Effectiveness and safety of biologics in pediatric inflammatory bowel disease: Real-life data from the Sicilian Network

ABSTRACT Introduction. The incidence and prevalence of pediatric inflammatory bowel disease (IBD) are rising worldwide, with a steep increase in children under 5 years of age. Compared to adult IBD, pediatric IBD presents with a more severe, aggressive phenotype and unique complications, notably growth impairment. The advent of anti–tumor necrosis factor (TNF) α agents has radically modified the management and disease course of IBD, resulting in greater remission and mucosal healing rates, fewer surgeries and hospitalizations, improved quality of life, and, notably for children, correction of growth failure, all while limiting drug toxicities. Objective: The aim of the study was to describe real-world experience with biologics, focusing on their effectiveness and safety, in pediatric IBD patients. Material and methods: Statistical analyses of the multicenter registry data from the Sicilian Network for Inflammatory Bowel Disease (SN-IBD) were performed for patients receiving biologics, with at least a follow up period of 26 weeks. The study population consisted of 93 children, divided into the study groups separately: 87 children (63CD, 24 UC) aged 7-17 years and 6 children (1 CD, 3 UC, 2 IC) who received biologics before the age of 7. Clinical benefit and safety were evaluated for each biologic agent used (Infliximab — IFX, Adalimumab — ADA, Golimumab — GOL). Results and conclusion: The research focused on 101 biologic treatments performed in the group 7—17 years children (63 Crohn’s disease [CD], 24 Ulcerative colitis [UC]), who received, 74 biologic treatments for CD, evaluated at 26, 52 and 104 weeks, that showed clinical benefit rates of 84.2%, 93.3%, and 66.7% with IFX (n = 38), and 88.9%, 84.4%, 65.2% with ADA (n= 36). Biologic treatments (n = 27) evaluated in the UC group at 26, 52, 104 weeks, led to clinical benefit rates of 85.7%, 83.3%, 50% in IFX subgroup (n = 21) and 40%, 50%, 33% in the ADA subgroup (n = 5), respectively. One patient treated with GOL showed 100% clinical benefit at 26 and 52 weeks. Overall adverse events (AEs) rate in this group of children was 9.25%. Effects of other 8 biologic treatments were studied in six younger children, aged < 6 years, (4 ADA, 4 IFX), who presented a clinical remission rate of 75% at 12 weeks and 25% at 52 weeks. AEs rate was 25% in this group. Conclusion: Our data show that biologic therapy in children, even at a younger age, is effective in allowing long-term remission with a good safety profile

Laser treatment of 13 benign oral vascular lesions by three different surgical techniques

Objectives: Benign Oral Vascular Lesions (BOVLs) are a group of vascular diseases characterized by congenital, inflammatory or neoplastic vascular dilations clinically evidenced as more or less wide masses of commonly dark bluish color. If traumatized BOVLs are characterized by a great risk of hemorrhage and their treatment usually requires great caution to prevent massive bleeding. In the last decades lasers have dramatically changed the way of treatment of BOVLs permitting the application of even peculiar techniques that gave interesting advantages in their management reducing hemorrhage risks. The aim of this study was to evaluate the capabilities and disadvantages of three laser assisted techniques in the management of BOVLs. Study design: In this study 13 BOVLs were treated by three different laser techniques: the traditional excisional biopsy (EB), and two less invasive techniques, the transmucosal thermocoagulation (TMT) and the intralesional photocoagulation (ILP). Two different laser devices were adopted in the study: a KTP laser (DEKA, Florence, Italy, 532nm) and a GaAlAs laser (Laser Innovation, Castelgandolfo, Italy, 808nm) selected since their great effectiveness on hemoglobin. Results: In each case, lasers permitted safe treatments of BOVLs without hemorrhages, both during the intervention and in the post-operative period. The minimally invasive techniques (TMT and ILP) permitted even the safe resolution of big lesions without tissue loss. Conclusions: Laser devices confirm to be the gold standard in BOVLs treatment, permitting even the introduction of minimal invasive surgery principles and reducing the risks of hemorrhage typical of these neoplasms. As usual in laser surgery, it is necessary a clear knowledge of the devices and of the laser-tissue interaction to optimize the results reducing risks and disadvantages

Evaluation of wound healing and postoperative pain after oral mucosa laser biopsy with the aid of compound with chlorhexidine and sodium hyaluronate: a randomized double blind clinical trial

OBJECTIVES: The aim of this study is to evaluate secondary intention healing process and postoperative pain of oral soft tissues after laser surgery with the use of a compound containing chlorhexidine and sodium hyaluronate. MATERIALS AND METHODS: This double-blind, randomized clinical study included 56 patients affected by benign oral lesions and subjected to excisional biopsy with diode laser and randomly divided into three groups. Study group (SG) received 0.2% chlorhexidine digluconate and 0.2% sodium hyaluronate treatment; control group (CG) received 0.2% chlorhexidine digluconate; and placebo group (PG) followed the same protocol, taking a neutral solution having the same organoleptic characteristics. Wound healing was evaluated using percentage healing index (PHI). Numeric rating scale (NRS) was used to evaluate postoperative pain. RESULTS: PHI (T1 = 7 days) was 67.25% for SG, 58.67% for CG, and 54.55% for PG. PHI (T2 = 14 days) was 94.35% for SG, 77.79% for CG, and 78.98% for PG. A statistically significant difference was between the groups for PHI at T2 p = 0.001. No difference was detectable for pain index. CONCLUSIONS: A solution containing sodium hyaluronate and chlorhexidine is a good support to increase wound healing by secondary intention after laser biopsy, but no differences were in postoperative perception of pain. CLINICAL RELEVANCE: The use of the tested solution can be recommended after laser oral biopsies, to achieve a healing without suture. About the postoperative pain, the compound has not showed the same results and did not have measurable effects

Wildlife Disease Monitoring:Methods and Perspectives

In the last few decades, scientific interest in wildlife diseases has steadily grown and has recently been boosted by the SARS-CoV-2 pandemic, which highlighted that the health of humans, livestock, wildlife and, ultimately, of the whole environment is inextricably linked [...

Job satisfaction and turnover intention among people with disabilities working in Special Employment Centers: The moderation effect of organizational commitment

With the goal of contributing to the growth of research on people with disabilities in employment, in particular in relation to their job satisfaction (JS), organizational commitment (OC) and turnover intention (TI), this study explores the effect of job satisfaction on turnover intention among employees with disabilities, and the moderation effect of organizational commitment and its four dimensions on this main relationship. A total of 245 Special Employment Center (SECs) employees in Spain answered a questionnaire. To analyze the results a descriptive analysis with bivariate correlations across the variables was performed, and the moderation model was tested subsequently using macro PROCESS for SPSS by Hayes. For the significant effects, a pick-a-point approximation was used to interpret the results. The results show that organizational commitment and its dimensions have no significant effect on the direct relationship. However, some components of job satisfaction, such as the relationship with co-workers and with supervisors, play a significant role in the relationship with turnover intention when moderated by affective and value commitment. Our results show that it is important that human resources departments create conditions favoring a work environment with positive interpersonal relationships between employees and managers in order to minimize turnover intention at SECs

Frequent detection of high human papillomavirus DNA loads in oral potentially malignant disorders

Human papillomavirus (HPV) is estimated to be the cause of 40-80% of the squamous cell carcinoma of the oropharynx but only of a small fraction of the oral cavity cancers. The prevalence of oral HPV infection has significantly increased in the last decade, raising concerns about the HPV role in progression of oral potentially malignant disorders (OPMD) toward squamous cell carcinomas. We sought to study HPV infection in patients with oral lesions, and in control individuals, using non-invasive and site-specific oral brushing and sensitive molecular methods. HPV DNA positivity and viral loads were evaluated in relation to patient data and clinical diagnosis. We enrolled 116 individuals attending Dental Clinics: 62 patients with benign oral lesions (e.g. fibromas, papillomatosis, ulcers) or OPMD (e.g. lichen, leukoplakia) and 54 controls. Oral cells were collected with Cytobrush and HPV-DNA detected with quantitative real-time PCR (qPCR) for the more common high-risk (HR) and low-risk (LR) genotypes. HPV detection rate, percentage of HR HPVs and HPV-DNA loads (namely HPV16 and in particular, HPV18) were significantly higher in patients than in controls. Lichen planus cases had the highest HPV positive rate (75.0%), hairy leukoplakia the lowest (33.3%). This study detected unexpectedly high rates of HPV infection in cells of the oral mucosa. The elevated HR HPV loads found in OPMD suggest the effectiveness of qPCR in testing oral lesions. Prospective studies are needed to establish whether elevated viral loads represent a clinically useful marker of the risk of malignant progression

The Agent is Right: When Motor Embodied Cognition is Space-Dependent

The role of embodied mechanisms in processing sentences endowed with a first person perspective is now widely accepted. However, whether embodied sentence processing within a third person perspective would also have motor behavioral significance remains unknown. Here, we developed a novel version of the Action-sentence Compatibility Effect (ACE) in which participants were asked to perform a movement compatible or not with the direction embedded in a sentence having a first person (Experiment 1: You gave a pizza to Louis) or third person perspective (Experiment 2: Lea gave a pizza to Louis). Results indicate that shifting perspective from first to third person was sufficient to prevent motor embodied mechanisms, abolishing the ACE. Critically, ACE was restored in Experiment 3 by adding a virtual “body” that allowed participants to know “where” to put themselves in space when taking the third person perspective, thus demonstrating that motor embodied processes are space-dependent. A fourth, control experiment, by dissociating motor response from the transfer verb's direction, supported the conclusion that perspective-taking may induce significant ACE only when coupled with the adequate sentence-response mapping

Clinical effectiveness of the START (STrAtegies for RelaTives) psychological intervention for family carers and the effects on the cost of care for people with dementia: 6-year follow-up of a randomised controlled trial

Background: The START (STrAtegies for RelaTives) intervention reduced depressive and anxiety symptoms of family carers of relatives with dementia at home over 2 years and was cost-effective. Aims:To assess the clinical effectiveness over 6 years and the impact on costs and care home admission. Method: We conducted a randomised, parallel group, superiority trial recruiting from 4 November 2009 to 8 June 2011 with 6-year follow-up (trial registration: ISCTRN 70017938). A total of 260 self-identified family carers of people with dementia were randomised 2:1 to START, an eight-session manual-based coping intervention delivered by supervised psychology graduates, or to treatment as usual (TAU). The primary outcome was affective symptoms (Hospital Anxiety and Depression Scale, total score (HADS-T)). Secondary outcomes included patient and carer service costs and care home admission. Results: In total, 222 (85.4%) of 173 carers randomised to START and 87 to TAU were included in the 6-year clinical efficacy analysis. Over 72 months, compared with TAU, the intervention group had improved scores on HADS-T (adjusted mean difference −2.00 points, 95% CI −3.38 to −0.63). Patient-related costs (START versus TAU, respectively: median £5759 v. £16 964 in the final year; P = 0.07) and carer-related costs (median £377 v. £274 in the final year) were not significantly different between groups nor were group differences in time until care home (intensity ratio START:TAU was 0.88, 95% CI 0.58–1.35). Conclusions: START is clinically effective and this effect lasts for 6 years without increasing costs. This is the first intervention with such a long-term clinical and possible economic benefit and has potential to make a difference to individual carers