods We recruited 33 patients and 23 controls. To investigate mSI, we delivered transcranial magnetic single pulses during index finger flexion. Motor evoked potentials were recorded and first dorsal interosseous (“active muscle”) and from the abductor digiti minimi (“surround muscle”). mSI was expressed as the ratio between Motor evoked potentials recorded from the surround muscle during movement and at rest. Participants underwent a magnetic resonance study. Results Patients had impaired mSI as compared with controls. Magnetic resonance showed that basal ganglia had smaller volumes and higher mean diffusivity than controls. Impaired mSI correlated with primary motor cortex and basal ganglia involvement in multiple sclerosis. Conclusion Altered mSI in multiple sclerosis is related to cortical and subcortical grey matter involvement. Significance Our study provides the first demonstration of a pathophysiological mechanism underlying hand movement control dysfunction in multiple sclerosis. mSI represents a new therapeutic target of multiple sclerosis rehabilitative approaches.

Introduction: In recent years, the advent of immunotherapy has remarkably improved the management of IgE-mediated food allergy. However, some barriers still exist. Therefore, the effort of researchers aims to investigate new perspectives in the field of non-allergen specific therapy, also based on the current knowledge of the pathogenesis of this disease.Areas covered: This review aims to focus on the role of biologics as a treatment option in patients with IgE-mediated food allergy. These agents are characterized by their ability to inactivate the Th2 pro-inflammatory pathways. Biologics can be used both alone and in association with immunotherapy. Monoclonal antibodies targeting IgE, the IL-4/IL-13 axis, IL-5, and alarmins have been proposed and investigated for treating food allergy.Expert opinion: The clinical efficacy and safety of biologics have been demonstrated in several preclinical studies and randomized controlled trials. Future studies are still required to address current unmet needs, including the identification of the optimal dose to be used by ensuring the effectiveness of therapy.

In the "parallel studies" project led by Carl Rogers at the Counseling Center of the University of Chicago over 70 years ago, measures of personality organization and other clinical ratings were applied to 10 recorded and transcribed cases. This paper applied computerized measures of the referential process to the treatment by Rogers of the client known as Miss Vib. The treatment was considered successful and used by Rogers to illustrate his theory of personality, and his view of the therapeutic process. Using the DAAP system, the measures were applied to therapist and client speech at embedded levels of magnification, including measures for the treatment as a whole to be compared to other treatments in the referential process data base; measures for individual sessions to show progression across the trajectory of a treatment for comparison with the clinical ratings; and measures representing word by word variation within a session to enable close examination of the process. The initial prediction concerning the relation of the referential process measures to the clinical measures was not confirmed. Close examination of pivotal sessions provided an account of the results beyond that emphasized in the client-centered approach.

Mastocytosis, a heterogeneous mastcell disease, include three different entities: cutaneous mastocytosis, systemic mastocytosis (SM) and mast-cell sarcoma. Tryptase levels can differentiate cutaneous mastocytosis from SM. In mastocytosis, quick onset drug hypersensitivity reactions (DHRs) that are facilitated by mastcell mediators, are investigated in adults. Due to the limited number of children with mastcell disease and increased serum tryptase levels, the role of drugs in this age group is less studied. In this review, we critically assessed relevant papers related with immediate DHRs in children with mastocytosis and discuss practical issues of the management. In childhood mastocytosis, anaphylaxis is frequently idiopathic, and elevated level of basal tryptase, and high burden of disease may increase the risk. Among drugs, antibiotics, NSAIDs and opioids can potentially induce anaphylaxis, anyway avoidance should be recommended only in case of previous reactions. Moreover, vaccinations are not contraindicated in patients with mastocytosis. The risk of severe systemic reactions after drugs intake seems to be extremely low and in general lower in children than in adults. Anyway, studies on this topic especially focusing on children, are missing to state final recommendations.

IntroductionThe Health Assessment Questionnaire (HAQ) has been translated into many languages and it has been classified as the predictor of disability and medical costs, however, the psychometric properties of the HAQ have never been studied in a population with neurological disease. The purpose of this study was the evaluation of the psychometric properties of HAQ in a population of individuals with multiple sclerosis (MS).Materials and MethodsThis cross-sectional study was conducted with patients diagnosed with MS. The evaluation tools administered were the 36-item short form health survey (SF–36) to evaluate the health state of the patients and HAQ and to evaluate the limitations of the activities of daily living (ADL).ResultsA total of 34 patients were included in this study. Cronbach's alpha assessed the internal consistency of the HAQ, and it is equal to 0.94. The study revealed some significant correlations between the dimensions of the SF-36 and the sub-categories of the HAQ using Pearson's Correlation Coefficient. Significant correlations emerged between the demographic and clinical characteristics of patients and the subcategories of HAQ.DiscussionThe HAQ is a valid and reliable tool to assess the limitations of the activities of daily living, and it could provide for the healthcare and rehabilitation sector with an additional evaluation tool.

Food allergy is a potentially life-threatening medical condition and a significant public health concern worldwide. The current management consists of strict avoidance of the culprit food and treating any adverse reactions from unintended food ingestion. The increasing prevalence of food allergy encouraged research and clinical trials in the field of specific allergen immunotherapy (AIT) which represents an appealing approach, especially in pediatric age. AIT consists of the gradual administration of growing amounts of the offending allergen in order to induce food desensitization, which is an increase in the threshold for reactivity while continuing on regular exposure to the allergen. AIT can be administered through oral, sublingual, epicutaneous, and subcutaneous routes. Reports on oral immunotherapy (OIT) thus far have been more extensive. The desirable goal is to achieve "post desensitization effectiveness", that is the ability to introduce food without reaction even after a period of discontinuation of the offending food. Other therapeutic approaches are being studied alongside immunotherapy such as modified proteins, probiotics, Chinese herbal supplements, biologic therapies, and DNA vaccines.

IntroductionThe Jebsen Taylor Hand Function Test (JTHFT) is a non-diagnostic assessment scale for hand and upper limb dexterity that is commonly used in various countries around the world for diseases, such as muscular dystrophy, stroke, spinal cord injury, Parkinson, carpal tunnel syndrome, and rheumatoid arthritis. This study aimed to evaluate the psychometric properties of the JTHFT in Italian adults with Multiple Sclerosis (MS).Materials and MethodsThe test's internal consistency was evaluated with Cronbach's alpha, whereas its concurrent validity was evaluated by comparing the JTHFT with the Health Assessment Questionnaire (HAQ) and by calculating Pearson's correlation coefficient.ResultsThe JTHFT was administered to 29 Italians with MS. The Cronbach's alpha showed that the nondominant hand has a value of 0.76 and 0.91 for the dominant hand. Pearson's correlation coefficient showed significant correlations between JTHFT and HAQ.DiscussionThe JTHFT is a reliable tool to evaluate the functionality of the upper limb and hand in patients with MS. This tool is useful for testing the effectiveness of a treatment in various diseases. The results obtained in this study are coherent with previous studies that are conducted in populations with different diseases. In particular, the correlation between JTHFT and HAQ showed that a disability related to the upper limbs can often have repercussions, not only on activities of daily living, but also on walking. Based on this correlation, the motor deficits that emerged may be linked to a brain marrow disease rather than a spinal disease, even if an essential deepening can confirm this hypothesis.

Background The disease-modifying therapies (DMTs) largely used in multiple sclerosis (MS) may result in higher infectious risk. Objective We aimed to investigate the infectious risk in DMT-treated MS patients. Methods MS patients were evaluated for infectious risk before starting, switching or during DMT. Results In this three-year observational cohort study 174 MS patients were enrolled. Among them, 18 patients were anti-HBc + and 19 patients were QuantiFERON®-TB Gold In-Tube (QFT) + . No patients with anti-HBc + showed a detectable HBV-DNA and all started DMT. Among QTB + patients, 17 latent TB infections (LTBIs) and 2 active TB infections (TBIs) were identified. After one month of LTBI prophylaxis or TB treatment, respectively, all patients started DMTs. Overall, 149 started DMTs. During DMTs, one ocrelizumab-treated patient with anti-HBc + developed HBV reactivation and six patients (3 on natalizumab, 2 on ocrelizumab and 1 on IFN-β) showed reactivation of HSV-1, with detectable plasma DNA. Finally, 1 cladribine-treated patient experienced VZV reactivation. All the reactivations of latent infections have been successfully treated. Conclusion Screening of infectious diseases in DMT candidate MS patients helps to mitigate the infectious risk. During DMTs, a regular assessment of infectious risk allows to avoid discontinuing MS therapy and guarantees a higher degree of safety.

The original version of this article unfortunately contained a mistake. The given and family names of authors were Interchanged except the following author Maria Chiara Buscarinu, Carolina Gabri Nicoletti, Alessandra Girolama Marfia and Antonio Gallo.

Secondary progressive multiple sclerosis (SPMS) subtype is retrospectively diagnosed, and biomarkers of the SPMS are not available. We aimed to identify possible neurophysiological markers exploring grey matter structures that could be used in clinical practice to better identify SPMS. Fifty-five people with MS and 31 healthy controls underwent a transcranial magnetic stimulation protocol to test intracortical interneuron excitability in the primary motor cortex and somatosensory temporal discrimination threshold (STDT) to test sensory function encoded in cortical and deep grey matter nuclei. A logistic regression model was used to identify a combined neurophysiological index associated with the SP subtype. We observed that short intracortical inhibition (SICI) and STDT were the only variables that differentiated the RR from the SP subtype. The logistic regression model provided a formula to compute the probability of a subject being assigned to an SP subtype based on age and combined SICI and STDT values. While only STDT correlated with disability level at baseline evaluation, both SICI and STDT were associated with disability at follow-up. SICI and STDT abnormalities reflect age-dependent grey matter neurodegenerative processes that likely play a role in SPMS pathophysiology and may represent easily accessible neurophysiological biomarkers for the SPMS subtype.

The COVID-19 pandemic has surprised the entire population. The world has had to face an unprecedented pandemic. Only, Spanish flu had similar disastrous consequences. As a result, drastic measures (lockdown) have been adopted worldwide. Healthcare service has been overwhelmed by the extraordinary influx of patients, often requiring high intensity of care. Mortality has been associated with severe comorbidities, including chronic diseases. Patients with frailty were, therefore, the victim of the SARS-COV-2 infection. Allergy and asthma are the most prevalent chronic disorders in children and adolescents, so they need careful attention and, if necessary, an adaptation of their regular treatment plans. Fortunately, at present, young people are less suffering from COVID-19, both as incidence and severity. However, any age, including infancy, could be affected by the pandemic.Based on this background, the Italian Society of Pediatric Allergy and Immunology has felt it necessary to provide a Consensus Statement. This expert panel consensus document offers a rationale to help guide decision-making in the management of children and adolescents with allergic or immunologic diseases.

Thyroid cancer (TC) in childhood is a rare disease characterized by an excellent prognosis. Thyroid nodules in children, although less common than in adults, have a greater risk of malignancies, particularly in those cases associated with anamnestic, clinical and ultrasonographic risk factors. Among the factors, which have been found to be linked with an increased relative risk of TC in children, an important role seems to be possibly played by an underlying nodular Hashimoto’s thyroiditis (HT) and by the serum levels of TSH. Aim of this Commentary was to specifically address this last point. According to the available pediatric literature on the relationships between these risk factors and phenotypical expression of TC in children, it is possible to conclude that: 1) It is not completely clarified if HT per se predisposes to malignancy or if it represents an incidental histologic finding in cases with TC or if it may be the result of an immune response against tumoral cells. 2) It is unclear whether phenotypic expression of TC is more severe in the cases with associated HT but normal TSH serum levels. 3) Persistently elevated TSH levels play an independent role as predictors of the likelihood of TC, especially in children but also in adults. 4) Patients with nodular HT and subclinical hypothyroidism need to be treated with Levothyroxine in order to prevent the development of both TC and severe thyroid dysfunctions.

Along with the anamnesis and clinical evaluation, diagnostic tests are one of the mainstream key points in the evaluation and management of drug hypersensitivity reactions (DHR). A wide knowledge gap, both in diagnosis and management of pediatric DHR, must be filled. Only a few published studies evaluated sensitivity and specificity of skin and in vitro tests in children. However, selected case series show that diagnostic work-up for adults could be useful, with some limitations, in pediatric age. Indeed, despite improvement in in vivo and in vitro diagnosis, drug provocation test remains the gold standard in pediatric age, too. Unmet needs in children include multi-centric studies on incidence of DHR, utility and feasibility of in vivo and in vitro diagnostic tests and specifically dedicated guidelines for the diagnosis and management of DHR in children. (www.actabiomedica.it)

The cause of chronic urticaria remains often elusive. The association between chronic urticaria and intake of medications have been reported in children. However, the causative role of drugs has been rarely ascertained by onset of symptoms on drug provocation test. Chronic urticaria can be mediated by immunologic and nonimmunologic mechanisms. The diagnostic work-up of chronic urticaria includes a comprehensive evaluation of triggering factors such as drugs. A diagnosis is necessary in order to permit a safely administration of drugs in children with chronic urticaria. (www.actabiomedica.it)

Anaphylaxis represents one of the most frequent medical emergencies in childhood. However, as compared to adults, drugs are less common triggers of anaphylaxis in children, with a frequency which is increasing from infancy to adolescence. Deaths seldom occur, maybe because of the paucity of comorbidities in children. Antibiotics and non-steroidal anti-inflammatory drugs (NSAIDs) are the main elicitors in drug-induced anaphylaxis in children. Both immune-mediated (mainly IgE-mediated) and non immune-mediated may be involved. IgG-mediated and complement-mediated mechanisms has been also hypothesized. Correct management relies on a right diagnosis and prompt therapy. A proper work-up is also important to prevent further potentially fatal re-exposures to the same drug or other structurally similar molecules but also unnecessary avoidance of medications not representing the culprit of the episode. (www.actabiomedica.it)

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) is a severe reaction to drugs. Incidence of DRESS in children is not well known and the mortality rate seems to be lower than 10%. Anticonvulsants are the main drugs involved both in adults and in children. The treatment of choice is intravenous immunoglobulins and corticosteroids used in synergy. Today there are not controlled clinical trials regarding DRESS treatment in children. Anyway, the prompt withdrawn of the offending drug is of paramount importance for a better prognosis. DRESS sequels may occur, consequently, follow-up visits are required at least until the first year after the reaction. (www.actabiomedica.it)

Adverse reactions to drugs are not frequent in childhood. Cutaneous reactions are the most frequent in this age group. Mild cutaneous reactions are immediate or delayed adverse reactions that do not seriously compromise the clinical condition of children. The patients usually early improve and recover the state of health. Although it is difficult to define the prevalence accurately, we could affirm that the rate adverse reaction to drugs are often over estimated by both the families and the physicians. Therefore, children may be prone to loss of school days and inappropriate or sub-optimal treatments. However, the identification of a true adverse reaction to drugs allows adequate treatment and alert to further exposure to harmful drugs. (www.actabiomedica.it)