Dupilumab induces a rapid decrease of pruritus in adolescents: A pilot real-life study.
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ABSTRACT:
SUBMITTER: Mastorino L
PROVIDER: S-EPMC9286471 | biostudies-literature | 2021 Nov
REPOSITORIES: biostudies-literature
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Dupilumab induces a rapid decrease of pruritus in adolescents: A pilot real-life study.
Mastorino Luca L Viola Riccardo R Panzone Michele M Avallone Gianluca G Gallo Giuseppe G Ortoncelli Michela M Cavaliere Giovanni G Quaglino Pietro P Ribero Simone S
Dermatologic therapy 20210902 6
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Project description:Epidermolysis bullosa pruriginosa (EBP) is a form of dystrophic EB associated with severe pruritus and has skewed Th2 inflammation. Our study suggests that JAK inhibitors may offer superior efficacy compared to dupilumab in treating EBP. Moreover, JAK inhibitors downregulate JAK-STAT signalling and Th1/2 cell differentiation in lesional skin while not in peripheral blood.
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Project description:Alopecia areata (AA) is nonscarring hair loss characterized by Th1 and concomitant Th2 skewing, particularly in atopic patients. Despite novel developments for adult AA, safe and effective treatments for pediatric patients remain limited. Dupilumab, with a well-studied safety profile, may have therapeutic potential for atopic pediatric AA. To evaluate the ability of dupilumab to regrow hair in pediatric AA patients. We conducted a single-center, retrospective, observational study to evaluate hair regrowth [using Severity of Alopecia Tool (SALT)] with dupilumab in 20 children with both AD and AA (age range 5-16 years, mean 10.8 years; baseline SALT range 3-100, mean 54.4). Patient demographics, atopic history, IgE and SALT scores were collected at 12wk follow-up visits, up to > 72wks, to evaluate hair regrowth. Spearman correlations with clinical data were performed. Patients showed clinical improvement over the follow-up period (range 24 to > 72wks, mean 67.6wks) with significant mean(± SD) reduction in SALT at 48wks versus baseline [20.4(± 35.1) vs 54.4(± 37.6), respectively; p < 0.01] and continued improvement up to > 72wks [2.2(± 4.9), p < 0.01]. Baseline SALT positively correlated with disease duration (r = 0.54, p < 0.01), and negatively correlated with improvement in SALT at weeks 24, 36, and 48 (|r|≥ 0.65, p < 0.01 for all comparisons). Baseline IgE positively correlated with improvement in SALT at week 36 (r > 0.60, p < 0.05). Dupilumab was well-tolerated, with no new safety concerns. These real-world data support the utility of dupilumab to safely treat pediatric AA patients, corroborating the role of Th2 skewing in children with AA and associated atopy, warranting larger clinical trials.
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Project description:BackgroundDupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin-4 and interleukin-13, key and central drivers of type 2 inflammation. In clinical studies, dupilumab reduced the risk of severe asthma exacerbations, and improved forced expiratory volume in 1 s and quality of life in patients with uncontrolled moderate-to-severe asthma.ObjectivesThe objectives of RAPID (NCT04287621) are to characterize patients with asthma initiating dupilumab in routine clinical practice and to collect information on long-term effectiveness and safety in these patients.MethodsRAPID is a global, prospective, observational registry that will enroll approximately 1000 patients (aged ≥ 12 years) with asthma from 150 sites globally. Dupilumab treatment will be initiated in routine clinical practice according to country-specific prescribing information, per physician discretion as part of routine care. Patients will be followed prospectively for up to 3 years, with postbaseline assessments at months 1 and 3, and every 3 months thereafter.Planned outcomesBaseline data collected will include patient demographics, disease characteristics, and medication history. Patient adherence and persistence will be recorded alongside health-care resource utilization, and effectiveness of dupilumab will be assessed (clinician assessment) as per standard of care. Quality of life, asthma control, type 2 inflammatory comorbidities, work productivity, and physical activity limitation will be assessed. Incidence and severity of adverse events will be recorded.ConclusionRAPID is the first global registry to characterize patients beginning dupilumab treatment for asthma in clinical practice and will expand on prior clinical studies by providing real-world data.Clinical trial registrationClinicalTrials.gov identifier NCT04287621.
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Project description:BackgroundModerate-to-severe atopic dermatitis (AD) in the adolescence is a high burden disease, and its treatment can be very challenging due to paucity of approved systemic drugs for this age and their side-effects. Dupilumab was recently approved for treatment of adolescent AD.ObjectivesA multicentre, prospective, real-world study on the effectiveness and safety of dupilumab in adolescents (aged from ≥12 to <18 years) with moderate-to-severe AD was conducted. The main AD clinical phenotypes were also examined.MethodsData of adolescents with moderate-to-severe AD treated with dupilumab at label dosage for 16 weeks were collected. Treatment outcome was assessed by EASI, NRS itch, NRS sleep loss and CDLQI scores at baseline and after 16 weeks of treatment. The clinical scores were also evaluated according to clinical phenotypes.ResultsOne hundred and thirty-nine adolescents were enrolled in the study. Flexural eczema and head and neck eczema were the most frequent clinical phenotypes, followed by hand eczema and portrait-like dermatitis. Coexistence of more than 1 phenotype was documented in 126/139 (88.5%) adolescents. Three patients (2.1%) contracted asymptomatic SARS-CoV-2 infection and 1 of the discontinued dupilumab treatment before the target treatment period. A significant improvement in EASI, NRS itch, NRS sleep loss and CDLQI was observed after 16 weeks of treatment with dupilumab. This outcome was better than that observed in clinical trials. Dupilumab resulted effective in all AD phenotypes, especially in diffuse eczema. Twenty-eight (20.1%) patients reported adverse events, conjunctivitis and flushing being the most frequent. None of patients discontinued dupilumab due to adverse event.ConclusionsDupilumab in adolescent AD showed excellent effectiveness at week 16 with consistent improvement of all clinical scores. Moreover, dupilumab showed a good safety profile also in this COVID-19 pandemic era.
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Project description:IntroductionPatients with uncontrolled, moderate-to-severe asthma have a higher risk for exacerbations, negatively impacting lung function and quality of life. Dupilumab, a fully human monoclonal antibody, blocks interleukins 4 and 13, key and central drivers of type 2 inflammation. Dupilumab has been effective in the treatment of certain types of moderate-to-severe asthma across several clinical trials. We describe the characteristics of patients enrolled in RAPID, a global prospective registry, who initiated dupilumab (primary indication: asthma) in a real-world clinical setting.MethodsA total of 205 patients (aged ≥ 12 years) were enrolled between March 2020 and October 2021 and are included in this analysis. Data are shown as mean (SD) unless stated otherwise.ResultsPatients were aged 50.1 (17.4) years and were mostly female (65.4%) and white (74.1%). At enrollment, 24.4% reported being current/former smokers and 86.8% had moderate-to-severe asthma (Global Initiative for Asthma steps 3-5). A mean (SD) of 4.4 (6.4) severe asthma exacerbations were reported in the year before enrolling in the registry in 78 of 152 patients with available data. Patients had reduced lung function [pre-bronchodilator forced expiratory volume in 1 s (FEV1): 2.3 (1.1) L; pre-bronchodilator percent predicted FEV1: 70.3 (20.3) %] and poor asthma control [6-item Asthma Control Questionnaire: 2.4 (1.2); Asthma Quality of Life Questionnaire: 4.1 (1.3)]. The median (Q1-Q3) blood eosinophil count was 305 (200-695) cells/µL and the mean (SD) fractional exhaled nitric oxide levels were 42 (35) ppb (range: 4-186 ppb).ConclusionOur findings suggest that most patients who enrolled in RAPID and initiated dupilumab in real-world clinical settings had a high disease burden, despite receiving current standard-of-care treatment at enrollment.
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Project description:BACKGROUND:Adolescence is a challenging period, where youth face rapid changes as well as increasing socioemotional demands and threats, such as bullying and cyberbullying. Adolescent mental health and well-being can be best supported by providing effective coaching on life skills, such as coping strategies and protective factors. Interventions that take advantage of online coaching by means of chatbots, deployed on Web or mobile technology, may be a novel and more appealing way to support positive mental health for adolescents. OBJECTIVE:In this pilot study, we co-designed and conducted a formative evaluation of an online, life skills coaching, chatbot intervention, inspired by the positive technology approach, to promote mental well-being in adolescence. METHODS:We co-designed the first life skills coaching session of the CRI (for girls) and CRIS (for boys) chatbot with 20 secondary school students in a participatory design workshop. We then conducted a formative evaluation of the entire intervention-eight sessions-with a convenience sample of 21 adolescents of both genders (mean age 14.52 years). Participants engaged with the chatbot sessions over 4 weeks and filled in an anonymous user experience questionnaire at the end of each session; responses were based on a 5-point Likert scale. RESULTS:A majority of the adolescents found the intervention useful (16/21, 76%), easy to use (19/21, 90%), and innovative (17/21, 81%). Most of the participants (15/21, 71%) liked, in particular, the video cartoons provided by the chatbot in the coaching sessions. They also thought that a session should last only 5-10 minutes (14/21, 66%) and said they would recommend the intervention to a friend (20/21, 95%). CONCLUSIONS:We have presented a novel and scalable self-help intervention to deliver life skills coaching to adolescents online that is appealing to this population. This intervention can support the promotion of coping skills and mental well-being among youth.
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